How to read a tag. Only
verified counts toward a score — it means a typed connector
resolved this against a primary US federal record.
unconfirmed means the Verifier checked and could not confirm,
which very often means the source could not be queried at all rather than that
the claim is doubtful. refuted means a primary source
contradicts it. unverified means nothing has checked it yet.
FDA (US Food and Drug Administration) product code KPI covers non-implanted electrical pelvic floor / continence stimulators and is Class II (FDA device class II)
jurisdiction: US — confidence: verified — source: classification --product-code KPI --jurisdiction US → openFDA device/classification product_code=KPI. Detail: "Device class 2: Stimulator, Electrical, Non-Implantable, For Incontinence (regulation 876.5320, review panel GU)". Checked against the stated…the full checkintended_use: (treatment of stress urinary incontinence in cognitively intact adult women, home setting, by prescription, after a documented failed four-week pelvic muscle exercise trial). Residual, NOT verified: the lookup establishes what KPI is, not that this device — closed-loop EMG (electromyography)-gated, app-linked — falls inside it. Whether the EMG-gating element keeps it in KPI or triggers a second product code is an FDA pre-submission question, not a database lookup
The classification regulation for a non-implanted electrical continence device is 21 CFR (Title 21 of the Code of Federal Regulations) 876.5320, Class II
jurisdiction: US — confidence: verified — source: classification --product-code KPI --jurisdiction US → openFDA device/classification product_code=KPI, which returns regulation_number 876.5320 and device_class 2 for "Stimulator, Electrical, Non-Implantable, For Incontinence". The same record carries…the full checksubmission_type_id 1 (510(k) (premarket notification)). Note for the Scorer: 876.5320 is the intravaginal/non-implanted continence stimulator regulation; the adjacent regulation 876.5330 (product code QAJ, "Cutaneous Electrode Stimulator For Urinary Incontinence") is a different code covering skin-electrode devices — see the K183585 (an FDA 510(k) clearance number)/K223884 lines below, which sit under QAJ, not KPI. Re-verification 2026-08-23 — now confirmed against the regulation text itself, a second independent primary source:regulation 876.5320 --title 21 --expect "Class II" --jurisdiction US → verified, eCFR versioner title-21, issue 2026-08-19, section=876.5320: "§ 876.5320 Nonimplanted electrical continence device... a pair of electrodes on a plug or a pessary... inserted into the rectum or into the vagina and used to stimulate the muscles of the pelvic floor to maintain urinary or fecal continence... (b) Classification. Class II (performance standards)." The intravaginal, non-implanted, pelvic-floor-stimulation description matches this candidate's mechanism, and Class II is stated in the CFR, not merely in an openFDA field. (An --expect "incontinence" probe returns unconfirmed on a phrase miss — the section is worded "continence", not "incontinence"; that is a wording artifact, not a finding.) New wrinkle surfaced by the regulation text and run down: 876.5320 expressly "excludes... the powered vaginal muscle stimulator for therapeutic use (§ 884.5940)", which is Class III (FDA device class III) (premarket approval). regulation 884.5940 --title 21 --jurisdiction US → verified, eCFR issue 2026-08-19: that section is scoped to devices "intended and labeled for therapeutic use in increasing muscular tone and strength in the treatment of sexual dysfunction" and states "This generic type of device does not include devices used to treat urinary incontinence." So the exclusion does not capture this candidate under its stated intended_use: — the PMA (premarket approval)-adjacent regulation is carved away by indication. Recorded because it is a live class risk if the indication ever broadens beyond continence
K133826 is a 510(k) clearance held by InControl Medical for a non-implanted pelvic floor stimulator and is a usable predicate for this device
jurisdiction: US — confidence: unconfirmed — note: tag lowered from verified on 2026-08-23 by a re-verification pass that could, for the first time, read the cleared Indications for Use; see residual (b) — source: openFDA device/510k k_number=K133826 (queried through connectors.fda against the same typed…the full check endpoint the 510k subcommand uses, by k_number rather than device name). Record: device_name "INTONEMV", applicant "Incontrol Medical, LLC", product_code KPI, regulation 876.5320, device_class 2, clearance_type Special, decided 2014-01-06. Correction to frontmatter: K133826 is InToneMV specifically; InTone is a separate clearance, K150180 (Incontrol Medical, KPI, Traditional, decided 2015-03-16) — also verified, 510k "InTone" --applicant "InControl Medical" --jurisdiction US. Residual, NOT verified: (a) "usable predicate" is a regulatory judgment, not a database fact — it depends on indication and technological-characteristics comparison and is settled by FDA, not by openFDA; (b) the cleared Indications for Use has now been read, and it does not say what this candidate says.clearance-summary K133826 --expect-indication "stress urinary incontinence" --jurisdiction US → unconfirmed, source: FDA 510(k) summary K133826 (https://www.accessdata.fda.gov/cdrh_docs/pdf13/K133826.pdf). Verbatim IFU (instructions for use) (OCR artifacts as returned): "The lnToneMVV device is a nan-implanted electrical stimulator Indicated for use In the treatment of female urinary incontinence. It applies electrical stimulation to the pelvic floor musculature and surrounding structures. It Is Intended for acute and ongoing treatment of mixed urinary incontinence where the following results may improve urinary control: strengthening of pelvic floor muscles and inhibition of the detrusor muscle through reflexive mechanisms. The biofeedback feature can be used for muscle re-education purposes." The same is true of K150180 — clearance-summary K150180 --expect-indication "stress urinary incontinence" --jurisdiction US → unconfirmed, https://www.accessdata.fda.gov/cdrh_docs/pdf15/K150180.pdf:"...indicated for use in the treatment of female urinary incontinence... intended for acute and ongoing treatment of mixed urinary incontinence... InTone is intended to provide electrical stimulation and/or visual biofeedback (via manometry) for the treatment of female urinary incontinence."Why this is unconfirmed and not refuted: an IFU is free prose, and whether "treatment of female urinary incontinence / mixed urinary incontinence" still supports a stress-UI predicate claim is an FDA substantial-equivalence judgment, not a database fact — the connector says so explicitly and a human makes that call. What changed for the Scorer: the line's existence half remains fully verified (clearance, applicant, product code, regulation, class, dates — all openFDA facts, none contradicted). It is the predicate half, the load-bearing half, that is now affirmatively unsupported rather than merely unread, so the line as written ("is a usable predicate for this device") cannot stand at verified. Two specific mismatches a human should weigh: this candidate's indication is stress UI while both InControl clearances name mixed UI, and K150180's biofeedback is manometry (pressure) while this candidate's is surface EMG — a technological-characteristics difference as well as an indication one. Re-verification 2026-09-19 — replayed cold, nothing moved, tag held at unconfirmed.clearance-summary K133826 --expect-indication "stress urinary incontinence" --jurisdiction US → unconfirmed again, source: FDA 510(k) summary K133826 (https://www.accessdata.fda.gov/cdrh_docs/pdf13/K133826.pdf), returning the same verbatim IFU quoted above with the same OCR artifacts and the same connector reasoning ("this is unconfirmed rather than refuted because an IFU is free prose... whether it still supports the claimed predicate is an FDA substantial-equivalence judgment, not a database fact"). One new observation worth recording for anyone replaying this line: 510k "InToneMV" --applicant "InControl Medical" --jurisdiction US → verified but resolves to openFDA device/510k k_number=K134020 ("INTONEMV / Incontrol Medical, LLC decided 2014-02-25"), not K133826 — the device name "InToneMV" is ambiguous across the two InControl clearances (see claim 37verified), so a name-keyed lookup cannot be used to check this claim and the k_number-keyed record above remains the citation. Residual (a) and (b) stand unchanged and undiminished: "usable predicate" is an FDA substantial-equivalence judgement no connector settles, and the cleared indication says mixed urinary incontinence where this candidate's intended_use: says stress urinary incontinence
K183585 (ELITONE) is a cleared non-implanted muscle stimulator indicated for stress urinary incontinence in women
jurisdiction: US — confidence: verified — note: tag raised from unconfirmed on 2026-08-23; the indication half is now read, not inferred — source: clearance-summary K183585 --expect-indication "stress urinary incontinence" --jurisdiction US → verified, FDA 510(k) summary K183585…the full check (https://www.accessdata.fda.gov/cdrh_docs/pdf18/K183585.pdf). Verbatim Indications for Use: "ELITONE is a non-implanted muscle stimulator designed to treat stress urinary incontinence in women. It applies stimulation to the pelvic floor muscles and surrounding tissues." That is a word-for-word match to the claim as written — non-implanted muscle stimulator, stress urinary incontinence, women. Also verified: openFDA device/510k k_number=K183585. What is verified: the clearance exists — device_name "Elitone Device", applicant "Elidah, Inc.", decided 2019-02-11, Traditional 510(k), device_class 2. The previously load-bearing gap is closed: the openFDA 510(k) record carries no Indications for Use text, and the prior pass recorded the summary PDF as unreachable. That was wrong; the summary reads cleanly and is quoted above. Material correction the Scorer must still carry — and it is now confirmed against the regulation text, not just the openFDA field: this device is product_code QAJ, regulation 876.5330 — not KPI / 876.5320 as the predicate_or_analog: frontmatter groups it. regulation 876.5330 --title 21 --expect "cutaneous" --jurisdiction US → verified, eCFR versioner title-21, issue 2026-08-19: "§ 876.5330 Transcutaneous electrical continence device. (a) Identification. A transcutaneous electrical continence device consists of cutaneous electrodes that are used to apply external stimulation to reduce urinary incontinence. (b) Classification. Class II (special controls)." So the indication matches this candidate (stress UI in women) while the delivery route does not — external skin electrodes versus this candidate's intravaginal probe. That is the shape of the finding a human needs: a verified same-indication analog under a different regulation, not a predicate in this candidate's code. Note also that 876.5330 carries enumerated special controls (electrical-output characterization, biocompatibility, EMC/electrical/thermal/mechanical safety, software V&V, labeling) added at 86 FR 73971 (Dec. 29, 2021), whereas 876.5320 is a bare performance-standards Class II section
K223884 (ELITONE URGE) is a cleared device indicated for urge urinary incontinence, i.e. a separate clearance was required to extend beyond SUI (stress urinary incontinence)
jurisdiction: US — confidence: verified — source: openFDA device/510k k_number=K223884 (also the top hit for 510k "ELITONE" --jurisdiction US and 510k "ELITONE URGE" --jurisdiction US). Record: device_name "ELITONE Urge Urinary Incontinence Device", applicant "Elidah, Inc.", decided 2023-02-24, Traditional 510(k),…the full check product_code QAJ, regulation 876.5330, device_class 2. Verified: Elidah holds two distinct clearances four years apart, and FDA's own device_name on the later one names urge urinary incontinence — the submission-count half of the claim stands. Residual now closed (2026-08-23 re-verification): the inference that the earlier clearance was SUI-limited rested on K183585's Indications for Use, which is now read. clearance-summary K223884 --expect-indication "urge urinary incontinence" --jurisdiction US → verified, FDA 510(k) summary K223884 (https://www.accessdata.fda.gov/cdrh_docs/pdf22/K223884.pdf): "ELITONE Urge is a non-implanted muscle stimulator designed to treat urge urinary incontinence in women. It applies stimulation to the pelvic floor muscles and surrounding tissues." Set against K183585's "designed to treat stress urinary incontinence in women", the two IFUs are identical in wording except for the incontinence type. That is direct primary-source evidence for the claim's actual point: Elidah had to file a second 510(k) to move from stress to urge on the same hardware, so indication scope drives submission count. This is the strongest support in the file for the Generator's narrow-indication strategy, and equally the strongest evidence that broadening later costs another clearance. Still carries the same QAJ / 876.5330 correction — this is not a KPI device, and the delivery route differs (cutaneous electrodes, not intravaginal)
A device with this intended use is eligible for 510(k) clearance and does not require a De Novo (De Novo classification request) or PMA
jurisdiction: US — confidence: unconfirmed — source: denovo "<device description>" → unconfirmed: "openFDA publishes no De Novo endpoint (device/denovo.json does not exist), and this repo has no cached copy of FDA's De Novo listing... Do NOT substitute a web search." Supporting but not determinative: the KPI…the full check classification record carries submission_type_id 1 (510(k)) and multiple KPI clearances exist (K133826, K150180, K121820). That establishes the product code is a 510(k) code; it does not establish that this device with this intended use is substantially equivalent to a predicate, and the negative half of the claim ("does not require a De Novo") was not searched at all — absence of a De Novo record here is absence of a query, not evidence. Settling it needs FDA's De Novo listing cached under data/, or a human checking fda.gov, plus a pre-submission on the closed-loop EMG element. Re-verification 2026-08-23 — the PMA half of the negative is now partly addressed, the De Novo half is not. The one Class III (PMA) regulation that could plausibly capture an intravaginal electrical stimulator is 884.5940, cross-referenced as an exclusion from 876.5320. regulation 884.5940 --title 21 --jurisdiction US → verified, eCFR issue 2026-08-19: it covers stimulators "intended and labeled for therapeutic use in increasing muscular tone and strength in the treatment of sexual dysfunction", is "Class III (premarket approval)", and states outright "This generic type of device does not include devices used to treat urinary incontinence." Under this candidate's stated intended_use: (treatment of stress urinary incontinence), that PMA route is carved away by indication in the regulation text itself. This does not upgrade the claim: it addresses one named PMA regulation, not "PMA" in general, and it says nothing at all about De Novo, whose listing was never searched because data/ holds no cached FDA De Novo file (still true this pass — data/ contains only README.md). Absence of a De Novo record here remains absence of a query. Re-verification 2026-08-30 — data/fda_denovo.csv is now populated (487 records) and the De Novo half has finally been searched.denovo "intravaginal electrical stimulation EMG biofeedback urinary incontinence" --jurisdiction US → refuted: "No granted De Novo request matching '...' in the cached FDA De Novo listing (487 records). A device with no De Novo grant may still be cleared via 510(k) or approved via PMA — this refutes the De Novo route specifically, not market authorization generally." Re-ran with two narrower device descriptions ("pelvic floor electrical stimulator"; "vaginal probe electrical stimulation incontinence") — both also refuted (no match). A manual grep of the cache for "pelvic", "incontinence" and "vaginal" turns up nothing on-point (a vaginal hydrogel packing system, a vaginal panel assay, a trigger-point wand, a trichomonas assay — none an electrical stimulator). What this establishes and what it does not: the "refuted" status here answers "does a De Novo grant matching this description exist" — no — which is evidence consistent with (not proof of) the claim's assertion that De Novo is not the pathway, since it shows FDA has never had to classify a device like this through that route; it does not, by itself, prove a De Novo could never be required for this device's specific closed-loop EMG-gating element (the live pre-submission question flagged elsewhere in this claim). Tag held at unconfirmed rather than moved to either verified or refuted: the compound claim's 510(k)-eligibility half still rests on other claims, the PMA half was already addressed via 884.5940, and this new search closes the "never searched" gap on the De Novo half without being dispositive proof of "does not require one." The negative claim about this exact device is still not something a description-matching search over granted De Novos can prove outright. Re-verification 2026-09-19 — all four lookups replayed, nothing moved, tag held at unconfirmed.denovo "intravaginal electrical stimulation EMG biofeedback urinary incontinence" --jurisdiction US → refuted; denovo "pelvic floor electrical stimulator" --jurisdiction US → refuted; denovo "vaginal probe electrical stimulation incontinence" --jurisdiction US → refuted — source: local cache of FDA De Novo listing (no match). The cache has grown from 487 to 494 records since the 2026-08-30 pass and still contains no on-point electrical stimulator, so the De Novo half is searched against a larger listing and returns the same answer. classification --product-code KPI --jurisdiction US → verified, openFDA device/classification product_code=KPI: "Device class 2: Stimulator, Electrical, Non-Implantable, For Incontinence (regulation 876.5320, review panel GU)" — checked against the frontmatter intended_use: "treatment of stress urinary incontinence in cognitively intact adult women in the home setting, by prescription, following a documented failed four-week trial of pelvic muscle exercise training", which is the indication that keeps this device inside KPI rather than pushing it toward 884.5940. Residual, NOT verified, unchanged from the 2026-08-30 disposition and restated because it is the load-bearing part: a refuted De Novo search proves only that no granted De Novo matches these descriptions; it cannot prove that FDA would not require one for this device's closed-loop EMG-gating element, which is a substantial-equivalence judgement made in a pre-submission, not a database fact. The 510(k)-eligibility half likewise rests on claim 3unconfirmed's predicate, which is itself unconfirmed. Addendum, same 2026-09-19 pass — a cross-check from claim 23unconfirmed materially weakens the De Novo evidence above, and anyone reading those three refuted results should read this first. Enumerating product code QAJ turned up DEN170049 (an FDA De Novo decision number) "Innovo" (Bio-Medical Research, Ltd., decided 2018-11-06) — a De Novo grant for a pelvic-floor electrical stimulator for urinary incontinence, and the authorisation that created product code QAJ. denovo "Innovo" --jurisdiction US → verified, source: local cache of FDA De Novo listing, denovo_number=DEN170049. So the cache does contain an on-point De Novo for a pelvic-floor stimulator, and the three description-keyed searches above did not find it. The reason is structural and matters for every De Novo check in this repo: the cache's device_name column holds trade names ("Innovo"), not device descriptions, so a query phrased as a device description ("pelvic floor electrical stimulator") cannot match an on-point record and its refuted means "no trade name matched", not "no such device was ever granted a De Novo". Consequence for this claim: the De Novo half is not as clean as the 2026-08-30 pass recorded. It remains true that no De Novo grant is needed for a KPI-coded device — KPI predates the 1976 amendments era and is a 510(k) code, as the classification lookup confirms — but the nearest adjacent product code to this candidate was brought into existence by exactly the route this claim says is unnecessary, for a pelvic-floor stimulator for urinary incontinence, within the last eight years. That is the live risk if FDA declines the KPI framing for the closed-loop EMG element. Tag stays unconfirmed and the reasoning for it is now stronger, not weaker
HCPCS (Healthcare Common Procedure Coding System) code E0740 (a HCPCS code for durable medical equipment) exists with a descriptor covering a non-implanted pelvic floor electrical stimulator, complete system
jurisdiction: US — confidence: verified — note: tag raised from unconfirmed on 2026-08-30 now that data/hcpcs_level_ii.csv is populated — source: hcpcs E0740 --expect "pelvic floor" --jurisdiction US → verified, "local cache of CMS (Centers for Medicare & Medicaid Services) HCPCS Level II file, code=E0740" — "HCPCS E0740: Non-implanted pelvic floor…the full check electrical stimulator, complete system". The official descriptor is a direct match to the claim as written, including "complete system"
Per PDAC (Pricing, Data Analysis and Coding contractor) coding guidance, E0740 is intended to describe non-implantable pelvic floor electrical stimulators with integrated monitoring capability, so a stim-only device without EMG sensing may not code to E0740
jurisdiction: US — confidence: unconfirmed — source: no connector covers PDAC coding-verification decisions; the nearest check, hcpcs E0740 --jurisdiction US, returned unconfirmed for the missing data/hcpcs_level_ii.csv cache and would only return the descriptor anyway, never PDAC's application guidance.…the full check Unresolvable in this repo as built. Settling it needs the current PDAC Coding Verification decision list (human-attached) and ideally a PDAC coding verification request filed on this device. Flagged because the Scorer treated this as a competitive tailwind — it is currently an unchecked web-search recollection. Re-verification 2026-08-30:data/hcpcs_level_ii.csv is now populated and hcpcs E0740 returns verified with the official descriptor "Non-implanted pelvic floor electrical stimulator, complete system" (see the HCPCS-existence claim above) — but that descriptor says nothing about "integrated monitoring capability," which is PDAC coding-verification-article language, not HCPCS Level II descriptor language. The underlying gap is unchanged: no connector in this repo reaches DME MAC (durable medical equipment Medicare administrative contractor)/PDAC coding-verification articles (see the near-identical, separately-sourced PDAC claim later in this file, which got a one-off WebFetch read of a named document as a lead for a human — that same document, if it names E0740, would be the thing that actually settles this one). Stays unconfirmed
Medicare NCD 230.8 (a Medicare national coverage determination number) covers pelvic floor electrical stimulation with a non-implantable stimulator for stress and/or urge urinary incontinence in cognitively intact patients who failed a documented four-week trial of pelvic muscle exercise training
jurisdiction: US — confidence: verified — note: **tag moved from refuted to verified on 2026-09-14 by the first direct read of the NCD (national coverage determination)'s own text — the new ncd connector reads CMS Pub. 100-3, and the manual states this claim almost verbatim; see the 2026-09-14 pass at the end of this line for what moved and what…the full check did not.** The 2026-08-30 disposition below is preserved unaltered because its reasoning was right and is still load-bearing: it recorded a coverage-cache linkage finding, correctly refused to reinterpret the connector's literal status, and explicitly warned against reading it as a finding about CMS policy. That warning has now been borne out. Prior pass, preserved as written: re-verified 2026-08-30 now that data/medicare_coverage_policies.csv is populated (646 rows); tag moved from unconfirmed (missing-cache) to refuted, but read the caveat below before treating this as a clean kill on Factor 2 — source: coverage E0740 --expect-stance covered --jurisdiction US → refuted: "local cache of CMS Medicare Coverage Database (no policy names this code), code=E0740" — "No NCD or LCD (local coverage determination) in the cached coverage file names E0740. That means Medicare has published no explicit coverage determination for it — claims are left to case-by-case contractor adjudication. This is a real reimbursement risk signal, but it is NOT the same as a denial." Adversarial follow-up the connector's code-column match cannot see, found by reading the same cache file directly:grep -n "^230.8," data/medicare_coverage_policies.csv returns a row that exists — 230.8,NCD,Non-Implantable Pelvic Floor Electrical Stimulator, — an exact document-number and title match to this claim's premise, but its codes column is blank. That is not unique to this row: 356 of the file's 646 rows have an empty codes field, so a blank-codes miss here is consistent with a cache-linkage gap (CMS's NCD title/number was captured but the HCPCS cross-reference was not populated for this row) rather than proof that CMS never issued NCD 230.8 or that it doesn't name E0740. I attempted to read the actual NCD 230.8 policy text directly (a targeted fetch of a named, resolvable CMS document, not an open-ended search) via https://www.cms.gov/medicare-coverage-database/search.aspx?ncdid=232 and it returned HTTP 403 — CMS's coverage database blocks this fetch path, the same way accessdata.fda.gov initially appeared to block 510(k) summary fetches before a working approach was found (see the 2026-08-23 correction note elsewhere in this file). Net disposition: the tag is set to refuted because that is the connector's literal, un-reinterpreted output for the check this claim maps to (a coverage policy naming E0740), per this Verifier's standing instruction not to reinterpret a connector's status — but a human should read this alongside the cache-row finding above before treating Factor 2 as conclusively holed. The specific coverage criteria this claim asserts (stress/urge UI, cognitively intact, failed 4-week PME trial) remain completely unconfirmed either way — nothing here, in either direction, is a read of NCD 230.8's actual text. Load-bearing for both Factor 1 and Factor 2 as before; the whole intended_use: was written to mirror this NCD's eligibility language, so a human resolving this (loading a codes-linked coverage cache, or manually pulling the NCD 230.8 PDF from the CMS National Coverage Determinations Manual, Pub. 100-3, outside this repo's automated reach) should be treated as urgent. Re-verification 2026-09-14 — the NCD's text has now been read, by section number, and the claim is verified.ncd 230.8 --jurisdiction US → verified, source: CMS Pub. 100-3 Medicare NCD Manual, chapter 1 part 4 (Rev. 13808, issued 05-29-26), section=230.8. Verbatim, from the manual: “Non-implantable pelvic floor electrical stimulators provide neuromuscular electrical stimulation through the pelvic floor with the intent of strengthening and exercising pelvic floor musculature. Stimulation is generally delivered by vaginal or anal probes connected to an external pulse generator… Pelvic floor electrical stimulation with a non-implantable stimulator is covered for the treatment of stress and/or urge urinary incontinence in cognitively intact patients who have failed a documented trial of pelvic muscle exercise (PME) training. A failed trial of PME training is defined as no clinically significant improvement in urinary continence after completing 4 weeks of an ordered plan of pelvic muscle exercises designed to increase periurethral muscle strength.” Both halves of this claim were then probed as exact phrases and both returned verified: ncd 230.8 --expect "covered for the treatment of stress and/or urge urinary incontinence in cognitively intact patients who have failed a documented trial of pelvic muscle exercise (PME) training" → verified, and ncd 230.8 --expect "after completing 4 weeks of an ordered plan of pelvic muscle exercises" → verified — the latter is where the claim's “four-week” gets its support, since the four weeks is in the manual's definition of a failed trial rather than in the coverage sentence itself. What changed, and why the earlier tag was wrong about the world: the refuted recorded on 2026-08-30 came from coverage E0740 --expect-stance covered, a code-keyed lookup over the local coverage cache. That check answers “does a cached policy row name E0740”; it does not and cannot answer “what does NCD 230.8 say”, which is what this claim asserts. The connector was answering a different question from the one the claim asked, and the prior pass said so in as many words (blank codes column on the very row 230.8,NCD,Non-Implantable Pelvic Floor Electrical Stimulator,, 356 blank-codes rows of 646). With the policy text in hand that ambiguity is resolved in the direction the prior pass suspected: CMS has published this NCD, and it covers this device class for these patients on these criteria. The earlier HTTP 403 against search.aspx?ncdid=232 is also superseded — and worth flagging, that URL was the wrong document anyway (ncdid=232 resolves to NCD 270.2, Noncontact Normothermic Wound Therapy), which is why the section-number address is the right one. What this does NOT establish, and must not be read as: (i) it does not establish that this candidate's device codes to NCD 230.8, nor that any particular claim will be paid — the connector states outright that coverage text is an eligibility statement, not a payment decision; (ii) it does not overturn the separate, still-standing coverage E0740 finding that no row in the cached coverage file links this NCD to E0740 by code — that remains a real cache/linkage gap and, to the extent the cache mirrors what a MAC (Medicare administrative contractor) has on file, a real claims-adjudication question; (iii) the NCD is a national policy from Rev. 48 (effective 2006) and says nothing about app-linked, EMG-gated, or RTM (remote therapeutic monitoring)-billed variants of the device class. Bearing on the intended_use:: the frontmatter indication was deliberately written to mirror this NCD's eligibility language, and the mirror is now confirmed against the source text rather than against a recollection of it — “cognitively intact”, “failed a documented trial of pelvic muscle exercise” and the 4-week definition all appear as quoted. The Scorer, not this Verifier, owns what that does to Factor 2 and to the Gate Check narrative built on the prior refuted
A Medicare DMEPOS (durable medical equipment, prosthetics, orthotics and supplies) fee schedule allowed amount is published for E0740
jurisdiction: US — confidence: verified — note: tag raised from unconfirmed on 2026-08-30 now that data/hcpcs_payment_rates.csv is populated; a dollar figure now exists, and it is a small one — source: payment E0740 --jurisdiction US → verified: "local cache of CMS payment file, code=E0740,…the full check schedule=DMEPOS, year=2026" — "E0740 pays $74.52. Schedule: DMEPOS, year 2026. National unadjusted rate — locality and wage-index adjustment moves this materially, and the same code pays differently under PFS (physician fee schedule) vs OPPS vs ASC vs DMEPOS." What this settles and what it doesn't: it establishes only that a code exists and a published fee schedule rate exists for it — it does not, by itself, establish that $74.52 exceeds this device's per-unit COGS (cost of goods sold) (an app-linked, EMG-sensing intravaginal probe is plausibly a higher-BOM (bill of materials) device than the bare non-monitoring stimulators E0740 was historically priced against), and TAM (total addressable market) component 3 ($350-$700 net revenue per system) still names no connector-checkable source for whether $74.52 is even the relevant payment line for this device versus a cash-pay or bundled-service model. Read as a real number that narrows, rather than closes, the reimbursement-margin question this claim was raised to answer
CPT (Current Procedural Terminology) 90912 exists and describes biofeedback training of perineal muscles / anorectal or urethral sphincter including EMG and/or manometry, initial 15 minutes
jurisdiction: US — confidence: unconfirmed — source: cpt 90912 → unverifiable by design: "CPT codes are AMA-licensed and cannot be scraped or reproduced verbatim (phase2-spec.md Section 3). Rescope this claim to HCPCS, or attach a licensed AMA/vendor source manually." Permanent status absent a human-attached…the full check licensed AMA CPT descriptor; no web search was run and none is permitted
CPT 90913 is the add-on code for each additional 15 minutes of the same service, and both replaced deleted code 90911 in 2020
jurisdiction: US — confidence: unconfirmed — source: cpt 90913 → unverifiable by design (AMA-licensed; connector cannot return verified or refuted under any circumstance). Needs a human-attached licensed AMA CPT source; the 90911-deletion history is equally unverifiable here
CPT 98977 exists and describes device supply for remote therapeutic monitoring of the musculoskeletal system, billable once per 30 days with 16 days of data
jurisdiction: US — confidence: unconfirmed — source: cpt 98977 → unverifiable by design (AMA-licensed). Needs a human-attached licensed AMA CPT 2026 descriptor
Pelvic floor muscle status qualifies as "musculoskeletal system status" for the purposes of billing CPT 98977, rather than requiring a different RTM device-supply code
jurisdiction: US — confidence: unconfirmed — source: cpt 98977 → unverifiable by design (AMA-licensed), and no connector in this repo reads CMS PFS final-rule commentary or the CMS RTM billing FAQ either. This is the claim the Generator itself flagged as most likely to be refuted and it carries the entire RTM leg of…the full check Factor 2 — record it as unresolved and unresolvable by any agent here, not as a soft yes. Settling it needs a human-attached licensed AMA descriptor plus a human read of the CMS PFS final rule / RTM FAQ
CPT 98980 and 98981 exist as RTM treatment-management codes (first 20 minutes / each additional 20 minutes per calendar month)
jurisdiction: US — confidence: unconfirmed — source: cpt 98980 and cpt 98981 → both unverifiable by design (AMA-licensed). Needs a human-attached licensed AMA CPT source
TAM component 1 — annual Medicare Part B (Medicare Part B) allowed services for CPT 90912 exceed 200,000
jurisdiction: US — confidence: refuted — note: re-verified 2026-08-30 now that data/medicare_procedure_volumes.csv is populated; tag moved from unconfirmed (missing-cache) to refuted — source: procedures 90912 --expect-volume 200000 --jurisdiction US → refuted: "local cache of CMS Medicare utilization…the full check file, code=90912, year=2024" — "90912: claimed 200,000 overstates the cached figure of 28,093 by 612%, outside the 25% tolerance. Medicare fee-for-service only, 2024 — excludes Medicare Advantage (Medicare Advantage), commercial, Medicaid, VA, and cash-pay. This is a FLOOR on US volume, not a market size." What this actually refutes: the specific numeric threshold this claim asserted (>200,000), not the existence of the service or a modest Medicare FFS (fee-for-service) volume for it — 28,093 allowed services/year is real, sourced, floor-level utilization, just an order of magnitude below what the claim stated. Standing caveat unchanged: this is a floor on Medicare FFS volume only and says nothing about commercial/Medicaid/cash-pay volume for the in-clinic service this claim is a proxy for
TAM component 2 — annual Medicare allowed units for HCPCS E0740 exceed 10,000
jurisdiction: US — confidence: refuted — note: re-verified 2026-08-30 now that data/medicare_procedure_volumes.csv is populated; tag moved from unconfirmed (missing-cache) to refuted — source: procedures E0740 --expect-volume 10000 --jurisdiction US → refuted: "local cache of CMS Medicare utilization…the full check file, code=E0740, year=2024" — "E0740 (Non-implanted pelvic floor electrical stimulator, complete system): claimed 10,000 overstates the cached figure of 4,130 by 142%, outside the 25% tolerance. Medicare fee-for-service only, 2024 — excludes Medicare Advantage, commercial, Medicaid, VA, and cash-pay. This is a FLOOR on US volume, not a market size." Same reading as component 1: this refutes the specific >10,000 threshold, not the existence of Medicare FFS demand for the device class — 4,130 allowed units/year is real, sourced floor volume for the exact code this candidate would bill under. Same Medicare-FFS-floor caveat applies
TAM component 3 — realistic net revenue per dispensed system is $350-$700 (device plus first-year app/monitoring), before any RTM professional-time billing accruing to the clinician rather than the manufacturer
jurisdiction: US — confidence: unconfirmed — source: market "<claim text>" → unverifiable: "no free, authoritative, machine-queryable source... Stays unconfirmed permanently unless a human attaches a licensed report and edits the claim by hand." No aggregator, vendor page or blog may be substituted. The closest…the full check defensible partial substitute is a verified payment E0740 allowed amount (itself blocked on the missing CMS file) plus a human-attached competitor price benchmark
TAM component 4 — addressable share assumption: the initial obtainable segment is women aged 45+ with diagnosed stress urinary incontinence who are already in pelvic floor physical therapy, which the Generator assumes is under 5% of all US women with SUI symptoms
jurisdiction: US — confidence: unconfirmed — source: market "<claim text>" → unverifiable, permanently. Correctly labelled by the Generator as a modeling choice; no connector can settle a share assumption. Note for the Scorer: C3 x C4 carry the entire dollar figure and neither is verifiable here, so even a fully…the full check successful volume check leaves TAM's revenue half unsourced
Prevalence claim — more than 15 million adult US women report stress urinary incontinence symptoms
jurisdiction: US — confidence: unconfirmed — source: market "<claim text>" → unverifiable. The literature connector is a Stage 0 scan returning a ScanResult, which carries no confidence tag and cannot verify a prevalence figure by construction. Settling it needs a human-pulled and human-read NHANES/NHIS citation…the full check attached to the file; the current source is an uncited recollection
FTO (freedom to operate) — no live, enforceable US patent claims closed-loop EMG-gated intravaginal NMES (neuromuscular electrical stimulation) for urinary incontinence in a way that blocks this design; core intravaginal stimulation patents from the 1990s (InCare/Hollister, Empi era) are expired
jurisdiction: US — confidence: unconfirmed — source: no connector call was possible and none was made.patent takes a specific patent_id and cannot run a landscape search; this claim names no patent number, no assignee-specific number, and no candidate blocking patent, so there is no object to pass it. This…the full check claim is unsearched, not merely unverified — the two are different, and nothing here is evidence in either direction, including for the "1990s patents are expired" half. Second, independent gap: re-checked 2026-08-30 — the patent connector has since changed credential providers, from PatentsView to EPO (European Patent Office) OPS.python3 -m connectors patent US1234567B2 --jurisdiction US (a placeholder number, since none is available for this claim) → unconfirmed: "EPO_OPS_KEY / EPO_OPS_SECRET not set — register a free app at https://developers.epo.org/ before running Stage 3 IP (intellectual property) checks." Confirmed both EPO_OPS_KEY and EPO_OPS_SECRET are unset in this environment. The credential-gap finding stands, just under a different pair of variable names than previously recorded here; the old PATENTSVIEW_API_KEY reference above is superseded and should not be treated as the current blocker. Missing-credential gap, reported as such and not as a finding about any patent. To make this checkable: (1) set EPO_OPS_KEY / EPO_OPS_SECRET; (2) a human runs a landscape search (USPTO (United States Patent and Trademark Office) Patent Public Search / Google Patents over CPC A61N1/36007, A61N1/372, A61B5/389; assignees InControl Medical, Zynex, Laborie/Uroplasty, Atlantic Therapeutics; claims live past ~2030) to yield candidate numbers; (3) each number then goes through patent <number>, whose output is a database fact about filing/grant dates with a naive-expiration caveat — never an FTO conclusion, which is a Stage 7 counsel memo. Re-verification 2026-09-19 — the credential gap is closed, the connector limit is not, and this claim is now SEARCHED rather than unsearched; direction of the new evidence is AGAINST it.python3 engine/scripts/connector_status.py reports patent available Environment variable(s) set — both EPO_OPS_KEY and EPO_OPS_SECRET are set in this environment, so the 2026-08-30 missing-credential finding above is superseded and is no longer the blocker. The landscape limit stands exactly as REQ-0002A patent landscape over closed-loop… describes it:connectors/patents.py::check_patent_family() takes one publication number and calls published-data/publication/epodoc/<number>/biblio; it wraps no CQL/search path, so a CPC-class landscape is still not a typed-connector operation and no invocation recorded here is one. How candidate numbers were obtained, stated plainly so it is not mistaken for a typed check: ad-hoc CQL queries against the same primary database (EPO OPS published-data/search, the endpoint the connector does not wrap) were used strictly as lead generation — a scan, carrying no confidence tag — and every number they returned was then put through patent <number>, which is the only step here that produced a status. That lead step is not a connector subcommand and is therefore not replayable by recheck_claims.py; the patent lookups below are. Queries run verbatim, with EPO result counts: cpc=A61N1/36007 (2,285); cpc=A61N1/36007 and ta=vaginal (103); cpc=A61N1/36007 and ta=biofeedback (36); cpc=A61N1/36007 and cpc=A61B5/389 (41); cpc=A61N1/0524 and cpc=A61B5/389 (4); cpc=A61N1/0524 and ta=biofeedback (8); cpc=A61B5/389 and ta=incontinence (3); cpc=A61N1/05 and ta=vaginal and ta=incontinence (3); pa="incontrol medical" (8); pa="atlantic therapeutics" (7); pa=elidah (3); cpc=A61N1/36007 and pn=US and pd within "1990 1999" (31). What it found, and it is material: one US patent family sits squarely in this candidate's design space and is live on a naive term. patent US10307589 --jurisdiction US → verified, EPO OPS published-data/publication epodoc=US10307589 — "INTERACTIVE MUSCLE TRAINING DEVICE AND METHOD", filed 2016-01-29, naive 20yr expiration 2036-01-29, not yet expired; CPC A61N1/0524 (vaginal electrode), A61N1/36007, A61N1/3603x; abstract: "an electrical stimulation signal to condition the pelvic wall muscles of a user... also provides a system for measuring the users muscle response." patent US11724100 --jurisdiction US → verified, epodoc=US11724100 — "REGULATED AND INTERACTIVE MUSCLE STIMULATION USING SENSORY REGULATED EMG TRIGGERED STIMULATION FOR FORGING NEURAL PATHWAYS", filed 2020-11-13, naive expiration 2040-11-13, not yet expired; abstract: "EMG regulated stimulation may be triggered by the controller." Two further live grants in the same INPADOC family (OPS family/publication/epodoc/US2019247651, 8 members, 4 of them US grants): patent US10646711 --jurisdiction US → verified, filed 2019-04-23, naive expiry 2039-04-23, not expired; patent US11865337 --jurisdiction US → verified, filed 2020-04-03, naive expiry 2040-04-03, not expired. Checked and not on point: patent US2023173269 --jurisdiction US → verified, "Method for neuromodulation treatment of low urinary tract dysfunction", filed 2023-02-01 — transcutaneous peroneal-nerve electrodes behind the knee, not intravaginal. The "1990s patents are expired" half is now supported, and scoped: the cohort cpc=A61N1/36007 and pn=US and pd within "1990 1999" returns 31 US publications, each carrying a term (20-from-filing, or 17-from-grant for pre-1995-06-08 filings) that ran out by ~2019; three were confirmed individually — patent US5199443 --jurisdiction US → verified, "INCONTINENCE ELECTRODE APPARATUS", filed 1991-03-26, naive expiry 2011-03-26, expired; patent US5385577 --jurisdiction US → verified, "Electrode for activating pelvic reflexes", filed 1992-11-12, expiry 2012-11-12, expired; patent US5562717 --jurisdiction US → verified, "Electrical stimulation for treatment of incontinence and other neuromuscular disorders", filed 1994-11-08, expiry 2014-11-08, expired. Residual, NOT verified — and it is most of the claim: (a) claim scope was never read. OPS ta= indexes title and abstract only, and the patent connector returns bibliographic data; nothing here reports what US10307589, US10646711, US11724100 or US11865337 actually claim, so "in a way that blocks this design" is untouched — a live grant in the same CPC groups is a lead for counsel, never an infringement finding. (b) in-force status was never checked. The connector's own docstring states it does not call OPS's /legal (INPADOC) service, so every "not yet expired" above is naive 20-year arithmetic modelling no PTA, no terminal disclaimer and no maintenance-fee lapse — a patent on this list may already be dead, or may run longer. (c) ownership is unknown. DOCDB returned no applicant record for any member of that family, so the assignee of the four live grants is not established here; the pa= searches under-recall for the same reason and cannot be read as "InControl/Elidah/Atlantic hold nothing further." The claim's attribution of the expired 1990s art to InCare/Hollister and Empi is likewise not verified — only the numbers, titles and dates are. (d) the search is not exhaustive. One database (EPO OPS/DOCDB), CPC- and abstract-keyed, in English; US continuations filed but unpublished, families classified outside these CPC groups, and any family whose abstract avoids these terms all sit outside it. Disposition: stays unconfirmed, but the reason has changed. This claim is no longer unsearched — a class-and-text landscape was run and is recorded above, which is the substance REQ-0002A patent landscape over closed-loop… commissioned, delivered by an untyped route. It does not reach refuted: no connector returned refuted, and refuting an FTO assertion requires a claim-scope read this repo cannot perform. A human should nonetheless read the new evidence as pointing against the claim — the specific thing it says no live patent covers, EMG-triggered closed-loop stimulation of the pelvic floor on an intravaginal electrode, is the literal subject matter of at least two live US grants. The next step is unchanged in kind and much narrower in scope: Stage 7 counsel reads the issued claims of US10307589, US10646711, US11724100 and US11865337 and pulls their Patent Center file histories and maintenance-fee status
Moat lever — the defensible asset is the longitudinal EMG-plus-adherence dataset feeding the RTM billing workflow and payer documentation, not the stimulator hardware, which is commodity
