Evidence · idea-001

claim 1verifiedUS

FDA product code KPI covers non-implanted electrical pelvic floor / continence stimulators and is 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…

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intended_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-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

claim 2verifiedUS

The classification regulation for a non-implanted electrical continence device is 21 CFR 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…

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submission_type_id 1 (510(k)). 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/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 (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-adjacent regulation is carved away by indication. Recorded because it is a live class risk if the indication ever broadens beyond continence

claim 3unconfirmedUS

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…

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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 (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

claim 4verifiedUS

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…

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(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

claim 5verifiedUS

K223884 (ELITONE URGE) is a cleared device indicated for urge urinary incontinence, i.e. a separate clearance was required to extend beyond SUI

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),…

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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)

claim 6unconfirmedUS

A device with this intended use is eligible for 510(k) clearance and does not require a De Novo 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…

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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

claim 7verifiedUS

HCPCS code E0740 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 HCPCS Level II file, code=E0740" — "HCPCS E0740: Non-implanted pelvic floor…

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electrical stimulator, complete system". The official descriptor is a direct match to the claim as written, including "complete system"

claim 8unconfirmedUS

Per PDAC 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.…

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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/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

claim 9refutedUS

Medicare NCD 230.8 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: refuted — note: 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…

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--expect-stance covered --jurisdiction US

 → **refuted**: "local cache of CMS Medicare Coverage Database (no policy names this code), code=E0740" — "No NCD or LCD 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=2325refuted6intended_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

claim 10verifiedUS

A Medicare DMEPOS 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,…

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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 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 (an app-linked, EMG-sensing intravaginal probe is plausibly a higher-BOM device than the bare non-monitoring stimulators E0740 was historically priced against), and TAM 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

claim 11unconfirmedUS

CPT 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…

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licensed AMA CPT descriptor; no web search was run and none is permitted

claim 12unconfirmedUS

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

claim 13unconfirmedUS

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

claim 14unconfirmedUS

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…

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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

claim 15unconfirmedUS

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

claim 16refutedUS

TAM component 1 — annual 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…

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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, 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 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

claim 17refutedUS

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…

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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

claim 18unconfirmedUS

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…

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defensible partial substitute is a verified payment E0740 allowed amount (itself blocked on the missing CMS file) plus a human-attached competitor price benchmark

claim 19unconfirmedUS

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…

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successful volume check leaves TAM's revenue half unsourced

claim 20unconfirmedUS

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…

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attached to the file; the current source is an uncited recollection

claim 21unconfirmedUS

FTO — no live, enforceable US patent claims closed-loop EMG-gated intravaginal NMES 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…

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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 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 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 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

claim 22unconfirmedUS

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…

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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

claim 23unconfirmedUS

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"…

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--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

claim 24unconfirmedUS

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

claim 25unconfirmedUS

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…

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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

claim 26unconfirmedUS

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 22847318: PFMT 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

claim 27unconfirmedUS

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

claim 28unconfirmedUS

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 (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

claim 29unconfirmedUS

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

claim 30unconfirmedUS

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)

claim 31unconfirmedUS

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

claim 32unconfirmedUS

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

claim 33unconfirmedUS

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

claim 34unconfirmedUS

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

claim 35unconfirmedUS

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

claim 36unconfirmedUS

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 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

claim 37verifiedUS

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…

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"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

claim 38unconfirmedUS

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

claim 39unconfirmedUS

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…

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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

claim 40unconfirmedUS

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

claim 41unconfirmedUS

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 →…

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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

claim 42unconfirmedUS

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 check

literature-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

claim 43unconfirmedUS

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.…

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literature-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

claim 44unconfirmedUS

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.…

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literature-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

claim 45unconfirmedUS

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).…

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Verifier 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

claim 46unverifiedUS

A device sold into the DME/Part B channel captures a material share of the addressable HCPCS E0740 Medicare FFS volume by year 3 of launch