jurisdiction: US — confidence: unconfirmed — source: adoption "<claim text>" → unverifiable: the payer-documentation half asserts what payers would require, which "needs primary research (interviews, survey, published preference study)... Do NOT substitute a model's own estimate of stakeholder behaviour." No…the full check connector settles a moat claim. The checkable proxy the connector suggests — a named MAC LCD or commercial policy with longitudinal documentation requirements — routes through coverage. Re-verified 2026-08-30 now that data/medicare_coverage_policies.csv is populated:coverage E0740 --jurisdiction US → refuted (no policy in the cache names E0740 by code — see the NCD 230.8 claim above for the full disposition and the cache-linkage caveat found on inspection of the same file). That means the specific proxy this claim named — a documented MAC/national policy requiring longitudinal EMG/adherence data as a coverage condition — is not established either way: there is no code-linked policy to read for documentation requirements, but per the NCD 230.8 finding above that may be a cache-completeness gap rather than a true absence of any Medicare policy touching this code. Stays unconfirmed — the core assertion (that payers would value/require this dataset) remains an unresearched stakeholder-preference claim regardless of what the coverage cache shows. Re-verification 2026-09-14 — the proxy half is no longer unreadable; the core half is unchanged and stays unconfirmed. The 2026-08-30 reasoning above is preserved because it was correct: coverage E0740 came back refuted on a code-linkage basis, and this pass does not disturb that. What has changed is that the national policy governing this device class can now be read directly. ncd 230.8 --jurisdiction US → verified, source: CMS Pub. 100-3 Medicare NCD Manual, chapter 1 part 4 (Rev. 13808, issued 05-29-26), section=230.8 (full text quoted in the NCD 230.8 claim above). Two targeted probes of that text: ncd 230.8 --expect "documentation" → unconfirmed; ncd 230.8 --expect "electromyography" → unconfirmed. Which half moved: the proxy this claim named — “a documented MAC/national policy requiring longitudinal EMG/adherence data as a coverage condition” — is now partly answered rather than unreadable: the one national coverage policy on non-implantable pelvic floor electrical stimulators exists, was read end to end (it is roughly 1,200 characters), and its conditions are a one-time eligibility gate (stress and/or urge UI, cognitively intact, a failed 4-week PME trial) with no ongoing-documentation, data-capture or EMG-reporting requirement appearing anywhere in it. Which half did not, and the limit on the above: per the connector's own rule a phrase miss is unconfirmed, never refuted — manual prose can state a requirement in other words, so “no documentation condition found in NCD 230.8” is a read of one policy, not a finding that no Medicare policy imposes one. LCDs, DME MAC supplier-documentation articles and commercial payer policies are all outside this connector's reach and remain unread. And the load-bearing half of this claim — that payers would value or require a longitudinal EMG-plus-adherence dataset — is a stakeholder-preference assertion that no connector settles and no agent here may answer from its own judgement. Tag stays unconfirmed. Direction of the new evidence, for a human: it points slightly against the moat thesis rather than for it — the national policy this device class bills under conditions coverage on a pre-treatment eligibility test, not on ongoing monitoring data, so the documentation the moat claim treats as a payer requirement is, at the national level, not one. Re-verification 2026-09-19 — the core half is unverifiable by design and stays so; one recorded lookup no longer returns what this claim wrote down, and the reason is our own reach, not the world.adoption "the defensible asset is the longitudinal EMG-plus-adherence dataset feeding the RTM billing workflow and payer documentation" → unverifiable (the subcommand takes no --jurisdiction flag): "asserts what clinicians, payers, or patients would do... needs primary research (interviews, survey, published preference study)... Do NOT substitute a model's own estimate of stakeholder behaviour: a synthetic stakeholder opinion is a fabricated claim." That is the correct and permanent outcome for the load-bearing half, and no agent here may answer it. ncd 230.8 --jurisdiction US → verified, unchanged, same source and revision as the 2026-09-14 pass recorded: CMS Pub. 100-3 Medicare NCD Manual, chapter 1 part 4 (Rev. 13808, issued 05-29-26), section=230.8. Drift to flag:coverage E0740 --expect-stance covered --jurisdiction US → unconfirmed this pass, where 2026-08-30 recorded refuted. This is not CMS changing anything. data/ now holds only README.md, fda_denovo.csv, medicare_procedure_volumes.csv, pfs_rvu.csv and provenance.json — data/medicare_coverage_policies.csv is gone, and the connector says so: "No local cache at data/medicare_coverage_policies.csv — Medicare coverage policy for E0740 cannot be checked until it exists... Do not substitute a web search for this file." So the 2026-08-30 refuted and every conclusion drawn from it are currently unreplayable, and the cache-linkage caveat recorded against it can no longer be inspected. In the vocabulary of _shared/claim-grammar.md this is our reach regressing, not new knowledge about medtech, and it should not be read as evidence in either direction. Residual, NOT verified, unchanged: whether payers would value or require a longitudinal EMG-plus-adherence dataset is a stakeholder-preference assertion with no primary research behind it; NCD 230.8's conditions remain a one-time pre-treatment eligibility gate with no ongoing-documentation requirement found in its text, which points slightly against the moat thesis; and LCDs, DME MAC supplier-documentation articles and commercial payer policies are all still unread — now more so, since the cache that indexed them is absent
Competitive intensity — InControl Medical, Elitone, and Zynex-class NMES vendors are the incumbent prescription players; Elvie and Perifit occupy the consumer-wellness segment without prescription claims
jurisdiction: US — confidence: unconfirmed — source: partially checked, and the checked parts split. Confirmed: InControl Medical holds KPI clearances (openFDA device/510k K133826, K150180); Elidah/Elitone holds QAJ clearances (K183585, K223884); Zynex holds a KPI clearance — `510k "InWave" --applicant "Zynex"…the full check --jurisdiction US → verified, openFDA device/510k k_number=K121820, "INWAVE / Zynex Medical, Inc. decided 2012-08-24", product_code KPI, regulation 876.5320. **Not confirmed:** the Elvie/Perifit half. 510k "Elvie" and 510k "Perifit" both return verified records — K210936 "Elvie Stride" (Chiaro Technology) and K231785 "Perifit Pump" (X6 Innovations) — but both are product_code HGX, regulation 884.5160, **powered breast pumps**, which say nothing about their pelvic-floor trainers. Their absence from an openFDA device-name search is not evidence they hold no clearance. Settling the roster needs FDA Establishment Registration & Device Listing for KPI/QAJ (no connector) and, for funding/launch activity, a human-attached licensed source. **Re-verification 2026-08-23 — all three cited K-numbers now checked at full depth via clearance-summary; the tag stays unconfirmed because the unresolved half is unchanged, but two findings are new.** (i) The Elvie/Perifit records are confirmed irrelevant from their IFUs, not merely from their product code: clearance-summary K210936 → "The Elvie Stride is a **powered breast pump** to be used by lactating women to express and collect milk from their breasts" (https://www.accessdata.fda.gov/cdrh_docs/pdf21/K210936.pdf); clearance-summary K231785 → "The Perifit Pump is a **wearable electric breast pump** intended to express milk from lactating women" (https://www.accessdata.fda.gov/cdrh_docs/pdf23/K231785.pdf). Both returned unconfirmed against an --expect-indication "pelvic floor" probe, as expected. This closes off the possibility that these records were mislabelled pelvic-floor devices; it still does **not** establish that Elvie or Perifit hold no pelvic-floor clearance under another device name, which is the actual open question and needs the establishment-registration roster. (ii) **The most directly comparable incumbent is Zynex, not InControl.** clearance-summary K121820 --expect-indication "stress urinary incontinence" --jurisdiction US → unconfirmed on an exact-phrase miss, but the verbatim IFU (https://www.accessdata.fda.gov/cdrh_docs/pdf12/K121820.pdf) reads: *"The InWave is intended to provide electrical stimulation and neuromuscular re-education for the purpose of rehabilitation of weak pelvic floor muscles for the treatment of **stress** urge and mixed urinary incontinence in women."* It is unconfirmed rather than verified only because the contiguous string "stress urinary incontinence" does not appear — the extracted text lists stress, urge and mixed as treated types (commas evidently lost in extraction). Flagged for a human: this is a **KPI / 876.5320** clearance that names **stress** UI and neuromuscular re-education of the pelvic floor, i.e. it is a closer indication-and-code match to this candidate than either InControl clearance, both of which name mixed UI. Whether it is the better predicate is an FDA substantial-equivalence judgment, not a database fact, so no tag is moved on it here — but the file's predicate framing currently leads with InControl and this evidence points elsewhere. **Re-verification 2026-09-19 — the Elvie/Perifit half is now answered as far as a product-code roster can answer it, and the claim's incumbent roster is found to be incomplete. Tag stays unconfirmed.** The open question above was "does Elvie or Perifit hold a pelvic-floor clearance under another device name". That is answerable by enumerating the two product codes rather than by device name: clearances --product-code KPI --since 1990-01-01 --until 2013-12-31 --limit 300 --jurisdiction US → found, 50 records; clearances --product-code KPI --since 2014-01-01 --until 2026-09-19 --limit 300 --jurisdiction US → found, 42 records; clearances --product-code QAJ --since 1990-01-01 --until 2026-09-19 --limit 300 --jurisdiction US` → found, 5 records; 97 pooled, none truncated. No record in any of the three names Chiaro Technology, Elvie, Perifit or X6 Innovations. So Elvie and Perifit hold no KPI or QAJ clearance at all, which is the half the 2026-08-23 pass could not reach. Residual on that half, NOT verified: a biofeedback-only or pressure-only pelvic trainer with no stimulation output falls under a different product code entirely, so this establishes "no prescription NMES clearance", not "no FDA clearance of any kind", and it is a scan result carrying no tag either way. Two corrections to the roster the claim asserts, both from the same enumeration. (i) InControl Medical holds seven KPI clearances, not the two this line cites: K110179 "INCONTROL" (2012-02-22), K133826 and K134020 both "INTONEMV" (2014-01-06, 2014-02-25), K141158 "APEX" (2014-11-26), K150180 "InTone" (2015-03-16), K150183 "ApexM" (2015-04-09), K182022 "ApexMV" (2019-03-15). (ii) Elidah holds three QAJ clearances and one is new to this file: K183585 (2019-02-11), K223884 (2023-02-24) and K253285 "Elitone for Men" (2026-01-23) — an indication expansion into male incontinence that post-dates every other entry in this candidate and that no claim here has assessed. Roster gap, and it is the more important of the two: the QAJ code contains exactly five records, and two of them belong to a vendor this claim does not name at all — K192357 "INNOVO" (Atlantic Therapeutics, Ltd., 2020-01-16) and its founding authorisation DEN170049 "Innovo" (Bio-Medical Research, Ltd., 2018-11-06), a De Novo grant, which is how product code QAJ came into existence. Atlantic Therapeutics is a prescription pelvic-floor stimulation incumbent on the same primary record as Elidah and Zynex, and the claim's list of "incumbent prescription players" omits it. A Scorer reading competitive intensity off this line should treat the roster as understated by at least one vendor
Assumption (not a checkable fact) — the idea depends on urogynecologists and pelvic floor PTs being willing to prescribe a home device and bill RTM alongside in-clinic 90912 sessions rather than treating the device as revenue cannibalization. There is no connector for clinician preference and no primary research behind this; it is stated here so it stays visible
jurisdiction: US — confidence: unconfirmed — source: adoption "<claim text>" → unverifiable: "asserts what clinicians, payers, or patients would do. No free, authoritative, machine-queryable source answers that — it needs primary research (interviews, survey, published preference study)... Do NOT substitute a…the full check model's own estimate of stakeholder behaviour: a synthetic stakeholder opinion is a fabricated claim." No opinion was produced here. The connector's suggested rescope — procedures 90912 as a proxy for how often the in-clinic service is actually performed — is already tracked as TAM component 1 and is itself blocked on the missing CMS volumes file
Competitive / fast-follower rate — 510(k) clearance activity in product code KPI has accelerated: 2014-2023 averaged roughly 2.8 clearances per year, while 2024 through 2026-08-23 totals 14 (2024:4, 2025:4, 2026:6), the 2026 partial year already matching the highest full year on record
jurisdiction: US — confidence: unconfirmed — source: Generator-added per backlog 3.4, from the 2026-08-23 entry in knowledge-base/signals/log.md (clearances --product-code KPI --since 2014-01-01 --limit 300 --jurisdiction US → 42 records; six most recent K260178, K252601, K252552, K252831, K252334, K251760). This…the full check file's own Factor 5 and Factor 8 gap-analysis cells name this exact scan and no claim in the file stated any clearance rate, which is why it is entered here rather than left in the log. Two things the Verifier must settle rather than inherit: (a) clearances is a Stage 0 scan returning a ScanResult, which carries no confidence tag and cannot acquire one by construction — so if no claim-tier connector can carry this, unconfirmed on those grounds is the correct and informative answer, not a failed check; (b) several records in this code are clinic chairs, magnetic stimulators and electrode accessories by device name, so whether each counted record is a competing prescription home NMES device is a per-record question the sweep does not settle — an unfiltered count overstates the fast-follower rate this claim is actually about. Verifier disposition 2026-09-19 — the arithmetic replays exactly; one sub-assertion is contradicted by the same registry; tag unconfirmed on the structural grounds (a) predicted.clearances --product-code KPI --since 2014-01-01 --until 2026-08-23 --limit 300 --jurisdiction US → {"status": "found", "count": 42, "total_matches": 42, "truncated": false, "requires_stage_3_verification": true}, the same 42 records, with the same six most recent K-numbers (K260178, K252601, K252552, K252831, K252334, K251760). Counted by decision year: 2014:3, 2015:6, 2016:3, 2017:1, 2018:3, 2019:2, 2020:1, 2021:3, 2022:3, 2023:3 — 28 over ten years, i.e. 2.8/yr exactly as claimed — and 2024:4, 2025:4, 2026:6 = 14 as claimed. Both numeric halves reproduce from the primary record. (a) stands as predicted: clearances returns a ScanResult with requires_stage_3_verification: true and no confidence field, so no tag can be issued from it regardless of how cleanly the arithmetic lands. Contradicted sub-assertion, and a human should read this as a correction, not a caveat: "the 2026 partial year already matching the highest full year on record" is true only inside the 2014-onward window the scan was run over. Extending the same scan backwards — clearances --product-code KPI --since 1990-01-01 --until 2013-12-31 --limit 300 --jurisdiction US → {"status": "found", "count": 50, "total_matches": 50, "truncated": false} — gives 1997:11, 2003:5, 1995:4, 1996:4, 2000:4, with a long tail. 1997 alone carries 11 KPI clearances, nearly double the 2026 partial-year figure, so 2026 is not matching the highest full year on record; it is matching the highest full year since 2014. The claim as written overstates by choosing a window, and the same registry that supplies its numerator supplies the refutation. This is flagged rather than tagged refuted only because a ScanResult cannot carry a tag in either direction — the substance is a contradiction, not a gap. Residual, NOT verified, and (b) is now confirmed as a real distortion rather than a worry: the counted records are not all prescription home NMES devices. Reading the scan's own device-name strings, at least four of the fourteen 2024-2026 records are clinic chair-form or magnetic-stimulation systems rather than home intravaginal NMES — K234061 "StarFormer" (Fotona D.O.O.), K241516 "BTL-398" (BTL Industries), K251026 "Regenesis EMS Chair" (Trinity Medical Solutions), K252334 "PELVIPOWER Pelvic Functional Magnetic Stimulation" — and at least one more is an electrode accessory (K231166 "Levina Incontinence Stimulation Electrodes"). Device name is a registry string and the categorisation above is a read of it, not an FDA field, so the filtered rate is not established here either; what is established is that the unfiltered count materially overstates the fast-follower rate this claim is about. Settling it needs a per-record read of each clearance's indication
A substantial number of US women discontinue treatment for stress urinary incontinence after a failed four-week pelvic muscle exercise trial, rather than escalating to another therapy
jurisdiction: US — confidence: unconfirmed — source: deck-surfaced assumption (desirability deck, 2026-08-24). Verifier disposition (2026-08-28):adoption "<claim text>" → unverifiable: "asserts what clinicians, payers, or patients would do... needs primary research... Do NOT substitute a model's own estimate of…the full check stakeholder behaviour." No opinion produced. The connector's suggested rescope is exactly what this pass already found by coincidence: the class-2 claims checked this round (PMID (PubMed identifier) 22847318: PFMT (pelvic floor muscle training) long-term adherence 10-70% with 0-39% loss to follow-up across 19 studies; PMID 26397715: 56.8% discontinued PFMT training at 5 years) are the revealed-behaviour twin docs/research-lane-spec.md §3.1 describes — but for PFMT itself, not specifically for discontinuation after a failed four-week trial before escalating, and both sit at unconfirmed themselves (structural, class-2). This claim stays unconfirmed, permanently absent primary research on the specific escalation-vs-discontinuation behaviour
Women prescribed a home intravaginal NMES device use it at the prescribed frequency for at least the 12 weeks a treatment effect would require
jurisdiction: US — confidence: unconfirmed — source: deck-surfaced assumption (desirability deck, 2026-08-24). Verifier disposition (2026-08-28):adoption "<claim text>" → unverifiable: asserts what patients would do; no primary research exists in this repo; no opinion produced. Closest checkable proxy already…the full check surfaced this pass: PMID 25074260 (InTone open-label pilot) found 5/33 (15.2%) withdrew before completing a 12-week single-arm course — evidence about a different, related device's completion rate, not this candidate's, and itself unconfirmed (class-2, structural). Stays unconfirmed, permanently absent primary research on this specific device
Adult women find an intravaginal home device acceptable enough to start and continue treatment with it, given a non-invasive external alternative exists on the market
jurisdiction: US — confidence: unconfirmed — source: deck-surfaced assumption (desirability deck, 2026-08-24). Verifier disposition (2026-08-28):adoption "<claim text>" → unverifiable: asserts patient preference/acceptability; no primary research exists here; no opinion produced. Closest checkable proxy already…the full check surfaced this pass: NCT03782116 (a ClinicalTrials.gov registration number) (Elidah's ELITONE transcutaneous, non-intravaginal pivotal trial) shows completion data for the external alternative named in this claim, but the specific per-arm dropout figures could not be confirmed from trial-detail's output this pass (see that claim's disposition above), and even if they had been, that trial says nothing about acceptability of the intravaginal route this candidate uses. Stays unconfirmed, permanently absent primary research
Prescribers will produce the documented failed four-week pelvic muscle exercise trial the intended use requires, rather than routing patients to a therapy with no documentation prerequisite
jurisdiction: US — confidence: unconfirmed — source: deck-surfaced assumption (desirability deck, 2026-08-24). Verifier disposition (2026-08-28):adoption "<claim text>" → unverifiable: asserts what prescribers would do; no primary research exists in this repo; no opinion produced. No checkable proxy was…the full check identified for this specific documentation-workflow behaviour this pass. Stays unconfirmed, permanently absent primary research
A 510(k) with a KPI predicate plus PDAC coding verification and the app/RTM software documentation is a low-single-digit-million, sub-two-year path to first revenue
jurisdiction: US — confidence: unconfirmed — source: deck-surfaced assumption (viability deck, 2026-08-24). Verifier disposition (2026-08-28): no connector in this repo covers capital-cost or time-to-revenue projections. Ran adoption "<claim text>" as the closest available tool and it returned unverifiable, but…the full check its stated reasoning ("asserts what clinicians, payers, or patients would do") does not actually describe this claim — this is a cost/timeline estimate, not a stakeholder-preference claim, and no connector of either kind reaches it. Flagged as genuinely uncheckable in this repo rather than forced through a mismatched tool's boilerplate reasoning. Stays unconfirmed; needs human-attached inputs per this file's own Capital-intensity Scores-table row (MDUFA decision-time reports, a contract-manufacturing BOM, a PDAC timeline)
Pelvic floor physical therapy clinics and urogynecology practices are a reachable distribution channel for a prescription home device
jurisdiction: US — confidence: unconfirmed — source: deck-surfaced assumption (viability deck, 2026-08-24). Verifier disposition (2026-08-28):adoption "<claim text>" → unverifiable: asserts what a distribution channel would do (be reachable/willing); no primary research exists in this repo; no opinion produced.…the full check Stays unconfirmed, permanently absent primary research
A material share of the addressable stress-urinary-incontinence population is commercially insured rather than Medicare fee-for-service, so Medicare volumes are a floor on the market rather than a measure of it
jurisdiction: US — confidence: unconfirmed — source: deck-surfaced assumption (viability deck, 2026-08-24). Verifier disposition (2026-08-28): no connector in this repo covers payer-mix / insurance-coverage distribution statistics. Ran adoption "<claim text>" as the closest available tool; it returned…the full check unverifiable, but again its reasoning ("what clinicians, payers, or patients would do") is a mismatch — this is a demographic/coverage-mix fact, not a stakeholder-preference claim, and this repo has no connector for either shape of it (it would need a CMS/NHIS insurance-coverage-by-condition breakdown, not a code, coverage-policy, or procedure-volume lookup). Flagged as genuinely uncheckable here rather than forced through a mismatched tool. Note the claim is directionally consistent with the standing Medicare-FFS-floor caveat already carried elsewhere in this file's TAM section, which is itself sourced from the procedures connector's own documentation, not from this claim
Closed-loop EMG-gated stimulation produces a better continence outcome than open-loop stimulation or pelvic muscle exercise alone, by a margin a clinician would act on
jurisdiction: US — confidence: unconfirmed — source: deck-surfaced assumption (feasibility deck, 2026-08-24). Verifier disposition (2026-08-28):adoption "<claim text>" → unverifiable on the "a clinician would act on" half; no primary research on clinician response margin exists here. On the comparative-efficacy…the full check half, the closest available evidence is the Cochrane review already checked this pass (PMID 29271482, itself unconfirmed, class-2): "low-quality evidence... no difference in cure or improvement for ES versus PFMT (RR 0.85, 95% CI 0.70-1.03)" — that is evidence about open-loop electrical stimulation versus PFMT; it says nothing about closed-loop EMG-gating specifically, which is exactly this file's own Scores-table observation that a closed-loop-vs-open-loop head-to-head likely does not exist in the published literature. No connector or scan surfaced one. Stays unconfirmed
Microvolt-scale surface EMG can be recovered on the same intravaginal probe that is delivering stimulation, with artifact rejection good enough to gate stimulation on it in real time
jurisdiction: US — confidence: unconfirmed — source: deck-surfaced assumption (feasibility deck, 2026-08-24). Verifier disposition (2026-08-28): this is a bench/engineering feasibility claim, not a regulatory, reimbursement, IP, market, or stakeholder-preference claim, and no connector in this repo reaches any of…the full check those shapes for hardware signal-recovery performance. adoption "<claim text>" was run as the only remotely-adjacent tool and returned unverifiable, but its own reasoning text ("asserts what clinicians, payers, or patients would do") does not describe this claim at all — noted so this isn't misread as a genuine adoption check. Genuinely unreachable by anything in this repo; needs a bench study, not a database lookup. Stays unconfirmed
The device and paired app can automatically capture at least 16 days of data in each 30-day period, which is the data threshold the remote-therapeutic-monitoring device-supply code is claimed to require
jurisdiction: US — confidence: unconfirmed — source: deck-surfaced assumption (feasibility deck, 2026-08-24). Verifier disposition (2026-08-28): an engineering feasibility claim (can this specific device/app achieve a data-capture rate) with no connector in this repo that reaches it. adoption "<claim text>" was…the full check run and returned unverifiable, but its reasoning text is a mismatch for the same reason noted on the adjacent bench-feasibility claim above — this asserts a device capability, not stakeholder behaviour. Separately, the 16-day/98977 threshold itself is CPT-descriptor territory and AMA-licensed (see the CPT 98977 claim elsewhere in this file, itself permanently unconfirmed), so even the regulatory premise this claim leans on is unverifiable here. Stays unconfirmed; needs a bench/engineering test, not a lookup
Probe materials and a single-patient cleaning regimen meet biocompatibility requirements for repeated mucosal contact at home
jurisdiction: US — confidence: unconfirmed — source: deck-surfaced assumption (feasibility deck, 2026-08-24). Verifier disposition (2026-08-28): a device-specific biocompatibility testing-outcome claim (ISO (International Organization for Standardization) 10993-type bench/lab testing on this device's actual materials), not a registry, literature, or…the full check stakeholder-preference claim, and no connector in this repo performs or reaches biocompatibility test results. adoption "<claim text>" was run and, as with the two adjacent bench-feasibility claims, returned unverifiable with reasoning text that does not actually describe this claim. Genuinely unreachable here; needs the manufacturer's own biocompatibility testing report, not a database lookup. Stays unconfirmed
InControl Medical holds a second, distinct KPI/876.5320 clearance for a device also named InToneMV, K134020 (decided 2014-02-25), separate from K133826 (decided 2014-01-06); K134020's Indications for Use name male and female urinary and fecal incontinence with visual biofeedback via manometry, materially different from K133826's female-only, urinary-only, muscle re-education framing
jurisdiction: US — confidence: verified — source: research lane, from dossier stress-urinary-incontinence §5 (2026-08-27) — primary source: K134020 — evidence class 1 (registry fact). Verifier disposition (2026-08-28): verified, independently re-checked cold, both halves. `510k "InToneMV" --applicant…the full check "InControl Medical" --jurisdiction US → verified, openFDA device/510k k_number=K134020, "Cleared 510(k): INTONEMV / Incontrol Medical, LLC decided 2014-02-25" — clearance existence, applicant, decision date all match. clearance-summary K134020 --jurisdiction US → verified, FDA 510(k) summary K134020 (https://www.accessdata.fda.gov/cdrh_docs/pdf13/K134020.pdf), verbatim IFU: *"InToneMV is intended to provide electrical stimulation and/or visual biofeedback (via manometry) for the treatment of male and female urinary and fecal incontinence"* — a word-for-word match to the claim's characterization (male and female, urinary and fecal, manometry biofeedback). Set against K133826's already-verified IFU elsewhere in this file (female-only, mixed urinary incontinence, muscle re-education, no manometry), the two InToneMV-named clearances are confirmed materially different devices under the same product name — direct primary-source support for the claim as written. Both distinct from this candidate's stated stress-UI, surface-EMG intended use, so neither closes the predicate gap already identified for K133826. **Re-verification 2026-09-19 — replayed cold, holds, tag stays verified.** clearance-summary K134020 --expect-indication "fecal incontinence" --jurisdiction US → **verified**, source: FDA 510(k) summary K134020 (https://www.accessdata.fda.gov/cdrh_docs/pdf13/K134020.pdf): "The cleared indication contains 'fecal incontinence'. Indications for Use (verbatim): InToneMV is intended to provide electrical stimulation and/or visual biofeedback (via manometry) for the treatment of male and female urinary and fecal incontinence" — a word-for-word match to this line's characterisation, on an exact-phrase probe this time rather than a bare fetch. The separate-clearance half is independently corroborated this pass by the full product-code enumeration run for claim 23unconfirmed: clearances --product-code KPI --since 2014-01-01 --until 2026-09-19 --limit 300 --jurisdiction US lists K133826 (2014-01-06) and K134020 (2014-02-25) as two distinct records both titled "INTONEMV" under Incontrol Medical, LLC, alongside five further InControl KPI clearances. One operational warning for anyone replaying this line or claim 3unconfirmed: because both clearances carry the device name "InToneMV", the name-keyed lookup 510k "InToneMV" --applicant "InControl Medical" --jurisdiction US` resolves to K134020 and silently will not return K133826 — always key these two by k_number
No FDA device recall record exists for product code KPI or product code QAJ over the window 2010-01-01 to 2026-08-27
jurisdiction: US — confidence: unconfirmed — source: research lane, from dossier stress-urinary-incontinence §5 (2026-08-27) — primary source: openFDA device/recall, product_code=KPI and product_code=QAJ — evidence class 1 (registry fact). **Verifier disposition (2026-08-28): unconfirmed, on structural grounds,…the full check not a failed check.** Re-ran the scan directly: recalls --product-code KPI --since 2010-01-01 --until 2026-08-27 --limit 100 --jurisdiction US → {"status": "none", "detail": "No device recalls for product_code:\"KPI\" in 2010-01-01 to 2026-08-27.", "count": 0, "requires_stage_3_verification": true}; identical result for --product-code QAJ. Both objects are ScanResults by construction — no confidence field, requires_stage_3_verification: true set on themselves — per connectors/result.py and CLAUDE.md, recalls is a Stage 0 scan tool and cannot acquire a confidence tag no matter how clean the "none" result reads, exactly the same structural finding this file already recorded for the KPI fast-follower clearances scan below. The "zero recalls found" result is recorded as the scan's honest output, not converted into verified. Re-verification 2026-09-19 — both scans replayed, both still none, tag held at unconfirmed on the same structural grounds.recalls --product-code KPI --since 2010-01-01 --until 2026-08-27 --limit 100 --jurisdiction US → {"status": "none", "query": "product_code:\"KPI\" AND event_date_initiated:[2010-01-01 TO 2026-08-27]", "count": 0, "requires_stage_3_verification": true}; recalls --product-code QAJ --since 2010-01-01 --until 2026-08-27 --limit 100 --jurisdiction US → identical shape for QAJ. Nothing in openFDA has moved in the window. The tag does not move either, and the reason is worth restating because a clean "none" is the easiest result in this file to over-read: a ScanResult carries no confidence field and sets requires_stage_3_verification: true on itself, so recalls cannot issue a tag under any circumstance — this is a structural property of the tool, not a weakness in the evidence. Residual, NOT verified: two further limits on what even a perfect scan would establish. openFDA's device/recall endpoint keys on event_date_initiated, so a recall initiated before 2010-01-01 and still open, or one initiated after 2026-08-27, falls outside this window by construction; and a negative registry result is evidence about FDA's published recall database, never about field safety — MAUDE (Manufacturer and User Facility Device Experience) adverse-event reports are a separate endpoint and were not queried for this claim
Long-term adherence to pelvic floor muscle training (PFMT) for stress urinary incontinence varies between 10% and 70% across studies with loss to follow-up ranging 0%-39%, per a systematic review of 19 studies following 1,141 women for 1-15 years
jurisdiction: US — confidence: unconfirmed — source: research lane, from dossier stress-urinary-incontinence §5 (2026-08-27) — primary source: PMID 22847318 — evidence class 2 (published finding). **Verifier disposition (2026-08-28): unconfirmed, cold re-retrieval done, content confirmed, tag held on structural…the full check grounds.** literature-detail 22847318 → PubMed PMID=22847318 (efetch), record found, title "Does it work in the long term?--A systematic review on pelvic floor muscle training for female stress urinary incontinence" (Neurourology and Urodynamics, 2013). Verbatim abstract: "Nineteen studies were included (1,141 women followed between 1 and 15 years)... Losses to follow-up during the long-term period ranged between 0% and 39%. Long-term adherence to PFMT varied between 10% and 70%." Every number in the claim matches the retrieved abstract exactly — 19 studies, 1,141 women, 1-15 years, 0-39% loss to follow-up, 10-70% adherence. Why the tag stays unconfirmed rather than verified despite the exact match:literature-detail returns a ScanResult (per CLAUDE.md and connectors/result.py), which cannot carry a confidence tag by construction, and this is a class-2 published finding — per docs/research-lane-spec.md §3/§5 that evidence shape routes to a Corroborator (fresh-context re-retrieval plus independent second source, or a named-methods single source under the not-yet-decided corroborated tag), not to the Verifier's registry-fact verified. A single-source content match, however exact, does not meet that bar. Recorded for a human: content is confirmed accurate as quoted, nothing here contradicts it
In a 5-year single-cohort follow-up of 208 women who completed a guided PFMT program for stress urinary incontinence, 56.8% (75 of 132 responders) had discontinued training entirely, and adherence at 5 years was not associated with superior treatment outcomes
jurisdiction: US — confidence: unconfirmed — source: research lane, from dossier stress-urinary-incontinence §5 (2026-08-27) — primary source: PMID 26397715 — evidence class 2 (published finding). **Verifier disposition (2026-08-28): unconfirmed, content confirmed, tag held on the same structural grounds as the…the full check PMID 22847318 line above.** literature-detail 26397715 → PubMed PMID=26397715 (efetch), record found, title "Pelvic floor muscle training for female stress urinary incontinence: Five years outcomes" (Neurourology and Urodynamics, 2017). Verbatim abstract: "Two hundred and eight consecutive women... One hundred and thirty-two (63%) women completed all questionnaires... 75 (56.8%, mean age 49.8...) discontinued training... this adherence was not associated with superior treatment outcomes." Every figure matches — 208 women, 132 responders, 75/132 = 56.8% discontinued, no association with outcome. Not verified: literature-detail is a ScanResult-returning Stage 0 tool with no confidence field by construction, and this class-2 finding is Corroborator territory (independent second source, or the queued corroborated tag) per docs/research-lane-spec.md §3/§5, not the Verifier's single-source registry standard. Content is confirmed accurate as quoted
In Elidah's sham-controlled pivotal trial of the ELITONE transcutaneous stimulation device for stress urinary incontinence (NCT03782116), 17 of 57 (29.8%) treatment-arm participants and 12 of 30 (40.0%) sham-arm participants did not complete the intervention period, with lost-to-follow-up and subject-withdrawal as the stated reasons
jurisdiction: US — confidence: unconfirmed — source: research lane, from dossier stress-urinary-incontinence §5 (2026-08-27) — primary source: NCT03782116 — evidence class 2 (published finding). Verifier disposition (2026-08-28): unconfirmed, partial content match, tag held.trial-detail NCT03782116 →…the full check ClinicalTrials.gov NCTId=NCT03782116, record found, status=COMPLETED, hasResults=true, INTERVENTIONAL/RANDOMIZED/PARALLEL, masking=QUADRUPLE (consistent with "sham-controlled"), enrollment 87 (ACTUAL), sponsor=Elidah, Inc., population FEMALE 21-75, primary outcome "Efficacy Assessed by Percent Reduction in Urinary Incontinence Episodes @ 12 weeks." The claimed arm sizes (57 treatment + 30 sham = 87) match the total enrollment exactly, which is consistent with, though not independent confirmation of, the per-arm split. What did not come back: the returned record is the protocol/design module; it does not include the detailed results/dropout tables, so the specific per-arm completion figures (17/57 = 29.8%, 12/30 = 40.0%) and the stated withdrawal reasons could not be independently confirmed from this connector's output, even though hasResults=true means a results module exists on ClinicalTrials.gov that this call did not surface. Not refuted — nothing retrieved contradicts the claim, the trial and its sham-controlled, 87-subject design are real and match. Also structurally capped at unconfirmed regardless: trial-detail is a ScanResult-returning Stage 0 tool with no confidence field by construction, and this is a class-2 finding routed to a Corroborator standard this pass does not meet. A human or a future Corroborator pass should pull the results module directly for the dropout table
In InControl Medical's open-label pilot trial of the InTone device for urinary incontinence, 5 of 33 enrolled women (15.2%) withdrew before completing the 12-week single-arm treatment course
jurisdiction: US — confidence: unconfirmed — source: research lane, from dossier stress-urinary-incontinence §5 (2026-08-27) — primary source: PMID 25074260 — evidence class 2 (published finding). Verifier disposition (2026-08-28): unconfirmed, content confirmed, tag held on structural grounds.…the full checkliterature-detail 25074260 → PubMed PMID=25074260 (efetch), record found, title "InTone: a novel pelvic floor rehabilitation device for urinary incontinence" (International Urogynecology Journal, 2015; type includes Clinical Trial). Verbatim abstract: "Thirty-three women were enrolled; five patients withdrew and were excluded... InTone was used 5-6 days a week for 12 weeks." 5/33 = 15.15%, rounds to the claimed 15.2%; 12-week course confirmed. The abstract does not use the words "open-label" or "single-arm" verbatim, but describes one treatment group with no comparator arm and no blinding language, consistent with that characterization. Not verified: literature-detail is a ScanResult-returning Stage 0 tool with no confidence field by construction, and this class-2 finding is Corroborator territory, not the Verifier's single-source registry standard
A Cochrane systematic review of 56 randomized trials (n=3,781) found electrical stimulation with non-implanted devices probably more effective than no active treatment for subjective cure of stress urinary incontinence (RR 2.31, 95% CI 1.06-5.02), but low-quality evidence of no difference between electrical stimulation and pelvic floor muscle training (RR 0.85, 95% CI 0.70-1.03)
jurisdiction: US — confidence: unconfirmed — source: research lane, from dossier stress-urinary-incontinence §5 (2026-08-27) — primary source: PMID 29271482 — evidence class 2 (published finding). Verifier disposition (2026-08-28): unconfirmed, content confirmed exactly, tag held on structural grounds.…the full checkliterature-detail 29271482 → PubMed PMID=29271482 (efetch), record found, title "Electrical stimulation with non-implanted devices for stress urinary incontinence in women" (Cochrane Database of Systematic Reviews, 2017; Meta-Analysis/Systematic Review). Verbatim abstract: "We identified 56 eligible trials (3781 randomised participants)... we found moderate-quality evidence that ES is probably better than no active treatment (risk ratio (RR) 2.31, 95% CI 1.06 to 5.02)... Low-quality evidence suggests that there may be no difference in cure or improvement for ES versus PFMT (RR 0.85, 95% CI 0.70 to 1.03)." Both figures match exactly, including the CIs and the quality grading. This is directly relevant background for Factor 6 (Mechanism & clinical risk), which currently states the file carries no efficacy claim at all — that gap is now partly filled, but only at unconfirmed. Not verified: literature-detail is a ScanResult-returning Stage 0 tool with no confidence field by construction, and this class-2 finding routes to a Corroborator standard (independent second source, or the queued corroborated tag) this pass does not meet
NHANES 2015-March 2020 data (n=6,446) found weighted symptomatic urinary incontinence prevalence of 22.3% among US women aged 20 and older, with stress-predominant incontinence comprising 16.2% of incontinence cases, up from an overall 17.1% prevalence reported for 2005-2010
jurisdiction: US — confidence: unconfirmed — source: research lane, from dossier stress-urinary-incontinence §5 (2026-08-27) — primary source: PMID 42606983 — evidence class 2 (published finding). Verifier disposition (2026-08-28): unconfirmed, content confirmed exactly, tag held on structural grounds.…the full checkliterature-detail 42606983 → PubMed PMID=42606983 (efetch), record found (this PMID is unusually high but real — checked precisely because a fabricated PMID is the single easiest thing to catch here), title "Prevalence of Urinary Incontinence in the United States 2015-2020" (Urogynecology (Philadelphia, Pa.), 2026). Verbatim abstract: "Among 6,446 participants, the weighted prevalence of UI was 22.3% (95% CI, 20.8-23.8), significantly higher than the 17.1% reported in 2005-2010... stress (16.2%)..." Every figure matches: n=6,446, 22.3% overall, 16.2% stress-predominant, up from 17.1% (2005-2010). Note for the Scorer: this is a general urinary incontinence prevalence figure with a stress-predominant subtype breakdown, not a stress-UI-specific prevalence study — the claim's own framing ("stress-predominant incontinence comprising 16.2% of incontinence cases") is accurate to the abstract. This is the sourced NHANES citation the earlier prevalence claim (TAM section) flagged as "an uncited recollection" — it is now cited, but still only unconfirmed: literature-detail is a ScanResult-returning Stage 0 tool with no confidence field by construction, and this class-2 finding is Corroborator territory, not the Verifier's single-source registry standard
The DME MAC/PDAC coding guidance for HCPCS E0740 states the code is intended for non-implantable pelvic floor electrical stimulators with integrated monitoring capability, and that devices limited to muscle-monitoring capability without electrical stimulation were not intended to be included in E0740
jurisdiction: US — confidence: unconfirmed — source: research lane, from dossier stress-urinary-incontinence §6 (2026-08-27) — primary source: https://med.noridianmedicare.com/web/jddme/policies/dmd-articles/pdac-code-review-e0740-non-implantable-pelvic-floor-electrical-stimulator — evidence class 1 (registry fact).…the full checkVerifier disposition (2026-08-28): unconfirmed — no typed connector in this repo covers PDAC coding-verification decisions, the same structural gap already on record for the near-identical PDAC claim earlier in this file (line "Per PDAC coding guidance, E0740 is intended..."): regulation reaches eCFR text only, hcpcs/coverage/payment reach CMS code/coverage/payment records, and none of them serve a DME MAC contractor's coding-verification article. This is a genuinely different primary source type from anything a typed connector here reaches, so per the Verifier's own standing instruction the correct move is to say so rather than substitute a search. For the record, not as a basis for the tag: because the research lane supplied a specific, resolvable document URL rather than a search query, I read that one document with WebFetch (a targeted fetch of a named document, not an open-ended search) and it returned text matching the claim close to verbatim — "HCPCS code E0740 is intended to describe non-implantable pelvic floor electrical stimulators with integrated monitoring capabilities" and "Devices limited to only muscle monitoring capability... were not intended to be included in E0740." That is offered to a human as a lead, exactly as the earlier PDAC claim's residual asked for, and does not move the tag — this repo's typed-connector standard does not cover PDAC/DME-MAC coding-verification articles, and a Verifier's own WebFetch read is not the typed primary-source check this claim type requires. A human confirming the same document, or a future connector, is what would actually move this
A device sold into the DME (durable medical equipment)/Part B channel captures a material share of the addressable HCPCS E0740 Medicare FFS volume by year 3 of launch
jurisdiction: US — confidence: unconfirmed — source: market "<claim text>" --jurisdiction US → unverifiable: "Market-size claim... has no free, authoritative, machine-queryable source. Stays unconfirmed permanently unless a human attaches a licensed report and edits the claim by hand." — note: a forward-looking…the full check share-capture forecast, the same shape as this file's other TAM/market-share claims; permanently unconfirmed absent a licensed source. Business-case assumption (2026-09-03), checked cold this pass
The manufacturer's price per unit sold to a DME supplier or a PT (physical therapist)/urogynecology practice is high enough to support a standalone device business at the volumes the Medicare FFS floor establishes
jurisdiction: US — confidence: unconfirmed — source: adoption "<claim text>" --jurisdiction US → unverifiable: "asserts what clinicians, payers, or patients would do... needs primary research... Do NOT substitute a model's own estimate of stakeholder behaviour." — note: this is really an internal pricing/economics…the full check assumption, not a stakeholder-preference claim, and no connector in this repo reaches manufacturer unit-economics projections either; adoption's own reasoning is a mismatch, flagged rather than treated as a real check. Business-case assumption (2026-09-03), genuinely uncheckable here
The device's fully-loaded cost of goods — probe, EMG front-end electronics, companion app and first-year connectivity — is below the $74.52 DMEPOS national allowed amount for E0740
jurisdiction: US — confidence: unconfirmed — source: adoption "<claim text>" --jurisdiction US → unverifiable: "asserts what clinicians, payers, or patients would do..." — note: mismatched tool, flagged as such; the $74.52 half is independently verified elsewhere in this file (payment E0740), but the COGS half…the full check is the manufacturer's own internal cost data, which no connector in this repo reaches. Business-case assumption (2026-09-03), genuinely uncheckable here
Gross margin at the achievable price and volume supports a standalone device business rather than only a subsidized or bundled model
jurisdiction: US — confidence: unconfirmed — source: adoption "<claim text>" --jurisdiction US → unverifiable: "asserts what clinicians, payers, or patients would do..." — note: mismatched tool; this is a financial-model conclusion depending on the two unresolved price/COGS claims above, and no connector reaches…the full check gross-margin projections. Business-case assumption (2026-09-03), genuinely uncheckable here
Pelvic floor PT and urogynecology practices or patients will pay a cash price for the device that is not anchored to the $74.52 DMEPOS allowable
jurisdiction: US — confidence: unconfirmed — source: adoption "<claim text>" --jurisdiction US → unverifiable: "asserts what clinicians, payers, or patients would do... needs primary research (interviews, survey, published preference study)... Do NOT substitute a model's own estimate of stakeholder behaviour." —…the full check note: a genuine stakeholder-willingness-to-pay claim, correctly routed to adoption; no opinion produced, stays unconfirmed permanently absent primary research. Business-case assumption (2026-09-03)
An incumbent KPI- or QAJ-code device manufacturer (InControl Medical, Elidah, or Zynex) would license or integrate a third-party closed-loop EMG-gating module rather than build the capability in-house
jurisdiction: US — confidence: unconfirmed — source: adoption "<claim text>" --jurisdiction US → unverifiable: "asserts what clinicians, payers, or patients would do... needs primary research... Do NOT substitute a model's own estimate of stakeholder behaviour." — note: a build-vs-license strategic-preference claim…the full check about named companies; no primary research exists in this repo (no interview, filing, or licensing-announcement source was searched or found), stays unconfirmed permanently absent one. Business-case assumption (2026-09-03). Re-verification 2026-09-19 — unverifiable by design, confirmed, tag stays unconfirmed permanently absent human-attached primary research.adoption "An incumbent KPI- or QAJ-code device manufacturer would license or integrate a third-party closed-loop EMG-gating module rather than build the capability in-house" → unverifiable (the subcommand takes no --jurisdiction flag, so the earlier recorded invocation with one would not replay as written): "asserts what clinicians, payers, or patients would do. No free, authoritative, machine-queryable source answers that — it needs primary research (interviews, survey, published preference study)... Do NOT substitute a model's own estimate of stakeholder behaviour." This is the correct outcome, not a failed check, and no agent in this repo may answer a build-vs-license question about named companies from its own judgement. The checkable proxy, offered as a rescope rather than as an answer: what these firms have actually done is a registry fact even though what they would do is not. The product-code enumeration run for claim 23unconfirmed this same pass shows all three named incumbents filing their own 510(k)s rather than appearing as integrators — InControl Medical holds seven KPI clearances across 2012-2019 (K110179, K133826, K134020, K141158, K150180, K150183, K182022) and Elidah three QAJ clearances across 2019-2026, the most recent being K253285 "Elitone for Men" (2026-01-23), an indication expansion filed in its own name. That is observed filing behaviour, not evidence about licensing preference: a licensed-in module would appear in the licensee's own 510(k) exactly the same way an in-house one does, so this proxy cannot distinguish build from license and is recorded as context only. A Generator or Scorer wanting a usable version of this claim should restate it as something the registry can answer
RTM platform revenue accrues in part to the device manufacturer, via a software/data-platform fee charged to the prescribing clinic, rather than solely to the clinician's own CPT billing
jurisdiction: US — confidence: unconfirmed — source: adoption "<claim text>" --jurisdiction US → unverifiable: "asserts what clinicians, payers, or patients would do..." — note: mismatched tool — this is a business-model/billing-structure assumption, not stakeholder preference, and it leans on CPT 98977/98980/98981…the full check billing mechanics, which are AMA-licensed and unverifiable here (cpt always returns unverifiable by design). No connector in this repo reaches how RTM software-fee revenue is split between manufacturer and clinic. Business-case assumption (2026-09-03), genuinely uncheckable here
Building direct-to-practice sales-channel coverage in pelvic floor PT and urogynecology practices is affordable within a launch budget and does not require DME/Medicare billing infrastructure
jurisdiction: US — confidence: unconfirmed — source: adoption "<claim text>" --jurisdiction US → unverifiable: "asserts what clinicians, payers, or patients would do..." — note: mismatched tool — this is an internal launch-budget/go-to-market assumption, not a stakeholder-preference claim, and (like the…the full check capital-cost/time-to-revenue claim elsewhere in this file) no connector in this repo covers launch-budget or channel-cost projections. Business-case assumption (2026-09-03), genuinely uncheckable here
Qualifying a closed-loop EMG-gating module as an OEM addition to an already-cleared KPI/QAJ device does not require a new full 510(k) for the host device
jurisdiction: US — confidence: unconfirmed — source: no connector reaches this. This is an FDA determination governed by the "Deciding When to Submit a 510(k) for a Change to an Existing Device" guidance document plus device-specific engineering-change analysis, not a CFR section — regulation reaches eCFR text only…the full check and this claim cites no section number for it to check. No connector in this repo reads FDA guidance documents (the same scope limit already on record elsewhere in this file for guidance-vs-regulation questions). Genuinely unreachable here; needs an FDA pre-submission or a regulatory-affairs read of the change-control guidance. Business-case assumption (2026-09-03). Re-verification 2026-09-19 — the "cites no section number" gap is closed; the governing regulation is now on record, the interpretation still is not, and the tag stays unconfirmed. The prior pass was right that no connector reads FDA guidance, but wrong that there is no CFR section behind this question: the change-control guidance interprets 21 CFR 807.81(a)(3), which is eCFR text and is reachable. regulation 807.81 --title 21 --expect "significant change or modification in design" --jurisdiction US → verified, source: eCFR versioner title-21, issue 2026-09-16, section=807.81. Text on point, verbatim: a premarket notification is required where the device "is about to be significantly changed or modified in design, components, method of manufacture, or intended use. The following constitute significant changes or modifications that require a premarket notification: (i) A change or modification in the device that could significantly affect the safety or effectiveness of the device, e.g., a significant change or modification in design, material, chemical composition, energy source, or manufacturing process. (ii) A major change or modification in the intended use of the device." Residual, NOT verified — the whole assertion: what is verified is that §807.81 exists and says the above; whether adding a closed-loop EMG-gating module to an already-cleared KPI/QAJ host falls inside (a)(3)(i) is precisely the interpretive determination the regulation connector cannot make and this repo's scope limit forbids an agent from making — FDA guidance documents, enforcement practice and the manufacturer's own change-control analysis are all out of reach here. A human should note the direction, though: the quoted text places the burden on showing the change could not significantly affect safety or effectiveness, which is the opposite of the claim's framing, and closed-loop gating alters when and whether stimulation energy is delivered. Settling it still needs an FDA pre-submission or a regulatory-affairs read against the "Deciding When to Submit a 510(k) for a Change to an Existing Device" guidance. Note also that this claim asserts something about a third party's host device, so even a favourable reading depends on an OEM partner's own change-control file, which is not a public record at all
This device — an intravaginal pelvic floor electrical stimulator with integrated surface-EMG monitoring and a paired app — obtains DME MAC/PDAC coding verification to HCPCS E0740, so that NCD 230.8's coverage of non-implantable pelvic floor electrical stimulators reaches it as billed
jurisdiction: US — confidence: unconfirmed — source: compound claim, each half already checked cold elsewhere in this file rather than re-run redundantly. HCPCS E0740 exists (hcpcs E0740 --jurisdiction US → verified, see the earlier HCPCS-existence claim) and NCD 230.8 covers non-implantable pelvic floor electrical…the full check stimulators on stated criteria (ncd 230.8 --jurisdiction US → verified, see the NCD 230.8 claim). What is NOT established by either: whether this specific device obtains PDAC coding verification — a future regulatory-administrative event, not a database fact, and no connector in this repo covers PDAC coding-verification decisions (see the two PDAC claims elsewhere in this file, both unconfirmed on the identical structural gap). Stays unconfirmed on that unresolved half
At least two named commercial payer medical policies cover non-implanted pelvic floor electrical stimulation for stress urinary incontinence, on eligibility criteria a device with this candidate's intended use would meet
jurisdiction: US — confidence: unconfirmed — source: no connector reaches this. coverage and ncd are both Medicare-only instruments — coverage reads data/medicare_coverage_policies.csv (CMS NCD/LCD index) and ncd reads CMS Pub. 100-3, the Medicare NCD Manual; neither touches commercial (non-Medicare) payer…the full check medical policy. No named commercial payer was checked or could be. Genuinely unreachable in this repo; needs a human pull of named commercial payer policy documents (e.g. UnitedHealthcare, Aetna, Cigna medical policy libraries)
Commercial payer allowed amounts for a non-implanted pelvic floor electrical stimulator (E0740 or its commercial equivalent) are set independently of the Medicare DMEPOS national unadjusted amount for E0740, rather than benchmarked to it
jurisdiction: US — confidence: unconfirmed — source: adoption "<claim text>" --jurisdiction US → unverifiable: "asserts what clinicians, payers, or patients would do... needs primary research..." — note: closest available tool given this asserts commercial-payer rate-setting behavior, but no connector in this repo…the full check reaches commercial payer fee-schedule methodology at all (same gap as the preceding claim); stays unconfirmed permanently absent a human-attached payer rate study
Medicare NCD 30.1.1 excludes home use of biofeedback therapy from coverage, so the biofeedback/EMG component of this device attracts no separate Medicare payment when furnished in the home
jurisdiction: US — confidence: verified — source: ncd 30.1.1 --expect "Home use of biofeedback therapy is not covered" --jurisdiction US → verified, CMS Pub. 100-3 Medicare NCD Manual, chapter 1 part 1 (Rev. 13800, issued 05-28-26), section=30.1.1. Verbatim: *"This policy applies to biofeedback therapy rendered…the full check by a practitioner in an office or other facility setting... Home use of biofeedback therapy is not covered."* Both the office/facility-only scope and the explicit home-exclusion sentence match the claim exactly — note: this NCD's coverage criteria (stress/urge incontinence, cognitively intact, failed 4-week PME trial) are the office-setting twin of NCD 230.8's device-based criteria already verified elsewhere in this file; the two policies are complementary, not duplicates — 230.8 covers the non-implantable device, 30.1.1 covers practitioner-rendered biofeedback service and explicitly excludes it in the home. What this does NOT establish: whether this candidate's app-based EMG feedback is "biofeedback therapy" under this NCD's own definition (an FDA/CMS coding question) or whether it is instead captured entirely by 230.8 and/or RTM codes — that classification is a human/regulatory-affairs judgment, not a database fact
A commercially insured woman prescribed a home pelvic floor electrical stimulator faces an out-of-pocket cost (deductible, coinsurance, or cash price) low enough that she takes delivery of the device rather than abandoning the prescription at the supplier
jurisdiction: US — confidence: unconfirmed — source: adoption "<claim text>" --jurisdiction US → unverifiable: "asserts what clinicians, payers, or patients would do... needs primary research (interviews, survey, published preference study)... Do NOT substitute a model's own estimate of stakeholder behaviour." —…the full check note: a genuine patient-behavior claim, correctly routed; no primary research exists in this repo. Stays unconfirmed permanently absent one. Deck-surfaced assumption (desirability deck, 2026-09-14)
Women prescribed a home intravaginal NMES device consent to their adherence and EMG-trend data being transmitted from the companion app to their prescribing clinician, and keep the app paired for the duration of the course
jurisdiction: US — confidence: unconfirmed — source: adoption "<claim text>" --jurisdiction US → unverifiable: "asserts what clinicians, payers, or patients would do..." — note: a genuine patient-behavior/consent claim, correctly routed; no primary research exists in this repo. Stays unconfirmed permanently absent…the full check one. Deck-surfaced assumption (desirability deck, 2026-09-14)
Women using a home pelvic floor NMES device observe a reduction in incontinence episodes within the first four weeks of use, early enough to sustain the twelve-week course a treatment effect would require
jurisdiction: US — confidence: unconfirmed — source: adoption "<claim text>" --jurisdiction US → unverifiable: "asserts what clinicians, payers, or patients would do..." — note: part clinical-efficacy, part patient-behavior claim; no connector or trial data specific to this (not-yet-built) device exists. The closest…the full check proxies already on record elsewhere in this file (PMID 25074260's InTone withdrawal rate, NCT03782116's ELITONE dropout data) are about different devices and themselves unconfirmed. Stays unconfirmed permanently absent primary research on this specific device. Deck-surfaced assumption (desirability deck, 2026-09-14)
A DME supplier or distributor will stock, dispense and bill a prescription home pelvic floor electrical stimulator that requires companion-app setup and ongoing data connectivity, rather than restricting its catalogue to stand-alone stimulators
jurisdiction: US — confidence: unconfirmed — source: adoption "<claim text>" --jurisdiction US → unverifiable: "asserts what clinicians, payers, or patients would do..." — note: a genuine distributor-behavior claim, correctly routed; no primary research exists in this repo. Stays unconfirmed permanently absent one.…the full check Deck-surfaced assumption (viability deck, 2026-09-14)
Prescribing urogynecology and pelvic floor PT practices will complete the prior-authorization documentation a commercial payer requires for a non-implanted pelvic floor electrical stimulator, rather than abandoning the prescription
jurisdiction: US — confidence: unconfirmed — source: adoption "<claim text>" --jurisdiction US → unverifiable: "asserts what clinicians, payers, or patients would do..." — note: a genuine clinician/practice-behavior claim, correctly routed; no primary research exists in this repo. Stays unconfirmed permanently…the full check absent one. Deck-surfaced assumption (viability deck, 2026-09-14)
The companion app, its data pathway and the EMG-gating firmware can be documented and validated to the FDA software and cybersecurity level a 510(k) for this device requires, without clinical data
jurisdiction: US — confidence: unconfirmed — source: adoption "<claim text>" --jurisdiction US → unverifiable: "asserts what clinicians, payers, or patients would do..." — note: mismatched tool — this is a software/cybersecurity regulatory-engineering feasibility claim (same shape as the bench-feasibility claims…the full check elsewhere in this file), not a stakeholder-preference claim, and no connector in this repo reaches FDA software/cybersecurity documentation-sufficiency questions. Genuinely unreachable here; needs a regulatory-affairs/software-QA read of FDA's software and cybersecurity guidance against this device's actual design. Deck-surfaced assumption (feasibility deck, 2026-09-14). Re-verification 2026-09-19 — the mismatched-tool note stands, the claim remains unreachable by any connector, and the tag stays unconfirmed; but the regulatory frame it would be documented against has changed and that is now on record. Two eCFR lookups, both recorded because the first is a real finding rather than a failed guess. regulation 820.30 --title 21 --expect "software" --jurisdiction US → refuted, source: eCFR versioner title-21, issue 2026-09-16: "There is no section 21 CFR 820.30 in the Code of Federal Regulations as of 2026-09-16. Part 820 of title 21 does exist, so this is a real finding about the section: either the citation is wrong, or the section was removed." The long-standing design-controls section every software-documentation plan in this space was written against no longer exists as a CFR section. What replaced it: regulation 820.10 --title 21 --expect "ISO 13485" --jurisdiction US → verified, same eCFR issue — "§ 820.10 Requirements for a quality management system. A manufacturer subject to this part... must: (a) Document. Document a quality management system that complies with the applicable requirements of ISO 13485 (incorporated by reference, see § 820.7)... (c) Design and development. Manufactu[rers]...". So design and software documentation now runs through ISO 13485 incorporated by reference, not through a free-standing FDA design-controls section. Residual, NOT verified — the entire assertion: what is verified is which regulation now governs, not that this candidate's app, data pathway and EMG-gating firmware can be documented to it. That is a regulatory-engineering feasibility judgement about a device that does not exist yet, made against FDA's premarket software-function and cybersecurity guidance documents, which this repo's regulation connector explicitly cannot reach (it serves regulation text only; guidance, enforcement practice and review precedent are out of scope). The "without clinical data" half is a review-outcome prediction and is further out of reach still. Two practical consequences a later pass should carry: ISO 13485 is a paywalled standard incorporated by reference and is not readable by any connector here, so even the governing text is only half-open; and any documentation-effort estimate written before the QMSR transition is now against a superseded framework and should be re-costed. Settling this still needs a regulatory-affairs/software-QA read, or an FDA pre-submission
Human-factors validation shows that cognitively intact adult women can set up and operate the intravaginal probe and its companion app at home, unsupervised, without critical use errors
jurisdiction: US — confidence: unconfirmed — source: adoption "<claim text>" --jurisdiction US → unverifiable: "asserts what clinicians, payers, or patients would do..." — note: mismatched tool — this is a human-factors/usability testing-outcome claim (same shape as the biocompatibility claim elsewhere in this…the full check file), not a stakeholder-preference claim, and no connector in this repo performs or reaches human-factors validation results. Genuinely unreachable here; needs the manufacturer's own IEC 62366 human-factors study, not a database lookup. Deck-surfaced assumption (feasibility deck, 2026-09-14)
In-clinic biofeedback service volume billed under CPT 90912 is not revenue a home-dispensed device can capture, because that payment attaches to a practitioner-rendered office or facility service rather than to a device the patient uses at home
jurisdiction: US — confidence: unconfirmed — source: rvu 90912 --jurisdiction US → verified (as a decomposition, not as this claim): "local cache of CMS PFS RVU (relative value unit) file, code=90912, year=2026" — 90912 carries a non-zero physician work RVU (0.9) plus practice-expense and malpractice RVUs, paying $82.17-$82.58…the full check non-facility / $37.41-$37.60 facility, confirming it is priced as a practitioner-time PFS service rather than a device-supply code. This directionally supports but does not fully establish the claim: the RVU decomposition shows 90912 is built around clinician work/site-of-service, which is consistent with the claim's premise, but whether a home-dispensed device is categorically barred from capturing that specific billing line is a CMS billing/place-of-service rule question (who may bill 90912 and under what circumstances), which is guidance/policy interpretation this connector does not reach — same scope limit as regulation on agency interpretation elsewhere in this file. Also note: the CPT 90912 descriptor itself is AMA-licensed and separately unconfirmed elsewhere in this file. Stays unconfirmed. Business-case assumption (2026-09-14)
The number of commercially insured women aged 45+ who would be dispensed a prescription home pelvic floor NMES device each year is materially larger than the 4,130 annual Medicare fee-for-service E0740 allowed units, and large enough to carry a standalone hardware business
jurisdiction: US — confidence: unconfirmed — source: market "<claim text>" --jurisdiction US → unverifiable: "Market-size claim... has no free, authoritative, machine-queryable source. Stays unconfirmed permanently unless a human attaches a licensed report..." — note: the anchor figure (4,130 Medicare FFS E0740…the full check allowed units, 2024) is itself already independently verified elsewhere in this file via procedures E0740, and carries its own standing caveat that it is a Medicare-FFS-only floor, excluding commercial/Medicaid/cash-pay. The comparative claim on top of that floor — that commercial volume is "materially larger" and "large enough" — has no connector reaching commercial-payer utilization or insurance-mix data in this repo (same structural gap as the payer-mix claim elsewhere in this file). Stays unconfirmed. Business-case assumption (2026-09-14)
A pelvic floor physical therapy or urogynecology practice's net revenue per patient episode is not reduced by prescribing a home device instead of retaining the patient for in-clinic biofeedback sessions
jurisdiction: US — confidence: unconfirmed — source: adoption "<claim text>" --jurisdiction US → unverifiable: "asserts what clinicians, payers, or patients would do..." — note: mismatched tool — this is a practice-revenue economics claim, not stakeholder preference per se, though it is adjacent to (and inherits the…the full check same non-answer as) the standing, unchecked assumption elsewhere in this file that prescribers will favor RTM billing over in-clinic revenue cannibalization. No connector in this repo reaches practice-level net-revenue-per-episode modeling. Stays unconfirmed. Business-case assumption (2026-09-14)
This device is dispensed to the patient as a DMEPOS item rather than furnished incident to an office visit, so no practice-expense RVU carries the device's cost and no site-of-care payment differential recovers it
jurisdiction: US — confidence: verified — source: rvu E0740 --jurisdiction US → literal connector status "refuted", source_ref "local cache of CMS PFS RVU file (not found), code=E0740": "No code E0740 in the cached CMS Physician Fee Schedule RVU file. It is not priced under the PFS — it may still be paid under OPPS,…the full check the ASC list or DMEPOS, none of which this connector reads." — note: read carefully rather than copied mechanically. This connector's "refuted" label is its generic answer whenever a code is absent from the PFS RVU file (i.e., its typical use tests "does code X have adequate PFS practice-expense RVU," and absence refutes that framing) — but this claim's own assertion is the mirror image: that no PFS practice-expense RVU exists for E0740 because it is billed DMEPOS, not PFS. The connector's finding — E0740 carries no PFS entry at all — is exactly what the claim as written requires, so the tag here is set to verified against the underlying fact the primary source establishes, not against the connector's generic status word. The DMEPOS-item premise is independently verified elsewhere in this file (payment E0740 → DMEPOS schedule, $74.52 national unadjusted, no facility/non-facility split), which also confirms the "no site-of-care payment differential" half: DMEPOS pricing is a flat national rate with no PFS-style site-of-service differential to apply in the first place. Business-case assumption (2026-09-14)
In Medicare fee-for-service data year 2024, HCPCS E0740 was furnished to 689 beneficiaries nationally, across 4,130 supplier services and 2,974 claims, billed by 28 suppliers and ordered by 553 referring providers
jurisdiction: US — confidence: verified — source: CMS "Medicare Durable Medical Equipment, Devices & Supplies — by Geography and Service", data year 2024 — dataset 27c150fd-8578-43b1-bba5-6388987e32af, file mup_dme_ry26_p05_v10_dy24_geor.csv; the CMS catalog (data.cms.gov/data.json, read 2026-09-19) records that…the full check distribution as data year 2024, temporal 2014-01-01/2024-12-31, modified 2026-07-23. National row retrieved 2026-09-19 from https://data.cms.gov/data-api/v1/dataset/27c150fd-8578-43b1-bba5-6388987e32af/data?filter[HCPCS_Cd]=E0740&filter[Rfrg_Prvdr_Geo_Lvl]=National — one row, returning Tot_Suplr_Benes 689, Tot_Suplr_Srvcs 4130, Tot_Suplr_Clms 2974, Tot_Suplrs 28, Tot_Rfrg_Prvdrs 553. All five figures match the claim exactly — evidence class 1 (registry fact) — note: the geography column in this release is Rfrg_Prvdr_Geo_Lvl (referring-provider geography), not the Rndrng_Prvdr_Geo_Lvl of the physician release. A replay filtered on the physician column name returns an empty array, which would read as a refutation when it is a wrong-column miss. No typed connector reaches this release:procedures E0740 --jurisdiction US → unconfirmed, "E0740 is a supplier-billed DMEPOS code, and the cached release (medicare_procedure_volumes.csv) covers physician-billed services … Nothing was looked up in either direction. This is a missing-file gap, not evidence that the code has no volume" (docs/backlog.md 1.13). So this claim is replayable by URL only and is invisible to recheck_claims.py. Verified 2026-09-19. Residual, NOT verified: Medicare fee-for-service only — the release excludes Medicare Advantage, commercial, Medicaid, VA and cash-pay, so 689 beneficiaries is a floor on US E0740 use and never a market size or a TAM input; and the row counts billing under code E0740 by any listed product, not use of a device resembling this candidate, so it establishes the code's utilization and nothing about this device's addressable population — re-check 2026-09-29, tag unchanged (verified): procedures E0740 --jurisdiction US → verified, "local cache of CMS Medicare DMEPOS utilization file (referring provider geography and service), code=E0740, geography=National": "rental 4,130 services / 689 beneficiaries … Medicare fee-for-service only … excludes Medicare Advantage, commercial, Medicaid, VA, and cash-pay … a rental service is typically one rental month, not one device". The typed connector now reaches this release (cache: data/medicare_dme_volumes.csv, from mup_dme_ry26_p05_v10_dy24_geor.csv per data/provenance.json, retrieved 2026-09-29), so the 2026-09-19 statement above that 'No typed connector reaches this release' is superseded as to reach, not as to result. It independently reproduces two of the five figures: 4,130 services and 689 beneficiaries, with the patient figure read against beneficiaries and not services. The connector detail does not print claims, suppliers or referring providers; the cached row carries 2,974 / 28 / 553, matching, but those three still rest on the 2026-09-19 URL read. Residuals above unchanged
The national average Medicare allowed amount for HCPCS E0740 in data year 2024 was $57.89 and the average Medicare payment amount $42.94, both below the $74.52 DMEPOS national unadjusted fee-schedule figure this candidate reasons from
jurisdiction: US — confidence: verified — source: CMS "Medicare Durable Medical Equipment, Devices & Supplies — by Geography and Service", data year 2024, dataset 27c150fd-8578-43b1-bba5-6388987e32af, file mup_dme_ry26_p05_v10_dy24_geor.csv; national row retrieved 2026-09-19 from…the full checkhttps://data.cms.gov/data-api/v1/dataset/27c150fd-8578-43b1-bba5-6388987e32af/data?filter[HCPCS_Cd]=E0740&filter[Rfrg_Prvdr_Geo_Lvl]=National — returns Avg_Suplr_Mdcr_Alowd_Amt 57.889305085 and Avg_Suplr_Mdcr_Pymt_Amt 42.940157385, i.e. $57.89 and $42.94 to the cent. Second operand checked with payment E0740 --jurisdiction US → unconfirmed: "No local cache at data/hcpcs_payment_rates.csv — payment rate for E0740 cannot be checked until it exists … Do not substitute a web search for this file" — evidence class 1 (registry fact) — note: tag split, and the split is the finding. The two realized figures are verified; the $74.52 they are compared against is not, in this pass. Per _shared/claim-grammar.md a half-checkable claim is not verified, so the line as written stays unconfirmed. The $74.52 enters this file through claim 10verified, tagged verified on a payment-connector lookup (unflagged invocation, recorded there without a jurisdiction argument) against data/hcpcs_payment_rates.csv; that cache is absent from data/ as of 2026-09-19 (the directory holds only fda_denovo.csv, medicare_procedure_volumes.csv, pfs_rvu.csv), so the comparison's second operand is currently unreplayable by any connector and this repo has no cached DMEPOS fee schedule at all. Same release-reading caution as claim 70verified: the geography column is Rfrg_Prvdr_Geo_Lvl, not Rndrng_Prvdr_Geo_Lvl, and this release is reachable by URL only — procedures E0740 --jurisdiction US → unconfirmed (physician-billed release, supplier-billed code), so recheck_claims.py will replay the payment-connector half of this line and nothing else. Checked 2026-09-19. Residual, NOT verified: (a) whether $74.52 is still the published DMEPOS national unadjusted rate, or was ever the rate for the 2024 data year these realized figures come from — claim 10verified's lookup is labelled schedule year 2026 against 2024 utilization, so the two numbers may not be commensurable in time either; (b) the comparison is not like-for-like even if both numbers are right.Avg_Suplr_Mdcr_Alowd_Amt is an average per service across 4,130 services for a code CMS flags as rentable (Suplr_Rentl_Ind = Y), so it blends rental-month lines with purchase lines, while $74.52 is a purchase-style national unadjusted rate for a complete system. Reading $57.89 as "the schedule rate is not being realized" is an inference the release does not support; it may equally reflect the rental mix. This is the part of the line that looks overstated and a human should re-word it before any score leans on it — re-check 2026-09-29, tag raised unconfirmed → verified: payment E0740 --jurisdiction US → verified, "local cache of CMS DMEPOS fee schedule, code=E0740, modifier=RR, schedule=DMEPOS, release=July 2026": "E0740 — RR (rental), category CR — capped rental items: non-rural $74.52 across 49 contiguous states/DC … Capped rental (CR): rented monthly, and title passes to the beneficiary after 13 continuous rental months (42 CFR 414.229)"; payment E0740 --modifier NU --jurisdiction US → unconfirmed: "E0740 is on the DMEPOS fee schedule (July 2026) but has no 'NU' line. Its lines are: RR."; procedures E0740 --jurisdiction US → verified, "local cache of CMS Medicare DMEPOS utilization file (referring provider geography and service), code=E0740, geography=National": "rental 4,130 services / 689 beneficiaries … Medicare fee-for-service only … excludes Medicare Advantage, commercial, Medicaid, VA, and cash-pay … a rental service is typically one rental month, not one device". The second operand is now answered by a typed connector, and the 2026-09-19 unconfirmed record above is kept as history. $57.89 and $42.94 are the 2024 national row's averages (cached row 57.889305085 / 42.940157385; the connector detail does not print them, so they rest on the 2026-09-19 URL read, which the cache matches), and both are below $74.52. Correction to the earlier residual (b): $74.52 is NOT a purchase-style rate for a complete system. It is the RR monthly rental fee, the only line E0740 carries, and all 4,130 of the 2024 services sit on the rental line, so the comparison is per rental month on both sides, like for like in unit. Residual, still NOT verified: (a) time: $74.52 is the July 2026 schedule against 2024 realized amounts, and the 2024 fee is not cached; (c) 'national unadjusted' is the earlier connector's label, not the DMEPOS schedule's: the schedule publishes per-state amounts, and $74.52 is E0740's ceiling and its non-rural fee in every state and DC except Puerto Rico ($89.44; floor $63.34). Nothing here says why realized averages sit below the fee
HCPCS E0740 is flagged as a rentable item in CMS's DME utilization release, so its service count exceeds its beneficiary count and a service count must not be read as a count of devices or of patients
jurisdiction: US — confidence: verified — source: CMS "Medicare Durable Medical Equipment, Devices & Supplies — by Geography and Service", data year 2024, dataset 27c150fd-8578-43b1-bba5-6388987e32af, file mup_dme_ry26_p05_v10_dy24_geor.csv; national row retrieved 2026-09-19 from…the full checkhttps://data.cms.gov/data-api/v1/dataset/27c150fd-8578-43b1-bba5-6388987e32af/data?filter[HCPCS_Cd]=E0740&filter[Rfrg_Prvdr_Geo_Lvl]=National — the row carries Suplr_Rentl_Ind = "Y", Tot_Suplr_Srvcs 4130 and Tot_Suplr_Benes 689, so services exceed beneficiaries by a factor of 6.0, and the release itself reports the two as separate columns. The CMS catalog entry (data.cms.gov/data.json, read 2026-09-19) describes the dataset as "information on usage, payments, and submitted charges organized by geography, Healthcare Common Procedure Coding System (HCPCS) code, and supplier rental indicator", which is what identifies the Suplr_Rentl_Ind field — evidence class 1 (registry fact) — note: same reach limit as claims 70 and 71 — procedures E0740 --jurisdiction US → unconfirmed (physician-billed release, supplier-billed code), so this is replayable by URL only, filtering on Rfrg_Prvdr_Geo_Lvl and not on the physician release's Rndrng_Prvdr_Geo_Lvl. Verified 2026-09-19. Residual, NOT verified: (a) the field-level definition of Suplr_Rentl_Ind. CMS's data dictionary and methodology pages for this release (data.cms.gov/resources/…-data-dictionary-0 and …-methodology) render client-side and returned a 2,974-byte JavaScript shell with no dictionary text to either curl or WebFetch on 2026-09-19, so "Y means the item is rentable" rests on the column name plus the catalog description, not on a retrieved definition; (b) the causal "so" is an inference, not a registry fact. The row establishes that the flag is Y and that services exceed beneficiaries; it does not establish that the rental flag is what produces the gap. Replacement supplies, multiple units per beneficiary and repeat dispensing would produce the same arithmetic, and the release carries nothing that separates them. The reading caution the claim draws — do not read 4,130 as 4,130 devices or 4,130 patients — holds regardless of which mechanism drives it, because Tot_Suplr_Benes 689 is the beneficiary count and it is a different number — re-check 2026-09-29, tag unchanged (verified): procedures E0740 --jurisdiction US → verified, "local cache of CMS Medicare DMEPOS utilization file (referring provider geography and service), code=E0740, geography=National": "rental 4,130 services / 689 beneficiaries … Medicare fee-for-service only … excludes Medicare Advantage, commercial, Medicaid, VA, and cash-pay … a rental service is typically one rental month, not one device"; payment E0740 --jurisdiction US → verified, "local cache of CMS DMEPOS fee schedule, code=E0740, modifier=RR, schedule=DMEPOS, release=July 2026": "E0740 — RR (rental), category CR — capped rental items: non-rural $74.52 across 49 contiguous states/DC … Capped rental (CR): rented monthly, and title passes to the beneficiary after 13 continuous rental months (42 CFR 414.229)". The typed connectors now reach both halves. Residual (a) above is narrowed: that E0740 is a rental item now rests on CMS's own fee schedule (category CR, capped rental, RR line only, no purchase line), not only on the column name, though the data-dictionary definition of Suplr_Rentl_Ind is still unretrieved. Residual (b) is narrowed: a capped-rental code is billed as one line per rental month, which accounts for services exceeding beneficiaries without any other mechanism being needed; the release still cannot rule the other mechanisms out
The PDAC has announced that all products currently listed on the PDAC Product Classification List under HCPCS E0740 will undergo a code re-review, with manufacturers notified to resubmit product information, and the article states no deadline and no consequence
jurisdiction: US — confidence: unconfirmed — source: no typed connector in this repo reaches a DME MAC article. The cited document is a Noridian JD DME article, "PDAC Code Review — E0740 Non-Implantable Pelvic Floor Electrical Stimulator"…the full check (med.noridianmedicare.com/web/jddme/policies/dmd-articles/pdac-code-review-e0740-non-implantable-pelvic-floor-electrical-stimulator), last updated 2023-11-10. coverage E0740 --jurisdiction US → unconfirmed: "No local cache at data/medicare_coverage_policies.csv — Medicare coverage policy for E0740 cannot be checked until it exists … Do not substitute a web search for this file" — and that lookup could not have answered this line even with the file, because the coverage connector is code-keyed and returns whether a policy names a code, never the text of a named article (docs/backlog.md 1.19, the same gap recorded for idea-018 claim 12unconfirmed and idea-017's L33800 (a Medicare local coverage determination number)/A52517). the ncd connector is section-keyed against the NCD Manual and does not serve local coverage or PDAC notices at all — evidence class 1 (registry fact) — note: left unconfirmed deliberately rather than resolved by web search. Per .claude/agents/verifier.md, a model-summarised retrieval is an opinion about a search result and cannot issue a tag; the only thing established here mechanically is that the URL is live (HTTP 200, 145,586 bytes, 2026-09-19), which is reachability and not evidence for a single word of the assertion. Checked 2026-09-19. Residual, NOT verified: (a) that the PDAC announced a re-review at all, its scope ("all products currently listed"), the manufacturer-resubmission instruction, and the two asserted absences (no deadline, no consequence) — an absence is the hardest thing to establish from a document and none of it has been read here by any instrument that can carry a tag; (b) currency. The article's stated last-update is 2023-11-10, roughly three years before this pass, and a document existing is not a process still running — a re-review announced then may have concluded, lapsed, or already relisted the products, and this line's present tense would then be wrong without the document having changed. What would settle it: a coverage connector that accepts an article identifier (backlog 1.19), or a human attaching the current PDAC Product Classification List entry for E0740
Aetna Clinical Policy Bulletin 0223 states no prior failed pelvic muscle exercise trial requirement and no minimum trial duration for intravaginal pelvic floor electrical stimulation, unlike Medicare NCD 230.8 which conditions coverage on a documented four-week failure
jurisdiction: US — confidence: verified — source: two sources, one per half. (1) Aetna CPB No. 0223, "Urinary Incontinence" — cold re-retrieval 2026-09-19 from https://www.aetna.com/cpb/medical/data/200_299/0223.html (HTTP 200, 514,124 bytes), server-rendered HTML reduced to 424,549 characters of text and searched…the full check mechanically over the whole document, not read in extract. The bulletin's only policy statement on this therapy is, in full: "Intravaginal Electrical Stimulation — Aetna considers intravaginal electrical stimulation of the pelvic floor medically necessary for women with stress, urgency or mixed urinary incontinence." That sentence is the entire coverage position: it is scoped by indication and sex only, and states no prior-therapy precondition and no duration. Corroborating counts over the whole document: "four-week" 0, "four week" 0, the single "4-week" hit is a wound-healing interval in an eCoin implant study in the background section, and all three "pelvic muscle exercise" hits are background prose or a PTNS comparison, none of them a condition on this therapy. (2) Medicare NCD 230.8 — ncd 230.8 --expect "4 weeks of an ordered plan of pelvic muscle exercises" --jurisdiction US → verified, CMS Pub. 100-3 Medicare NCD Manual, chapter 1 part 4 (Rev. 13808, issued 05-29-26), section 230.8, whose text reads "covered for the treatment of stress and/or urge urinary incontinence in cognitively intact patients who have failed a documented trial of pelvic muscle exercise (PME) training. A failed trial of PME training is defined as no clinically significant improvement in urinary continence after completing 4 weeks of an ordered plan of pelvic muscle exercises designed to increase periurethral muscle strength." — evidence class 2 (published finding) — note: tagged on _shared/evidence-classes.md, which gives class 2 the same four-tag vocabulary and names its check as "a cold re-retrieval by someone who did not draft it" — that is what was done, and the absence half is a mechanical full-text search rather than a model reading, which is the only form in which an absence can carry a tag. corroborated is a proposed fifth tag and is not live, so it was not used. Note also that the NCD writes the interval as "4 weeks", not "four weeks": an --expect "four weeks" run returns unconfirmed on spelling alone, which is why the recorded invocation uses the manual's own wording. Verified 2026-09-19. Residual, NOT verified: (a) the Aetna half is an absence, and an absence is only as good as the retrieval. It rests on one fetch of one URL on one date; the bulletin carries no version number or effective date on the retrieved page, so there is no identifier by which a later reader can confirm they are looking at the same text. (b) The coding tables complicate the picture without contradicting it: E0740 appears three times — once under "Pelvic Floor Stimulation / HCPCS codes covered if selection criteria are met", once in a not covered table attached to high-intensity focused electromagnetic therapy, and once under "Pelvic Muscle Trainers" annotated "[not covered for Athena pelvic muscle trainer]". The phrase "if selection criteria are met" points at criteria stated elsewhere in the bulletin, and the only criteria stated are the indication and sex in the sentence quoted above — but a human reading this for a payer strategy should read those tables directly. (c) What the contrast means commercially — that a commercial payer's looser precondition is an accessible route for this device — is inference, not evidence, and is not tagged here
Aetna Clinical Policy Bulletin 0223 contains no cross-reference to Medicare NCD 230.8 and does not distinguish home-use from in-office pelvic floor electrical stimulation
jurisdiction: US — confidence: verified — source: Aetna CPB No. 0223, "Urinary Incontinence", cold re-retrieval 2026-09-19 from https://www.aetna.com/cpb/medical/data/200_299/0223.html (HTTP 200, 514,124 bytes; 424,549 characters of extracted text), searched mechanically over the whole document. **Counts: "230.8" 0,…the full check "NCD" 0 as a whole word, "national coverage determination" 0, "CMS" 0, "Centers for Medicare" 0.** On the second half: the bulletin's single policy statement on this therapy — "Aetna considers intravaginal electrical stimulation of the pelvic floor medically necessary for women with stress, urgency or mixed urinary incontinence" — names no site of care, and every one of the 17 "home" occurrences in the document sits in the background literature review or the reference list (home PFMT comparator arms in the Weinstein trials, at-home tibial nerve stimulation, the Indrekvam "home-managed electrical stimulation" citation), never in a coverage statement — evidence class 2 (published finding) — note: tagged on _shared/evidence-classes.md, which gives class 2 the four-tag vocabulary and names its check as a cold re-retrieval by someone who did not draft it; the absences here are mechanical full-text counts, not a model's reading of an extract, which is the only form in which an absence can carry a tag. Verified 2026-09-19. Residual, NOT verified: (a) "no cross-reference to NCD 230.8" is not "no reference to Medicare". The bulletin does cite Medicare material elsewhere — Palmetto GBA LCD L39543 for sacral nerve stimulation appears in the references, and one further "Medicare" hit is Australia's Medicare Services Advisory Committee, which is not CMS at all. The claim as written is exact; a reader must not widen it into "Aetna ignores Medicare policy". (b) Silence on site of care is not permission for home use. The absence of a home/in-office distinction establishes that the bulletin does not draw one; whether a home-dispensed device is therefore payable under this bulletin is a benefit-design and DME-administration question the document does not reach — and Medicare's own NCD 230.8, by contrast, does mention that stimulation parameters vary "between clinic and home settings" while still not conditioning coverage on site. (c) Same retrieval caveat as claim 74verified: one fetch, one date, and the bulletin carries no version identifier on the retrieved page
Cigna removed pelvic floor electrical stimulation from Medical Coverage Policy 0160 in its 2025-01-15 revision, and HCPCS E0740 appears nowhere in that policy's current 2026-09-15 version, so Cigna's current coverage position on the therapy is not established by that document
jurisdiction: US — confidence: verified — source: Cigna Medical Coverage Policy 0160, "Electrical Stimulation Therapy and Devices in a Home Setting", cold re-retrieval 2026-09-19 from https://static.cigna.com/assets/chcp/pdf/coveragePolicies/medical/mm_0160_coveragepositioncriteria_electrical_stimulators.pdf (HTTP…the full check 200, 898,354 bytes), 77 pages extracted with pypdf 6.19.0 to 279,768 characters and searched mechanically over the whole document. The document's own header reads "Effective Date 9/15/2026 · Next Review Date 9/15/2027 · Coverage Policy Number 0160", which fixes the version. "E0740" occurs 0 times in all 77 pages (E0731 and E0745 do occur, so the coding tables were extracted and the zero is a real absence, not a failed extraction). The Revision Details table on page 77 carries a 1/15/2025 entry reading "Removed the following therapies/devices from the policy statement: auricular electroacupuncture; cranial electrical stimulation; pelvic floor electrical stimulation; transcutaneous electrical joint stimulation." The two remaining "pelvic" hits in the document are a 2008 Demirtürk RCT (randomised controlled trial) summary in the background section and a pelvic-floor-strength outcome measure — neither is a coverage statement — evidence class 2 (published finding) — note: tagged on _shared/evidence-classes.md, which gives class 2 the four-tag vocabulary and names its check as a cold re-retrieval by someone who did not draft it; both halves here are mechanical full-text findings against the payer's own current PDF, and the revision entry is a positive statement by Cigna rather than an inference from silence. Replayable by URL only — no typed connector in this repo reaches a commercial payer's coverage policy, and the coverage connector is code-keyed against a CMS index that is in any case absent from data/. Verified 2026-09-19. Residual, NOT verified: (a) removal from this policy is not a coverage position, in either direction. The claim is correctly worded as "not established by that document", and it must stay that way — Cigna may address the therapy in another policy, in plan documents, or through case-by-case review, and policy 0160's own "Related Coverage Resources" list names Physical Therapy and "Electric Stimulation for Pain, Swelling and Function in a Clinic Setting" among others, none of which was retrieved here. (b) Why it was removed is not stated by the revision table and is not established: removal from a noncoverage statement and removal from a coverage statement look identical in that table, and the 1/15/2025 entry shows both an "Added … to the noncoverage policy statement" list and a "Removed … from the policy statement" list, so a reader cannot infer from it that Cigna's stance softened. (c) Currency is good but bounded — effective 2026-09-15, four days before this check, with next review 2027-09-15
CMS Transmittal R11118CP (Change Request 12446) scopes the Remote Therapeutic Monitoring device-supply codes to two body systems only, respiratory and musculoskeletal, and a full-text search of that transmittal for pelvic, genitourinary, urologic, bladder, continence and incontinence returns no occurrence, so CMS neither includes nor excludes pelvic floor muscle status
jurisdiction: US — confidence: verified — source: CMS Pub. 100-04 Medicare Claims Processing, Transmittal 11118, Change Request 12446, "2022 Annual Update to the Therapy Code List", dated November 10, 2021, effective 2022-01-01, implementation 2022-01-03. Retrieved 2026-09-19 from…the full checkhttps://www.cms.gov/files/document/r11118cp.pdf (HTTP 200, 263,074 bytes), 4 pages, all four text-bearing with zero embedded images — i.e. a real text layer, not a scan — extracted with pypdf 6.19.0 to 11,049 characters and searched case-insensitively over the whole document. Counts: pelvic 0, genitourinary 0, urolog 0, bladder 0, continence 0, incontinence 0; respiratory 4, musculoskeletal 4. The transmittal's Business Requirement 12446.2 names five codes (98975, 98976, 98977, 98980, 98981) and the two device-supply codes among them are scoped one to the respiratory system and one to the musculoskeletal system, which is the "two body systems only" the claim asserts. The CPT long descriptors printed in the transmittal are AMA-licensed and are deliberately not reproduced here (docs/phase2-spec.md §3) — code numbers and body-system scope only. CMS's own prose, quotable, reads: "CMS considers these CPT codes remote therapeutic monitoring (RTM) services that physical therapists (PTs), occupational therapists (OTs), and speech-language pathologists can furnish, when appropriate." — evidence class 1 (registry fact) — note: no typed connector reaches a CMS manual transmittal. The policy connector serves the Federal Register and a Pub. 100-04 transmittal never appears there; a CR has no FR document number. So this claim is replayable by URL only and is invisible to recheck_claims.py. The full-text-absence finding is a mechanical count over the extracted text, not a model reading, which is why it can carry a tag where claims 73-76 cannot. Verified 2026-09-19. Residual, NOT verified: (a) what the silence means is not established by the silence. The transmittal says nothing about pelvic floor muscle status; whether pelvic floor status is already inside "musculoskeletal system" for coding purposes is an AMA/CMS coding judgment and this document does not answer it either way. The claim is careful to say "neither includes nor excludes" and that reading is sound, but it must not be carried downstream as CMS having considered and permitted the indication; (b) currency. This is the CY2022 annual therapy-code update, dated 2021-11-10, now nearly five years old. It establishes the RTM device-supply scope as of that update and nothing about subsequent annual updates, later CRs, or PFS rulemaking since — a document existing is not a policy still operating in the form it was issued. Any use of this line as a statement of RTM scope today needs the current-year therapy code list as a second source
Women with stress urinary incontinence accept a prescription intravaginal home stimulator as a first-line offer, without first attempting and failing a pelvic muscle exercise programme, where the payer's medical policy imposes no prior-exercise-trial requirement
jurisdiction: US — confidence: unconfirmed — note: Verifier pass 2026-09-29. Class-3 stakeholder-future claim; the adoption connector refuses it by design and no Verifier opinion is substituted. The payer-policy fact the line is conditioned on (Aetna CPB 0223 states no prior-PME requirement) is claim 74verified, a policy…the full check fact, not evidence of patient acceptance. — source: adoption "<claim text>" → unverifiable: "asserts what clinicians, payers, or patients would do. No free, authoritative, machine-queryable source answers that — it needs primary research (interviews, survey, published preference study)" (the adoption subcommand takes no --jurisdiction flag) — origin: deck-surfaced assumption (desirability deck, 2026-09-19) — never checked; recorded so the Verifier can see it — evidence class 3 (stakeholder future)
A commercially insured woman whose health plan publishes no medical policy on pelvic floor electrical stimulation still takes delivery of a prescribed home stimulator rather than abandoning it while coverage is decided case by case
jurisdiction: US — confidence: unconfirmed — note: Verifier pass 2026-09-29. Class-3 stakeholder-future claim; the adoption connector refuses it by design and no Verifier opinion is substituted. No connector reaches commercial plan-level dispensing or abandonment behaviour. — source: adoption "<claim text>" →…the full check unverifiable: "asserts what clinicians, payers, or patients would do. No free, authoritative, machine-queryable source answers that — it needs primary research (interviews, survey, published preference study)" (the adoption subcommand takes no --jurisdiction flag) — origin: deck-surfaced assumption (desirability deck, 2026-09-19) — never checked; recorded so the Verifier can see it — evidence class 3 (stakeholder future)
A woman prescribed a home pelvic floor electrical stimulator dispensed under a rental arrangement sustains a recurring monthly patient cost share for the full twelve-week course rather than returning the device early
jurisdiction: US — confidence: unconfirmed — note: Verifier pass 2026-09-29. Class-3 stakeholder-future claim; the adoption connector refuses it by design and no Verifier opinion is substituted. The rental structure the line presumes is registry-checkable and is claim 82verified (verified this pass: E0740 is a capped-rental,…the full check RR-only code in Medicare); the patient's cost-share persistence is not. — source: adoption "<claim text>" → unverifiable: "asserts what clinicians, payers, or patients would do. No free, authoritative, machine-queryable source answers that — it needs primary research (interviews, survey, published preference study)" (the adoption subcommand takes no --jurisdiction flag) — origin: deck-surfaced assumption (desirability deck, 2026-09-19) — never checked; recorded so the Verifier can see it — evidence class 3 (stakeholder future)
Commercial payers whose medical policies impose no prior failed pelvic-muscle-exercise requirement for intravaginal pelvic floor electrical stimulation cover a material share of commercially insured US women aged 45 and over with stress urinary incontinence
jurisdiction: US — confidence: unconfirmed — note: Verifier pass 2026-09-29. Market/coverage-share claim: no connector reaches commercial enrolment by plan or the share of plans by policy content. The one policy fact under it (Aetna CPB 0223, no prior-PME requirement) is claim 74verified; Cigna's current position is not…the full check established (claim 76verified). 'Material share' is not a registry quantity. — source: market "<claim text>" → unverifiable: "has no free, authoritative, machine-queryable source. Stays unconfirmed permanently unless a human attaches a licensed report" (the market subcommand takes no --jurisdiction flag) — origin: deck-surfaced assumption (viability deck, 2026-09-19) — never checked; recorded so the Verifier can see it
Payment for a home pelvic floor electrical stimulator billed under HCPCS E0740 is realized across monthly rental lines rather than at a single point of sale, under the DMEPOS payment category the code sits in
jurisdiction: US — confidence: verified — note: Verifier pass 2026-09-29. Verified for Medicare fee-for-service: E0740 carries a single RR (rental) line in capped-rental category CR and no purchase line (no NU, no UE), and 42 CFR 414.229 prices capped-rental items as a monthly rental fee schedule amount with title…the full check passing after 13 continuous rental months, so Medicare payment is realized across monthly rental lines and not at a single point of sale. The realized book agrees: all 4,130 of E0740's 2024 services sit on the rental line, across 689 beneficiaries (about 6.0 rental months each). Residual, NOT verified: (a) the 'DMEPOS payment category' is Medicare's classification, and commercial plans' DME benefit terms are not reached; (b) the fee is an allowed amount and not the payment, and it varies by state (Puerto Rico $89.44; floor $63.34) — source: payment E0740 --jurisdiction US → verified, "local cache of CMS DMEPOS fee schedule, code=E0740, modifier=RR, schedule=DMEPOS, release=July 2026": "E0740 — RR (rental), category CR — capped rental items: non-rural $74.52 across 49 contiguous states/DC … Capped rental (CR): rented monthly, and title passes to the beneficiary after 13 continuous rental months (42 CFR 414.229)"; payment E0740 --modifier NU --jurisdiction US → unconfirmed: "E0740 is on the DMEPOS fee schedule (July 2026) but has no 'NU' line. Its lines are: RR."; regulation 414.229 --title 42 --expect "monthly fee schedule amount" --jurisdiction US → verified, eCFR versioner title-42, issue 2026-08-13, section=414.229 ("§ 414.229 Other durable medical equipment—capped rental items"); regulation 414.229 --title 42 --expect "13 continuous rental months" --jurisdiction US → verified, same source_ref; procedures E0740 --jurisdiction US → verified, "local cache of CMS Medicare DMEPOS utilization file (referring provider geography and service), code=E0740, geography=National": "rental 4,130 services / 689 beneficiaries … Medicare fee-for-service only … excludes Medicare Advantage, commercial, Medicaid, VA, and cash-pay … a rental service is typically one rental month, not one device"; hcpcs E0740 --jurisdiction US → verified, "local cache of CMS HCPCS Level II file, code=E0740": "HCPCS E0740: Non-implanted pelvic floor electrical stimulator, complete system" — origin: deck-surfaced assumption (viability deck, 2026-09-19) — never checked; recorded so the Verifier can see it
The device's stimulation output envelope - amplitude, pulse width, frequency, duty cycle and session length - can be specified within ranges already cleared for KPI / 21 CFR 876.5320 devices
jurisdiction: US — confidence: unconfirmed — note: Verifier re-attempt 2026-10-01, clearance-summary now runs (the 2026-09-29 import crash was an environment fault, not a finding). Checked against the frontmatter intended_use as it stands on 2026-10-01 ("The device is indicated for the treatment of stress urinary…the full check incontinence in cognitively intact adult women in the home setting, by prescription, following a documented failed four-week trial of pelvic muscle exercise training."). NOW CHECKED: the cleared output envelope of the InTone family is read from K150180's own 510(k) summary, Table 7.3 (KPI/HIR, 21 CFR 876.5320): monophasic alternating-polarity square pulses; 50 Hz and 13 Hz; 200 µs/phase; cycle 1 s at 50 Hz / 2 s off / 2 s at 13 Hz / 2 s off, repeating; session approximately 12 min (2 min volitional contractions, 5 min stimulation, 5 min volitional contractions); max 40 Vdc / 80 mA / 16 µC phase charge at 500 Ω; regulated voltage, one channel. The same table gives its predicates: K110179 InTone (50 Hz, 200 µs/phase, 20 s on / 10 s off, 12 min, 50 Vdc / 100 mA / 20 µC) and K134020 InToneMV (50 Hz + 13 Hz, 200 µs/phase, 50 Vdc / 100 mA / 20 µC). STILL OPEN: (a) the rest of the pool — K133826's public summary defers technical characteristics to a 'Section 12' that is not in the posted PDF, and K121820 (InWave) has no 510(k) summary posted at all (letter and IFU page only), so the envelope is known for the InControl InTone family, not the KPI pool; (b) 'can be specified within' is a design assertion about an envelope this file has not specified, which no source answers, and claim 101unconfirmed's envelope is itself unconfirmed. — source: clearance-summary K150180 --jurisdiction US → verified, FDA 510(k) summary K150180 (https://www.accessdata.fda.gov/cdrh_docs/pdf15/K150180.pdf), full text read for Table 7.3; clearance-summary K133826 --jurisdiction US → verified (IFU only; no output parameters in the posted summary); clearance-summary K121820 --jurisdiction US → verified (IFU page only; no summary in the PDF) — origin: deck-surfaced assumption (feasibility deck, 2026-09-19) — never checked; recorded so the Verifier can see it
An intravaginal probe supplied under a rental-flagged HCPCS code can be built as a single-patient-use component of a returnable system, so that no probe is reprocessed between patients
jurisdiction: US — confidence: unconfirmed — note: Verifier pass 2026-09-29. Design/manufacturing-feasibility assertion; no connector reaches it. A registry fact bears on the premise without testing it: E0740's HCPCS descriptor is 'complete system' and it is a capped-rental code (claim 82verified), so whether a…the full check single-patient-use probe can be supplied inside a rented complete system, and who bears its cost, is a DME coding question (PDAC, supplier billing) that this pass does not answer. — source: hcpcs E0740 --jurisdiction US → verified, "local cache of CMS HCPCS Level II file, code=E0740": "HCPCS E0740: Non-implanted pelvic floor electrical stimulator, complete system" (bears on the premise only; does not test the claim) — origin: deck-surfaced assumption (feasibility deck, 2026-09-19) — never checked; recorded so the Verifier can see it
A design that avoids the issued claims of US10307589, US10646711, US11724100 and US11865337 retains EMG-triggered closed-loop control of pelvic floor stimulation rather than removing it
jurisdiction: US — confidence: unconfirmed — note: Verifier pass 2026-09-29. Design-around/FTO assertion. patent returns filing and naive-expiry dates only and never reads claims, so no connector can test whether a design avoids a patent's issued claims; an FTO opinion is Tier 3 legal work. The four numbers were…the full check deliberately not run, because a date result would be recorded against a question it does not answer. — source: no typed connector reaches this claim and none was invoked — origin: deck-surfaced assumption (feasibility deck, 2026-09-19) — never checked; recorded so the Verifier can see it
Medicare Advantage rather than Medicare fee-for-service accounts for a majority of US Medicare beneficiaries, so the commercially insured share of the diagnosed stress urinary incontinence population in women aged 45 and over cannot be derived as the complement of the Medicare fee-for-service population from which the 689-beneficiary HCPCS E0740 count is drawn
jurisdiction: US — confidence: unconfirmed — note: Verifier pass 2026-09-29. No connector in this repo reaches Medicare enrolment by program (Medicare Advantage vs fee-for-service). procedures states the FFS-only exclusion but carries no enrolment split. The inference half (the commercial share cannot be derived as…the full check a complement) follows only if the premise holds, and is a method point, not a fact. — source: no typed connector reaches this claim and none was invoked; procedures E0740 --jurisdiction US confirms only that the 689 figure is Medicare FFS-only — origin: condition C1 from the commercial position (2026-09-19) — stated by a chair, never checked; recorded so the Verifier can see it
The average Medicare fee-for-service allowed amount per beneficiary for HCPCS E0740 in data year 2024 is approximately 347 dollars - 4,130 supplier services at an average allowed amount of 57.89 dollars per service, divided by 689 beneficiaries - so the revenue unit for a rental-flagged DMEPOS code is allowed amount per beneficiary per year rather than the per-service average or the DMEPOS national unadjusted schedule amount
jurisdiction: US — confidence: unconfirmed — note: Verifier pass 2026-09-29. The arithmetic is exact: 4,130 × 57.889305085 ÷ 689 = 346.9998, about $347. Inputs: 4,130 services and 689 beneficiaries re-verified today by procedures E0740 (rental line); 57.889305085 is the Avg_Suplr_Mdcr_Alowd_Amt of the same 2024…the full check national row (claim 71verified), which the connector detail does not print. NOT verified: that allowed amount per beneficiary per year is 'the' revenue unit, a modelling choice no source settles. Two registry facts inform it: $74.52 is a monthly RR rental fee, so it is a per-month and not a per-device figure (claim 82verified), and 4,130 ÷ 689 = 6.0 rental months per beneficiary in 2024. 'Per year' is a data-year aggregate, and a rental spanning two data years splits across them. — source: procedures E0740 --jurisdiction US → verified, "local cache of CMS Medicare DMEPOS utilization file (referring provider geography and service), code=E0740, geography=National": "rental 4,130 services / 689 beneficiaries … Medicare fee-for-service only … excludes Medicare Advantage, commercial, Medicaid, VA, and cash-pay … a rental service is typically one rental month, not one device" — origin: condition C2 from the commercial position (2026-09-19) — stated by a chair, never checked; recorded so the Verifier can see it
A money model that counts no remote-therapeutic-monitoring revenue and no biofeedback service revenue, leaving only the device line billed under HCPCS E0740 or its commercial equivalent, supports a standalone hardware business at the unit volumes the commercially insured population would produce
jurisdiction: US — confidence: unconfirmed — note: Verifier pass 2026-09-29. Financial-model conclusion; no connector reaches commercial unit volumes or margins. Registry facts that bear on it, not settle it: the only Medicare line is a capped-rental monthly fee (claim 82verified), and the 2024 Medicare FFS floor is 689…the full check beneficiaries (claim 70verified). — source: market "<claim text>" → unverifiable: "has no free, authoritative, machine-queryable source. Stays unconfirmed permanently unless a human attaches a licensed report" (the market subcommand takes no --jurisdiction flag) — origin: condition C3 from the commercial position (2026-09-19) — stated by a chair, never checked; recorded so the Verifier can see it
This candidate's intended use, by requiring a documented failed four-week trial of pelvic muscle exercise training, restricts the population the device may be sold to below the population its best-evidenced commercial payer medical policy would cover, because that policy conditions coverage on indication and sex alone
jurisdiction: US — confidence: unconfirmed — note: Verifier pass 2026-09-29. checked against the frontmatter intended_use as it stands on 2026-09-29 ("treatment of stress urinary incontinence in cognitively intact adult women in the home setting, by prescription, following a documented failed four-week trial of pelvic…the full check muscle exercise training"). The two document halves hold: this intended_use is SUI-only and requires a documented failed four-week PME trial, and Aetna CPB 0223's only policy sentence covers 'stress, urgency or mixed urinary incontinence' in women with no prior-therapy precondition (claim 74verified, verified 2026-09-19 by cold re-retrieval; not re-fetched this pass). So the intended-use population is a subset of that policy's. NOT verified: (a) 'restricts the population the device may be sold to' — a cleared indication constrains labelling and promotion, and whether it restricts sale or prescription is an FDA-interpretation question no connector reaches; (b) 'best-evidenced commercial payer medical policy' is a ranking, not a fact. — source: no typed connector reaches this claim and none was invoked; relies on claim 74verified's recorded retrieval and this file's frontmatter — origin: condition C4 from the commercial position (2026-09-19) — stated by a chair, never checked; recorded so the Verifier can see it
A prescription home pelvic floor electrical stimulator reaches a commercially insured patient through the same DMEPOS supplier channel that bills Medicare, so the 28 suppliers and 553 referring providers recorded against HCPCS E0740 in Medicare fee-for-service data year 2024 describe the national size of the channel a launch must be dispensed through rather than only its Medicare-billing subset
jurisdiction: US — confidence: unconfirmed — note: Verifier pass 2026-09-29. The release is Medicare fee-for-service only by construction, so the 28 suppliers and 553 referring providers are those with Medicare FFS E0740 claims in 2024 (both are in the cached national row; the connector detail does not print them).…the full check The release cannot show whether a commercial-only dispensing channel exists, so it neither establishes nor refutes the claim's reading of those counts as the national channel. That reading rests entirely on the unchecked premise that commercial patients are dispensed through the same suppliers. — source: procedures E0740 --jurisdiction US → verified, "local cache of CMS Medicare DMEPOS utilization file (referring provider geography and service), code=E0740, geography=National": "rental 4,130 services / 689 beneficiaries … Medicare fee-for-service only … excludes Medicare Advantage, commercial, Medicaid, VA, and cash-pay … a rental service is typically one rental month, not one device" — origin: condition C5 from the commercial position (2026-09-19) — stated by a chair, never checked; recorded so the Verifier can see it
No randomised comparison of closed-loop EMG-gated intravaginal electrical stimulation against open-loop intravaginal electrical stimulation in women with stress urinary incontinence exists in the published literature or in the ClinicalTrials.gov trials registry, so the margin claim 33unconfirmed asserts has never been measured in any population
jurisdiction: US — confidence: unconfirmed — note: **checked 2026-09-19, including the specific near-miss the chair's own sweeps missed. The claim SURVIVES as worded: the one randomised trial of sEMG-triggered intravaginal stimulation in SUI is sham-controlled, not open-loop-controlled. Tag is unconfirmed because an…the full check absence cannot be established by term-matched sweeps that return ScanResults, not because anything was found against it.** — source: The recorded correction is confirmed and the chair's sweep was indeed token-blind.literature “EMG-triggered electrical stimulation stress urinary incontinence” --since 30y --limit 15 → status none; literature “sEMG-triggered electrical stimulation” --since 30y --limit 15 → status found, 2 records. The hyphenated token is the whole difference, exactly as docs/backlog.md records. PMID 42190320 read in full at abstract depth and its comparator is SHAM.literature-detail 42190320 → ScanResult found, source_ref PubMed PMID=42190320 (efetch), https://pubmed.ncbi.nlm.nih.gov/42190320/ — European Journal of Obstetrics, Gynecology, and Reproductive Biology 2026, “Pelvic muscle training and electrostimulation to treat weak pelvic floor: a multicentre-randomised parallel group trial” (Randomized Controlled Trial, Multicenter Study). Verbatim AIM: “To determine whether adding sEMG-triggered intravaginal electrical stimulation to supervised PFMT improves PFM strength and continence outcomes compared with PFMT plus sham stimulation in women with SUI and very weak PFMs.” Verbatim METHODS: 42 women allocated to “(1) PFMT + sEMG-triggered electrical stimulation, or (2) PFMT + placebo stimulation”, double-blind, supervised 3×/week for 10 weeks. So the comparator is inactive placebo stimulation, not active open-loop stimulation, and this trial measures the gated modality against nothing rather than against its ungated form. It does not measure the margin claim 33unconfirmed asserts. Registry half, swept this pass.trials --condition “stress urinary incontinence” --intervention “EMG-triggered electrical stimulation” --since 30y --limit 25 → found, total 1: NCT06419517, which is the registration of PMID 42190320 above (“Pelvic Muscle Training and Electrostimulation to Treat Weak Pelvic Floor”, COMPLETED, Azienda Unità Sanitaria Locale di Piacenza). trials --condition “stress urinary incontinence” --intervention “closed-loop electrical stimulation” --since 30y → status none. --intervention “biofeedback electrical stimulation” → found, 5 (NCT05531071, NCT03875196, NCT01763762, NCT07792031, NCT05272644) — none a closed-loop-versus-open-loop comparison on inspection of titles. --intervention “intravaginal electrical stimulation” → found, 2 (NCT07792031, NCT07466537). The only one worth opening, trial-detail NCT07792031 → found, is not on point: electromagnetic chair therapy versus standard electrostimulation-plus-biofeedback in mixed UI, NOT_YET_RECRUITING, hasResults=false, enrollment 58 ESTIMATED — a different-modality non-inferiority study, not a gating comparison. One further lead checked and discarded. The second record from the sEMG-triggered sweep, literature-detail 21509105, is “Effectiveness of surface electromyographic biofeedback-triggered neuromuscular electrical stimulation on knee rehabilitation” (NAJSPT 2009) — wrong anatomy, and its comparator is an exercise-only group, not open-loop NMES. So even the “in any population” half of this claim is not broken by the nearest orthopaedic analogue: that literature also compares triggered stimulation against no stimulation rather than against ungated stimulation. Residual, NOT verified: (a) This is an absence claim answered by term-matched sweeps, which cannot establish absence. Every lookup above returns a ScanResult (found/none/unavailable), a vocabulary with no confidence tag and no to_claim_line() (connectors/result.py), and this pass has just demonstrated on this very claim how a one-token difference turns none into found. A none here means “these strings matched nothing”, never “no such trial exists”. (b) One sweep failed outright and is not a negative result:literature “biofeedback-triggered stimulation versus stimulation alone incontinence” --since 30y → status unavailable — the source could not be queried, which per connectors/result.py must never be logged as “nothing found”. That query is unrun. (c) Coverage is two registries short of the claim's own wording. “The published literature” was searched in PubMed only; EMBASE, CENTRAL, CINAHL and the trial registries the claim does not name (EudraCT, ISRCTN, ChiCTR, UMIN — relevant, since the on-point trial found here is Italian) were not searched at all. (d) Non-randomised and within-subject comparisons were not sought, and the claim as worded only excludes randomised ones, so it is silent about a literature that may exist. Direction for a human: the evidence found this pass is consistent with the claim and the specific correction on the record has been run down — PMID 42190320 exists, is on point for the architecture, and is sham-controlled, so it does not measure the closed-loop margin. claim 33unconfirmed's margin remains unmeasured as far as anything read here shows
Between-day reliability of vaginal surface electromyography in women is too low for it to be used as a between-day outcome measure of pelvic floor muscle function, so an EMG trend transmitted from a home device to a prescribing clinician is not a clinically interpretable measure of change
jurisdiction: US — confidence: unconfirmed — note: attempted 2026-09-19 and structurally unverifiable, not unattempted. Both cited papers were re-retrieved cold and both say what the chair says they say; the tag cannot go higher through this repo because literature-detail returns a ScanResult, and the claim's…the full check second half was never measured by either paper. Split disposition below. — source: literature-detail 19539646 31642114 → ScanResult status found, 2 abstracts retrieved (the subcommand takes no --jurisdiction flag). Paper 1 — source_ref PubMed PMID=19539646 (efetch), https://pubmed.ncbi.nlm.nih.gov/19539646/**,Journal of Neuroscience Methods 2009, "The reliability of surface EMG recorded from the pelvic floor muscles" (Evaluation Study). Two vaginal probes (Femiscan, Periform), tasks were PFM maximum voluntary contractions and a coughing task. Verbatim: between-trial reliability was “fair to high for the Femiscan (ICC((3,1))=0.58-0.98, CV=8.5-20.7%) and good to high for the Periform (ICC((3,1))=0.80-0.98, CV=9.6-19.5%), **however between-day reliability was generally poor for both vaginal probes (ICC((3,1))=0.08-0.84).” The chair's “ICC 0.08–0.84 across two probes” is exact, and the contrast matters: the poor reliability is specifically between-day; within-day it is fair to high. The quoted conclusion is the authors' own words, and the quotation is accurate — but it starts mid-sentence and drops a concessive clause that cuts the other way. The full sentence reads: “The results suggest that although it is acceptable to use PFM surface EMG as a biofeedback tool for training purposes, it is not recommended for use to make between-subject comparisons or to use as an outcome measure between-days when evaluating PFM function.” So the same sentence the chair cites against the clinician-facing trend endorses sEMG for the in-session training-biofeedback use, which is the candidate's other use of the same signal. A reader of this claim should not carry it across to the biofeedback function. Paper 2 — source_ref PubMed PMID=31642114 (efetch), https://pubmed.ncbi.nlm.nih.gov/31642114/**,Neurourology and Urodynamics 2020, "Intraday and interday reliability of pelvic floor muscles electromyography in continent woman". Population verbatim: “19 healthy continent women” — the chair's population description is correct, and the n (19) is small and not stated in the claim. Three parameters: EMGmax, EMGA0.5 (mean over 500 ms around EMGmax) and EMGA2-4 (mean over 2 s of the MVC plateau). Verbatim: intrasession ICC 0.93–0.97; intraday “moderate” ICC 0.64–0.75; “the **interday reliability was only fair for EMGmax (ICC = 0.48; CI = 0.04-0.77) and EMGA0.5 (ICC = 0.51; CI = 0.07-0.78) but moderate for EMGA2-4 (ICC = 0.65; CI = 0.28-0.85).” Two places the chair's reading outruns this source. (i) “ICC 0.48–0.65 for peak measures” spans the right three numbers but mislabels them: EMGA2-4, the 0.65 endpoint, is a 2-second plateau mean, not a peak; the two genuinely peak-derived parameters are the lower pair, 0.48 and 0.51, and every confidence interval reaches as low as 0.04–0.28. (ii) “supervised” appears in neither abstract. Both are laboratory/clinic reliability studies by their design, but neither states supervision as a condition, so that word is the chair's characterisation rather than a retrieved fact. And neither paper's own conclusion is a prohibition. 19539646 says “not recommended” as a between-day outcome measure; 31642114 concludes the narrower thing — that EMGA2-4 “exhibited the highest reliability and is recommended for further studies” and that “the interday reliability might be enhanced by considering the menstruation cycle” — i.e. its authors treat interday reliability as a parameter-choice and timing problem, not as a bar on the measure. Residual, NOT verified: (a) the home half, which is the load-bearing half of this claim. Both studies measured a probe positioned in a clinic or laboratory under one controlled protocol. Neither measured a self-inserted probe, unsupervised, at home, where placement depth and rotation, hydration, time of day and contraction technique all vary in ways these designs hold constant. The step from “between-day ICC is poor in the lab” to “a home-device EMG trend is not a clinically interpretable measure of change” is an inference, not a finding, and no source retrieved here reaches it. Direction for a human, recorded as reasoning and not as evidence: the lab condition is the best case, so home variance is unlikely to be lower — but nobody has measured it, and the claim is not verified on the strength of papers that did not. (b) the claim states no threshold. “Clinically interpretable measure of change” is unquantified here and unquantified in both papers; neither states what ICC a clinician-facing trend would need, so even with these ICCs in hand there is no stated bar to test them against. (c) Neither abstract was appraised for design, blinding or risk of bias beyond what it states, and 19539646's abstract reports no sample size and no population description at all — “in women”, in the claim text, is not established for paper 1. (d) Structural, and why this cannot be verified here:literature-detail returns a ScanResult (found/none/unavailable), a vocabulary deliberately disjoint from confidence tags, with no to_claim_line() renderer (connectors/result.py; phase2-spec.md §3) — there is no code path from this connector to a verified tag. Same treatment as claims 9 and 20 of idea-002
Medicare NCD 230.8's four-week definition of a failed pelvic muscle exercise trial is shorter than the minimum duration of first-line supervised pelvic floor muscle training that clinical guideline recommends - NICE (National Institute for Health and Care Excellence) NG123 recommendation 1.4.4 offers a trial of supervised pelvic floor muscle training of at least 3 months' duration as first-line treatment - so a woman who satisfies this candidate's intended-use precondition has not completed a guideline-standard trial of first-line conservative therapy
jurisdiction: US — confidence: unconfirmed — note: checked 2026-09-19; both cited durations are confirmed verbatim and the arithmetic holds. The tag is held at unconfirmed for one structural reason only: half the evidence is a UK guideline, which no connector in this repo can reach. — source: **US half, typed…the full check connector, ncd 230.8 --jurisdiction US → verified, source_ref CMS Pub. 100-3 Medicare NCD Manual, chapter 1 part 4 (Rev. 13808, issued 05-29-26), section=230.8. Verbatim: “Pelvic floor electrical stimulation with a non-implantable stimulator is covered for the treatment of stress and/or urge urinary incontinence in cognitively intact patients who have failed a documented trial of pelvic muscle exercise (PME) training. **A failed trial of PME training is defined as no clinically significant improvement in urinary continence after completing 4 weeks of an ordered plan of pelvic muscle exercises designed to increase periurethral muscle strength.” The four-week figure is exact, and it is the same precondition this candidate's frontmatter intended_use: carries. UK half, no connector exists — read by URL, verbatim, not by search. nice.org.uk returns HTTP 403 to this repo's fetcher, so the guideline was read from NCBI Bookshelf NBK542416 (HTTP 200), which republishes the guideline full text: Urinary incontinence and pelvic organ prolapse in women: management, NICE Guideline No. 123, National Institute for Health and Care Excellence, 2019 Jun, ISBN-13 978-1-4731-3319-8, https://www.ncbi.nlm.nih.gov/books/NBK542416/. Recommendation 1.4.4, verbatim and complete: “Offer a trial of supervised pelvic floor muscle training of at least 3 months’ duration as first-line treatment to women with stress or mixed urinary incontinence. [2019]” — the chair's paraphrase is accurate word for word, the recommendation number is right, and it is a [2019] recommendation, i.e. one the 2019 update actually revisited. One thing the comparison understates, in the claim's own favour: the two trials differ in kind as well as length. NCD 230.8 requires “an ordered plan of pelvic muscle exercises” and says nothing anywhere in its text about supervision; NG123 1.4.4 requires the 3 months to be supervised. So the gap between the two is 4 unsupervised weeks against 12 supervised ones, not merely 4 weeks against 12. Residual, NOT verified: (a) NG123 is a UK guideline and this claim is tagged jurisdiction: US. The field is doing double duty — the NCD half is US, the comparator half is UK — and NG123 has no standing in US practice. “The minimum duration … that clinical guideline recommends” therefore means one guideline, in another regulatory system; what a US guideline says about first-line PFMT duration is a separate question this lookup does not answer (see claim 94unconfirmed, AUA (American Urological Association)/SUFU). (b) “Has not completed a guideline-standard trial” is an inference, not a retrieved statement. NG123 nowhere says a 4-week trial is inadequate; it says offer at least 3 months. The step from the second to the first is short and reasonable, and it is still a reasoning step, not a line of text anyone published. (c) Not replayable by a typed connector, for the UK half.recheck_claims.py can replay ncd 230.8 and nothing else on this line; the Bookshelf read is a URL fetch of a named accession, reproducible by hand but outside the connector set. Per _shared/claim-grammar.md, a jurisdiction with no connector stays unconfirmed for that reason, which is the whole of why this line is not verified
No United States clinical guideline recommends electrical stimulation as a treatment option for stress urinary incontinence: the AUA/SUFU Stress Urinary Incontinence Guideline's non-surgical treatment statement names continence pessary, vaginal inserts and pelvic floor muscle exercises with or without biofeedback, at Expert Opinion grade, and names no electrical stimulation option
jurisdiction: US — confidence: unconfirmed — note: **checked 2026-09-19 against the guideline itself, not a summary. The specific half is verbatim-exact; the headline half is OVERSTATED in three separate ways, one of which is a direct quotation from the same document pointing the other way. Read the residual before…the full check citing this line.** — source: no connector reaches a specialty-society guideline and none was invoked. Document read directly: AUA/SUFU guideline page, HTTP 200, https://www.auanet.org/guidelines-and-quality/guidelines/stress-urinary-incontinence-(sui)-guideline — “Surgical Treatment of Female Stress Urinary Incontinence: AUA/SUFU Guideline”, Published 2017; Amended 2023; citation as printed: Kobashi KC, Albo ME, Dmochowski RR et al, J Urol 2017, and the amendment Kobashi KC, Vasavada S, Bloschichak A, et al, J Urol 2023;209(6):1091-1098. Evidence base: literature searched 2005-01-01 to 2015-12-31, extended by the amendment to 2016-01-01 through 2022-02-28. Guideline Statement 11, verbatim and complete: “In patients with SUI or stress-predominant MUI, clinicians may offer the following non-surgical treatment options: (Expert Opinion) — Continence pessary / Vaginal inserts / Pelvic floor muscle exercises (PFME) ± biofeedback.” The chair's three named options, their order, the ± biofeedback qualifier and the Expert Opinion grade are all exact, and Statement 11 names no electrical stimulation option. Also confirmed and not cited by the chair: the counselling statement earlier in the document (Clinical Principle) lists “Observation / Pelvic floor muscle training (± biofeedback) / Other non-surgical options (e.g., continence pessary) / Surgical intervention” — likewise no electrical stimulation. So within the graded statements, the absence is real. Residual, NOT verified — three ways the headline outruns the document.(a) The guideline is not silent on electrical stimulation, and what it says is closer to a qualified yes than to an absence. Its Future Directions / Therapeutic Opportunities section, verbatim: “Laser and magnetic/electrical stimulation therapy are emerging therapies for the treatment of SUI. However, evidence to date is inconsistent and of poor quality. The Panel acknowledges that these therapies exist and may offer some benefit in index SUI patients seeking non-surgical treatment. However, given the limitations in rigorous evidence-based data supporting their use and FDA advisory warning against the use of energy-based devices for ‘vaginal rejuvenation’, patients should be extensively counseled on the immaturity of the data.” It reviews the ES evidence at length — including the Cochrane review this file already carries as claim 107unconfirmed (Stewart F, Berghmans B, Bø K et al, Cochrane Database Syst Rev 2017:CD012390, 51 studies, n=3,781) — and concludes: “while laser or magnetic/ES therapy may provide some benefit compared to placebo it remains vital to counsel patients on the immaturity of the data. It appears current data does not suggest superiority of these new emerging technologies in comparison to established non-invasive therapies such as PFME.” “Names no electrical stimulation option” is true of Statement 11 and false of the guideline as a whole. The accurate narrow statement is that ES appears in no graded guideline statement; the panel's stated position is non-superiority on immature evidence, which is a weaker and different thing from silence. (b) This is a surgical guideline, so its silence is weak evidence for an absence argument. The document's own title is “Surgical Treatment of Female Stress Urinary Incontinence”. A guideline scoped to surgery, carrying exactly one non-surgical treatment statement at Expert Opinion grade, is the wrong instrument for establishing what US guidance says about a conservative modality — an absence-in-a-named-document is weaker than a statement to begin with (as the task framing notes), and weaker again when the document's remit does not cover the modality. (c) “No United States clinical guideline” is a universal quantifier resting on one document. ACOG (American College of Obstetricians and Gynecologists), AUGS (American Urogynecologic Society), the AUA/SUFU non-neurogenic overactive bladder guideline and any specialty consensus statement were not read this pass and are not covered by this citation. One guideline read cannot establish a claim about all of them. (d) Structural: not replayable by recheck_claims.py — a URL fetch of a society guideline, no typed connector exists for specialty-society guidance, and auanet.org served this page on the first URL only (a second path reset the connection). Disposition:unconfirmed rather than verified because the load-bearing headline is broader than what was read and is contradicted in emphasis by the same source; unconfirmed rather than refuted because nothing read contradicts the specific, checkable half, which is exact
UK clinical guideline NICE NG123 recommends against the routine use of pelvic floor electromyography as biofeedback in pelvic floor muscle training (recommendation 1.4.6) and against the routine use of electrical stimulation in combination with pelvic floor muscle training (1.4.9), and confines electrical stimulation and biofeedback to women who cannot actively contract the pelvic floor muscles (1.4.10)
jurisdiction: UK — confidence: unconfirmed — note: **checked 2026-09-19. All three recommendation numbers are right and two of the three paraphrases are verbatim-accurate; the third (“confines”) is the chair's synthesis rather than 1.4.10's wording — see below. The tag is unconfirmed structurally: this is a UK…the full check claim, every connector in this repo queries a US or EU source, and _shared/claim-grammar.md states that a jurisdiction beyond US and EU has no connector at all and stays unconfirmed for that reason. No US database was used to answer it.** — source: no connector call was possible and none was made. nice.org.uk returns HTTP 403 to this repo's fetcher. The guideline full text was read from NCBI Bookshelf accession NBK542416 (HTTP 200, fetched directly by accession — a document read, not a search): Urinary incontinence and pelvic organ prolapse in women: management, NICE Guideline No. 123, National Institute for Health and Care Excellence, 2019 Jun, ISBN-13 978-1-4731-3319-8, https://www.ncbi.nlm.nih.gov/books/NBK542416/, §1.4 “Non-surgical management of urinary incontinence”. The three recommendations, verbatim and complete, with the bracketed review year NICE prints against each: 1.4.6 (under “Pelvic floor muscle training”): “Do not use perineometry or pelvic floor electromyography as biofeedback as a routine part of pelvic floor muscle training. [2006]” — note it names perineometry as well as EMG. That is material beyond this claim: technology condition C8 (claim 100unconfirmed-series) proposes substituting intravaginal manometry for surface EMG as the biofeedback modality, and 1.4.6 declines manometry and EMG in the same breath, so that substitution buys nothing against this guideline. 1.4.9 (under “Electrical stimulation”): “Do not routinely use electrical stimulation in combination with pelvic floor muscle training. [2006]” — the chair's paraphrase is word for word. 1.4.10: “Electrical stimulation and/or biofeedback should be considered for women who cannot actively contract pelvic floor muscles to aid motivation and adherence to therapy. [2006]” Also retrieved, adjacent and relevant, though this claim does not cite it — 1.4.8: “Do not routinely use electrical stimulation in the treatment of women with overactive bladder. [2006]” (bears on claim 97unconfirmed's broadening-to-urgency question). Where the chair's reading outruns the text. “Confines electrical stimulation and biofeedback to women who cannot actively contract” is not what 1.4.10 says. 1.4.10 is a positive recommendation — “should be considered for” that population — and contains no restrictive clause. The confinement is an inference from the conjunction of 1.4.6 and 1.4.9 (do not use routinely) with 1.4.10 (consider for this group); it is a fair reading of §1.4 as a whole and it is still a reading, not a quotation. And 1.4.10's stated purpose is narrower than “recommended for its modality” suggests: the reason given is “to aid motivation and adherence to therapy” — a motivational adjunct to PFMT, not a continence-efficacy recommendation. Anyone relying on 1.4.10 as the modality's one positive indication (claim 96unconfirmed does) should carry that qualifier with it. Residual, NOT verified: (a) structural and permanent within this repo — UK guidance has no typed connector, so this line is not replayable by recheck_claims.py and cannot reach verified here; upgrading it needs a human attaching the primary NICE publication, not a different agent lookup. (b) What the recommendations mean for this candidate is untouched. NG123 is UK guidance and this candidate's launch_jurisdiction: is US; a UK “do not routinely use” has no bearing on a US 510(k), on NCD 230.8 coverage, or on US clinician behaviour, and no source here connects the two. (c) Vintage, and it cuts the candidate's way — all three cited recommendations carry [2006], meaning the 2019 update did not revisit them (contrast 1.4.4, which is [2019]). The negative stance on electrical stimulation and EMG biofeedback therefore rests on evidence roughly two decades old and predating the current home-device generation. That is context a human should weigh, not a finding that the recommendations have changed — they are current as published in the June 2019 guideline read here
Women who cannot actively contract the pelvic floor muscles - the population for which NICE NG123 recommendation 1.4.10 says electrical stimulation and biofeedback should be considered - cannot generate the voluntary surface EMG a closed-loop EMG-gated stimulator needs to trigger on, so this candidate's architecture excludes the one population with a positive guideline recommendation for its modality
jurisdiction: US — confidence: unconfirmed — note: **checked 2026-09-19. NOT refuted, and not verified either. This line is one retrieved fact welded to two reasoning steps, and only the fact was checkable. Stated plainly for the assessment: nothing found this pass contradicts the claim, so the refuted finding that…the full checkB1The discriminating trigger works in the…'s stated trigger requires did not occur.** — source: What was retrieved, and it holds. NICE NG123 recommendation 1.4.10, read verbatim from NCBI Bookshelf NBK542416 (nice.org.uk returns HTTP 403 to this repo's fetcher; the Bookshelf accession returned HTTP 200): Urinary incontinence and pelvic organ prolapse in women: management, NICE Guideline No. 123, NICE, 2019 Jun, ISBN-13 978-1-4731-3319-8, https://www.ncbi.nlm.nih.gov/books/NBK542416/ — “Electrical stimulation and/or biofeedback should be considered for women who cannot actively contract pelvic floor muscles to aid motivation and adherence to therapy. [2006]”. The population description in this claim is exactly 1.4.10's. “The one population with a positive guideline recommendation for its modality” is also supported within NG123: §1.4 was read end to end, and every other mention of the modality is negative or is a different modality — 1.4.6 (do not use perineometry or pelvic floor EMG as biofeedback routinely), 1.4.8 (do not routinely use electrical stimulation for overactive bladder), 1.4.9 (do not routinely use electrical stimulation with PFMT), 1.4.13/1.4.14 (do not offer transcutaneous sacral or posterior tibial nerve stimulation), 1.4.15 (percutaneous PTNS only after MDT review). 1.4.52's percutaneous sacral nerve stimulation is implanted neurostimulation for overactive bladder, not this candidate's modality. So 1.4.10 is the only positive recommendation for non-implanted pelvic floor electrical stimulation or biofeedback anywhere in NG123 §1.4. Whether it is the only one across all guidelines depends on claim 94unconfirmed (AUA/SUFU), checked separately. Residual, NOT verified — and it is the load-bearing majority of this claim. Two distinct steps, neither a database fact:(a) The physiological premise was searched and is unmeasured. “Cannot actively contract” is a clinical category in NG123, which prints no operational definition of it; in practice it is assessed by digital palpation (an Oxford/modified Oxford grade of 0). Whether a woman in that category generates no voluntary surface-EMG signal, or a signal merely below whatever threshold a detector is set to, is an empirical question, and the two are not the same claim — the second is a threshold-design parameter, not an exclusion. Lead sweeps run this pass (recorded as leads, carrying no tag, since literature returns a ScanResult): literature “pelvic floor surface electromyography women unable to contract” --since 30y --limit 12 → status found, 6 records, none on point (PMIDs 38892773, 36248694, 33289476, 25503578, 21995304, 16496395 — biofeedback training technique, firing order, life-cycle EMG activity, overactive-bladder comparison, Valsalva activation patterns); literature “pelvic floor muscle Oxford grade 0 electromyography” --since 30y → status none; literature “EMG-triggered stimulation patients unable to voluntarily contract” --since 30y → status none. A scan none is a term-matching miss, not evidence that no such study exists and not evidence for the claim either. This premise is therefore searched and unresolved, which is a stronger statement than unsearched and a much weaker one than verified. (b) The architectural step is a statement about a device that does not exist, checked against this file rather than against the world. That this candidate gates stimulation on a voluntary sEMG threshold crossing comes from its own frontmatter mechanism: and from technology condition C1 (2026-09-19), which established that the trigger is sensed before the burst rather than during it. C1 resolves an artefact-timing question and has no bearing here: it changes when the signal is sensed, not whether a voluntary signal exists to sense, so it neither supports nor weakens this claim. Beyond that, “excludes” treats a design parameter as fixed — nothing establishes that such a device could not ship a non-gated or open-loop mode for exactly this population, which would dissolve the exclusion without changing the physiology. No source settles either point, and no agent here may settle them by reasoning. Disposition and what would move it.unconfirmed, not refuted: no connector returned refuted, no retrieved document contradicts the claim, and the quoted guideline text supports its retrievable half exactly. unconfirmed, not verified: the assertion that actually carries the consequence — that the gating architecture structurally excludes the 1.4.10 population — rests on an unmeasured physiological premise plus a design assumption, and was not established by anything read this pass. Settling it needs a study reporting voluntary sEMG amplitude against palpation grade in women graded unable to contract (class 2, commissionable), plus a stated trigger threshold for this design. Carry forward from claim 95unconfirmed: 1.4.10's own rationale is “to aid motivation and adherence to therapy”, so even fully granted, the population this claim says the architecture forfeits is one the guideline recommends the modality for as a motivational adjunct, not on continence efficacy ADDENDUM, same 2026-09-19 pass — a cross-check run for claim 91unconfirmed found the single most on-point piece of evidence against this claim's physiological premise, and anyone reading this line must read this paragraph.trials --condition “stress urinary incontinence” --intervention “EMG-triggered electrical stimulation” --since 30y --limit 25 → found, total 1 → trial-detail NCT06419517 → ScanResult found: “Pelvic Muscle Training and Electrostimulation to Treat Weak Pelvic Floor”, sponsor Azienda Unità Sanitaria Locale di Piacenza, INTERVENTIONAL / RANDOMIZED / PARALLEL / masking=DOUBLE, status COMPLETED, enrollment 50 ACTUAL, population FEMALE 18–50 years, published as PMID 42190320. Its inclusion criteria, verbatim from the registry record: “Adult women (18 years old - 50 years old), with a Modified Oxford Score, determined by digital palpation, of 0 - 1, complaining leakage episode occurring more than once a week”, six to eighteen months postpartum. Registered summary, verbatim: “This research will determine 1) whether the very weak pelvic floor can be improved with surface electromyography (s-EMG)-triggered electrostimulation added to pelvic floor muscle training”. Why this matters here: a Modified Oxford Score of 0 is the absence of a palpable voluntary contraction — operationally the population NG123 1.4.10 describes as “women who cannot actively contract pelvic floor muscles”. A completed, double-blind randomised trial deliberately enrolled that band into an sEMG-triggered stimulation arm and reported PFM strength and continence gains from it (PMID 42190320: +0.48 Oxford points at 10 weeks, p=0.033; −1.51 leakage episodes/week at 12 months, p=0.001). That is evidence pointing against this claim's premise, and it is the first evidence in either direction anyone here has put on this line. It does not refute the claim, and must not be recorded as doing so. Three reasons, each a real gap rather than a hedge: (i) the criterion is a range, 0 - 1, and neither the registry record nor the abstract reports how many enrolled participants were Oxford 0 rather than 1 — a trial can admit a band and enrol almost nobody at its floor; (ii) neither source reports trigger-detection performance — no failure rate, no threshold, nothing on whether any participant could not drive the trigger, which is the exact quantity this claim turns on; (iii) enrolment is recorded as 50 ACTUAL in the registry against 42 allocated in the publication, an unexplained discrepancy that makes per-band counts unreadable from either document. Revised disposition: the tag stays unconfirmed, but the claim's physiological premise is now weakly contradicted by an on-point randomised trial rather than merely unmeasured, and a human weighing pillar B1The discriminating trigger works in the… should treat this claim as weaker than the chair stated it, not stronger. What would settle it: the full text of PMID 42190320 reporting the baseline Oxford distribution and any trigger-detection failures (ScienceDirect returned 403 to two previous agents; not retried here)
Intravaginal electrical stimulation for urgency and mixed urinary incontinence rests on a different proposed mechanism and a different stimulation frequency band from stimulation for stress urinary incontinence - neuromodulatory inhibition of detrusor overactivity at low frequency versus motor recruitment and strengthening at higher frequency - so broadening this candidate's indication within continence is a second therapy on the same hardware rather than a wider claim on the same therapy
jurisdiction: US — confidence: unconfirmed — note: **checked 2026-09-19. This is a compound claim whose halves came back differently: the two-mechanisms half is supported by a typed connector against an FDA-cleared indication statement; the frequency-band half — ‘low’ versus ‘higher’, with a direction — was NOT…the full check established by any source retrieved, and the regulatory evidence found points mildly AGAINST the ‘second therapy’ conclusion.** — source: Mechanism half — supported, and from a primary source.clearance-summary K133826 --expect-indication “detrusor” --jurisdiction US → verified, source_ref FDA 510(k) summary K133826 (https://www.accessdata.fda.gov/cdrh_docs/pdf13/K133826.pdf). Indications for Use, verbatim (OCR artifacts as returned): “… It Is Intended for acute and ongoing treatment of mixed urinary incontinence where the following results may improve urinary control: strengthening of pelvic floor muscles and inhibition of the detrusor muscle through reflexive mechanisms.” So FDA's own cleared indication for an intravaginal stimulator in this product pool names the two mechanisms the claim names, as two distinct things, in the same sentence. Second, supporting: ncd 230.8 --jurisdiction US → verified, CMS Pub. 100-3 NCD Manual ch. 1 pt. 4 (Rev. 13808, issued 05-29-26), §230.8, verbatim: “The methods of pelvic floor electrical stimulation vary in location, stimulus frequency (Hz), stimulus intensity or amplitude (mA), pulse duration (duty cycle) … In general, the stimulus frequency and other parameters are chosen based on the patient’s clinical diagnosis.” That is CMS stating that frequency is diagnosis-dependent — which supports the shape of the claim. Residual, NOT verified — and this is where the claim's specificity lives. (a) Neither source names a band, a number, or a direction. NCD 230.8 says frequency varies by diagnosis and stops there; it does not say urge is lower and stress is higher, and K133826's IFU carries no stimulation parameters at all. The claim's parenthetical — “neuromodulatory inhibition of detrusor overactivity at low frequency versus motor recruitment and strengthening at higher frequency” — is therefore unsourced as retrieved. The only stimulation envelope anywhere in this file's evidence is the stress-side one (50 Hz, from PMID 42190320, recorded at claim 101unconfirmed); nothing retrieved this pass establishes the urge-side band, so the contrast that makes this claim informative is one measured number short. (b) Searched, and the sweeps did not close it.literature “intravaginal electrical stimulation frequency urge incontinence detrusor inhibition” --since 40y --limit 10 → status none; literature “pelvic floor electrical stimulation stimulation frequency stress versus urge incontinence” --since 40y --limit 10 → found, 3, none on point (PMID 24560290 a lifestyle/PFMT review, 23740763 non-implanted electrodes in men, 23023996 a disposable tampon-like electrostimulation device evaluation). A none from a term-matched ScanResult sweep is a string miss, never an absence — this half is searched and unresolved, not refuted. (c) The conclusion runs against the one regulatory fact found. “A second therapy on the same hardware rather than a wider claim on the same therapy” is a characterisation, and K133826 is FDA clearing one device under one indication statement — “treatment of female urinary incontinence … mixed urinary incontinence” — that spans both mechanisms at once. Whatever is true mechanistically, the regulatory system has already treated the pair as one cleared indication rather than two therapies, which is the frame that actually governs whether broadening is a new submission. A human weighing the ‘second therapy’ framing should weigh that against it. (d) Whether two mechanisms imply two clinical evidence packages — the consequence this claim exists to carry — is an FDA submission-strategy judgement settled in a pre-submission, not by any database read here
No published trial of home pelvic floor electrical stimulation for stress urinary incontinence reports its primary efficacy endpoint at four weeks or earlier; the registered sponsor trials of the two adjacent cleared devices set primary endpoints at twelve weeks (NCT03782116, stress) and six weeks (NCT04752709, urge)
jurisdiction: US — confidence: unconfirmed — note: **checked 2026-09-19. Both named endpoints are exact, and a wider registry sweep found two further home-use trials that point the same way and are not cited in the claim. Nothing found with a primary endpoint at four weeks or earlier. unconfirmed because an absence…the full check claim cannot be settled by term-matched ScanResult sweeps.** — source: The two named trials, both confirmed exactly.trial-detail NCT03782116 → ScanResult found, ClinicalTrials.gov NCTId=NCT03782116, https://clinicaltrials.gov/study/NCT03782116 — “Stress Incontinence Trial With Elitone Device”, sponsor Elidah, Inc. (INDUSTRY), RANDOMIZED / PARALLEL / masking=QUADRUPLE, COMPLETED, enrollment 87 ACTUAL, FEMALE 21–75, primary outcome “Efficacy Assessed by Percent Reduction in Urinary Incontinence Episodes @ 12 weeks”, every secondary also @ 12 weeks; hasResults=true; summary states subjects were “assigned to either a treatment group or a control (sham) group”. trial-detail NCT04752709 → ScanResult found, NCTId=NCT04752709 — primary outcomes “Change in Average Number of Urinary Incontinence Episodes Per Day @ 6 weeks” and safety @ 6 weeks (full record dispositioned at claim 99unconfirmed). Twelve weeks and six weeks are both exact.Two further home-use trials found this pass, neither cited by the chair, both supporting the claim.trials --condition “stress urinary incontinence” --intervention “home electrical stimulation” --since 30y --limit 25 → found, total 4 → trial-detail NCT00762593 → found: “Trial Evaluating Transvaginal Electrical Stimulation With a Home Use Programmable Device for Urinary Stress Incontinence”, sponsor Akontis (INDUSTRY), PHASE2 / RANDOMIZED / PARALLEL / masking=DOUBLE, enrollment 150 ACTUAL, primary endpoints at 8 weeks (7-day diary episode count and a 0–100 VAS, both “at 8 weeks”), secondaries at 4 and 8 weeks. This is the closest trial in the registry to this candidate — intravaginal, home, SUI — and its primary is 8 weeks, i.e. twice the four-week precondition. trials --condition “stress urinary incontinence” --intervention “pelvic floor electrical stimulation” --since 30y --limit 25 → found, total 12 → trial-detail NCT02423005 → found: “Neurotech Vital Compact Versus Itouch Sure Pelvic Floor Exerciser US”, sponsor Atlantic Therapeutics, RANDOMIZED / PARALLEL, COMPLETED, enrollment 180 ACTUAL, primary at 12 weeks (“Proportion of subjects who have achieved >50% improvement on the provocative pad weight test @ 12 weeks”), all thirteen listed outcomes at 12 weeks. The earliest primary endpoint found anywhere in these sweeps is 8 weeks.The nearest thing to a counterexample, recorded because it is one token away from looking like one. NCT06419517 (PMID 42190320, dispositioned at claims 91 and 96) lists its registry primary outcome as “Pelvic Floor Muscles (PFM) Strength @ Baseline, four weeks, 6 and 12 months follow-up”. It does not break this claim, for two independent reasons: it is supervised clinic PFMT plus stimulation three times a week, not home electrical stimulation, so it falls outside this claim's scope as worded; and the publication reports the primary as change in PFM strength at 10 weeks, not four — a registry-versus-publication discrepancy on the primary endpoint timepoint that a human should be aware of when citing either document. Residual, NOT verified: (a) The first half is a universal negative over “published trials” and was answered with registry sweeps.trials and literature return ScanResults (found/none/unavailable) with no confidence tag and no to_claim_line(); a none is a string-matching miss, not an absence, and claim 91unconfirmed in this same file demonstrates the failure mode concretely. Older published trials not registered on ClinicalTrials.gov — which is most pelvic-floor stimulation literature before ~2007 — are outside every sweep run here. (b) Registered endpoints are intentions, not publications. NCT00762593 (status UNKNOWN) and NCT02423005 both carry hasResults=false, so what those trials reported is not on this record at all; only what they planned to measure. The claim says “reports its primary efficacy endpoint”, and for two of the four trials cited here nothing has been reported. (c) “The two adjacent cleared devices” are one sponsor and one regulation, and only one trial is a stress trial. Both named trials are Elidah/ELITONE, product code QAJ under 21 CFR 876.5330 — transcutaneous, explicitly not this candidate's KPI/876.5320 intravaginal regulation per its own frontmatter — and NCT04752709 is an urge trial being cited inside a claim about stress urinary incontinence. (d) What the claim is for is untouched. That no trial has measured efficacy at four weeks says nothing about whether four weeks is too short to measure an effect; that is a clinical-design judgement no registry record settles
In Elidah's registered trial of the ELITONE urge urinary incontinence device (NCT04752709), 31 of 82 randomised women - 37.8 percent - did not complete a six-week intervention period, across two active arms with no sham, so broadening the indication from stress to urgency is not supported by any better completion record than the stress indication has
jurisdiction: US — confidence: unconfirmed — note: **checked 2026-09-19 against the posted results module. Every number and every structural detail in this claim is EXACT — 31, 82, 37.8 percent, six weeks, two active arms, no sham. The tag is unconfirmed on one structural ground only: trial-detail returns a…the full checkScanResult, which carries no confidence tag. This is the best-evidenced line in this set.** — source: trial-detail NCT04752709 → ScanResult found, source_ref ClinicalTrials.gov NCTId=NCT04752709, https://clinicaltrials.gov/study/NCT04752709 — “Efficacy of Surface Electrical Stimulation for Urge Urinary Incontinence in Women”, sponsor Elidah, Inc. (INDUSTRY), INTERVENTIONAL / NA / RANDOMIZED / PARALLEL / masking=QUADRUPLE, status COMPLETED, enrollment 82 (ACTUAL), FEMALE 21–80 years, primary outcomes “Change in Average Number of Urinary Incontinence Episodes Per Day @ 6 weeks” and safety @ 6 weeks. The connector reports hasResults=true — posted results exist and ARE findings (sponsor-reported, unappraised). Participant flow, read from the posted results module (ClinicalTrials.gov API v2, studies/NCT04752709?fields=ResultsSection, period “Overall Study”): STARTED FG000=26, FG001=56 (82); COMPLETED FG000=17, FG001=34 (51); NOT COMPLETED FG000=9, FG001=22 = 31. 31/82 = 37.80%. The chair's arithmetic is exact to the decimal place. “Two active arms with no sham” is confirmed structurally (studies/NCT04752709?fields=ArmsInterventionsModule): Arm 1 “Active Group A”, type EXPERIMENTAL; Arm 2 “Active Group B”, type ACTIVE_COMPARATOR; one intervention, DEVICE “ELITONE UUI”, both arms receiving stimulation and differing only in stimulation protocol. There is no PLACEBO_COMPARATOR or SHAM_COMPARATOR arm in the record. Worth stating because it is counter-intuitive from the protocol summary alone: masking=QUADRUPLE despite there being no sham — the blinding is between two active stimulation protocols, not against an inactive control. Residual, NOT verified: (a) Why 31 women did not complete is NOT on the record. The results module posts the milestone counts and no dropWithdraws reasons at all — no withdrawal categories, no recruitment or pre-assignment details. So the completion rate is established and its cause is not: nothing here attributes non-completion to device burden, discomfort, adherence, or anything else, and this line must not be cited as evidence about why women stop. (b) “Randomised” is a one-step inference. The flow module labels the 82 as STARTED, not “randomized”, and posts no pre-assignment detail; 82 matches enrollment ACTUAL and the design is RANDOMIZED, so the reading is sound but it is not the word the registry uses. (c) A marked arm imbalance is unexplained — 26 against 56 in a parallel randomised trial — and nothing in the posted record accounts for it. (d) The comparison this claim draws is across different device classes. ELITONE UUI is a transcutaneous, surface perineal-electrode device (arm descriptions: “surface applied electrode shaped to fit the perineal region”) — product code QAJ, 21 CFR 876.5330, which this candidate's own frontmatter is explicit is not its regulation. This candidate is intravaginal under KPI / 876.5320. So a completion record from a surface-electrode urge device is an adjacent-market data point about the urge indication, not a completion record for intravaginal stimulation, and the inference “broadening from stress to urgency is not supported by a better completion record” carries that substitution inside it. (e) Sponsor-reported and unappraised, as the connector states in terms. (f) Structural: trial-detail returns a ScanResult (found/none/unavailable) with no to_claim_line() (connectors/result.py), so there is no code path from this lookup to a verified tag, however exact the numbers are
A closed loop in which stimulation is initiated by a threshold crossing of the patient's own voluntary surface EMG requires that EMG be sensed before the stimulation burst begins, not during it, so recovering microvolt surface EMG concurrently with stimulation on the same intravaginal electrode is not required for the closed-loop control function this candidate's mechanism describes
jurisdiction: US — confidence: unconfirmed — note: Verifier pass 2026-09-29. Control-architecture reasoning; no connector reaches it. claim 104unconfirmed's patent record is consistent with an alternating stimulate/measure architecture existing, but that is not evidence for the 'requires' half. — source: no typed connector…the full check reaches this claim and none was invoked — origin: condition C1 from the technology position (2026-09-19) — stated by a chair, never checked; recorded so the Verifier can see it
The therapeutic stimulation envelope reported for sEMG-triggered intravaginal electrical stimulation in women with stress urinary incontinence in PMID 42190320 is 50 Hz, 250 microsecond symmetrical biphasic pulses, 2 seconds on and 4 seconds off with 1 second ramp up and down, so the inter-burst quiet interval available to an EMG trigger detector under a published pelvic floor stress-urinary-incontinence envelope is approximately 4,000 milliseconds
jurisdiction: US — confidence: unconfirmed — note: Verifier pass 2026-09-29. The abstract retrieved today contains none of the envelope figures: no 50 Hz, no 250 µs, no 2 s on/4 s off, no ramp. They would be in the full-text methods, which no connector retrieved, so the envelope is unconfirmed rather than…the full check contradicted. The ~4,000 ms quiet interval is derived, and whether the 1 s ramps sit inside the 2 s on-time or the 4 s off-time is not established. A ScanResult carries no tag in any case. — source: literature-detail 42190320 → ScanResult found (no confidence tag obtainable), source_ref PubMed PMID=42190320 (efetch), https://pubmed.ncbi.nlm.nih.gov/42190320/ — "Pelvic muscle training and electrostimulation to treat weak pelvic floor: a multicentre-randomised parallel group trial", Eur J Obstet Gynecol Reprod Biol 2026 — origin: condition C2 from the technology position (2026-09-19) — stated by a chair, never checked; recorded so the Verifier can see it
Real-time recovery of volitional surface EMG concurrently with functional electrical stimulation on shared electrodes requires a hardware blanking window of the order of 8 milliseconds per stimulus pulse to keep the detection front end out of saturation - 7.6 ms in PMID 33836509 - which at a 50 Hz stimulation frequency consumes roughly 38 percent of the 20 ms inter-pulse period, so the concurrent architecture operates on a millisecond timing budget while the inter-burst architecture operates on a budget about 500 times larger
jurisdiction: US — confidence: unconfirmed — note: Verifier pass 2026-09-29. The abstract retrieved today confirms that this paper's sEMG detection front-end prevents saturation 'with a blanking time of 7.6 ms', tested in functional electrical stimulation on eight able-bodied volunteers and three stroke patients, not…the full check intravaginally. The arithmetic 7.6/20 = 38% holds. NOT verified: generalising one prototype's blanking time into what concurrent recovery 'requires'; and 'about 500 times larger' rests on claim 101unconfirmed's 4,000 ms, which is unconfirmed. A ScanResult carries no tag. — source: literature-detail 33836509 → ScanResult found, source_ref PubMed PMID=33836509 (efetch), https://pubmed.ncbi.nlm.nih.gov/33836509/ — "A hybrid method for real-time stimulation artefact removal during functional electrical stimulation with time-variant parameters", J Neural Eng 2021 — origin: condition C3 from the technology position (2026-09-19) — stated by a chair, never checked; recorded so the Verifier can see it
EMG-triggered electrical stimulation delivered through a single intravaginal probe used for both stimulation and surface-EMG sensing is a capability of a device marketed today for pelvic floor rehabilitation (Thought Technology MyoTrac Infiniti / MyOnyx, vaginal sensor specified for STIM and EMG, unit specified for EMG triggered stimulation), so the inter-burst architecture is a product-level capability in this anatomy rather than an unbuilt one
jurisdiction: US — confidence: unconfirmed — note: Verifier re-attempt 2026-10-01, clearance-summary now runs. NOW CHECKED from the K053266 510(k) summary (MyoTrac Infiniti, Thought Technology, cleared 2005-12-29, 21 CFR 890.5850, product codes IPF/HCC — not KPI/876.5320): the device is described as 'an electrical…the full check muscle stimulator' that 'is also an electromyography device'; one predicate is the Danmeter AutoMove AM800 'EMG Triggered Stimulator' (K972997); programmable features include a 'threshold trigger by the patient and physician'. So EMG-triggered stimulation in one unit is a cleared capability at summary level. STILL OPEN: (a) the single intravaginal probe for both STIM and EMG is NOT in the summary — the only electrodes it lists are Axelgaard surface electrodes (K874469A) 'for EMG or Stim' and Uni-Gel / Triode / Single electrodes 'for EMG only'; the vaginal-sensor specification is manufacturer literature (REQ-0153Read the full specifications of US6240315…, still open); (b) 'for pelvic floor rehabilitation': the cleared IFU names no pelvic floor or incontinence indication (relaxation of muscle spasms, disuse atrophy, local blood circulation, post-surgical calf stimulation, range of motion, stroke rehab, biofeedback/relaxation/muscle re-education) — a phrase miss, so unconfirmed and not refuted, but the K053266 clearance does not by itself support 'in this anatomy'; a human should judge that; (c) 'marketed today' is answered by no connector. — source: 510k "MyoTrac Infiniti" --applicant "Thought Technology" --jurisdiction US → verified, openFDA device/510k k_number=K053266, decided 2005-12-29; clearance-summary K053266 --jurisdiction US → verified, FDA 510(k) summary K053266 (https://www.accessdata.fda.gov/cdrh_docs/pdf5/K053266.pdf), full text read; clearance-summary K053266 --expect-indication "incontinence" --jurisdiction US → unconfirmed: 'The cleared indication does NOT contain the claimed phrase' — origin: condition C4 from the technology position (2026-09-19) — stated by a chair, never checked; recorded so the Verifier can see it
US6240315 (priority 1998, filed 2000-05-30, expired) discloses an apparatus that applies electrical stimulation to vaginal wall muscles and measures EMG from the same muscles in a combination mode that carries out the stimulation mode and the measurement mode alternately, with a user-settable automatic switching interval - an inter-burst stimulation and EMG architecture in this exact anatomy, disclosed and now in the public domain
jurisdiction: US — confidence: unconfirmed — note: Verifier pass 2026-09-29. Dates only, and only partly: the filing date matches exactly, and 'expired' matches only as a naive 20-year estimate (2020-05-30). The connector returns no priority date, so 'priority 1998' is not checked. The disclosure content (alternate…the full check stimulation and measurement modes, a settable switching interval, vaginal-wall muscles) is read by no connector; the returned title ('using EMG envelope signal') is consistent but is not the disclosure. 'In the public domain' is a legal conclusion and Tier 3 work. — source: patent US6240315B1 --jurisdiction US → verified, EPO OPS published-data/publication docdb=US.6240315.B1The discriminating trigger works in the…: "Electrical apparatus for medical treatment using EMG envelope signal: filed 2000-05-30, naive 20yr term expiration 2020-05-30 (expired) — naive estimate, does not model PTA/SPC extensions/terminal disclaimers/maintenance lapses" — origin: condition C5 from the technology position (2026-09-19) — stated by a chair, never checked; recorded so the Verifier can see it
No published study reports the sensitivity or specificity with which a vaginal surface-EMG channel can discriminate a voluntary pelvic floor muscle contraction from a Valsalva or abdominal-bracing manoeuvre, so the specificity of an unsupervised home EMG-trigger detector in this anatomy - the condition under which stimulation is not delivered on, and does not reinforce, the incorrect manoeuvre - has never been measured
jurisdiction: US — confidence: unconfirmed — note: Verifier pass 2026-09-29. An absence claim. literature and literature-detail return ScanResults, and a term-matched sweep cannot establish that no study exists (the same structural limit recorded on claim 91unconfirmed). No sweep was run this pass, because none could change…the full check the tag. — source: no typed connector reaches this claim and none was invoked — origin: condition C6 from the technology position (2026-09-19) — stated by a chair, never checked; recorded so the Verifier can see it
Moving from a concurrent to an inter-burst EMG architecture removes the stimulation-artefact problem and does not change the between-day reliability of the vaginal surface EMG measure itself, so it does nothing to make a clinician-facing home EMG trend more interpretable
jurisdiction: US — confidence: unconfirmed — note: Verifier pass 2026-09-29. Reasoning over claim 92unconfirmed (between-day reliability of vaginal sEMG, itself unconfirmed); no connector reaches the inference. — source: no typed connector reaches this claim and none was invoked — origin: condition C7 from the technology…the full check position (2026-09-19) — stated by a chair, never checked; recorded so the Verifier can see it
Closed-loop control contingent on a detected voluntary pelvic floor contraction can be implemented with an intravaginal pressure (manometry) sensor instead of surface EMG - the biofeedback modality the InControl KPI predicates' own cleared Indications for Use name in K150180 - so a design that removes surface EMG entirely can still retain closed-loop control of stimulation
jurisdiction: US — confidence: unconfirmed — note: Verifier re-attempt 2026-10-01, clearance-summary now runs. Checked against the frontmatter intended_use as it stands on 2026-10-01 ("The device is indicated for the treatment of stress urinary incontinence in cognitively intact adult women in the home setting, by…the full check prescription, following a documented failed four-week trial of pelvic muscle exercise training."). NOW CHECKED, the K150180 half holds: the IFU form (summary p.8) reads 'InTone is intended to provide electrical stimulation and/or visual biofeedback (via manometry) for the treatment of female urinary incontinence'; the device summary says 'Biofeedback is monitored via a pressure sensor within the Insertion Unit which records changes in pressure related to volitional muscle contraction'; Table 7.3 lists biofeedback as 'Manometric, Air pressure, 0 – 2 psi'. (Reader caution: the connector's IFU extract for K150180 concatenates the SE-table IFU row for K110179, K134020 and the new InTone; only the last sentence is K150180's own IFU. K133826's IFU says 'biofeedback feature' without naming manometry.) STILL OPEN: the design half — the cleared device uses pressure for VISUAL biofeedback to the patient, and nothing in the summary describes stimulation made contingent on a detected pressure rise; whether manometry can drive closed-loop control is answered by no source. — source: clearance-summary K150180 --expect-indication "visual biofeedback (via manometry)" --jurisdiction US → verified, FDA 510(k) summary K150180 (https://www.accessdata.fda.gov/cdrh_docs/pdf15/K150180.pdf) — origin: condition C8 from the technology position (2026-09-19) — stated by a chair, never checked; recorded so the Verifier can see it
Automatic capture of at least 16 days of data in each 30-day period is not limited by the device or the app, since session logging in firmware and a periodic Bluetooth sync to a phone are ordinary engineering requiring no new development, but by whether the patient uses the device on at least 16 days in the period, so candidate claim 35unconfirmed is an adherence claim rather than an engineering-feasibility claim
jurisdiction: US — confidence: unconfirmed — note: Verifier pass 2026-09-29. Engineering-effort and adherence assertion; no connector reaches either half. — source: no typed connector reaches this claim and none was invoked — origin: condition C9 from the technology position (2026-09-19) — stated by a chair, never…the full check checked; recorded so the Verifier can see it
The only published randomised trial of sEMG-triggered intravaginal electrical stimulation in stress urinary incontinence (PMID 42190320) delivered it under supervision in a clinic, three times per week for ten weeks, alongside supervised pelvic floor muscle training, so it evidences the architecture and not its unsupervised home use
jurisdiction: US — confidence: unconfirmed — note: Verifier pass 2026-09-29. The abstract retrieved today says: 42 women randomised to 'PFMT + sEMG-triggered electrical stimulation' or 'PFMT + placebo stimulation', and 'Both groups received supervised PFMT three times/week for 10 weeks plus a daily home program'. So…the full check the supervision and the 3×/week, 10-week schedule are stated for the PFMT; the abstract does not state where, or under whose supervision, the stimulation itself was delivered. 'The only published randomised trial' is an absence, which a ScanResult cannot establish (claim 91unconfirmed records the sweep history). A ScanResult carries no tag. — source: literature-detail 42190320 → ScanResult found (no confidence tag obtainable), source_ref PubMed PMID=42190320 (efetch), https://pubmed.ncbi.nlm.nih.gov/42190320/ — "Pelvic muscle training and electrostimulation to treat weak pelvic floor: a multicentre-randomised parallel group trial", Eur J Obstet Gynecol Reprod Biol 2026 — origin: condition C10 from the technology position (2026-09-19) — stated by a chair, never checked; recorded so the Verifier can see it
A closed-loop EMG-gating module can be an accessory to an already-cleared stimulator only where that host device already exposes an external stimulation-trigger input as a cleared function; where it does not, gating requires the module to control the timing of the host's energy delivery, which is a change to the host device rather than the addition of a sensor to it
jurisdiction: US — confidence: unconfirmed — note: Verifier pass 2026-09-29. checked against the frontmatter intended_use as it stands on 2026-09-29 ("treatment of stress urinary incontinence in cognitively intact adult women in the home setting, by prescription, following a documented failed four-week trial of pelvic…the full check muscle exercise training"). This is a question of how FDA treats accessories and device modifications, which is guidance and practice; regulation serves CFR text only and cannot settle interpretation (regulatory.md scope limit). — source: no typed connector reaches this claim and none was invoked — origin: condition C11 from the technology position (2026-09-19) — stated by a chair, never checked; recorded so the Verifier can see it
This candidate is at least four manufactured or delivered objects with four different lifetimes - a single-patient-use intravaginal probe consumed per patient, a returnable reusable controller amortised across patients, a companion app and cloud data pathway that is a software lifecycle rather than a bill-of-materials line, and a connectivity subscription that is an operating cost per beneficiary-year - so a single fully-loaded per-unit cost of goods as candidate claim 48unconfirmed is worded cannot be stated without naming which of those objects it covers and over what service life
jurisdiction: US — confidence: unconfirmed — note: Verifier pass 2026-09-29. Operations/product-architecture assertion; no connector reaches it. — source: no typed connector reaches this claim and none was invoked — origin: condition C1 from the operations-npi position (2026-09-19) — stated by a chair, never checked;…the full check recorded so the Verifier can see it
On a rental-flagged HCPCS code the cost comparator a manufacturer needs is fleet cost per beneficiary-year against allowed amount per beneficiary-year, not per-unit cost of goods against the DMEPOS national unadjusted schedule amount, so candidate claim 48unconfirmed's comparison of a fully-loaded cost of goods against 74.52 dollars compares a per-object-built figure to a per-service payment figure and cannot be closed in the unit it is written in
jurisdiction: US — confidence: unconfirmed — note: Verifier pass 2026-09-29. One premise is now registry-supported: $74.52 is E0740's RR monthly rental fee, the code's only line, so it is a per-rental-month payment figure and not a per-device price (see source). The costing-method conclusion (fleet cost per…the full check beneficiary-year as 'the' comparator, and claim 48unconfirmed 'cannot be closed' in its unit) is a method judgment that no source settles. — source: payment E0740 --jurisdiction US → verified, "local cache of CMS DMEPOS fee schedule, code=E0740, modifier=RR, schedule=DMEPOS, release=July 2026": "E0740 — RR (rental), category CR — capped rental items: non-rural $74.52 across 49 contiguous states/DC … Capped rental (CR): rented monthly, and title passes to the beneficiary after 13 continuous rental months (42 CFR 414.229)"; payment E0740 --modifier NU --jurisdiction US → unconfirmed: "E0740 is on the DMEPOS fee schedule (July 2026) but has no 'NU' line. Its lines are: RR." — origin: condition C2 from the operations-npi position (2026-09-19) — stated by a chair, never checked; recorded so the Verifier can see it
A returnable rental system leaves a reprocessing and asset-management burden on the reusable controller even where candidate claim 84unconfirmed's single-patient-use probe removes it from the probe: each returned controller requires exterior and cable cleaning and disinfection, incoming functional and electrical-safety test, battery state-of-health assessment, and de-provisioning of the previous patient's data before redeployment, and the fleet carries a non-return and loss rate - so claim 84unconfirmed removes reprocessing of the probe and not of the system
jurisdiction: US — confidence: unconfirmed — note: Verifier pass 2026-09-29. Operations/reprocessing assertion; no connector reaches it. — source: no typed connector reaches this claim and none was invoked — origin: condition C3 from the operations-npi position (2026-09-19) — stated by a chair, never checked; recorded…the full check so the Verifier can see it
Measuring the trigger sensitivity and specificity that candidate claim 105unconfirmed says nobody has measured requires a functionally representative stimulating-and-sensing intravaginal probe applied to human volunteers, because the discrimination depends on electrode area, inter-electrode spacing and probe seating and not on the detector alone; so unless an already-cleared clinic device of the kind candidate claim 103unconfirmed names exposes a raw surface-EMG channel and a settable trigger threshold and can serve as the rig, the study's schedule is set by a prototype probe build plus a biocompatibility and electrical-safety justification for the test article rather than by the study itself
jurisdiction: US — confidence: unconfirmed — note: Verifier pass 2026-09-29. Study-design and schedule assertion; no connector reaches it. — source: no typed connector reaches this claim and none was invoked — origin: condition C4 from the operations-npi position (2026-09-19) — stated by a chair, never checked;…the full check recorded so the Verifier can see it
ISO 10993-1 biological evaluation of a single-patient-use intravaginal probe that the patient cleans between her own sessions must be performed on test articles conditioned through the labelled cleaning regimen and aged to the labelled shelf life rather than on virgin material, so candidate claim 36unconfirmed cannot be closed before the cleaning regimen is specified as a design input, and cleaning validation and test-article conditioning sit ahead of the biocompatibility test battery on the schedule rather than beside it
jurisdiction: US — confidence: unconfirmed — note: Verifier pass 2026-09-29. ISO 10993-1 is a licensed standard and FDA's biocompatibility guidance is guidance; neither is reached by any connector (regulatory.md scope limit). — source: no typed connector reaches this claim and none was invoked — origin: condition C5…the full check from the operations-npi position (2026-09-19) — stated by a chair, never checked; recorded so the Verifier can see it
Replacing the surface-EMG trigger with an intravaginal manometric trigger as candidate claim 107unconfirmed describes adds a component or a production-test step to the single-patient-use probe rather than removing one, because surface EMG places only electrodes and wiring in the disposable and its analog front end in the returnable controller, whereas an air-coupled manometric probe requires a bacterial or viral barrier filter on the disposable side to stop the reusable controller becoming a between-patient contamination route, and an in-probe transducer - the architecture the InTone insertion unit uses - moves transducer cost and a per-unit calibration step into the disposable
jurisdiction: US — confidence: unconfirmed — note: Verifier pass 2026-09-29. Design/production assertion; no connector reaches it. The InTone insertion-unit architecture is manufacturer or 510(k)-summary content, and clearance-summary could not run this pass. — source: no typed connector reaches this claim and none…the full check was invoked; clearance-summary unavailable this pass (crash at import, see claim 83unconfirmed) — origin: condition C6 from the operations-npi position (2026-09-19) — stated by a chair, never checked; recorded so the Verifier can see it
Intravaginal pelvic floor electrical stimulator probes in the KPI / 21 CFR 876.5320 pool are supplied non-sterile and cleaned by the user, so this candidate requires no terminal sterilisation process, no sterile barrier system and no sterilisation-residual or package-integrity validation, and the most expensive process qualification a patient-contact device normally carries is not on this device's critical path
jurisdiction: US — confidence: unconfirmed — note: Verifier re-attempt 2026-10-01, clearance-summary now runs. Checked against the frontmatter intended_use as it stands on 2026-10-01 ("The device is indicated for the treatment of stress urinary incontinence in cognitively intact adult women in the home setting, by…the full check prescription, following a documented failed four-week trial of pelvic muscle exercise training."). NOW CHECKED: K150180's Table 7.3 records 'Sterilization N/A N/A N/A' for InTone (K110179), InToneMV (K134020) and the new InTone, and its biocompatibility section classes the inflatable probe as tissue-contacting for under 24 hours (cytotoxicity, sensitization, irritation only) — so the InControl InTone family is cleared non-sterile. STILL OPEN: (a) the rest of the pool — K133826's posted summary says nothing on sterility, and K121820 (InWave) has no summary posted, so 'probes in the KPI pool' is shown for one family only; (b) 'cleaned by the user' appears in no summary read — that is labelling/user-manual content, not reached; (c) the consequence half (which validations drop off the critical path) is reasoning, not a fact a source holds. — source: clearance-summary K150180 --jurisdiction US → verified, FDA 510(k) summary K150180 (https://www.accessdata.fda.gov/cdrh_docs/pdf15/K150180.pdf), full text read for Table 7.3 and the biocompatibility section; clearance-summary K133826 --jurisdiction US → verified (no sterility statement in the posted summary); clearance-summary K121820 --jurisdiction US → verified (IFU page only, no summary) — origin: condition C7 from the operations-npi position (2026-09-19) — stated by a chair, never checked; recorded so the Verifier can see it
In MAUDE reports coded to product code KPI between 2010-01-01 and 2026-09-19, the recurring device-related complaint for non-implanted pelvic floor stimulators is a burning or painful sensation at the stimulating electrode, and no report in that set attributes an event to an EMG, manometric or biofeedback sensing function, so the per-unit production controls this device needs sit on electrode geometry, surface finish, plating consistency and charge-balance verification rather than on the sensing chain - MAUDE carries no denominator, so this is a statement about which failure mode recurs and never about a rate
jurisdiction: US — confidence: unconfirmed — note: Verifier pass 2026-09-29. MAUDE is a scan and its result carries no tag. As a lead: burning at the electrode recurs among the non-implanted reports (MW5110267, MW5110278 'PATHWAY VAGINAL EMG/STIMULATION', 1723686-2013-00002 Zynex 'burning sensation … at 23mA'), and…the full check MW5110278, the one EMG-capable device, describes a stimulation burn, not a sensing fault. No denominator, so no rate. The 'so the production controls sit on …' half is inference. — source: maude --product-code KPI --since 2010-01-01 --until 2026-09-19 --limit 100 --jurisdiction US → ScanResult found, 24 reports, total_matches 24, truncated false (no confidence tag obtainable) — origin: condition C8 from the operations-npi position (2026-09-19) — stated by a chair, never checked; recorded so the Verifier can see it
MAUDE reports returned under product code KPI over 2010-01-01 to 2026-09-19 include implanted sacral neuromodulation devices, a non-implanted electromagnetic chair device, an I.V. bag and an orthopaedic plating system, so product code KPI is not a usable retrieval filter for this device's complaint handling or post-market surveillance and a plan that specifies it will be reading other manufacturers' devices in other device classes
jurisdiction: US — confidence: unconfirmed — note: Verifier pass 2026-09-29. MAUDE is a scan and its result carries no tag. As a lead, the 24 KPI-coded reports do include every category the claim names: implanted sacral neuromodulation (InterStim, e.g. 20300107, 7120554, MW5093294, MW5073208), a non-implanted…the full check electromagnetic chair (Emsella, e.g. MW5118108, MW5149580), an I.V. bag (MW5071908) and an orthopaedic plating system (0009613350-2017-01398). The conclusion ('not a usable retrieval filter') is inference. — source: maude --product-code KPI --since 2010-01-01 --until 2026-09-19 --limit 100 --jurisdiction US → ScanResult found, 24 reports, total_matches 24, truncated false (no confidence tag obtainable) — origin: condition C9 from the operations-npi position (2026-09-19) — stated by a chair, never checked; recorded so the Verifier can see it
No annual build volume has been stated anywhere in this candidate file, and the only unit figure it carries - 689 Medicare fee-for-service beneficiaries nationally in data year 2024, candidate claim 70verified - is a floor on one payer's population and not a build plan; at a build in the hundreds of probes per year the fully-loaded cost of goods is dominated by non-recurring engineering amortisation and hand assembly and production tooling is not amortisable, while at tens of thousands per year it is dominated by the bill of materials and the moulding cycle, so candidate claims 48 and 49 are functions of a volume this file does not have rather than numbers nobody has looked up
jurisdiction: US — confidence: unconfirmed — note: Verifier pass 2026-09-29. The first half is a statement about this file, not the world; no connector answers it. A text search of this file on 2026-09-29 for 'build volume', 'units per year' and 'annual volume' found no build-volume figure (the 'annual volume' hits…the full check are Medicare utilization, claim 80unconfirmed and the Stage 4 notes). The cost-structure half is reasoning that no source reaches. — source: no typed connector reaches this claim and none was invoked — origin: condition C10 from the operations-npi position (2026-09-19) — stated by a chair, never checked; recorded so the Verifier can see it
Revenue per beneficiary for a home pelvic floor electrical stimulator billed under HCPCS E0740 is bounded by the number of monthly rental payment lines the DMEPOS payment category the code sits in permits over a twelve-week treatment course, rather than by the allowed amount per beneficiary per year realized across the whole Medicare fee-for-service book in data year 2024
jurisdiction: US — confidence: unconfirmed — note: Verifier pass 2026-09-29. The category half is registry-verified: E0740 is a capped-rental (CR), RR-only code, paid monthly with a 13-continuous-month cap (42 CFR 414.229), so a 12-week course bills about three rental months, well under the cap. NOT verified: that…the full check this device's revenue is bounded by a 12-week course. That is a clinical and commercial premise, and it sits in tension with the realized Medicare book, where 4,130 rental services across 689 beneficiaries is 6.0 rental months per beneficiary, about twice a 12-week course, or about $347 allowed per beneficiary against about $174 for three months at the 2024 average of $57.89. Nothing returned refuted: the registry describes Medicare's E0740 book, not this device's course. — source: payment E0740 --jurisdiction US → verified, "local cache of CMS DMEPOS fee schedule, code=E0740, modifier=RR, schedule=DMEPOS, release=July 2026": "E0740 — RR (rental), category CR — capped rental items: non-rural $74.52 across 49 contiguous states/DC … Capped rental (CR): rented monthly, and title passes to the beneficiary after 13 continuous rental months (42 CFR 414.229)"; regulation 414.229 --title 42 --expect "monthly fee schedule amount" --jurisdiction US → verified, eCFR versioner title-42, issue 2026-08-13, section=414.229 ("§ 414.229 Other durable medical equipment—capped rental items"); regulation 414.229 --title 42 --expect "13 continuous rental months" --jurisdiction US → verified, same source_ref; procedures E0740 --jurisdiction US → verified, "local cache of CMS Medicare DMEPOS utilization file (referring provider geography and service), code=E0740, geography=National": "rental 4,130 services / 689 beneficiaries … Medicare fee-for-service only … excludes Medicare Advantage, commercial, Medicaid, VA, and cash-pay … a rental service is typically one rental month, not one device" — origin: business-case assumption (2026-09-20) — never checked; recorded so the Verifier can see it — evidence class 1 (registry fact)
A DME supplier dispensing a home pelvic floor electrical stimulator pays the manufacturer a wholesale price materially below the allowed amount the supplier bills for it, so manufacturer revenue per beneficiary is strictly below the allowed amount per beneficiary recorded in the CMS Medicare durable medical equipment release for HCPCS E0740
jurisdiction: US — confidence: unconfirmed — note: Verifier pass 2026-09-29. Manufacturer–supplier transfer pricing is not reached by any connector; 'strictly below' is a commercial assumption. — source: no typed connector reaches this claim and none was invoked — origin: business-case assumption (2026-09-20) — never…the full check checked; recorded so the Verifier can see it — evidence class 2 (published finding)
A commercial medical policy that finds intravaginal pelvic floor electrical stimulation medically necessary results in payment under that plan's durable medical equipment benefit for a home-dispensed device billed under HCPCS E0740 or its commercial equivalent, rather than the medical-necessity determination being administered separately from DME benefit coverage
jurisdiction: US — confidence: unconfirmed — note: Verifier pass 2026-09-29. Commercial-plan benefit administration is not reached by any connector. claim 75verified records that Aetna CPB 0223 draws no home/in-office distinction and its residual (b) says silence on site of care is not a DME-benefit determination. — source:…the full check no typed connector reaches this claim and none was invoked — origin: business-case assumption (2026-09-20) — never checked; recorded so the Verifier can see it — evidence class 2 (published finding)
Women with stress urinary incontinence and the clinicians who would prescribe for them start a home electrical stimulation device that no United States clinical guideline names among its recommended non-surgical treatment options for the condition
jurisdiction: US — confidence: unconfirmed — note: Verifier pass 2026-09-29. Class-3 stakeholder-future claim; the adoption connector refuses it by design and no Verifier opinion is substituted. The guideline premise is claim 94unconfirmed (unconfirmed, and recorded there as overstated); adoption despite it is not answerable. —…the full check source: adoption "<claim text>" → unverifiable: "asserts what clinicians, payers, or patients would do. No free, authoritative, machine-queryable source answers that — it needs primary research (interviews, survey, published preference study)" (the adoption subcommand takes no --jurisdiction flag) — origin: deck-surfaced assumption (desirability deck, 2026-09-24) — never checked; recorded so the Verifier can see it — evidence class 3 (stakeholder future)
Women prescribed a home pelvic floor electrical stimulator treat their own observed change in incontinence episodes, rather than the EMG trend the device transmits to their prescriber, as the evidence that the device is working
jurisdiction: US — confidence: unconfirmed — note: Verifier pass 2026-09-29. Class-3 stakeholder-future claim; the adoption connector refuses it by design and no Verifier opinion is substituted. — source: adoption "<claim text>" → unverifiable: "asserts what clinicians, payers, or patients would do. No free,…the full check authoritative, machine-queryable source answers that — it needs primary research (interviews, survey, published preference study)" (the adoption subcommand takes no --jurisdiction flag) — origin: deck-surfaced assumption (desirability deck, 2026-09-24) — never checked; recorded so the Verifier can see it — evidence class 3 (stakeholder future)
A prescribing urogynecology or pelvic floor physical therapy practice gives a manufacturer access to survey or observe its own patients' uptake and twelve-week continuation of a prescribed home pelvic floor stimulator
jurisdiction: US — confidence: unconfirmed — note: Verifier pass 2026-09-29. Class-3 stakeholder-future claim; the adoption connector refuses it by design and no Verifier opinion is substituted. — source: adoption "<claim text>" → unverifiable: "asserts what clinicians, payers, or patients would do. No free,…the full check authoritative, machine-queryable source answers that — it needs primary research (interviews, survey, published preference study)" (the adoption subcommand takes no --jurisdiction flag) — origin: deck-surfaced assumption (desirability deck, 2026-09-24) — never checked; recorded so the Verifier can see it — evidence class 3 (stakeholder future)
A commercial payer or a prescribing practice requires longitudinal adherence and EMG-trend documentation as a condition of continued coverage or continued prescription for a home pelvic floor electrical stimulator, so the dataset this candidate names as its defensible asset has a buyer even though no Medicare payment attaches to it
jurisdiction: US — confidence: unconfirmed — note: Verifier pass 2026-09-29. Class-3 stakeholder-future claim; the adoption connector refuses it by design and no Verifier opinion is substituted. No Medicare payment attaching to the dataset is itself unestablished here; whether any buyer requires it is stakeholder…the full check future. — source: adoption "<claim text>" → unverifiable: "asserts what clinicians, payers, or patients would do. No free, authoritative, machine-queryable source answers that — it needs primary research (interviews, survey, published preference study)" (the adoption subcommand takes no --jurisdiction flag) — origin: deck-surfaced assumption (viability deck, 2026-09-24) — never checked; recorded so the Verifier can see it — evidence class 3 (stakeholder future)
Manufacturer revenue for a home pelvic floor electrical stimulator is realized when a DME supplier acquires a unit into rental inventory rather than per beneficiary dispensed, so manufacturer revenue is decoupled from the number of monthly rental lines the supplier subsequently bills
jurisdiction: US — confidence: unconfirmed — note: Verifier pass 2026-09-29. Class-3 stakeholder-future claim; the adoption connector refuses it by design and no Verifier opinion is substituted. Stamped class 3 by its drafter; it is a revenue-recognition assumption about supplier purchasing, which no connector reaches…the full check either. — source: adoption "<claim text>" → unverifiable: "asserts what clinicians, payers, or patients would do. No free, authoritative, machine-queryable source answers that — it needs primary research (interviews, survey, published preference study)" (the adoption subcommand takes no --jurisdiction flag) — origin: deck-surfaced assumption (viability deck, 2026-09-24) — never checked; recorded so the Verifier can see it — evidence class 3 (stakeholder future)
No manufacturer in the KPI / 21 CFR 876.5320 pool has listed a closed-loop EMG-gated intravaginal stimulator on the PDAC Product Classification List under HCPCS E0740
jurisdiction: US — confidence: unconfirmed — note: Verifier pass 2026-09-29. An absence on the PDAC Product Classification List; no connector in this repo reaches the PDAC (the same gap as claim 73unconfirmed, docs/backlog.md 1.19). — source: no typed connector reaches this claim and none was invoked — origin: deck-surfaced…the full check assumption (viability deck, 2026-09-24) — never checked; recorded so the Verifier can see it — evidence class 1 (registry fact)
A closed-loop EMG-gated intravaginal stimulator is found substantially equivalent to a KPI / 21 CFR 876.5320 predicate whose cleared indications and output specifications do not include EMG-gated stimulation, without the gating function raising a new question of safety or effectiveness
jurisdiction: US — confidence: unconfirmed — note: Verifier re-attempt 2026-10-01; checked against the frontmatter intended_use as it stands on 2026-10-01 ("treatment of stress urinary incontinence in cognitively intact adult women in the home setting, by prescription, following a documented failed four-week trial of…the full check pelvic muscle exercise training"). clearance-summary now runs (the 2026-09-29 pass crashed at import). Sub-premise now checked: the frontmatter predicate pool's IFUs contain no EMG-triggered indication: K150180, K133826 and K121820 each miss on 'EMG' (K150180 and K133826 name only a biofeedback feature; K121820 'electrical stimulation and neuromuscular re- education ... stress urge and mixed urinary incontinence in women'). But the premise that the candidate must rely on such a predicate no longer holds: KPI predicates WITH a cleared EMG-triggered stimulation mode exist (K243079, claim 153verified; K201014, claim 154verified; also K220161, OTC). So this claim describes the harder of two routes; it is not refuted, because whether FDA would find SE to a non-ETS (electrical tissue stimulation) predicate is still FDA's future judgment, which no source answers. Read it with claims 153, 154 and 155. — source: clearance-summary K150180 --expect-indication "EMG" --jurisdiction US → unconfirmed: 'The cleared indication does NOT contain the claimed phrase'; clearance-summary K133826 --expect-indication "EMG" --jurisdiction US → unconfirmed (same); clearance-summary K121820 --expect-indication "EMG" --jurisdiction US → unconfirmed (same); clearance-summary K243079 --jurisdiction US → verified, FDA 510(k) summary K243079; clearance-summary K201014 --jurisdiction US → verified, FDA 510(k) summary K201014 — origin: deck-surfaced assumption (feasibility deck, 2026-09-24) — never checked; recorded so the Verifier can see it
A single intravaginal probe geometry satisfies both the stimulating-electrode area a therapeutic NMES envelope requires and the inter-electrode spacing a discriminating surface-EMG channel requires, so no design trade between the two functions is forced on the probe
jurisdiction: US — confidence: unconfirmed — note: Verifier pass 2026-09-29. Electrode/probe design assertion; no connector reaches it. — source: no typed connector reaches this claim and none was invoked — origin: deck-surfaced assumption (feasibility deck, 2026-09-24) — never checked; recorded so the Verifier can…the full check see it — evidence class 2 (published finding)
Manufacturer unit demand for a home pelvic floor electrical stimulator splits by object: single-patient-use intravaginal probes are acquired one per beneficiary dispensed, while the returnable controller is acquired into a DME supplier's rental inventory once and amortized across successive beneficiaries, so candidate claim 128unconfirmed's decoupling of manufacturer revenue from beneficiaries dispensed applies to the controller line and not to the probe line
jurisdiction: US — confidence: unconfirmed — note: Verifier pass 2026-09-29. Business-model assertion about unit demand; no connector reaches it. A registry fact bears on 'returnable': under 42 CFR 414.229 a capped-rental item passes to the beneficiary after 13 continuous rental months, well beyond a 12-week course,…the full check but the realized Medicare book averages 6.0 rental months per beneficiary (claim 121unconfirmed). — source: regulation 414.229 --title 42 --expect "monthly fee schedule amount" --jurisdiction US → verified, eCFR versioner title-42, issue 2026-08-13, section=414.229 ("§ 414.229 Other durable medical equipment—capped rental items"); regulation 414.229 --title 42 --expect "13 continuous rental months" --jurisdiction US → verified, same source_ref — origin: business-case assumption (2026-09-24) — never checked; recorded so the Verifier can see it — evidence class 1 (registry fact)
A prescribing urogynecology or pelvic floor physical therapy practice pays a recurring per-patient software or data-platform fee for the longitudinal adherence and EMG-trend documentation this candidate names as its defensible asset, out of practice overhead and with no reimbursement line behind it
jurisdiction: US — confidence: unconfirmed — note: Verifier pass 2026-09-29. Class-3 stakeholder-future claim; the adoption connector refuses it by design and no Verifier opinion is substituted. — source: adoption "<claim text>" → unverifiable: "asserts what clinicians, payers, or patients would do. No free,…the full check authoritative, machine-queryable source answers that — it needs primary research (interviews, survey, published preference study)" (the adoption subcommand takes no --jurisdiction flag) — origin: business-case assumption (2026-09-24) — never checked; recorded so the Verifier can see it — evidence class 3 (stakeholder future)
PDAC coding verification of a closed-loop EMG-gated intravaginal stimulator to HCPCS E0740 — a configuration candidate claim 129unconfirmed records as listed by no manufacturer in the KPI pool — resolves inside the sub-two-year time-to-first-revenue window candidate claim 30unconfirmed asserts, rather than returning a different code, a non-listing, or a delay behind the announced re-review of every currently listed product
jurisdiction: US — confidence: unconfirmed — note: Verifier pass 2026-09-29. PDAC process timing and outcome; no connector reaches the PDAC (docs/backlog.md 1.19). — source: no typed connector reaches this claim and none was invoked — origin: business-case assumption (2026-09-24) — never checked; recorded so the…the full check Verifier can see it — evidence class 1 (registry fact)
A commercial health plan that pays for a home-dispensed non-implanted pelvic floor electrical stimulator under its durable medical equipment benefit, billed as HCPCS E0740 or its commercial equivalent, pays it as a monthly rental in the way Medicare's capped-rental payment category does, rather than as a single purchase of the complete system
jurisdiction: US — confidence: unconfirmed — note: Verifier pass 2026-10-01. What a commercial plan does is payer behaviour; no connector reaches commercial payer contracts or fee schedules, and adoption returned unverifiable (stays unconfirmed permanently absent a human-attached payer policy or primary research).…the full check The Medicare comparator is on record elsewhere in this file (claim at file line 146: E0740 is a single RR line in capped-rental category CR), but that is Medicare's category, not any commercial plan's. — source: adoption "A commercial health plan pays for a home pelvic floor electrical stimulator billed as E0740 as a monthly rental rather than a single purchase" → unverifiable: 'asserts what clinicians, payers, or patients would do … needs primary research' — origin: business-case assumption (2026-09-29) — never checked; recorded so the Verifier can see it — evidence class 2 (published finding)
A pelvic floor physical therapy or urogynecology practice, or a patient, buying a complete home pelvic floor electrical stimulator system for cash compares its price against the cumulative rental Medicare would allow over the months a treatment course lasts, up to the thirteen-month capped-rental limit, rather than against the single monthly HCPCS E0740 rental fee schedule amount
jurisdiction: US — confidence: unconfirmed — note: Verifier pass 2026-10-01. A buyer's price-comparison behaviour is a stakeholder claim; adoption returned unverifiable, and no opinion was produced in its place. Stays unconfirmed permanently absent primary research. — source: `adoption "A pelvic floor PT practice or…the full check patient buying a home pelvic floor stimulator for cash compares its price against cumulative Medicare rental"` → unverifiable: 'asserts what clinicians, payers, or patients would do … needs primary research' — origin: business-case assumption (2026-09-29) — never checked; recorded so the Verifier can see it — evidence class 3 (stakeholder future)
Medicare Advantage organizations must cover non-implantable pelvic floor electrical stimulation for enrollees who meet Medicare NCD 230.8's criteria, because 42 CFR 422.101 requires an MA (Medicare Advantage) organization to cover all services covered by Medicare Part B and to comply with CMS's national coverage determinations, so the covered population on a Medicare route includes Medicare Advantage enrollees who are absent from the 689-beneficiary fee-for-service count for HCPCS E0740
jurisdiction: US — confidence: verified — note: Verifier pass 2026-10-01; verified as a compound, every operand traced to a primary source. (1) 42 CFR 422.101 text: each MA organization must '(a) Provide coverage of … all services that are covered by Part A and Part B of Medicare … or by Medicare Part B' and '(b)…the full check Comply with— (1) CMS's national coverage determinations'. (2) NCD 230.8 text: non-implantable pelvic floor electrical stimulation 'is covered for the treatment of stress and/or urge urinary incontinence in cognitively intact patients who have failed a documented trial of pelvic muscle exercise (PME) training'. (3) The 689 figure: CMS 'Medicare Durable Medical Equipment, Devices & Supplies — by Geography and Service', data year 2024, national E0740 row, Tot_Suplr_Benes 689. (4) MA enrollees are absent from that count: CMS's own methodology for the release states 'the Durable Medical Equipment, Devices & Supplies Dataset does not include information for patients who are enrolled in any form of Medicare Advantage plan' and that it covers 'Medicare beneficiaries with Part B FFS coverage'. Limits: this verifies a duty to cover, not MA utilisation-management practice (prior authorisation, network) and not the size of the MA covered population, which no connector reaches. — source: regulation 422.101 --title 42 --expect "national coverage determinations" --jurisdiction US → verified, eCFR versioner title-42, issue 2026-09-29, section=422.101; ncd 230.8 --jurisdiction US → verified, CMS Pub. 100-3 Medicare NCD Manual, ch.1 pt.4 (Rev. 13808, issued 05-29-26), section=230.8; procedures E0740 --jurisdiction US → unconfirmed: data/medicare_dme_volumes.csv not cached ('a missing-file gap, not evidence that the code has no volume'), so the release it names was read directly: https://data.cms.gov/data-api/v1/dataset/27c150fd-8578-43b1-bba5-6388987e32af/data?filter[HCPCS_Cd]=E0740&filter[Rfrg_Prvdr_Geo_Lvl]=National (retrieved 2026-10-01: Tot_Suplr_Benes 689, Tot_Suplr_Srvcs 4130, Suplr_Rentl_Ind Y) and its methodology https://data.cms.gov/sites/default/files/2025-06/a837dcf7-3d06-4c1f-8d4a-82ee737b7932/MUP_DME_RY25_Methodology_20250617_508.pdf (listed by data-api/v1/dataset-resources for that dataset) — origin: business-case assumption (2026-09-29) — never checked; recorded so the Verifier can see it — evidence class 1 (registry fact)
A woman prescribed a home pelvic floor electrical stimulator under a rental arrangement accepts delivery of a reprocessed controller previously rented to another patient, provided the intravaginal probe supplied to her is new and single-patient-use, rather than declining the device
jurisdiction: US — confidence: unconfirmed — note: Verifier pass 2026-10-01. Patient acceptance of a reprocessed controller is a stakeholder claim; adoption returned unverifiable, no opinion produced. Stays unconfirmed permanently absent primary research. — source: `adoption "A woman accepts a reprocessed rental…the full check controller provided the vaginal probe is new"` → unverifiable: 'asserts what clinicians, payers, or patients would do … needs primary research' — origin: deck-surfaced assumption (desirability deck, 2026-09-29) — never checked; recorded so the Verifier can see it — evidence class 3 (stakeholder future)
Under the capped-rental payment for HCPCS E0740, a DME supplier furnishes the single-patient-use intravaginal probe of a home pelvic floor electrical stimulator within the monthly rental payment, because no separately payable HCPCS Level II line exists for a replacement vaginal probe used with this device, so the probe's cost is carried by the rental months the beneficiary generates
jurisdiction: US — confidence: unconfirmed — note: Verifier re-attempt 2026-10-01; the HCPCS Level II and DMEPOS caches now exist, so the search ran. Three halves. (a) Capped rental: verified, E0740 RR category CR, non-rural $74.52 across 49 contiguous states/DC (July 2026), title passing after 13 continuous rental…the full check months. (b) Descriptor: E0740 'Non-implanted pelvic floor electrical stimulator, complete system'; NCD 230.8 says stimulation 'is generally delivered by vaginal or anal probes connected to an external pulse generator' and does not contain 'supplies'. (c) The negative: the full cached Level II file (8,770 rows) was searched for vaginal, pelvic floor, probe and incontinence-stimulator language, and NO code describes a replacement vaginal probe or electrode for a pelvic floor stimulator, or supplies for E0740 (E0716 is supplies for the separate E0715 intravaginal kegel device). But generic, fee-scheduled supply codes exist that a supplier might try: A4595 (a HCPCS code for a supply) 'Electrical stimulator supplies, 2 lead, per month, (e.g., tens, nmes)' ($11.40 to $13.24 non-rural), A4556 'Electrodes, (e.g., apnea monitor), per pair' ($14.71 to $17.31), A9999 miscellaneous supply; E1399 has no fee-schedule row (individually priced). Whether a DME MAC treats an E0740 probe as included in the rental or billable under one of these is a MAC coding and policy-article question no connector answers (coverage E0740 finds no NCD/LCD in the cached index naming the code), and whether suppliers in fact furnish the probe within the rental is supplier practice. So 'no separately payable line exists' is narrowed to 'no dedicated code exists', and the payability half stays open. — source: payment E0740 --jurisdiction US → verified, local cache of CMS DMEPOS fee schedule, code=E0740, modifier=RR, release=July 2026; hcpcs E0740 --jurisdiction US → verified, local cache of CMS HCPCS Level II file, code=E0740; hcpcs A4595 --jurisdiction US → verified; hcpcs A4556 --jurisdiction US → verified; hcpcs A4557 --jurisdiction US → verified; hcpcs E0716 --jurisdiction US → verified; hcpcs A9999 --jurisdiction US → verified; hcpcs E1399 --jurisdiction US → verified; payment A4595 --jurisdiction US → verified, DMEPOS July 2026, category SU; payment A4556 --jurisdiction US → verified, DMEPOS July 2026, category SU; payment E1399 --jurisdiction US → refuted: 'No row for E1399 on the cached DMEPOS fee schedule' (a fact about the code's pricing, not about this claim); coverage E0740 --jurisdiction US → refuted: 'No NCD or LCD in the cached coverage file names E0740' (index linkage, see claim 9verified; not a statement about the probe); ncd 230.8 --expect "supplies" --jurisdiction US → unconfirmed: text does NOT contain the phrase; full-file search of data/hcpcs_level_ii.csv (retrieved 2026-10-01T05:17Z) — origin: deck-surfaced assumption (viability deck, 2026-09-29) — never checked; recorded so the Verifier can see it — evidence class 1 (registry fact)
Women prescribed a rented home pelvic floor electrical stimulator for stress urinary incontinence keep it on rental beyond a twelve-week treatment course, so the monthly rental lines billed per beneficiary exceed the three that a twelve-week course spans
jurisdiction: US — confidence: unconfirmed — note: Verifier pass 2026-10-01. The behavioural half (women keep it beyond twelve weeks) is a stakeholder claim; adoption returned unverifiable. Checkable proxy for the consequence half, read and NOT sufficient to verify: Medicare FFS 2024 E0740 national row shows 4,130…the full check supplier services across 689 beneficiaries, all on the rental indicator, i.e. a mean of about 6.0 rental services per beneficiary — above three, so the record does not cut against the claim. Why it does not verify: it is a mean (it does not show the per-beneficiary distribution), it covers every E0740 indication and both sexes rather than women treated for SUI, it is Medicare FFS only (no MA, commercial or cash), and it is a calendar-year count that can split one rental across two years. — source: adoption "Women keep a rented pelvic floor stimulator beyond a twelve-week course" → unverifiable; procedures E0740 --jurisdiction US → unconfirmed: data/medicare_dme_volumes.csv not cached, so the release it names was read directly: https://data.cms.gov/data-api/v1/dataset/27c150fd-8578-43b1-bba5-6388987e32af/data?filter[HCPCS_Cd]=E0740&filter[Rfrg_Prvdr_Geo_Lvl]=National (retrieved 2026-10-01: Tot_Suplr_Srvcs 4130, Tot_Suplr_Benes 689, Suplr_Rentl_Ind Y) — origin: deck-surfaced assumption (viability deck, 2026-09-29) — never checked; recorded so the Verifier can see it — evidence class 3 (stakeholder future)
The returnable controller of a home pelvic floor electrical stimulator can be designed so that its enclosure, cable and battery survive repeated cleaning, disinfection, functional and electrical-safety re-test and redeployment across successive rental beneficiaries, giving it a service life that spans more than one beneficiary
jurisdiction: US — confidence: unconfirmed — note: Verifier pass 2026-10-01. A design-capability assertion about a controller this file has not specified; no typed connector answers whether an enclosure, cable and battery survive a reprocessing cycle, and none was invoked. Needs design verification (reprocessing and…the full check durability testing), not a lookup. — source: no typed connector reaches this claim — origin: deck-surfaced assumption (feasibility deck, 2026-09-29) — never checked; recorded so the Verifier can see it
In a multicentre double-blind randomised trial of 42 women with stress urinary incontinence and very weak pelvic floor muscles, sEMG-triggered intravaginal electrical stimulation added to supervised pelvic floor muscle training outperformed pelvic floor muscle training plus sham stimulation on leakage episodes at 12 months
jurisdiction: US — confidence: unconfirmed — note: Verifier pass 2026-10-01; cold re-retrieval done, content matches, tag held on structural grounds (same as the PMID 22847318 / 26397715 lines). PubMed PMID 42190320, 'Pelvic muscle training and electrostimulation to treat weak pelvic floor: a multicentre-randomised…the full check parallel group trial', Eur J Obstet Gynecol Reprod Biol, 2026. Abstract: 'multicentre, randomized, double-blind, parallel-group trial, 42 women with SUI … PFMT + sEMG-triggered electrical stimulation, or … PFMT + placebo stimulation'; 'At 12 months, experimental group showed larger reductions in weekly leakage (-1.51 episodes/week; p = 0.001)'. Every element of the claim matches. Three cautions for the reader: leakage episodes were a SECONDARY outcome (primary was PFM strength); 36 of 42 completed 12-month follow-up; and the abstract does not state the trial's country (a European journal) — the finding is published evidence, not a US-specific fact, so the jurisdiction: US field should not be read as a US population. Not verified because literature-detail returns a ScanResult, which carries no confidence tag by construction; a class-2 finding needs independent corroboration per docs/research-lane-spec.md. — source: literature-detail 42190320 → found (ScanResult, no tag), PubMed PMID=42190320 (efetch), https://pubmed.ncbi.nlm.nih.gov/42190320/ — origin: research lane, from dossier stress-urinary-incontinence §clinical-evidence via report stress-urinary-incontinence.reference-products.analog-sensing-while-stimulating (2026-10-01) — primary source: PMID 42190320 — evidence class 2 (published finding); not independently checked — needs a cold re-retrieval of the cited source by someone who did not draft this
Among women referred to pelvic floor physical therapy for urinary incontinence in 2009-2010, 33% of those with private insurance did not participate, and insurance noncoverage was a risk factor for nonparticipation
jurisdiction: US — confidence: unconfirmed — note: Verifier pass 2026-10-01; cold re-retrieval done, content matches, tag held on structural grounds. PubMed PMID 21620356, 'Barriers to pelvic floor physical therapy utilization for treatment of female urinary incontinence', Am J Obstet Gynecol, 2011. Abstract: 'A…the full check cross-sectional study of women referred to PFPT for urinary incontinence between January 2009 and June 2010'; 'Thirty-three percent of women with private insurance and 17% with other insurance were PFPT nonparticipants'; 'Risk factors for nonparticipation included insurance noncoverage (OR, 103.85; 95% CI, 6.21-infinity)'. Matches; note the window is Jan 2009 – Jun 2010, and the noncoverage OR has a CI to infinity, i.e. very sparse cells. Not verified because literature-detail returns a ScanResult with no tag; class-2 needs independent corroboration. — source: literature-detail 21620356 → found (ScanResult, no tag), PubMed PMID=21620356 (efetch), https://pubmed.ncbi.nlm.nih.gov/21620356/ — origin: research lane, from dossier stress-urinary-incontinence §care-pathway via report stress-urinary-incontinence.reference-products.analog-documented-conservative-failure-prescribing (2026-10-01) — primary source: PMID 21620356 — evidence class 2 (published finding); not independently checked — needs a cold re-retrieval of the cited source by someone who did not draft this
The only randomised trial of sEMG-triggered intravaginal electrical stimulation in stress urinary incontinence (PMID 42190320, registered as NCT06419517) enrolled only women aged 18 to 50 who were six to eighteen months after childbirth and had a Modified Oxford Score of 0-1 on digital palpation, so its result does not establish an effect of sEMG-triggered stimulation in women with stress urinary incontinence outside the early postpartum period or with a pelvic floor contraction of Oxford grade 2 or above, neither of which this candidate's intended use excludes
jurisdiction: US — confidence: unconfirmed — note: Verifier pass 2026-10-01. Origin label corrected: this is clinical condition C10 (the source string says C12 because of a since-fixed tool bug; mapping in knowledge-base/positions/idea-001-clinical.md); the substance was checked as written. Registry content matches:…the full check NCT06419517 eligibility is 'Adult women (18 years old - 50 years old), with a Modified Oxford Score, determined by digital palpation, of 0 - 1', 'Between six and eighteen months after childbirth'; PMID 42190320 abstract describes 'women with SUI and very weak PFMs'. Held unconfirmed on structural grounds: both records came back as ScanResults (trial-detail, literature-detail), which carry no confidence tag by construction, and 'the only randomised trial' is an absence no sweep can establish (see claims 91, 109). Whether the eligibility window limits generalisation to this intended use is a clinical reading, not a registry fact. — source: trial-detail NCT06419517 → found (ScanResult, no tag), ClinicalTrials.gov NCTId=NCT06419517, https://clinicaltrials.gov/study/NCT06419517;literature-detail 42190320 → found (ScanResult, no tag), PubMed PMID=42190320 (efetch) — origin: condition C12 from the clinical position (2026-10-01) — stated by a chair, never checked; recorded so the Verifier can see it
In NCT06419517 the comparator arm received intravaginal stimulation at 2 Hz and 10 microsecond pulse width to sensory response, against 50 Hz and 250 microseconds to motor response in the sEMG-triggered arm, with supervised pelvic floor muscle training in both arms, so PMID 42190320 compares therapeutic-dose sEMG-triggered stimulation against a sub-therapeutic stimulation sham and does not measure the contribution of the EMG trigger separately from that of therapeutic-dose stimulation
jurisdiction: US — confidence: unconfirmed — note: Verifier pass 2026-10-01. Origin label corrected: this is clinical condition C11 (source string says C12, tool bug; mapping in knowledge-base/positions/idea-001-clinical.md). Registry content matches: arm B 'Supervised PFMT + sham EMG-triggered ES', 'Frequency: 2 Hz.…the full check - Pulse width 10 microseconds Intensity: to sensory response'; arm A 'Frequency: 50 Hz. - Pulse width 250 microseconds Intensity: to motor response'; supervised PFMT in both arms. The inference that the PUBLISHED comparison is therapeutic-dose against sub-therapeutic sham assumes the publication followed the registered arm parameters, which the abstract does not state and which claim 146unconfirmed says the two records disagree on. Registry arms read via the ClinicalTrials.gov API record the trial-detail result points to. ScanResult, no tag obtainable. — source: trial-detail NCT06419517 → found (ScanResult, no tag), ClinicalTrials.gov NCTId=NCT06419517; arms read from https://clinicaltrials.gov/api/v2/studies/NCT06419517 (armsInterventionsModule), retrieved 2026-10-01 — origin: condition C12 from the clinical position (2026-10-01) — stated by a chair, never checked; recorded so the Verifier can see it
The NCT06419517 registry record and its publication PMID 42190320 disagree on how the trial was conducted: the registry states 50 participants enrolled (actual), a primary-outcome time point at four weeks, twenty supervised sessions at two per week over ten weeks and, in a separate intervention description, daily endovaginal stimulation for four weeks on a portable unit, while the publication abstract reports 42 women allocated, a primary time point at 10 weeks and supervised training three times per week; the registry record has no posted results
jurisdiction: US — confidence: unconfirmed — note: Verifier pass 2026-10-01. Origin label: this is clinical condition C12 (correct as recorded). Every operand matches the two records retrieved today: registry enrollment 50 (ACTUAL); primary outcome time frame 'Baseline, four weeks, 6 and 12 months follow-up'; arms…the full check 'Twenty sessions will be applied, 2 per week for ten weeks'; the device intervention text 'daily endovaginal electrostimulation sessions for four weeks', 'portable unit EVOSTIM'; hasResults=false. Abstract: '42 women with SUI were allocated', primary 'Change in PFM strength at 10 weeks', 'supervised PFMT three times/week for 10 weeks'. Held unconfirmed only on structural grounds: trial-detail and literature-detail return ScanResults, which carry no confidence tag by construction (same treatment as claim 142unconfirmed). — source: trial-detail NCT06419517 → found (ScanResult, no tag), ClinicalTrials.gov NCTId=NCT06419517 (status=COMPLETED, hasResults=false); https://clinicaltrials.gov/api/v2/studies/NCT06419517 read 2026-10-01; literature-detail 42190320 → found (ScanResult, no tag), PubMed PMID=42190320 (efetch) — origin: condition C12 from the clinical position (2026-10-01) — stated by a chair, never checked; recorded so the Verifier can see it
The MyoTrac Infiniti User Guide (Thought Technology Ltd, copyright 2005, https://www.performancehealth.com/media/support/kb/IF_921079740_man.pdf) describes EMG-triggered stimulation sessions that use the same electrodes for stimulation and surface EMG, in which stimulation is triggered when the EMG signal stays above a set threshold for longer than a set delay during a work step and is then delivered for the remainder of that work step, with stimulation and the trigger disabled during the rest step, so a commercial same-electrode EMG-triggered stimulator takes its trigger from EMG sensed before the stimulation burst and not during it
jurisdiction: US — confidence: unconfirmed — note: Verifier pass 2026-10-01. No connector reaches a manufacturer user guide; the guide is manufacturer labelling hosted on a distributor site, not a document any connector output points to, so it was not fetched and its content is unchecked. The FDA 510(k) summaries for…the full check the same product family do not describe the trigger timing: K053266 lists only 'threshold for trigger by the patient and physician' and work/rest periods. The inference about when the trigger is sensed rests entirely on the unread guide. — source: no typed connector for manufacturer user guides; clearance-summary K053266 --jurisdiction US → verified, FDA 510(k) summary K053266 (https://www.accessdata.fda.gov/cdrh_docs/pdf5/K053266.pdf), read for context only — origin: condition C12 from the technology position (2026-10-01) — stated by a chair, never checked; recorded so the Verifier can see it
The MyoTrac Infiniti User Guide (Thought Technology Ltd, copyright 2005) states 'EMG triggered STIM is not available for incontinence application' and states that EMG-Stim sessions are run as script sessions in which no data is recorded, so as labelled the device delivers neither EMG-triggered stimulation in its incontinence mode nor a recorded log of trigger events from any EMG-Stim session
jurisdiction: US — confidence: unconfirmed — note: Verifier pass 2026-10-01. The user-guide quotation is unchecked (no connector reaches manufacturer labelling). FLAG for a human: the conclusion 'as labelled the device delivers neither EMG-triggered stimulation in its incontinence mode' is contradicted for at least…the full check the later labelling by an FDA primary source: the K201014 510(k) summary's comparison table lists the predicate MyoTrac Infiniti System (K053434) with 'EMG-Triggered Stimulation (ETS) using NMES specifications for incontinence' and a preloaded 'Stress incontinence ETS' program (200 us, 45 Hz, work 6 s, rest 10 s). A phrase reading cannot return refuted and the 2005 guide may describe an earlier firmware, so this stays unconfirmed, not refuted; the claim should not be read as saying the device cannot do ETS for incontinence (see claim 165verified). — source: no typed connector for manufacturer user guides; clearance-summary K201014 --jurisdiction US → verified, FDA 510(k) summary K201014 (https://www.accessdata.fda.gov/cdrh_docs/pdf20/K201014.pdf), full text read — origin: condition C13 from the technology position (2026-10-01) — stated by a chair, never checked; recorded so the Verifier can see it
The MyoTrac Infiniti records two channels of surface EMG at a nominal 2048 samples per second with a 14-bit ADC and a 20-500 Hz internal amplifier bandwidth, saves all raw EMG data to a compact flash card or streams it to a PC by USB during EMG sessions (User Guide, copyright 2005), and its 510(k) summary K053266 lists a trigger threshold programmable by patient and physician, so the sensing half of a trigger-specificity study - a vaginal surface-EMG channel and an abdominal reference channel recorded during voluntary pelvic floor contractions and Valsalva manoeuvres, with candidate detectors applied offline - can be run on a purchased cleared device without building a prototype probe
jurisdiction: US — confidence: unconfirmed — note: Verifier pass 2026-10-01. Compound; the FDA-reachable operands check out, the rest does not resolve. Checked: K053266 summary lists programmable 'threshold for trigger by the patient and physician'; the K201014 summary's predicate column gives the MyoTrac Infiniti…the full check (K053434) EMG as '14-bit ADC, Bipolar, 2048 samples/s', '20Hz - 500Hz (Band-Pass Filter)', 2 channels. Unchecked: the compact-flash and USB raw-data claims come only from the user guide, which no connector reaches; whether the sensing study can be run 'without building a prototype probe' is a feasibility inference no source answers. Note K053266 is IPF / 21 CFR 890.5850, not KPI; the incontinence indication is K053434. — source: clearance-summary K053266 --jurisdiction US → verified, FDA 510(k) summary K053266 (https://www.accessdata.fda.gov/cdrh_docs/pdf5/K053266.pdf), full text read; clearance-summary K201014 --jurisdiction US → verified, FDA 510(k) summary K201014 (https://www.accessdata.fda.gov/cdrh_docs/pdf20/K201014.pdf), full text read — origin: condition C14 from the technology position (2026-10-01) — stated by a chair, never checked; recorded so the Verifier can see it
Pelvic floor surface EMG recorded with a vaginal probe rises during a Valsalva manoeuvre and during abdominal bracing as well as during a voluntary pelvic floor contraction (PMID 19730763), and incontinent women who depress the bladder base when asked to contract show more pelvic floor EMG during Valsalva, and more abdominal and chest-wall EMG during an attempted pelvic floor contraction, than continent women (PMID 16496395), so an amplitude threshold on a single vaginal surface-EMG channel cannot be assumed to discriminate a voluntary pelvic floor contraction from Valsalva in this candidate's population, and a discriminating trigger needs a reference signal of abdominal muscle activity or intra-abdominal pressure
jurisdiction: US — confidence: unconfirmed — note: Verifier pass 2026-10-01. Content matches the abstracts: PMID 19730763 (nine continent women, vaginal probe) 'PFM EMG and IAP increased during all tasks' including bracing and Valsalva; PMID 16496395 (13 symptomatic women who depress the bladder base vs 13 continent)…the full check 'During PFM contraction the PFM were less active and the abdominal and chest wall muscles were more active in the symptomatic group. During Valsalva, the PFM and EO were more active in the symptomatic group'. Held unconfirmed: literature-detail returns a ScanResult with no tag obtainable; both are small studies outside the US; the design conclusion (a discriminating trigger needs a reference channel) is an engineering inference, and claim 105unconfirmed records that no study has measured single-channel discrimination at all. — source: literature-detail 19730763 16496395 → found (ScanResult, no tag), PubMed PMID=19730763, PMID=16496395 (efetch) — origin: condition C15 from the technology position (2026-10-01) — stated by a chair, never checked; recorded so the Verifier can see it
In 13 continent women the change in vaginal pressure did not differ between a correct pelvic floor muscle contraction and a Valsalva manoeuvre (P = 0.971, PMID 16302270), while intra-abdominal pressure change and abdominal and chest-wall EMG were greater during Valsalva, so an intravaginal pressure (manometric) signal alone does not discriminate a voluntary pelvic floor contraction from Valsalva and a manometric-trigger design carries the same trigger-specificity bench gate as a surface-EMG trigger
jurisdiction: US — confidence: unconfirmed — note: Verifier pass 2026-10-01. Content matches the abstract of PMID 16302270: 'Thirteen continent women'; 'there was no difference in the change in vaginal pressure between PFM contraction and Valsalva (P = 0.971)'; 'The change in IAP was greater during Valsalva (P =…the full check 0.001)'; abdominal muscles and chest wall more active during Valsalva. Held unconfirmed: literature-detail is a ScanResult, no tag obtainable; the extension to a manometric-trigger device carrying 'the same' bench gate is a design inference. — source: literature-detail 16302270 → found (ScanResult, no tag), PubMed PMID=16302270 (efetch) — origin: condition C16 from the technology position (2026-10-01) — stated by a chair, never checked; recorded so the Verifier can see it
The cleared stimulation envelopes read from the 510(k) summaries of this device's nearest products leave stimulation-off periods of at least 2 seconds - K150180 InTone (1 s at 50 Hz, 2 s off, 2 s at 13 Hz, 2 s off, repeating), its predicate K110179 InTone (20 s on, 10 s off) and K053266 MyoTrac Infiniti (rest period 2 to 50 s) - so an inter-burst EMG trigger detector under any of these envelopes has at least 2,000 ms between bursts, about 260 times the 7.6 ms per-pulse blanking window reported in PMID 33836509
jurisdiction: US — confidence: unconfirmed — note: Verifier pass 2026-10-01. The FDA-reachable operands check out: K150180 summary comparison table, new InTone '1 second at 50 Hz, 2 seconds no stimulation, 2 seconds at 13 Hz, 2 second no stimulation (repeating)' and predicate InTone (K110179) 'On 20 seconds, Off 10…the full check seconds'; K053266 MyoTrac Infiniti 'Rest Period (sec) 2 - 50 seconds'. 2,000 / 7.6 = 263, so 'about 260' is arithmetically right. Not resolved: the 7.6 ms blanking figure is from PMID 33836509 ('blanking time of 7.6 ms'), a ScanResult with no tag. Caution for the reader: these three are not the nearest EMG-triggered products; K243079 and K201014 are, and K201014 lists stimulation delivery 'Continuous (no rest phase) for EMG-triggered stimulation', so 'nearest products' and 'any of these envelopes' must be read as these three only. — source: clearance-summary K150180 --jurisdiction US → verified, FDA 510(k) summary K150180 (https://www.accessdata.fda.gov/cdrh_docs/pdf15/K150180.pdf), full text read; clearance-summary K053266 --jurisdiction US → verified, FDA 510(k) summary K053266; literature-detail 33836509 → found (ScanResult, no tag), PubMed PMID=33836509 — origin: condition C17 from the technology position (2026-10-01) — stated by a chair, never checked; recorded so the Verifier can see it
K243079 (NeuroTrac MyoPlus Pro, Verity Medical Ltd, cleared 2025-06-26) is a 510(k) under 21 CFR 876.5320, product codes KPI and HCC, whose cleared Indications for Use include an EMG-triggered stimulation (ETS) mode for the treatment of stress, urge or mixed urinary incontinence in adult women; its 510(k) summary describes stimulation delivered through a vaginal probe, labels it prescription use and home use, and lists only non-clinical testing (IEC 60601-1, IEC 60601-1-2, software verification and validation, cybersecurity) as the basis for substantial equivalence
jurisdiction: US — confidence: verified — note: Verifier pass 2026-10-01; checked against the frontmatter intended_use as it stands on 2026-10-01 ("treatment of stress urinary incontinence in cognitively intact adult women in the home setting, by prescription, following a documented failed four-week trial of pelvic…the full check muscle exercise training"). Every operand traced to FDA primary records, read in full by the Verifier, not the drafting chair. openFDA: K243079, NeuroTrac MyoPlus Pro (MYO120U), Verity Medical Ltd, decided 2025-06-26, KPI, 876.5320, Traditional, SE. Summary: 'Classification Regulation: 21 CFR 876.5320', 'Product Code: KPI, HCC'; IFU 'ETS Treatment of stress, urge or mixed urinary incontinence by assessing EMG activity of the pelvic floor and strengthening pelvic floor muscles using electrical stimulation. This device is intended to be used by adult woman (aged above 22 years)'; 'Stimulation is delivered using a vaginal probe' (probe cleared under K122194); comparison table 'Prescription Only Yes', 'Home Use Yes'; section 7 lists only nonclinical testing (IEC 60601-1:2020, IEC 60601-1-2:2020, software V&V per FDA software guidance, cybersecurity per the 2023 guidance, plus calculated net charge and power density) and no clinical data. Its predicates are K083704 (STIM) and K201290 Medline DeNovo 4Pro (EMG and ETS modes). — source: 510k "MyoPlus" --applicant "Verity" --jurisdiction US → verified, openFDA device/510k k_number=K243079, decided 2025-06-26; clearance-summary K243079 --expect-indication "assessing EMG activity of the pelvic floor and strengthening pelvic floor muscles using electrical stimulation" --jurisdiction US → verified, FDA 510(k) summary K243079 (https://www.accessdata.fda.gov/cdrh_docs/pdf24/K243079.pdf), full text read — origin: condition C2 from the regulatory position (2026-10-01) — stated by a chair, never checked; recorded so the Verifier can see it
K201014 (MyOnyx System, Thought Technology Ltd, cleared 2021-01-13) is a prescription-use 510(k) under 21 CFR 876.5320 and 21 CFR 882.5050, product codes KPI and HCC, indicated for stress, urge or mixed urinary incontinence, whose 510(k) summary lists EMG-triggered stimulation (ETS) using NMES specifications for incontinence, single-patient reusable vaginal EMG/Stim probes, and a mobile app that records RMS EMG and pressure data on a tablet during biofeedback and EMG-triggered stimulation
jurisdiction: US — confidence: verified — note: Verifier pass 2026-10-01; checked against the frontmatter intended_use as it stands on 2026-10-01 ("treatment of stress urinary incontinence in cognitively intact adult women in the home setting, by prescription, following a documented failed four-week trial of pelvic…the full check muscle exercise training"). Every operand traced to FDA primary records. openFDA k_number=K201014: MyOnyx System, Thought Technology Ltd, decided 2021-01-13, KPI, 876.5320 (the name-keyed 510k "MyOnyx" lookup returns the later K213197, so K201014 was read from the same openFDA device/510k endpoint by k_number). Summary: '21 CFR 876.5320 ... Product Code: KPI', '21 CFR 882.5050 ... Product Code: HCC', 'The MyOnyx System is a Prescription Use device'; IFU 'stress, urge, or mixed urinary incontinence'; modalities 'EMG-Triggered Stimulation (ETS) using NMES specifications for incontinence'; vaginal probes 'Life-care Vaginal Probe, Model PR-02A (Single patient, reusable)' listed as both EMG electrode and stimulation probe; 'When used in remote control mode for biofeedback or EMG-triggered stimulation, the device can record on the tablet root-mean-square (RMS) EMG signal and pressure data at 20 samples/s. Stimulation data are not recorded.' Predicate: MyoTrac Infiniti K053434. — source: openFDA device/510k k_number=K201014 (https://api.fda.gov/device/510k.json?search=k_number:K201014, retrieved 2026-10-01); clearance-summary K201014 --expect-indication "stress, urge, or mixed urinary incontinence" --jurisdiction US → verified, FDA 510(k) summary K201014 (https://www.accessdata.fda.gov/cdrh_docs/pdf20/K201014.pdf), full text read — origin: condition C3 from the regulatory position (2026-10-01) — stated by a chair, never checked; recorded so the Verifier can see it
A closed-loop intravaginal stimulator with this candidate's intended use, whose stimulation is triggered by a threshold crossing of pelvic floor surface EMG sensed before the stimulation burst, is substantially equivalent to K243079 on intended use and on the EMG-triggered stimulation characteristic, so its closed-loop element does not raise a different question of safety or effectiveness and does not by itself require clinical performance data in a 510(k)
jurisdiction: US — confidence: unconfirmed — note: Verifier pass 2026-10-01; checked against the frontmatter intended_use as it stands on 2026-10-01 ("treatment of stress urinary incontinence in cognitively intact adult women in the home setting, by prescription, following a documented failed four-week trial of pelvic…the full check muscle exercise training"). A substantial-equivalence finding and whether clinical data are required are FDA judgments on a future submission; no connector answers them in advance. What is on record: K243079's IFU (stress, urge or mixed UI in adult women, ETS mode) encompasses this candidate's narrower indication (claim 153verified), and K243079 itself was cleared on nonclinical testing alone. Neither summary describes the trigger detector (threshold on EMG sensed before the burst), so equivalence on 'the EMG-triggered stimulation characteristic' as this claim specifies it is not shown by the predicate record. — source: clearance-summary K243079 --jurisdiction US → verified, FDA 510(k) summary K243079, full text read; no connector answers an SE determination — origin: condition C4 from the regulatory position (2026-10-01) — stated by a chair, never checked; recorded so the Verifier can see it
The documented failed four-week pelvic-muscle-exercise precondition in this candidate's intended use does no classification or predicate work: the identification in 21 CFR 876.5320 names no prior-therapy condition, and none of the KPI Indications for Use read in this file (K133826, K134020, K150180, K201014, K220161, K243079) carries one, so removing the precondition leaves the device on the 21 CFR 876.5320 / KPI 510(k) route against the same predicates
jurisdiction: US — confidence: verified — note: Verifier pass 2026-10-01; checked against the frontmatter intended_use as it stands on 2026-10-01 ("treatment of stress urinary incontinence in cognitively intact adult women in the home setting, by prescription, following a documented failed four-week trial of pelvic…the full check muscle exercise training"). Verified as a compound of classification text and predicate IFUs. (1) 21 CFR 876.5320(a) identification names no prior-therapy condition: 'used to stimulate the muscles of the pelvic floor to maintain urinary or fecal continence'. (2) None of the six IFUs carries one; each read in full and searched for 'failed', 'pelvic muscle exercise', 'prior': K133826 (mixed UI), K134020 (male and female urinary and fecal incontinence), K150180 (female UI), K201014 (stress, urge or mixed UI), K220161 (stress, urge and mixed UI in women), K243079 (stress, urge and mixed UI in adult women). All six are KPI / 876.5320 in openFDA. Limit: the precondition does mirror NCD 230.8's coverage criterion ('failed a documented trial of pelvic muscle exercise (PME) training'), so it may do reimbursement work even though it does no classification work; and an SE determination remains FDA's. — source: regulation 876.5320 --jurisdiction US → verified, eCFR versioner title-21, issue 2026-09-25, section=876.5320; clearance-summary K133826 --jurisdiction US → verified; clearance-summary K134020 --jurisdiction US → verified; clearance-summary K150180 --jurisdiction US → verified; clearance-summary K201014 --jurisdiction US → verified; clearance-summary K220161 --jurisdiction US → verified; clearance-summary K243079 --jurisdiction US → verified (FDA 510(k) summaries, accessdata.fda.gov cdrh_docs) — origin: condition C5 from the regulatory position (2026-10-01) — stated by a chair, never checked; recorded so the Verifier can see it
Under 21 CFR 801.4 a cleared indication's prior-therapy precondition bounds the manufacturer's labelling and promotion, not the patients to whom a licensed practitioner may prescribe the device: 801.4 states that a firm is not regarded as intending an unapproved new use for a cleared device based solely on its knowledge that health care providers prescribe or use it for that use, and 21 CFR 801.109(a)(2) conditions a prescription device's sale on the order of a licensed practitioner without reference to the patient's prior treatment
jurisdiction: US — confidence: unconfirmed — note: Verifier pass 2026-10-01. The regulation text the claim quotes is there: 21 CFR 801.4 'a firm would not be regarded as intending an unapproved new use for a device approved, cleared, granted marketing authorization, or exempted from premarket notification based solely…the full check on that firm's knowledge that such device was being prescribed or used by health care providers for such use' (the connector's exact-phrase test missed only on wording); 21 CFR 801.109(a)(2) 'Is to be sold only to or on the prescription or other order of such practitioner', with no reference to prior treatment. Not resolved: the head proposition, that a precondition bounds labelling and promotion and not prescribing, is an interpretation of how FDA applies these sections (and of the practice-of-medicine boundary), which regulation text does not settle. — source: regulation 801.4 --expect "knowledge that such device is being prescribed or used by health care providers" --jurisdiction US → unconfirmed: 'exists but its text does NOT contain the phrase' (text quoted above), eCFR versioner title-21, issue 2026-09-25, section=801.4; regulation 801.109 --jurisdiction US → verified, eCFR versioner title-21, issue 2026-09-25, section=801.109 — origin: condition C6 from the regulatory position (2026-10-01) — stated by a chair, never checked; recorded so the Verifier can see it
An intended use broadened from stress to stress, urge and mixed urinary incontinence stays inside 21 CFR 876.5320 / KPI, has KPI predicates whose cleared Indications for Use name all three types (K243079 including its EMG-triggered mode, K201014, K220161), and does not reopen 21 CFR 884.5940, which states that it does not include devices used to treat urinary incontinence
jurisdiction: US — confidence: verified — note: Verifier pass 2026-10-01; checked against the broadened indication the claim states (stress, urge and mixed UI), not the frontmatter intended_use; a later reader should re-check if the indication moves beyond urinary incontinence. (1) 21 CFR 876.5320(a): 'to maintain…the full check urinary or fecal continence', no restriction by incontinence type. (2) KPI predicates naming all three types: K243079 (STIM 'stress, urge and mixed urinary incontinence in adult women'; ETS 'stress, urge or mixed urinary incontinence'), K201014 ('stress, urge, or mixed urinary incontinence'), K220161 ('stress, urge and mixed urinary incontinence in women'); all KPI / 876.5320 in openFDA. (3) 21 CFR 884.5940(a): 'This generic type of device does not include devices used to treat urinary incontinence'. Caution: K220161 is labelled OTC, not prescription, in its own comparison table. — source: regulation 876.5320 --jurisdiction US → verified, eCFR versioner title-21, issue 2026-09-25, section=876.5320; regulation 884.5940 --expect "does not include devices used to treat urinary incontinence" --jurisdiction US → verified, eCFR versioner title-21, issue 2026-09-25, section=884.5940; clearance-summary K243079 --jurisdiction US → verified; clearance-summary K201014 --jurisdiction US → verified; clearance-summary K220161 --jurisdiction US → verified; 510k "Biofeedback Nerve and Muscle Stimulator" --jurisdiction US → verified, openFDA device/510k k_number=K220161 — origin: condition C7 from the regulatory position (2026-10-01) — stated by a chair, never checked; recorded so the Verifier can see it
No KPI / 21 CFR 876.5320 510(k) summary read in this file describes stimulation triggered from an intravaginal pressure signal: pressure is cleared as biofeedback only (K150180, K201014), while EMG-triggered stimulation is cleared in K243079 and K201014, so a manometric-trigger closed loop is further from the cleared KPI predicate pool than a surface-EMG-trigger closed loop
jurisdiction: US — confidence: unconfirmed — note: Verifier pass 2026-10-01; checked against the frontmatter intended_use as it stands on 2026-10-01 ("treatment of stress urinary incontinence in cognitively intact adult women in the home setting, by prescription, following a documented failed four-week trial of pelvic…the full check muscle exercise training"). The record-level operands hold in the summaries read this pass (K110179, K121820, K133826, K134020, K150180, K201014, K220161, K243079, K053434): pressure appears only as biofeedback (K134020, K150180 'visual biofeedback (via manometry)'; K201014 'pressure biofeedback'), and every 'trigger' is EMG (K243079, K201014, also K220161, whose ETS 'provides a passive pulse stimulation when the level of active contraction of the pelvic floor muscles reaches a threshold'). Not resolved: 'read in this file' is an undefined set, some pages of these summaries are scanned and extract as noise, so the negative is bounded by what extracted; and 'further from the cleared predicate pool' is a substantial-equivalence characterisation that only FDA makes. — source: clearance-summary K150180 --jurisdiction US → verified; clearance-summary K201014 --jurisdiction US → verified; clearance-summary K243079 --jurisdiction US → verified; clearance-summary K220161 --jurisdiction US → verified; clearance-summary K134020 --jurisdiction US → verified (FDA 510(k) summaries, full text read) — origin: condition C8 from the regulatory position (2026-10-01) — stated by a chair, never checked; recorded so the Verifier can see it
FDA's guidance 'Deciding When to Submit a 510(k) for a Change to an Existing Device' (issued 2017-10-25) defines a control mechanism as 'the manner by which the actions of a device are directed' and states that almost all changes in the control mechanism for a device could significantly affect safety and effectiveness and will usually require submission of a new 510(k), so an EMG-gating module that directs when a host stimulator lacking a cleared trigger input delivers stimulation is a change to the host under 21 CFR 807.81(a)(3)(i)
jurisdiction: US — confidence: unconfirmed — note: Verifier pass 2026-10-01. Rests on an FDA guidance document; no typed connector serves guidance, and the guidance was not read through a connector, so the quoted definition and 'will usually require submission' are unchecked. The regulation half exists: 21 CFR…the full check 807.81(a)(3)(i) contains 'significantly affect the safety or effectiveness'. Whether an external gating module is a change to the host device, rather than a separate device or accessory, is FDA interpretation regulation text does not settle. — source: no typed connector for FDA guidance documents; regulation 807.81 --expect "significantly affect the safety or effectiveness" --jurisdiction US → verified, eCFR versioner title-21, issue 2026-09-25, section=807.81 — origin: condition C9 from the regulatory position (2026-10-01) — stated by a chair, never checked; recorded so the Verifier can see it
FDA's guidance 'Use of International Standard ISO 10993-1' (issued 2023-09-08) recommends biocompatibility testing of devices 'in the condition that they will be used, whenever possible', and contains no statement that test articles must be aged to labelled shelf life, so conditioning probe test articles through the labelled patient cleaning regimen is a recommendation that places the cleaning regimen ahead of the final test battery, while the shelf-life-ageing half of candidate claim 115unconfirmed is not supported by that guidance
jurisdiction: US — confidence: unconfirmed — note: Verifier pass 2026-10-01. Rests entirely on the content of an FDA guidance document ('Use of International Standard ISO 10993-1'), including a negative about what it does not say; no typed connector serves guidance, so neither the quoted recommendation nor the absence…the full check was checked. — source: no typed connector for FDA guidance documents — origin: condition C10 from the regulatory position (2026-10-01) — stated by a chair, never checked; recorded so the Verifier can see it
Because this candidate's intravaginal probe contacts vaginal mucosa in repeated home sessions over a treatment course of at least twelve weeks, its biological-evaluation contact-duration category under ISO 10993-1 as applied by FDA is set by cumulative contact over the course rather than by single-session duration, placing it above the under-24-hour mucosal-contact category K150180's 510(k) summary used, with additional endpoints beyond cytotoxicity, sensitisation and irritation
jurisdiction: US — confidence: unconfirmed — note: Verifier pass 2026-10-01. One operand checks: the K150180 summary states 'The inflatable probe on the Insertion Unit is considered tissue contacting for a duration of less than 24 hours' with 'Cytotoxicity, Sensitization, Irritation'. The load-bearing half, how FDA…the full check applies ISO 10993-1 contact-duration categories to repeated use, is FDA guidance and interpretation (and ISO 10993-1 is a licensed standard); no connector reaches either. — source: clearance-summary K150180 --jurisdiction US → verified, FDA 510(k) summary K150180 (https://www.accessdata.fda.gov/cdrh_docs/pdf15/K150180.pdf), full text read; no typed connector for FDA guidance or ISO standards — origin: condition C11 from the regulatory position (2026-10-01) — stated by a chair, never checked; recorded so the Verifier can see it
The QMSR amendment to 21 CFR 820 (89 FR 7496, Federal Register document 2024-01709) took effect on 2026-02-02, so any design transfer for this device is documented under 21 CFR 820 as amended, incorporating ISO 13485:2016 by reference, and FDA states that ISO 13485 requirements, taken in totality, are substantially similar to those of the former QS regulation, so existing design-transfer, process-validation and supplier-control activity lists need re-mapping to ISO 13485 clauses rather than new activities
jurisdiction: US — confidence: unconfirmed — note: Verifier pass 2026-10-01. The documentary operands verify: Federal Register 2024-01709 is 89 FR 7496, a Rule, 'This rule is effective February 2, 2026'; it states 'the requirements in ISO 13485 are, when taken in totality, substantially similar to the requirements of…the full check the QS regulation'; 21 CFR 820.7 incorporates ISO 13485:2016 by reference. Not resolved: the conclusion that existing design-transfer, process-validation and supplier-control activity lists need only re-mapping to ISO 13485 clauses rather than new activities is a reading of what the amended Part 820 requires in practice, which the document's existence and wording do not settle. — source: policy 2024-01709 --expect-type rule --jurisdiction US → verified, Federal Register document_number=2024-01709 (89 FR 7496); policy 2024-01709 --expect "February 2, 2026" --jurisdiction US → verified; policy 2024-01709 --expect "substantially similar" --jurisdiction US → verified; regulation 820.7 --expect "13485:2016" --jurisdiction US → verified, eCFR versioner title-21, issue 2026-09-25, section=820.7 — origin: condition C12 from the regulatory position (2026-10-01) — stated by a chair, never checked; recorded so the Verifier can see it
The software and cybersecurity documentation a 510(k) for this device must contain is set by FDA's premarket software-function and cybersecurity guidance and, for a device that connects to the internet, by section 524B of the FD&C Act, not by 21 CFR 820, so the QMSR transition does not change its content; the 2025 KPI clearance K243079 documents software verification and validation and cybersecurity against those guidances
jurisdiction: US — confidence: unconfirmed — note: Verifier pass 2026-10-01. One operand checks: the K243079 summary lists 'Software Verification and Validation Testing according to FDA's Guidance "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices"' and 'Cybersecurity risk…the full check management activities according to FDA Guidance "Cybersecurity in Medical Devices ...", issued September 27, 2023'. The rest (what the guidances require, section 524B of the FD&C Act, and that the QMSR transition leaves the content unchanged) is guidance and statute; no typed connector serves either. — source: clearance-summary K243079 --jurisdiction US → verified, FDA 510(k) summary K243079 (https://www.accessdata.fda.gov/cdrh_docs/pdf24/K243079.pdf), full text read; no typed connector for FDA guidance or the FD&C Act — origin: condition C13 from the regulatory position (2026-10-01) — stated by a chair, never checked; recorded so the Verifier can see it
Thought Technology holds a KPI / 21 CFR 876.5320 clearance, K201014 (MyOnyx, 2021), whose 510(k) summary lists EMG-triggered stimulation for incontinence through vaginal EMG/Stim probes, and its MyoTrac Infiniti incontinence indication is cleared under K053434 (KPI, IPF, HCC) rather than K053266, so the 2005 MyoTrac Infiniti user-guide statement that EMG-triggered stimulation is not available for incontinence (candidate claim 148unconfirmed) is not evidence that EMG-triggered stimulation through a vaginal probe for incontinence cannot be built or cleared
jurisdiction: US — confidence: verified — note: Verifier pass 2026-10-01; checked against the frontmatter intended_use as it stands on 2026-10-01 ("treatment of stress urinary incontinence in cognitively intact adult women in the home setting, by prescription, following a documented failed four-week trial of pelvic…the full check muscle exercise training"). Every operand traced to FDA primary records. (1) openFDA K201014: applicant Thought Technology Ltd, KPI, 876.5320, 2021-01-13; summary lists 'EMG-Triggered Stimulation (ETS) using NMES specifications for incontinence' and single-patient reusable vaginal EMG/Stim probes. (2) K053434 decision letter: 'MyoTrac Infiniti System', 21 CFR 876.5320 KPI, 890.5850 IPF, 882.5050 HCC; IFU 'acute and ongoing treatment of stress, urge or mixed urinary incontinence'. K053266 is IPF / 890.5850 in openFDA and its IFU contains no incontinence indication (phrase miss on 'incontinence', claim 103unconfirmed). (3) The conclusion follows: ETS through a vaginal probe for incontinence has been cleared (K201014, and K243079 'Stimulation is delivered using a vaginal probe' with an ETS indication), so it is demonstrably buildable and clearable, whatever the 2005 guide says. — source: openFDA device/510k k_number=K201014 and k_number=K053434 (https://api.fda.gov/device/510k.json, retrieved 2026-10-01); clearance-summary K201014 --jurisdiction US → verified, FDA 510(k) summary K201014; clearance-summary K053434 --jurisdiction US → verified, FDA 510(k) summary K053434 (https://www.accessdata.fda.gov/cdrh_docs/pdf5/K053434.pdf); clearance-summary K053266 --jurisdiction US → verified, FDA 510(k) summary K053266; clearance-summary K243079 --jurisdiction US → verified — origin: condition C14 from the regulatory position (2026-10-01) — stated by a chair, never checked; recorded so the Verifier can see it
A sensing-only study that records vaginal and abdominal surface EMG with a cleared KPI/HCC device in women being treated for urinary incontinence, delivering no stimulation and applying candidate trigger detectors offline, uses the device within its cleared labelling (K053434: 'assessing EMG activity of the pelvic floor and accessory muscles such as the abdominal or gluteal muscles') and so is exempt from 21 CFR 812 under 812.2(c)(2), whereas the same study in continent volunteers falls outside that labelling and needs an IRB significant-risk determination under 21 CFR 812.2(b)
jurisdiction: US — confidence: unconfirmed — note: Verifier pass 2026-10-01. The labelling phrase is in the K053434 IFU: 'It is also indicated during incontinence treatment for assessing EMG activity of the pelvic floor and accessory muscles such as the abdominal or gluteal muscles'. 21 CFR 812.2(c) exempts…the full check investigations of devices FDA has found substantially equivalent when used or investigated in accordance with the labelled indications, and 812.2(b) sets abbreviated requirements for non-significant-risk investigations. Not resolved: whether an offline-detector study 'uses the device within its cleared labelling', and what a continent-volunteer study needs, are determinations made by FDA and the IRB. Note also 812.2(b) turns on an IRB non-significant-risk finding; the claim's 'IRB significant-risk determination' wording is loose. — source: clearance-summary K053434 --jurisdiction US → verified, FDA 510(k) summary K053434 (https://www.accessdata.fda.gov/cdrh_docs/pdf5/K053434.pdf); regulation 812.2 --expect "substantially equivalent" --jurisdiction US → verified, eCFR versioner title-21, issue 2026-09-25, section=812.2 — origin: condition C15 from the regulatory position (2026-10-01) — stated by a chair, never checked; recorded so the Verifier can see it
No prescription device offered for sale in the United States as of October 2026 delivers intravaginal electrical stimulation for urinary incontinence that is triggered by the patient's own pelvic floor surface EMG; in particular, neither the NeuroTrac MyoPlus Pro (K243079, Verity Medical) nor the MyOnyx System (K201014, Thought Technology), whose 510(k) summaries list an EMG-triggered stimulation mode, is marketed in the US with that mode, so closed-loop EMG triggering is a feature no US-marketed incumbent prescription device sells
jurisdiction: US — confidence: refuted — note: Re-attempted by Verifier 2026-10-01 (fresh context). Old tag unconfirmed, new tag refuted. REFUTED on MyOnyx (K201014, Thought Technology). The claim is a universal negative, so one counterexample settles it, and MyOnyx meets every element: (a) In US commercial…the full check distribution. The FDA Establishment Registration & Device Listing record for K201014 (openFDA device/registrationlisting, a 21 CFR Part 807 listing) shows Thought Technology Ltd. (CA, FEI 1000639819), registration status active (status_code 1), registration expires 2026, establishment type 'Manufacture Medical Device', initial_importer N, US agent Cimetra LLC. It lists product codes KPI (non-implantable electrical stimulator for incontinence) and HCC (biofeedback), listed 2021-11-05, under the proprietary names 'SA9020 - MyOnyx', 'SA9030 - MyOnyx Mobile App', 'SA9005 - Vaginal Pressure Probe', 'SA9003 - Pressure Sensor' and 'T3425 - Electrodes'. (b) Offered for sale in the US, prescription only [manufacturer]. Thought Technology's Incontinence Expert System page says 'the MyOnyx unit is only available for sale in the USA' and 'USA Federal law restricts this device to sale by or on the order of a physician'. It quotes a price of $3,645.00 with Add to Cart, and the bundle includes the T9000 MyOnyx Extended. (c) EMG-triggered mode. The same page says the MyOnyx app can 'run 1 or 2 channels of surface EMG biofeedback or EMG triggered STIM'. (d) Intravaginal stimulation and EMG. The page offers the optional 'SA9572 - Vaginal Sensor - STIM & EMG' ($50.00), described as 'used vaginally or in the rectum to stimulate or sense the pelvic floor muscles'. (e) For incontinence. The K201014 IFU, read fresh by the connector, covers stress, urge or mixed urinary incontinence through electrical stimulation plus EMG biofeedback of the pelvic floor. Weakest link: no single sentence on the page says the triggered mode runs through the vaginal sensor. That is read from a dual STIM & EMG vaginal sensor sold in the same incontinence bundle as the ETS-capable unit. Other leads, not needed for the refutation: K243079 (NeuroTrac MyoPlus Pro, Verity Medical Ltd, IE, FEI 3019822804) has an active registration (expires 2026), KPI and HCC listed 2026-07-10, initial_importer N, US agent Mansour Consulting LLC. Its IFU (connector) includes 'ETS Treatment of stress, urge or mixed urinary incontinence'. Verity's product page (veritymedical.com/product/myoplus-pro/) states 'Single channel ETS (EMG triggered stimulation)', vaginal and rectal probes, and 'prescribed home users'. It shows no US-sale statement, no price and no Rx legend ('Request a Quote'). So for MyoPlus Pro the listing is shown and the US offer of sale is not. K201290 (Medline DeNovo 4Pro) has active registrations for Medline Industries LP (US, initial_importer Y, spec developer) and Microtek Medical LLC, with KPI listed 2021-04-14. No product page was read, so its US offer of the ETS mode is not shown. K220161 (Shenzhen Konmed, CN) has an active registration with KPI listed 2022-08-22, but it is labelled OTC, so it is outside 'prescription'. No typed connector covers device/registrationlisting (docs/backlog.md 1.6 lists it as unbuilt), so the listing was read directly from the federal API and is not machine-replayable. — source: openFDA Establishment Registration & Device Listing https://api.fda.gov/device/registrationlisting.json?search=k_number:K201014 (also K243079, K201290, K220161), retrieved 2026-10-01 → active listing, KPI, MyOnyx; Thought Technology Incontinence Expert System page https://thoughttechnology.com/incontinence-expert-bundle/ [manufacturer], retrieved 2026-10-01 → Rx legend, US-only sale, priced, EMG triggered STIM, vaginal STIM & EMG sensor; Verity Medical https://veritymedical.com/product/myoplus-pro/ [manufacturer] → ETS and vaginal probe, no US sale shown; clearance-summary K201014 --jurisdiction US → verified, FDA 510(k) summary K201014 (https://www.accessdata.fda.gov/cdrh_docs/pdf20/K201014.pdf); clearance-summary K243079 --jurisdiction US → verified, FDA 510(k) summary K243079 (https://www.accessdata.fda.gov/cdrh_docs/pdf24/K243079.pdf); clearance-summary K201290 --jurisdiction US → verified (prior pass); clearance-summary K220161 --jurisdiction US → verified (prior pass) — origin: assessment-surfaced proposition (pillar B3The discriminating trigger is a difference…, 2026-10-01) — the opportunity rests on this and no checkable statement existed for it; never checked
A prescribing urogynecologist or pelvic floor physical therapist who decides to prescribe a home pelvic floor electrical stimulator for stress urinary incontinence chooses a device whose stimulation is triggered by the patient's own pelvic floor surface EMG over a stimulation-only device, for a woman who can voluntarily contract her pelvic floor muscles
jurisdiction: US — confidence: unconfirmed — note: Verifier pass 2026-10-01. Prescriber preference between an EMG-triggered and a stimulation-only device is stakeholder behaviour; no connector or primary record answers it and no primary research is attached. Permanently unconfirmed absent a human-attached preference…the full check study. — source: adoption "<claim text>" → unverifiable; as recorded before this pass: deck-surfaced assumption (desirability deck, 2026-10-01) — never checked; recorded so the Verifier can see it — evidence class 3 (stakeholder future)
Women with stress urinary incontinence who start a prescribed home intravaginal electrical stimulator do not discontinue the course because of a burning or painful sensation at the stimulating electrode
jurisdiction: US — confidence: unconfirmed — note: Verifier pass 2026-10-01. Whether patients discontinue because of electrode burning or pain is patient behaviour; no primary research attached. MAUDE narratives (see claim 186unconfirmed and the earlier KPI MAUDE lines) can show that burning is reported, never how often it ends…the full check a course. — source: adoption "<claim text>" → unverifiable; as recorded before this pass: deck-surfaced assumption (desirability deck, 2026-10-01) — never checked; recorded so the Verifier can see it — evidence class 3 (stakeholder future)
A DME supplier that dispenses home pelvic floor electrical stimulators under HCPCS E0740 adds this candidate to its rental inventory alongside or in place of an already-cleared prescription home EMG-triggered stimulator such as the NeuroTrac MyoPlus Pro (K243079)
jurisdiction: US — confidence: unconfirmed — note: Verifier pass 2026-10-01. A DME supplier's stocking decision is stakeholder behaviour with no connector and no primary research attached. — source: adoption "<claim text>" → unverifiable; as recorded before this pass: deck-surfaced assumption (viability deck,…the full check 2026-10-01) — never checked; recorded so the Verifier can see it — evidence class 3 (stakeholder future)
Medicare Advantage enrollees who meet Medicare NCD 230.8's criteria are furnished a home pelvic floor electrical stimulator under HCPCS E0740 in a number that adds materially to the 689 Medicare fee-for-service beneficiaries recorded for that code in data year 2024
jurisdiction: US — confidence: unconfirmed — note: Verifier pass 2026-10-01. The FFS anchor checks out: E0740 supplier-billed rental 4,130 services / 689 beneficiaries, data year 2024 (provenance: mup_dme_ry26_p05_v10_dy24_geor.csv). The claim is about Medicare Advantage volume, which this file excludes by…the full check construction, and no connector reads MA encounter data. Whether MA adds 'materially' is unmeasured. — source: procedures E0740 --jurisdiction US → verified (FFS only, 689 beneficiaries); MA half has no connector; as recorded before this pass: deck-surfaced assumption (viability deck, 2026-10-01) — never checked; recorded so the Verifier can see it — evidence class 1 (registry fact)
A trigger detector that discriminates a voluntary pelvic floor contraction from a Valsalva manoeuvre by using an abdominal-muscle surface-EMG or intra-abdominal-pressure reference channel can be built into a home device whose reference sensor the woman places and operates herself, unsupervised, without critical use errors
jurisdiction: US — confidence: unconfirmed — note: Verifier pass 2026-10-01. A feasibility and use-error assertion about a device not yet built. It can only be settled by formative and summative human-factors testing of this design; no connector or published record answers it. — source: no connector; human-factors…the full check testing not performed; as recorded before this pass: deck-surfaced assumption (feasibility deck, 2026-10-01) — never checked; recorded so the Verifier can see it
None of the four cleared products whose 510(k) records list an EMG-triggered stimulation (ETS) mode for urinary incontinence - the NeuroTrac MyoPlus Pro (K243079, Verity Medical), the MyOnyx System (K201014, Thought Technology), the Medline DeNovo 4Pro (K201290) and the Shenzhen Konmed device (K220161) - uses an abdominal-muscle surface-EMG, intra-abdominal-pressure or other reference channel in deciding when to fire stimulation; each fires its triggered stimulation on the pelvic floor EMG signal alone crossing a threshold, and this holds for the MyOnyx even though its app can run one or two surface-EMG channels
jurisdiction: US — confidence: unconfirmed — note: Verifier pass 2026-10-01. Read all four summaries myself. None describes a reference channel used in the fire decision, but only two describe the decision at all: K220161 ('passive pulse stimulation when the level of active contraction of the pelvic floor muscles…the full check reaches a threshold') and K201290 ('As soon as the EMG activity reaches a target threshold then an assisting electrical stimulus begins'). K243079 and K201014 do not describe their trigger logic, and a summary that is silent cannot show what the device does not do, so the 'each fires on pelvic floor EMG alone' half, and the MyOnyx half in particular, are not established. Two things cut against reading silence as absence: K201014 has 2 EMG channels both usable for ETS, and the K201014 table attributes to its predicate K053434 an IFU for 'assessing EMG activity of the pelvic floor and accessory muscles such as the abdominal or gluteal muscles'. K220161 is stated to be technologically identical to K202648, whose summary says it is 'supplied with biofeedback reference lead wire with skin electrodes' and has 'independent dual-channel EMG signals acquisition'. That reads as an EMG reference (common) electrode, not an abdominal decision channel, but it is a skin electrode in the EMG input chain of an OTC ETS device. Not refuted: nothing read describes an abdominal or IAP veto. To settle it, read the labelling or user manuals, which no connector reaches. — source: clearance-summary K243079 --jurisdiction US, clearance-summary K201014 --jurisdiction US, clearance-summary K201290 --jurisdiction US, clearance-summary K220161 --jurisdiction US and clearance-summary K202648 --jurisdiction US, full summary text read (FDA 510(k) summaries, accessdata.fda.gov cdrh_docs pdf20/pdf22/pdf24); as recorded before this pass: assessment-surfaced proposition (pillar B3The discriminating trigger is a difference…, 2026-10-01) — the opportunity rests on this and no checkable statement existed for it; never checked
A prescribing urogynecologist or pelvic floor physical therapist who has decided to prescribe a home EMG-triggered pelvic floor stimulator for stress urinary incontinence chooses a device whose trigger uses an abdominal reference electrode, placed by the woman herself each session, to withhold stimulation during a Valsalva manoeuvre or abdominal brace, over a cleared single-channel EMG-triggered device such as the NeuroTrac MyoPlus Pro (K243079), despite the extra electrode
jurisdiction: US — confidence: unconfirmed — note: Verifier pass 2026-10-01. Prescriber choice between a two-electrode discriminating trigger and a cleared single-channel ETS device is stakeholder behaviour; no connector, no primary research attached. This is the P2the discriminating trigger desirability premise and it remains unmeasured. —…the full check source: adoption "<claim text>" → unverifiable; as recorded before this pass: assessment-surfaced proposition (pillar B1The discriminating trigger works in the…, 2026-10-01) — the opportunity rests on this and no checkable statement existed for it; never checked
Incorrect pelvic floor contraction technique is documented among untaught incontinent women at a size relevant to a pelvic floor EMG trigger: after brief standardized verbal instruction, 12 of 47 women (25%) performed a Kegel effort that could potentially promote incontinence and only 23 (49%) an ideal effort without appreciable Valsalva (PMID 1872333), and on initial instruction without biofeedback teaching 30% of 60 incontinent women (30 stress, 30 urge) depressed the bladder neck when attempting an elevating pelvic floor contraction, against 17% of 60 continent women (PMID 16532264)
jurisdiction: US — confidence: unconfirmed — note: Verifier pass 2026-10-01. Cold re-retrieval done and the numbers match. PMID 1872333 (Am J Obstet Gynecol 1991): 'Forty-seven women ... after brief standardized verbal instruction. Twenty-three (49%) had an ideal Kegel effort ... without an appreciable Valsalva…the full check effort. Twelve subjects (25%) displayed a Kegel technique that could potentially promote incontinence'. One discrepancy: the abstract does not say the 47 were incontinent, but the claim calls them 'untaught incontinent women'. PMID 16532264 (Int Urogynecol J 2006): 60 continent and 60 incontinent (30 SUI, 30 UUI), 'on initial instruction without biofeedback teaching', bladder neck depression in '17% of continent and 30% of incontinent women'. Tag held on structural grounds: literature-detail is a ScanResult tool with no confidence field, and a class-2 published finding is Corroborator territory (docs/research-lane-spec.md §3/§5). — source: literature-detail 1872333 16532264 → found (PubMed efetch); as recorded before this pass: condition C13 from the clinical position (2026-10-01) — stated by a chair, never checked; recorded so the Verifier can see it
No published study reports the proportion of women with stress urinary incontinence who still perform a Valsalva or bladder-neck-depressing manoeuvre on attempted pelvic floor contraction after a documented failed four-week trial of pelvic muscle exercise training, so the size of the population in which a two-channel (pelvic floor plus abdominal reference) trigger behaves differently from a single-channel pelvic floor EMG trigger is unmeasured for this candidate's intended use; the published figures (PMID 1872333, PMID 16532264) are from women assessed on initial or brief instruction, before any exercise programme
jurisdiction: US — confidence: unconfirmed — note: Verifier pass 2026-10-01. A claim that a study does not exist cannot be verified by any connector. PubMed sweeps run as leads only found no counter-example, and a sweep is never a tag. The second half (the cited figures come from initial or brief instruction) matches…the full check the abstracts of PMID 1872333 and 16532264. — source: literature-detail 1872333 16532264 → found; literature "(pelvic floor) AND (electromyography) AND (abdominal) AND (Valsalva OR straining) AND (discriminat* OR classif* OR detect*)" --since 1970-01-01 --until 2026-10-01 --limit 100 → found 2, neither on point; as recorded before this pass: condition C14 from the clinical position (2026-10-01) — stated by a chair, never checked; recorded so the Verifier can see it
Abdominal muscle EMG rises above baseline during a voluntary pelvic floor muscle contraction in women without symptoms of stress urinary incontinence (PMID 11135380: all seven parous women, fine-wire EMG, in at least one spinal position), so a trigger that withholds stimulation whenever abdominal surface EMG rises would also withhold it on correct pelvic floor contractions, and a discriminating trigger's false-withhold rate on correct contractions is a stimulation-dose parameter that has to be measured in women, not only set on the bench
jurisdiction: US — confidence: unconfirmed — note: Verifier pass 2026-10-01. Content matches PMID 11135380 (Neurourol Urodyn 2001): seven parous women with no SUI symptoms, fine-wire EMG, 'In all subjects, the EMG activity of the abdominal muscles was increased above the baseline level during contractions of the PF…the full check muscles in at least one of the spinal positions'. The trigger consequence (false withhold on correct contractions; a dose parameter to measure in women) is a design inference no source states. Tag held on structural grounds (literature-detail is a ScanResult; class-2 finding is Corroborator territory). — source: literature-detail 11135380 → found (PubMed efetch); as recorded before this pass: condition C15 from the clinical position (2026-10-01) — stated by a chair, never checked; recorded so the Verifier can see it
No published study or registered trial compares pelvic floor stimulation triggered by a two-channel detector (pelvic floor EMG plus an abdominal-muscle EMG or intra-abdominal-pressure reference that withholds stimulation on Valsalva or bracing) against stimulation triggered by pelvic floor EMG alone on any continence outcome, so whether withholding stimulation on the wrong manoeuvre changes a continence outcome has never been measured in any population
jurisdiction: US — confidence: unconfirmed — note: Verifier pass 2026-10-01. A claim that no study or trial exists cannot be verified by a connector. Lead sweeps (never tags): PubMed 'EMG-triggered AND (pelvic floor OR incontinence)', all dates, 3 records, none two-channel; ClinicalTrials.gov condition 'urinary…the full check incontinence' with intervention 'EMG triggered stimulation', 2000 to 2026-10-01, 1 record (NCT06419517, PFMT plus electrostimulation, not a two-channel comparison). No counter-example surfaced. — source: PubMed sweep via literature for EMG-triggered AND (pelvic floor OR incontinence), 1970-01-01 to 2026-10-01 → found 3 (leads); trials --condition "urinary incontinence" --intervention "EMG triggered stimulation" --since 2000-01-01 --until 2026-10-01 --limit 100 → found 1 (lead); as recorded before this pass: condition C16 from the clinical position (2026-10-01) — stated by a chair, never checked; recorded so the Verifier can see it
A two-channel trigger that withholds stimulation on raised abdominal EMG delivers fewer stimulated contractions per session than a single-channel pelvic floor EMG trigger to women who co-activate their abdominal and chest-wall muscles on attempted pelvic floor contraction, the pattern PMID 16496395 reports in symptomatic women who depress the bladder base, and no published study reports whether such women learn, within a twelve-week unsupervised home course, to produce a contraction such a trigger accepts
jurisdiction: US — confidence: unconfirmed — note: Verifier pass 2026-10-01. The cited pattern matches PMID 16496395 (Neurourol Urodyn 2006): 13 symptomatic women who depress the bladder base; 'During PFM contraction the PFM were less active and the abdominal and chest wall muscles were more active in the symptomatic…the full check group'. The claim's actual assertions (a two-channel trigger delivers fewer stimulated contractions to these women; no study reports whether they learn within twelve weeks) are a prediction and a non-existence claim, neither checkable by a connector. — source: literature-detail 16496395 → found (PubMed efetch); as recorded before this pass: condition C17 from the clinical position (2026-10-01) — stated by a chair, never checked; recorded so the Verifier can see it
A home pelvic floor stimulator in the P2the discriminating trigger configuration - an intravaginal stimulating and pelvic-floor-EMG-sensing probe plus a self-placed abdominal surface-EMG reference electrode used only to decide when stimulation fires - is coded by the PDAC as one complete system under HCPCS E0740, with the abdominal reference electrode and its lead treated as components of that system, rather than the reference channel being coded separately as an EMG biofeedback device under HCPCS E0746 (which carries no DMEPOS fee schedule amount) or the system being assigned the miscellaneous code E1399
jurisdiction: US — confidence: unconfirmed — note: Verifier pass 2026-10-01. HCPCS coding of a specific product is a PDAC determination. No connector reads PDAC coding verification decisions, and none has been made for a device that does not exist. Context only, not an answer: E0740 'Non-implanted pelvic floor…the full check electrical stimulator, complete system' exists; E0746 'Electromyography (emg), biofeedback device' exists and has no row on the July 2026 DMEPOS fee schedule (matches the claim's parenthetical); E1399 'Durable medical equipment, miscellaneous' exists. — source: hcpcs E0740 --jurisdiction US → verified; hcpcs E0746 --jurisdiction US → verified; payment E0746 --jurisdiction US → refuted (no fee schedule row); hcpcs E1399 --jurisdiction US → verified; as recorded before this pass: condition C8 from the market-access position (2026-10-01) — stated by a chair, never checked; recorded so the Verifier can see it
Under Medicare capped-rental payment for HCPCS E0740, the self-placed abdominal surface-EMG reference electrodes a P2the discriminating trigger device consumes in each rental month are not separately payable under HCPCS A4595, A4556 or any other Level II supply code when furnished with an E0740 rental, so the DME supplier carries their cost inside the monthly E0740 rental allowed amount
jurisdiction: US — confidence: unconfirmed — note: Verifier pass 2026-10-01. Whether a supply code is separately payable with an E0740 capped rental is a DME MAC policy-article and PDAC question that no connector reads. A4595 ('Electrical stimulator supplies, 2 lead, per month, (e.g., tens, nmes)', SU, $11.40 to…the full check $13.24 non-rural) and A4556 ('Electrodes, (e.g., apnea monitor), per pair', SU, $14.71 to $17.31) both exist and are priced, which neither proves nor disproves bundling. NCD 230.8 does not contain 'suppl'. 42 CFR 414.229 does not contain 'supplies'. The code-keyed coverage index names neither code, and that is a linkage gap, not a policy statement. — source: hcpcs A4595 --jurisdiction US → verified; payment A4595 --jurisdiction US → verified; hcpcs A4556 --jurisdiction US → verified; payment A4556 --jurisdiction US → verified; ncd 230.8 --expect "suppl" --jurisdiction US → unconfirmed; regulation 414.229 --title 42 --expect "supplies" --jurisdiction US → unconfirmed; as recorded before this pass: condition C9 from the market-access position (2026-10-01) — stated by a chair, never checked; recorded so the Verifier can see it
No HCPCS Level II code and no DMEPOS fee schedule line or modifier distinguishes a non-implanted pelvic floor electrical stimulator whose trigger uses an abdominal reference channel from a single-channel EMG-triggered or an open-loop one: all are billed as HCPCS E0740 on the single RR capped-rental line at the same fee schedule amount, so the P2the discriminating trigger trigger earns no Medicare fee-for-service payment premium over the cleared single-channel triggered devices
jurisdiction: US — confidence: unconfirmed — note: Verifier pass 2026-10-01. The code and fee-schedule half checks out. A scan of the cached HCPCS Level II file for pelvic/incontinence/EMG/trigger/biofeedback descriptors found no code describing an EMG-triggered or reference-channel stimulator (nearest: E0740, E0746…the full check EMG biofeedback, E0715/E0716 intravaginal Kegel device, S9002 (a HCPCS temporary national code) intravaginal motion-sensor biofeedback). E0740 has exactly one fee schedule row, RR, category CR, $74.52 non-rural in every contiguous state/DC, $89.44 PR, rural columns 0.00 (none applies). The claim also asserts that all such devices, the P2the discriminating trigger device included, 'are billed as HCPCS E0740'. For P2the discriminating trigger that coding outcome is open (claim 180unconfirmed: PDAC could code it E0740, split out E0746, or assign E1399, and E1399 is individually priced). So 'earns no Medicare FFS payment premium' is not established. This is why it differs from claim 193verified, which is conditional on the device being coded to E0740 and was verified. — source: hcpcs E0740 --jurisdiction US → verified; payment E0740 --modifier RR --min-expected 74.52 --jurisdiction US → verified; hcpcs E0746 --jurisdiction US → verified; payment E0746 --jurisdiction US → refuted (no fee schedule row); local HCPCS Level II cache searched by descriptor; as recorded before this pass: condition C10 from the market-access position (2026-10-01) — stated by a chair, never checked; recorded so the Verifier can see it
Under the P2the discriminating trigger mechanism the abdominal surface-EMG reference electrode that the woman places herself each session is a consumable whose demand scales with sessions delivered, not with beneficiaries dispensed or with controllers in a rental fleet, so the system is at least five objects with different lifetimes (single-patient-use probe, returnable controller, app and cloud pathway, connectivity, per-session skin electrode), and a per-beneficiary cost of goods cannot be stated without the number of home sessions per treatment course and the number of skin electrodes consumed per session, neither of which this candidate file states
jurisdiction: US — confidence: unconfirmed — note: Verifier pass 2026-10-01. A cost-structure and bill-of-materials argument about an unbuilt device. No primary source states consumable lifetimes or sessions per course for it. I confirmed that the candidate file states no number of home sessions per course and no skin…the full check electrodes per session. That is a fact about this file, not about the world, and it does not make the cost model checkable. — source: no connector; design reasoning; as recorded before this pass: condition C11 from the operations-npi position (2026-10-01) — stated by a chair, never checked; recorded so the Verifier can see it
Self-adhesive cutaneous electrodes are a 510(k)-cleared device type under 21 CFR 882.1320 (product code GXY, Class II), and at least two unrelated manufacturers hold clearances for cutaneous electrodes labelled for recording surface EMG on intact skin, so the P2the discriminating trigger abdominal reference electrode can be purchased as a cleared component from more than one source rather than designed and manufactured for this candidate, provided the system's reference lead uses a connector interface those electrodes share
jurisdiction: US — confidence: verified — note: Verifier pass 2026-10-01; checked against the frontmatter intended_use as it stands on 2026-10-01 ('treatment of stress urinary incontinence in cognitively intact adult women in the home setting, by prescription, following a documented failed four-week trial of pelvic…the full check muscle exercise training'). (1) 21 CFR 882.1320 'Cutaneous electrode ... applied directly to a patient's skin either to record physiological signals ... or to apply electrical stimulation', Class II; openFDA classification GXY: class 2, 'Electrode, Cutaneous', regulation 882.1320. (2) At least two unrelated manufacturers hold GXY clearances labelled for surface EMG recording on skin: K142159 (Rochester Electro-Medical, IFU 'recording/stimulation and monitoring of Electromyography (EMG)'; listed in FDA Registration & Listing by LifeSync Corporation, 2026 registration) and K153019 (Bio Protech, IFU '... surface Electromyography (EMG)'; listed as 'PROEMG' by BIO PROTECH, INC., 2026 registration). A third is K180247 (Daehan Medical Systems, IFU 'surface Electromyography (EMG) ... applied to the patient's skin'), not found in R&L by K-number. The connector-interface proviso is a design condition the claim states as a condition, not an assertion. 'Can be purchased' rests on active listings, not on a supply agreement. — source: regulation 882.1320 --expect "record physiological signals" --jurisdiction US → verified; classification --product-code GXY --jurisdiction US → verified; clearance-summary K142159 --expect-indication "EMG" --jurisdiction US → verified; clearance-summary K153019 --expect-indication "EMG" --jurisdiction US → verified; clearance-summary K180247 --expect-indication "EMG" --jurisdiction US → verified; openFDA 510k search product_code:GXY with device_name EMG/surface (22 records); api.fda.gov/device/registrationlisting.json?search=k_number:K142159 and k_number:K153019 (retrieved 2026-10-01); as recorded before this pass: condition C12 from the operations-npi position (2026-10-01) — stated by a chair, never checked; recorded so the Verifier can see it
Pre-gelled self-adhesive cutaneous electrodes carry a labelled shelf life and a labelled storage temperature range, and FDA has classified a recall of disposable cutaneous electrodes (Z-1595-2022, product code GXY) whose stated reason was temperature exposure before delivery and whose FDA root cause was environmental control, so a home course's supply of P2the discriminating trigger reference electrodes has to be dispensed and stored within those limits or replenished during the course, which makes electrode kitting, lot rotation and replenishment a supply-chain item that neither the probe nor the controller carries
jurisdiction: US — confidence: unconfirmed — note: Verifier pass 2026-10-01. The recall half verifies: Z-1595-2022, product code GXY, Class II, McKesson Medical-Surgical (Cadwell Disposable Ground Electrodes, model 302288-000), reason 'Facility Temperature excursions (from June 2021-August 2021) prior to delivery;…the full check exposure to higher temperatures may have impacted product effectiveness', root cause 'Environmental control', initiated 2022-05-25. The labelling half is only partly shown. Of the GXY summaries read, K142159 states 'Shelf Life: 18 Months in unopened pouch' and K211839 lists shelf-life testing, but none states a labelled storage temperature range. The general statement about pre-gelled electrodes as a class is not checkable by connector. The supply-chain conclusion is an inference. — source: openFDA api.fda.gov/device/recall.json?search=product_res_number:"Z-1595-2022" and device/enforcement.json?search=recall_number:"Z-1595-2022" (retrieved 2026-10-01); clearance-summary K142159 --jurisdiction US text read; as recorded before this pass: condition C13 from the operations-npi position (2026-10-01) — stated by a chair, never checked; recorded so the Verifier can see it
Among MAUDE reports coded to product code GXY (cutaneous electrode, 21 CFR 882.1320) received between 2024-01-01 and 2026-10-01, the most frequently recurring patient-injury narrative for electrodes applied by patients at home is skin irritation, rash, blistering or burn under the adhesive electrode, so skin reaction is the leading complaint category to plan for on the P2the discriminating trigger self-placed abdominal reference electrode, and adhesive and hydrogel selection, a skin-contact biological evaluation and complaint coding for skin reactions belong on its design-input and post-market lists; MAUDE has no denominator, so this is a statement about which complaint recurs and not about a rate
jurisdiction: US — confidence: unconfirmed — note: Verifier pass 2026-10-01. MAUDE is a scan and its result carries no tag. As a lead the content fits. GXY, received 2024-01-01 to 2026-10-01: 158 reports (total_matches 158, not truncated), 64 Injury and 94 Malfunction. Of the 64 injury narratives, about 42 by keyword…the full check describe skin irritation, rash, redness, blistering or burn, mostly on patient-applied home electrodes (Biomet SpinalPak/OrthoPak, Biowave, TENS pads). The remaining injury reports are mostly administrative follow-ups with no event text, plus isolated pain, shock and pressure-injury reports. So skin reaction is the most frequent injury narrative. No denominator and no rate, as the claim says. — source: maude --product-code GXY --since 2024-01-01 --until 2026-10-01 --limit 500 --jurisdiction US → found 158 (ScanResult, no tag); as recorded before this pass: condition C14 from the operations-npi position (2026-10-01) — stated by a chair, never checked; recorded so the Verifier can see it
The abdominal surface-EMG sensing that pivot P2the discriminating trigger adds is already a labelled function of cleared KPI / HCC devices: the Indications for Use of K053434 (MyoTrac Infiniti), K201014 (MyOnyx) and K201290 (Medline DeNovo 4Pro) each include assessing EMG activity of the pelvic floor and accessory muscles such as the abdominal or gluteal muscles during incontinence treatment, K201014's 510(k) summary lists single-use surface EMG skin electrodes (Uni-Gel, Thought Technology T3425) among its accessories and two EMG channels, and K243079's summary lists two EMG channels; none of these four 510(k) summaries describes an abdominal EMG channel used as an input that withholds or permits EMG-triggered stimulation
jurisdiction: US — confidence: unconfirmed — note: Verifier pass 2026-10-01; checked against the frontmatter intended_use as it stands on 2026-10-01 ('treatment of stress urinary incontinence in cognitively intact adult women in the home setting, by prescription, following a documented failed four-week trial of pelvic…the full check muscle exercise training'). Most operands check out. K053434 IFU contains 'assessing EMG activity of the pelvic floor and accessory muscles such as the abdominal or gluteal muscles'. K201290 ETS-mode IFU contains '... pelvic floor and accessory muscles (abdominal or gluteal)'. K201014 lists 'Uni-Gel Single Electrodes (Single Use), Thought Technology Ltd, #T3425' and '2 channels for EMG or pressure biofeedback, electrical stimulation, and EMG-Triggered stimulation'. K243079 lists 'For EMG: 2'. None of the four summaries describes an abdominal channel gating ETS. THE K201014 OPERAND DOES NOT HOLD AS WRITTEN. MyOnyx's own Indications for Use in its summary reads 'indicated for acute and ongoing treatment of stress, urge, or mixed urinary incontinence ... The system also uses EMG-based or pressure-based biofeedback ...' and contains no accessory-muscle sentence. That sentence appears in K201014 only inside the comparison table, quoted as the predicate MyoTrac Infiniti's IFU (marked 'Same'). The Form 3881 page of the PDF has no text layer and no extractable image, so the formal IFU could not be read. CONNECTOR FALSE POSITIVE: clearance-summary K201014 --expect-indication "accessory muscles" returned verified only because its IFU extraction ran into the comparison table and matched the predicate's quoted IFU. Do not cite that result. A phrase miss on the subject IFU is unconfirmed, not refuted (IFU is free prose). — source: clearance-summary K053434 --expect-indication "accessory muscles" --jurisdiction US → verified; clearance-summary K201290 --expect-indication "accessory muscles" --jurisdiction US → verified; clearance-summary K201014 --expect-indication "accessory muscles" --jurisdiction US → verified (extraction artifact, see note); clearance-summary K243079 --jurisdiction US text read; as recorded before this pass: condition C16 from the regulatory position (2026-10-01) — stated by a chair, never checked; recorded so the Verifier can see it
At pivot P2the discriminating trigger a 510(k) under 21 CFR 876.5320 / product code KPI remains this candidate's route: a trigger that fires on pelvic floor surface EMG and withholds stimulation while an abdominal surface-EMG reference channel indicates a Valsalva manoeuvre or abdominal brace is a difference in technological characteristics from K243079 and K201014, not a different intended use, and does not raise different questions of safety or effectiveness where non-clinical performance testing verifies the withhold logic, so the reference channel does not by itself require a De Novo request or clinical performance data
jurisdiction: US — confidence: unconfirmed — note: Verifier pass 2026-10-01; checked against the frontmatter intended_use as it stands on 2026-10-01 ('treatment of stress urinary incontinence in cognitively intact adult women in the home setting, by prescription, following a documented failed four-week trial of pelvic…the full check muscle exercise training'). Whether a withhold-logic reference channel is a technological difference that raises no different questions of safety or effectiveness, and so needs no De Novo or clinical data, is an FDA substantial-equivalence judgment. It is guided by FDA's 510(k) program guidance, which no connector reaches. KPI is Class II under 876.5320 and K243079/K201014 are cleared KPI devices, but that does not answer the SE question. — source: classification --product-code KPI --jurisdiction US → verified (class 2, 876.5320); SE judgment and FDA guidance have no connector; as recorded before this pass: condition C17 from the regulatory position (2026-10-01) — stated by a chair, never checked; recorded so the Verifier can see it
A labelling or promotional statement that this device withholds stimulation during a Valsalva manoeuvre or abdominal brace, or that it stimulates the correct contraction where a single-channel EMG-triggered device such as K243079 would also fire on the wrong one, is a performance representation, and against a named device a comparative one under 21 CFR 801.6, that must be supported by test data on the detector's discrimination in women; a functional description of the logic (stimulation inhibited while abdominal EMG exceeds a set level) can rest on bench verification of the software alone; and neither K243079's nor K201014's 510(k) summary makes any discrimination claim for its EMG-triggered stimulation mode
jurisdiction: US — confidence: unconfirmed — note: Verifier pass 2026-10-01. The factual tail holds: neither the K243079 nor the K201014 summary makes any discrimination claim for its ETS mode. The rest is interpretation. 21 CFR 801.6 reads in full 'Among representations in the labeling of a device which render such…the full check device misbranded is a false or misleading representation with respect to another device or a drug or food or cosmetic.' It says nothing about test data in women or about bench verification sufficing for a functional description. Those are FDA interpretation and enforcement practice, which the CFR does not contain and no connector reaches. — source: regulation 801.6 --expect "comparison" --jurisdiction US → unconfirmed (text quoted); K243079 and K201014 summaries read; as recorded before this pass: condition C18 from the regulatory position (2026-10-01) — stated by a chair, never checked; recorded so the Verifier can see it
A skin electrode used only to record abdominal surface EMG and delivering no stimulation is a cutaneous electrode under 21 CFR 882.1320 (product code GXY, Class II), not a transcutaneous electrical continence device under 21 CFR 876.5330, whose identification is cutaneous electrodes used to apply stimulation; it can be supplied as an already-cleared cutaneous electrode, as K201014 (Uni-Gel T3425 surface EMG electrodes) and K201290 (adhesive electrodes, GXY, K160138) do, so it adds no second classification regulation or separate submission to this candidate's 510(k)
jurisdiction: US — confidence: unconfirmed — note: Verifier pass 2026-10-01; checked against the frontmatter intended_use as it stands on 2026-10-01 ('treatment of stress urinary incontinence in cognitively intact adult women in the home setting, by prescription, following a documented failed four-week trial of pelvic…the full check muscle exercise training'). The regulation text supports the split. 882.1320 covers electrodes applied to skin 'either to record physiological signals ... or to apply electrical stimulation'. 876.5330 identifies 'cutaneous electrodes that are used to apply external stimulation to reduce urinary incontinence'. Both examples are weaker than stated. (a) FDA Registration & Listing lists Uni-Gel T3425 under K201014 itself (product codes HCC, KPI) and earlier under K935213 (HIR), never under a GXY clearance. So K201014 shows the EMG skin electrode carried inside the system's own 510(k), not supplied as a separately cleared 882.1320 cutaneous electrode. (b) K160138 (GMDASZ, GXY, cleared 2016-08-11) is labelled in K201290 as an interface 'for transmitting electrical current' to TENS/EMS stimulators, a stimulation electrode rather than an EMG-recording one. Whether the reference electrode 'adds no second classification regulation or separate submission' is an FDA judgment no connector answers. — source: regulation 882.1320 --expect "record physiological signals" --jurisdiction US → verified; regulation 876.5330 --expect "apply" --jurisdiction US → verified; classification --product-code GXY --jurisdiction US → verified; api.fda.gov/device/registrationlisting.json?search=registration.name:"thought technology" and proprietary_name:(unigel OR "uni-gel" OR T3425); openFDA 510k k_number=K160138 (retrieved 2026-10-01); as recorded before this pass: condition C19 from the regulatory position (2026-10-01) — stated by a chair, never checked; recorded so the Verifier can see it
No cleared home-use EMG-triggered stimulator's 510(k) summary read in this file shows a skin electrode placed by the patient as an input to the stimulation decision: K243079, the only one labelled for home use, lists only the vaginal probe among the subject device's applied parts and lists no usability testing, while K201014 (designed for use under medical supervision) and K201290 (clinic environments, under the supervision of a trained clinical healthcare provider) documented usability engineering under IEC 60601-1-6 and IEC 62366; so self-placement of the abdominal reference electrode at home each session is a use task this candidate's 510(k) must address with its own usability engineering file and cannot borrow from a predicate
jurisdiction: US — confidence: refuted — note: Verifier pass 2026-10-01; checked against the frontmatter intended_use as it stands on 2026-10-01 ('treatment of stress urinary incontinence in cognitively intact adult women in the home setting, by prescription, following a documented failed four-week trial of pelvic…the full check muscle exercise training'). REFUTED on a stated fact, not on the conclusion. The claim says K243079 is 'the only one labelled for home use' among the ETS summaries read in this file. K220161 (Shenzhen Konmed, KPI/HCC, an ETS device for stress, urge and mixed incontinence, cleared 2022-07-20, and cited by claims 173 and 202) is cleared for Over-The-Counter Use on its Form 3881. Its summary lists testing to IEC 60601-1-11 ('used in the home healthcare environment') and a 'Usability Study according to IEC 60601-1-6 ... and IEC 62366-1'. K243079's own comparison table also records its predicate K201290 as 'Home Use: Yes', although K201290's own summary describes clinic environments under supervision. Further, K220161 states identical technology to K202648, whose summary says the device is 'supplied with biofeedback reference lead wire with skin electrodes' connected with the vaginal electrode for dual-channel EMG acquisition. That is a skin electrode in the EMG input of an ETS device sold OTC, though as an EMG reference electrode rather than an abdominal decision channel. The other operands hold: K243079 lists only the 'Vaginal Probe' as the subject's applied part and no usability testing; K201014 and K201290 list IEC 60601-1-6/IEC 62366. Whether the candidate can borrow any usability evidence for self-placed electrode use is an FDA judgment this pass does not settle. The 'cannot borrow from a predicate' conclusion is weakened, not reversed. — source: clearance-summary K220161 --jurisdiction US → verified (FDA 510(k) summary K220161, accessdata.fda.gov/cdrh_docs/pdf22/K220161.pdf), full text read; clearance-summary K243079 --jurisdiction US, clearance-summary K201290 --jurisdiction US, clearance-summary K202648 --jurisdiction US full text read; openFDA 510k k_number=K220161 decision 2022-07-20; as recorded before this pass: condition C20 from the regulatory position (2026-10-01) — stated by a chair, never checked; recorded so the Verifier can see it
If a detached, lifted or misplaced abdominal reference electrode makes this candidate's detector either withhold stimulation or fall back to pelvic-floor-only triggering, and never deliver stimulation that the pelvic floor channel did not trigger, then no use error in placing the reference can cause serious harm, and under FDA's human factors guidance ('Applying Human Factors and Usability Engineering to Medical Devices', 2016) reference placement is not a critical task for which a human factors validation study must be submitted in the 510(k)
jurisdiction: US — confidence: unconfirmed — note: Verifier pass 2026-10-01. The conditional rests on FDA's 2016 human factors guidance and on how FDA would classify a critical task. Guidance documents are outside every connector here, and the premise (fail-safe fallback) describes a design that does not yet exist. —…the full check source: no connector (FDA guidance); see claim 205unconfirmed for the design premise; as recorded before this pass: condition C21 from the regulatory position (2026-10-01) — stated by a chair, never checked; recorded so the Verifier can see it
Under the Medicare DMEPOS fee schedule, HCPCS E0740 carries one capped-rental allowed amount per modifier and state (74.52 dollars non-rural, modifier RR, July 2026 release) that does not vary with the features of the device billed under the code, so a pelvic floor stimulator with a two-channel discriminating EMG trigger coded to E0740 is allowed the same monthly rental amount as a single-channel EMG-triggered or stimulation-only device coded to E0740, and the abdominal reference channel cannot raise the Medicare allowable
jurisdiction: US — confidence: verified — note: Verifier pass 2026-10-01. Checked on its own text, which is conditional on the device being coded to E0740. The July 2026 DMEPOS fee schedule carries exactly one E0740 line: modifier RR, category CR (capped rental), $74.52 non-rural in every contiguous state and DC…the full check ($89.44 PR; rural columns 0.00, meaning none applies). The schedule has no field keyed to device features, so any device coded E0740 is allowed the same monthly rental amount, and a reference channel cannot raise the allowable under that code. The amount is Medicare's allowed amount, not its payment. Why this differs from claim 182unconfirmed: 182 asserts that the P2the discriminating trigger device will in fact be billed as E0740, which is the open PDAC question in claim 180unconfirmed; 193 does not. — source: payment E0740 --modifier RR --min-expected 74.52 --jurisdiction US → verified, local cache of CMS DMEPOS fee schedule, code=E0740, modifier=RR, release=July 2026; hcpcs E0740 --jurisdiction US → verified; as recorded before this pass: condition C6 from the commercial position (2026-10-01) — stated by a chair, never checked; recorded so the Verifier can see it
Thought Technology offers the MyOnyx (K201014) for sale in the US on prescription as a purchased system at a published manufacturer list price, 3,645.00 dollars for its Incontinence Expert System bundle as retrieved 2026-10-01, so the price of the one EMG-triggered intravaginal incumbent shown offered for US sale is a one-time purchase price set by its manufacturer, not a payer-set monthly rental allowable under HCPCS E0740
jurisdiction: US — confidence: unconfirmed — note: Verifier pass 2026-10-01. A manufacturer's list price is published only on the vendor's own site, a secondary source under this gate's rules. No connector reads device prices. What the primary record does show: FDA Registration & Listing lists 'SA9020 - MyOnyx',…the full check 'SA9030 - MyOnyx Mobile App' and 'T3425 - Electrodes 100 Uni-Gel Single' under K201014 for Thought Technology Ltd. with a 2026 registration. A listing shows the device is listed for commercial distribution, not its price or its sale model. — source: api.fda.gov/device/registrationlisting.json?search=registration.name:"thought technology" (retrieved 2026-10-01); price has no connector; as recorded before this pass: condition C7 from the commercial position (2026-10-01) — stated by a chair, never checked; recorded so the Verifier can see it
Independent claim 1verified of US10307589 (Interactive muscle training device and method, inventor Brent C. Reider, filed 2016-01-29) recites an electronic stimulator in communication with a first processor but not the second processor, a probe transducer that detects pelvic floor muscle contractions and communicates with the biofeedback receiver but not with the electronic stimulator, stimulation produced in response to the user's selection, and a firewall adapted to prevent the production of any electrical stimulation signals at the electrodes during biofeedback monitoring, so that independent claim does not recite stimulation triggered by a sensed EMG or muscle-contraction signal
jurisdiction: US — confidence: unconfirmed — note: Verifier pass 2026-10-01. The bibliographic facts verify: US10307589B2 'INTERACTIVE MUSCLE TRAINING DEVICE AND METHOD', filed 2016-01-29, applicant 'Reider Brent C.'. The claim is about the wording of independent claim 1verified, and claim text cannot be read here: EPO OPS…the full check returns CLIENT.InvalidCountryCode for US claims full text, and the patent connectors read dates and legal events only. Not checked. Claim construction is Tier 3 legal work in any case. — source: patent US10307589B2 --jurisdiction US → verified (dates only); EPO OPS published-data/publication/docdb/US.10307589.B2What the manufacturer collects per…/claims → 404 InvalidCountryCode; as recorded before this pass: condition C3 from the legal-ip position (2026-10-01) — stated by a chair, never checked; recorded so the Verifier can see it
US10646711, US11865337 and US11724100 are continuations-in-part in a chain claiming the benefit of US application 15/010,372 filed 2016-01-29 (issued as US10307589), so under 35 USC 154(a)(2) the term of each is measured from 2016-01-29 and ends in or about 2036 subject to patent term adjustment and any terminal disclaimer, not on the naive 20-years-from-own-filing dates of 2039-04-23, 2040-04-03 and 2040-11-13 recorded under claim 21unconfirmed
jurisdiction: US — confidence: unconfirmed — note: Verifier pass 2026-10-01. The chain verifies on EPO OPS biblio. US10646711B2, US11865337B2 and US11724100B2 each carry a national priority claim to US 15/010,372 filed 2016-01-29 (with 16/391,933 of 2019-04-23 and, for the last two, 16/839,105), and US10307589B2's own…the full check priority is 15/010,372. INPADOC: all four in force, record last exchanged 2024-01-20 (over a year old, so a later maintenance lapse would not show). Not checked: the continuation-in-part characterisation (OPS priority data does not state the continuation type), and the 35 USC 154(a)(2) term computation. The statute is not served by any connector and term with PTA and terminal disclaimers is a legal conclusion. — source: patent US10646711B2 --jurisdiction US, patent US11865337B2 --jurisdiction US, patent US11724100B2 --jurisdiction US → verified (naive dates); patent-status US10307589B2 --expect in-force --jurisdiction US → verified; EPO OPS published-data/publication/docdb/<each>/biblio priority-claims read; as recorded before this pass: condition C4 from the legal-ip position (2026-10-01) — stated by a chair, never checked; recorded so the Verifier can see it
WO2024095257A1 (Femme Medical Ltd, filed 2023-10-25) discloses an intravaginal device carrying a pressure sensor and electrodes that applies electrostimulation to the pelvic floor in response to a detected increase in intra-abdominal pressure, and its US national-phase application US20260014373A1 is published and pending as of 2026-10-01, so its US claims can still be amended within the scope of that disclosure
jurisdiction: US — confidence: unconfirmed — note: Verifier pass 2026-10-01. Most of it verifies. WO2024095257A1, applicant FEMME MEDICAL LTD, PCT (Patent Cooperation Treaty)/IL2023/051105 filed 2023-10-25 (priority US 63/422,055 of 2022-11-03). Abstract: 'The device may include a pressure sensor and electrodes ... In response to intra-abdominal…the full check pressure the device may apply electrostimulation'. claim 1verified recites stimulation in response to sensed 'urinary related activity', and claim 2verified includes 'increase of intra-abdominal pressure, pelvic floor contraction, and electromyographic activity of the pelvic floor'. US2026014373A1 (appl. 19/125,321, Femme Medical) was published 2026-01-15 and claims priority to the PCT. NOT verified: that it is 'pending as of 2026-10-01'. patent-status finds no INPADOC family for the US number, so status is unknown. 'Claims can still be amended within the disclosure' is a legal conclusion. — source: patent WO2024095257A1 --jurisdiction US → verified; patent US2026014373A1 --jurisdiction US → verified; patent-status US2026014373A1 --expect pending --jurisdiction US → unconfirmed (no family found); EPO OPS WO.2024095257.A1The classification regulation for a… abstract, claims and biblio read; as recorded before this pass: condition C5 from the legal-ip position (2026-10-01) — stated by a chair, never checked; recorded so the Verifier can see it
No issued and in-force US patent, and no published pending US application, claims an intravaginal pelvic floor stimulator, or a method of operating one, in which stimulation triggered by pelvic floor surface EMG is withheld while a separate abdominal-muscle surface-EMG reference channel indicates a Valsalva manoeuvre or abdominal brace
jurisdiction: US — confidence: unconfirmed — note: Verifier pass 2026-10-01. A negative FTO claim cannot be verified by a sweep; patent-scan returns leads, never a tag, and an FTO opinion is Tier 3. Sweeps of cpc=A61N1/36007, any date: text 'abdominal electromyography' 0 families; 'Valsalva' 0; 'electromyography…the full check trigger' 0; 'abdominal' 56 publications. Among the 56, US2023248964A1 (intravaginal stimulator firing on sensed IAP) and WO2024095257A1/US2026014373A1 (claim 197unconfirmed) are the nearest US-relevant documents; neither abstract recites withholding on an abdominal EMG channel. Claims of pending US applications were not read. — source: patent-scan --cpc A61N1/36007 --text "abdominal" --limit 100 --jurisdiction US → found 56 (ScanResult, no tag); patent-scan --cpc A61N1/36007 --text "abdominal electromyography" --jurisdiction US → none; as recorded before this pass: condition C6 from the legal-ip position (2026-10-01) — stated by a chair, never checked; recorded so the Verifier can see it
No publication dated before 2026-10-01 - patent document, 510(k) summary, device labelling or journal article - discloses withholding or blocking EMG-triggered pelvic floor electrical stimulation on a signal from an abdominal-muscle surface-EMG reference channel
jurisdiction: US — confidence: unconfirmed — note: Verifier pass 2026-10-01. A universal non-existence claim over all publications cannot be verified. The sweep turned up two close leads that need full-text reading before anyone relies on P2the discriminating trigger novelty. CN120167970A (2025) acquires 'pelvic floor muscle surface…the full check myoelectricity values and abdominal surface myoelectricity values' and has a 'myoelectricity triggering training module'. CN118105093A (2024) describes a pelvic floor rehabilitation instrument with a 'pelvic floor muscle detection channel and an abdominal muscle detection channel'. Neither abstract says the abdominal channel withholds stimulation, but two-channel pelvic-plus-abdominal sEMG in pelvic floor stimulators is published. Separately, K202648/K220161 ship a skin reference electrode on the EMG lead (see claim 173unconfirmed). — source: patent-scan --cpc A61N1/36007 --text "abdominal" --limit 100 --jurisdiction US → found 56 (leads); EPO OPS abstracts of CN.120167970.A and CN.118105093.A read; as recorded before this pass: condition C7 from the legal-ip position (2026-10-01) — stated by a chair, never checked; recorded so the Verifier can see it
USPTO assignment records show no recorded assignment of US10307589, US10646711, US11724100 or US11865337 away from the named inventor Brent C. Reider as of 2026-10-01, so the holder of the four live US grants on EMG-triggered pelvic floor stimulation is an individual inventor rather than a device company
jurisdiction: US — confidence: unconfirmed — note: Verifier pass 2026-10-01. USPTO assignment records are not read by any connector. EPO OPS shows the applicant of record at filing ('Reider Brent C.') for all four grants, which says nothing about later recorded assignments. — source: EPO OPS biblio applicants read for…the full check US10307589B2, US10646711B2, US11865337B2, US11724100B2; USPTO assignment database has no connector; as recorded before this pass: condition C8 from the legal-ip position (2026-10-01) — stated by a chair, never checked; recorded so the Verifier can see it
The FDA 510(k) decisions that describe EMG-triggered stimulation through a vaginal probe for urinary incontinence post-date the filing dates of three of the four live Reider-family grants: K201290 (Medline DeNovo 4Pro) was decided 2020-09-21 and K201014 (MyOnyx) 2021-01-13, both after US10307589 (filed 2016-01-29), US10646711 (filed 2019-04-23) and US11865337 (filed 2020-04-03), and K243079 was decided 2025-06-26; only K201290's decision date precedes the 2020-11-13 filing of US11724100, and K053434 (2005), which precedes all four, does not describe triggering
jurisdiction: US — confidence: unconfirmed — note: Verifier pass 2026-10-01. The dates verify. openFDA: K201290 decided 2020-09-21, K201014 2021-01-13, K243079 2025-06-26. Patent filings: US10307589 2016-01-29, US10646711 2019-04-23, US11865337 2020-04-03, US11724100 2020-11-13. So the ordering stated holds, including…the full check K201290 being the only one before 2020-11-13. Two operands do not hold as written. (a) K053434 was decided 2006-03-15 (received 2005-12-09), not 2005. (b) 'K053434 does not describe triggering' cannot be confirmed: its readable pages carry only the IFU, and the comparison page is a scan with no usable text layer. Meanwhile K201014's own comparison table credits the K053434 MyoTrac Infiniti predicate with 'EMG-Triggered Stimulation (ETS) using NMES specifications for incontinence' and a preloaded stress-incontinence ETS program. K202648 (Konmed, decided 2020-12-08) also describes ETS through a vaginal probe and post-dates three of the filings. The claim's framing ('The FDA 510(k) decisions that describe ETS ...') is therefore incomplete as a list. The IP significance is for legal-ip. — source: openFDA device/510k k_number=K201290, K201014, K243079, K053434, K220161, K202648 (retrieved 2026-10-01); patent US10307589B2 --jurisdiction US, patent US10646711B2 --jurisdiction US, patent US11865337B2 --jurisdiction US, patent US11724100B2 --jurisdiction US → verified; clearance-summary K053434 --jurisdiction US text read; as recorded before this pass: condition C9 from the legal-ip position (2026-10-01) — stated by a chair, never checked; recorded so the Verifier can see it
Where the FDA 510(k) summaries of the cleared products carrying an EMG-triggered stimulation (ETS) mode for urinary incontinence describe how the trigger decides to fire, they describe a threshold on pelvic floor EMG activity alone: K220161 (Shenzhen Konmed) provides stimulation 'when the level of active contraction of the pelvic floor muscles reaches a threshold by means of electrical feedback from the pelvic floor muscles', and K201290 (Medline DeNovo 4Pro) describes ETS as 'As soon as the EMG activity reaches a target threshold then an assisting electrical stimulus begins', with RMS processing and bipolar detection; K243079 and K201014 do not describe their trigger logic; while K243079 lists one stimulation channel and two EMG channels and K201014 lists two EMG channels, so a second sensing channel is already present in cleared ETS hardware and the engineering difference P2the discriminating trigger's mechanism adds over these devices, at summary level, is detector logic plus a skin-electrode accessory rather than new sensing hardware
jurisdiction: US — confidence: verified — note: Verifier pass 2026-10-01. Every quoted operand matches the FDA summaries. K220161: ETS mode 'provides a passive pulse stimulation when the level of active contraction of the pelvic floor muscles reaches a threshold by means of electrical feedback from the pelvic floor…the full check muscles'. K201290: 'As soon as the EMG activity reaches a target threshold then an assisting electrical stimulus begins'; EMG signal processing 'Root Mean Square (RMS)', EMG detection 'Bipolar'. K201290 names a single EMG activity threshold and no muscle beyond the contracted one; no second-channel condition is described. K243079 and K201014 do not describe their trigger logic. K243079 'No. of Output Channels: For stimulation: 1, For EMG: 2'. K201014 '2 channels for EMG or pressure biofeedback, electrical stimulation, and EMG-Triggered stimulation' plus 2 stimulation-only channels, with Uni-Gel T3425 surface EMG electrodes as accessories. The conclusion is scoped 'at summary level' and follows: a second EMG channel and surface EMG electrodes already exist in cleared ETS hardware. This is a statement about what the summaries say. It does not settle what the devices do, which is claim 173unconfirmed (unconfirmed). — source: clearance-summary K220161 --jurisdiction US → verified, FDA 510(k) summary K220161; clearance-summary K201290 --jurisdiction US → verified, FDA 510(k) summary K201290; clearance-summary K243079 --jurisdiction US → verified, FDA 510(k) summary K243079; clearance-summary K201014 --jurisdiction US → verified, FDA 510(k) summary K201014; full text of each read; as recorded before this pass: condition C18 from the technology position (2026-10-01) — stated by a chair, never checked; recorded so the Verifier can see it
In women with stress urinary incontinence a maximal voluntary pelvic floor contraction raised intra-abdominal pressure by about 17 cmH2O against about 9 cmH2O for a submaximal one, and was accompanied by bladder-neck descent in 28 percent of them (PMID 30069729), and pelvic floor EMG and intra-abdominal pressure both rise during correct contractions as well as during Valsalva and bracing (PMID 19730763), so a P2the discriminating trigger trigger that withholds stimulation whenever the abdominal reference channel rises would also withhold on correct effortful contractions, and the decision rule has to be relational, a pelvic-floor-to-abdominal activation ratio or the relative onset order of the two channels, gated on a pelvic floor channel threshold, rather than a veto on the reference channel alone
jurisdiction: US — confidence: unconfirmed — note: Verifier pass 2026-10-01. Content matches. PMID 30069729 (Int Urogynecol J 2018; 68 SUI women, 14 continent): 'A maximal PFMC resulted in BN descent in 29% of continent and 28% of incontinent women'; 'IAP increase was significantly greater with maximal PFMC in both…the full check groups (24 vs. 9.6 cmH2O and 17 vs. 9 cmH2O, respectively)', and the second pair is the incontinent group by the abstract's ordering. PMID 19730763 (Int Urogynecol J 2010; nine women without PFM dysfunction): 'PFM EMG and IAP increased during all tasks', which included PFM contractions, bracing and Valsalva. The decision-rule conclusion (relational ratio or onset order, not a veto) is a design inference no source states. Tag held on structural grounds (literature-detail is a ScanResult; class-2 is Corroborator territory). — source: literature-detail 30069729 19730763 → found (PubMed efetch); as recorded before this pass: condition C19 from the technology position (2026-10-01) — stated by a chair, never checked; recorded so the Verifier can see it
No published study reports the sensitivity or specificity with which a two-channel detector, pelvic floor surface EMG from a vaginal or perineal electrode plus an abdominal-muscle surface-EMG or intra-abdominal-pressure reference, discriminates a voluntary pelvic floor contraction from a Valsalva or abdominal-bracing manoeuvre, and none reports how such a detector's discrimination changes when the abdominal electrode is displaced from its intended site, so the readiness of P2the discriminating trigger's discriminating trigger, including its tolerance to self-placement by the patient, has never been measured
jurisdiction: US — confidence: unconfirmed — note: Verifier pass 2026-10-01. A non-existence claim about the literature cannot be verified by a connector. Lead sweeps found no study reporting sensitivity or specificity of a two-channel PFM-versus-Valsalva detector or its tolerance to electrode displacement (see claim…the full check 178 for the queries). PMID 32119158 (sEMG normalization reliability) and 12853805 (PFM behaviour during VLPP) surfaced and are not on point. Sweeps are leads, never tags. — source: literature "(pelvic floor) AND (electromyography) AND (abdominal) AND (Valsalva OR straining) AND (discriminat* OR classif* OR detect*)" --since 1970-01-01 --until 2026-10-01 --limit 100 → found 2 (leads); as recorded before this pass: condition C20 from the technology position (2026-10-01) — stated by a chair, never checked; recorded so the Verifier can see it
If P2the discriminating trigger's detector fires only when the pelvic floor EMG channel crosses its own threshold and the abdominal reference condition is also met, so the reference can only remove a trigger and never add one, then no fault of the reference electrode can cause a stimulation burst the pelvic floor channel did not trigger, and the worst case of any reference fault is single-channel triggering or no stimulation; contact-impedance (lead-off) monitoring, a standard function of biopotential front ends, together with flat-line and saturation checks, detects a detached, lifted, flat or saturated reference before and during a session, but an electrode adhered over the wrong muscle presents normal contact impedance and is not detected by it, and is detectable only from the signals, for example by a per-session calibration in which a guided pelvic floor contraction and a guided strain must separate on the two channels before triggering is enabled
jurisdiction: US — confidence: unconfirmed — note: Verifier pass 2026-10-01. A design-logic and front-end engineering argument about an unbuilt detector. The safety property follows from the AND-gate premise as stated, but the claims about lead-off monitoring behaviour and wrong-muscle detectability are engineering…the full check assertions no connector or primary record checks. Verification belongs on the built device. — source: no connector; engineering reasoning; as recorded before this pass: condition C21 from the technology position (2026-10-01) — stated by a chair, never checked; recorded so the Verifier can see it
In a device whose intravaginal probe delivers stimulation of up to about 90 to 100 mA into 500 ohms and which also connects a self-placed abdominal skin electrode to its EMG front end, stimulation current is kept out of the abdominal electrode in normal condition and under single fault only if the stimulator output is galvanically isolated from the EMG front end's patient connections or the abdominal input is disconnected during each burst, which is a design requirement verified on the built device by patient auxiliary current and leakage measurement under IEC 60601-1 and the nerve and muscle stimulator particular standard IEC 60601-2-10
jurisdiction: US — confidence: unconfirmed — note: Verifier pass 2026-10-01. The output figures are consistent with K243079 (90 mA @ 500 ohm) and K201014 (100 mA ± 20% @ 500 ohm). The isolation and auxiliary-current requirements are content of IEC 60601-1 and IEC 60601-2-10, licensed standards no connector reads. The…the full check design requirement is engineering reasoning to be verified on the built device. — source: K243079 and K201014 summaries read for output current; IEC standards have no connector; as recorded before this pass: condition C22 from the technology position (2026-10-01) — stated by a chair, never checked; recorded so the Verifier can see it
K201014's 510(k) summary lists EMG-triggered stimulation delivered 'Continuous (no rest phase)' and a preloaded stress-incontinence ETS program of 45 Hz, 200 microseconds, 6 s work and 10 s rest, so once an ETS burst fires it runs for its work time with no stimulation-off interval; a two-channel detector that decides only before the burst therefore cannot withhold stimulation on a Valsalva or brace that begins during a burst, and doing so would require reading the abdominal reference channel while the probe is stimulating at 45 to 50 Hz, the concurrent-recovery problem with per-pulse blanking that candidate claim 102unconfirmed describes, moved to an electrode remote from the stimulating site
jurisdiction: US — confidence: unconfirmed — note: Verifier pass 2026-10-01. The quoted figures match K201014: delivery 'Synchronous or Alternating; Continuous (no rest phase) for EMG-triggered stimulation', and preloaded 'Stress incontinence ETS: Pulse width 200 µs, Frequency 45 Hz, Repetitions 63, Work time 6 s,…the full check Rest time 10 s'. Two things are not established. (a) The summary does not say what 'Continuous (no rest phase)' means for an ETS burst. Reading it as 'runs for its work time with no stimulation-off interval' is plausible but is an interpretation, and it sits awkwardly beside the same program's 10 s rest time. (b) The 45 to 50 Hz range and the comparison to claim 102unconfirmed's blanking problem are not in K201014. The withhold-before-burst consequence is design reasoning. — source: clearance-summary K201014 --jurisdiction US → verified, FDA 510(k) summary K201014; full text read; as recorded before this pass: condition C23 from the technology position (2026-10-01) — stated by a chair, never checked; recorded so the Verifier can see it
A bipolar abdominal surface-EMG reference channel consumes two skin electrodes per session where it shares a common electrode with the intravaginal probe and three where it does not, and its lead can terminate in the 4 mm snap used by commodity pre-gelled surface-EMG electrodes, as K201014 already specifies single-use surface EMG skin electrodes (Uni-Gel, T3425) as accessories, so nothing in the detector requires a proprietary electrode
jurisdiction: US — confidence: unconfirmed — note: Verifier pass 2026-10-01. One operand verifies: K201014 lists 'Uni-Gel Single Electrodes (Single Use), Thought Technology Ltd, #T3425' as surface EMG electrodes. Electrode count per configuration and the 4 mm snap are engineering assertions. No primary record read…the full check here states the T3425 connector type or that commodity electrodes share it. — source: clearance-summary K201014 --jurisdiction US → verified, text read; as recorded before this pass: condition C24 from the technology position (2026-10-01) — stated by a chair, never checked; recorded so the Verifier can see it
Intravaginal pelvic floor neuromuscular electrical stimulation delivered while a woman with stress urinary incontinence performs a Valsalva manoeuvre or abdominal brace causes no clinical harm beyond a reduced or lost training effect - no reported worsening of leakage, reinforcement of a bladder-neck-depressing pattern, pain or prolapse-related harm - so a trigger that decides only before each stimulation burst, and cannot stop a burst on a strain that begins during it, is a performance limitation and not a hazard
jurisdiction: US — confidence: unverified — source: assessment-surfaced proposition (pillar B1The discriminating trigger works in the…, 2026-10-01) — the opportunity rests on this and no checkable statement existed for it; never checked
Women prescribed a home intravaginal EMG-triggered stimulator whose trigger also needs an abdominal skin electrode they place themselves each session complete the twelve-week course at a rate no lower than women prescribed a cleared single-channel EMG-triggered device that needs no skin electrode
jurisdiction: US — confidence: unverified — source: deck-surfaced assumption (desirability deck, 2026-10-01) — never checked; recorded so the Verifier can see it — evidence class 3 (stakeholder future)
A woman using a home stimulator that withholds a stimulation burst when its detector sees a Valsalva manoeuvre or abdominal brace reads a withheld burst as feedback on her contraction technique rather than as a device fault, and does not stop the course because bursts are withheld
jurisdiction: US — confidence: unverified — source: deck-surfaced assumption (desirability deck, 2026-10-01) — never checked; recorded so the Verifier can see it — evidence class 3 (stakeholder future)
A prescribing urogynecologist or pelvic floor physical therapist teaches a woman to place the abdominal reference electrode herself before she takes the device home, rather than declining to prescribe a device that needs that instruction
jurisdiction: US — confidence: unverified — source: deck-surfaced assumption (desirability deck, 2026-10-01) — never checked; recorded so the Verifier can see it — evidence class 3 (stakeholder future)
A manufacturer holding a cleared EMG-triggered intravaginal stimulator with two EMG channels (K243079 or K201014) cannot add a condition that withholds triggered stimulation on an abdominal surface-EMG reference channel without submitting a new 510(k), because that change alters how the device decides when to deliver stimulation
jurisdiction: US — confidence: unverified — source: deck-surfaced assumption (viability deck, 2026-10-01) — never checked; recorded so the Verifier can see it
A DME supplier that bills HCPCS E0740 pays the manufacturer of a stimulator whose trigger uses a self-placed abdominal reference electrode a wholesale price high enough to cover the per-session reference electrodes, although Medicare allows the same monthly E0740 rental amount for it as for a single-channel EMG-triggered device
jurisdiction: US — confidence: unverified — source: deck-surfaced assumption (viability deck, 2026-10-01) — never checked; recorded so the Verifier can see it — evidence class 3 (stakeholder future)
The landed cost per rental month of a home pelvic floor stimulator in the pivot P2the discriminating trigger configuration billed under HCPCS E0740 - the returnable controller amortised over its rental life, the single-patient-use intravaginal probe, connectivity, and the self-placed abdominal surface-EMG reference electrodes consumed in that month's sessions - is below the 74.52 dollar non-rural E0740 RR monthly allowed amount on the July 2026 DMEPOS fee schedule
jurisdiction: US — confidence: unverified — source: business-case assumption (2026-10-01) — never checked; recorded so the Verifier can see it
The verification and validation work pivot P2the discriminating trigger adds to a 510(k) for this device - verification of the two-channel trigger detector, usability validation of the woman placing the abdominal reference electrode herself, and isolation and leakage testing of the abdominal EMG input - keeps time and capital to first revenue inside the low-single-digit-million, sub-two-year envelope candidate claim 30unconfirmed asserts
jurisdiction: US — confidence: unverified — source: business-case assumption (2026-10-01) — never checked; recorded so the Verifier can see it
A pelvic floor physical therapy or urogynecology practice buying a clinic EMG-triggered intravaginal stimulation system for incontinence pays more for one whose trigger withholds stimulation on an abdominal surface-EMG reference channel than the 3,645 dollar list price Thought Technology publishes for its MyOnyx (K201014) Incontinence Expert System bundle
jurisdiction: US — confidence: unverified — source: business-case assumption (2026-10-01) — never checked; recorded so the Verifier can see it — evidence class 3 (stakeholder future)
Verity Medical or Thought Technology, which hold cleared EMG-triggered intravaginal stimulators with two EMG channels (K243079, K201014), would pay a licence fee for a trigger that withholds stimulation on an abdominal surface-EMG reference channel rather than develop one in-house or do without it
jurisdiction: US — confidence: unverified — source: business-case assumption (2026-10-01) — never checked; recorded so the Verifier can see it — evidence class 3 (stakeholder future)
Words on this page55 abbreviation(s) and code(s), with what each stands for — copied from _shared/plain-language.md
21 CFR
Title 21 of the Code of Federal Regulations — the US food-and-drug rulebook; a number after it is one regulation, often the one that classifies a device type
510(k)
premarket notification — the FDA route for a device shown to be as safe and effective as one already on the market; months, no clinical trial as a rule
A####
a HCPCS code for a supply — one billing code for a supply or an accessory; the letter A and four digits
ACOG
American College of Obstetricians and Gynecologists — the US specialist society whose guidelines obstetricians and gynaecologists follow
AUA
American Urological Association — the US specialist society for urologists
AUGS
American Urogynecologic Society — the US specialist society for pelvic-floor medicine
BOM
bill of materials — the list of parts in a product and what each costs
Class II
FDA device class II — moderate-risk devices, usually cleared by 510(k)
Class III
FDA device class III — the highest-risk devices, usually approved by PMA
CMS
Centers for Medicare & Medicaid Services — the US agency that runs Medicare, and so decides what Medicare pays for
COGS
cost of goods sold — what it costs to make one unit
CPT
Current Procedural Terminology — the US billing codes for what a clinician does; owned by the American Medical Association
De Novo
De Novo classification request — the FDA route for a new, lower-risk device with no comparable product to point at; longer than a 510(k), usually needs clinical data
DEN######
an FDA De Novo decision number — the public record of one device granted a De Novo
DME
durable medical equipment — equipment a patient uses at home, such as a pump or a stimulator, that Medicare pays for under its own rules
DME MAC
durable medical equipment Medicare administrative contractor — one of the four regional contractors that process Medicare's home-equipment claims and write its local coverage rules
DMEPOS
durable medical equipment, prosthetics, orthotics and supplies — the Medicare benefit and fee schedule that home equipment is paid under
E####
a HCPCS code for durable medical equipment — one billing code for a piece of home equipment; the letter E and four digits
EMG
electromyography — reading the electrical activity of a muscle
EPO
European Patent Office — the European patent office
ETS
electrical tissue stimulation — the FDA's name for the product family of stimulators
FDA
US Food and Drug Administration — the US regulator that clears or approves a device before it can be sold
FFS
fee-for-service — the traditional form of Medicare that pays per item or service
FTO
freedom to operate — whether a product can be sold without infringing someone else's live patent
HCPCS
Healthcare Common Procedure Coding System — the US billing codes for equipment, supplies and some services; a code is how a payer recognises what to pay for
IFU
instructions for use — the labelling that says what a device is for and how to use it
IP
intellectual property — patents and the other rights that let a company stop others copying it
ISO
International Organization for Standardization — the body whose numbered standards devices and laboratories are tested against
K######
an FDA 510(k) clearance number — the public record of one cleared device; the letter K and six digits
L#####
a Medicare local coverage determination number — the public id of one local coverage rule; the letter L and five digits
LCD
local coverage determination — a Medicare contractor's rule, valid in its region, saying when something is covered
MA
Medicare Advantage — Medicare delivered through a private insurer; must cover at least what Medicare covers
MAC
Medicare administrative contractor — a regional contractor that processes Medicare claims and writes local coverage rules
MAUDE
Manufacturer and User Facility Device Experience — the FDA's public database of reported device problems
Medicare Advantage
Medicare Advantage — Medicare delivered through a private insurer; must cover at least what Medicare covers
Medicare Part B
Medicare Part B — the part of Medicare that pays for outpatient care and equipment used at home
NCD
national coverage determination — a Medicare rule, valid everywhere in the US, saying whether and when something is covered
NCD ###.#
a Medicare national coverage determination number — the public id of one national coverage rule
NCT########
a ClinicalTrials.gov registration number — the public id of one registered clinical trial
NICE
National Institute for Health and Care Excellence — the English body whose guidelines say what the NHS should use
NMES
neuromuscular electrical stimulation — making a muscle contract with a small electrical current
PCT
Patent Cooperation Treaty — the route for filing one patent application in many countries at once
PDAC
Pricing, Data Analysis and Coding contractor — the Medicare contractor that decides which billing code a specific product falls under
PFMT
pelvic floor muscle training — the exercise programme for incontinence, usually taught by a physiotherapist
PFS
physician fee schedule — the Medicare price list for what clinicians do
PMA
premarket approval — the FDA route for the highest-risk devices; years and clinical trials
PMID
PubMed identifier — the public id of one published medical paper
PT
physical therapist — a physiotherapist
RCT
randomised controlled trial — the kind of clinical study that compares a treatment against an alternative by chance assignment
RTM
remote therapeutic monitoring — billing codes that pay a clinician for following a patient's use of a device from a distance
RVU
relative value unit — the unit Medicare uses to price a clinician's work
S####
a HCPCS temporary national code — a billing code used by some private payers and not by Medicare
SUI
stress urinary incontinence — leaking urine on a cough, a laugh or a lift
TAM
total addressable market — how much money the whole market would be worth if every possible buyer bought
USPTO
United States Patent and Trademark Office — the US patent office