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.
claim 1verifiedUS
21 CFR 884.3575 classifies the vaginal pessary — "a removable structure placed in the vagina to support the pelvic organs" for conditions including uterine prolapse — as a Class II device, and FDA assigns product code HHW ("Pessary, Vaginal") to that regulation
jurisdiction: US — confidence: verified — note: both halves checked, and against two independent primary sources (openFDA classification record and the CFR text itself). Checked against the stated intended_use: — clinician-fitted removable intravaginal support device for stage II-III anterior-compartment or apical…the full check POP in adult women electing non-surgical management, SUI and stage IV excluded — so a later change of indication invalidates this finding. Residual and NOT verified: the lookup establishes what HHW is, not that a device whose support diameter is set and locked mechanically stays inside HHW rather than triggering a different code or a De Novo reading. That is an FDA pre-submission question, not a database lookup. — source: classification --product-code HHW --jurisdiction US → verified, openFDA device/classification product_code=HHW, detail "Device class 2: Pessary, Vaginal (regulation 884.3575, review panel OB)"; and regulation 884.3575 --title 21 --expect "support the pelvic organs" --jurisdiction US → verified, eCFR versioner title-21, issue 2026-09-16, section text in full: "§ 884.3575 Vaginal pessary. (a) Identification. A vaginal pessary is a removable structure placed in the vagina to support the pelvic organs and is used to treat conditions such as uterine prolapse (falling down of uterus), uterine retroposition (backward displacement), or gynecologic hernia. (b) Classification. Class II (performance standards)."
claim 2unconfirmedUS
Whether devices under product code HHW / 21 CFR 884.3575 require a 510(k) or are exempt from premarket notification subject to the limitations in 21 CFR 884.9 is not established; web sources assert a 510(k) is required and multiple real 510(k)s exist in this space, but no primary FDA classification record showing (or not showing) the premarket-notification exemption flag was retrieved, and voluntary clearances inside exempt product codes are common enough that the existence of K-numbers does not settle the question
jurisdiction: US — confidence: unconfirmed — note: still not established after a Verifier pass, and the reason is now precise rather than vague. The openFDA classification connector in this repo returns class, device name, regulation number and review panel only — its detail surfaces no premarket-notification…the full check exemption field — so the one call the Scorer expected to settle this ("an openFDA device/classification lookup on product_code=HHW would settle it in one call") does not in fact settle it. The regulation text carries no exemption language either, and FDA's exemption determinations live in the classification database's own flags and in guidance, neither of which is reachable from the eCFR connector. A non-tagging sweep (connectors clearances --product-code HHW, 2010-01-01 to 2026-09-18) returned 16 Substantially Equivalent decisions in this code, which is exactly the ambiguous evidence the claim already describes and does not resolve it. What would close it: the FDA Product Classification database record for HHW read for its "510(k) Exempt" flag, i.e. a connector change or a human lookup, not a re-run. — source: classification --product-code HHW --jurisdiction US → verified for class and regulation but carries no exemption flag in its output; regulation 884.3575 --title 21 --expect "exempt" --jurisdiction US → unconfirmed, "21 CFR 884.3575 exists but its text does NOT contain the phrase 'exempt'" (the full section is quoted in claim 1 — it says only "Class II (performance standards)"); regulation 884.9 --title 21 --expect "exempt" --jurisdiction US → verified, eCFR title-21 issue 2026-09-16, § 884.9 exists and is the limitations-of-exemption section the claim names, but it states the limits on an exemption rather than whether HHW has one
claim 3verifiedUS
K190277 is a real FDA 510(k) held by ConTIPI Medical Ltd. for a disposable, self-inserted, collapsible vaginal device for the non-surgical management of pelvic organ prolapse (marketed as ProVate), with an FDA decision in 2019
jurisdiction: US — confidence: verified — note: K-number, holder ("Contipi Medical , Ltd." as FDA spells it), the 2019 decision (2019-07-08) and the non-surgical POP indication are all confirmed, and the HHW product code is confirmed separately by the product-code sweep. Two residuals a Scorer should not read past:…the full check the cleared Indications for Use say "temporary, nonsurgical management" and contain none of the words "disposable", "self-inserted" or "collapsible" — that device description rests on vendor material, not on the clearance record; and the clearance confirms what ProVate was cleared to do, not that it is an available predicate for an adjustable-diameter mechanism (the file already treats it as an analog, correctly). — source: 510k "ProVate" --jurisdiction US → verified, openFDA device/510k k_number=K190277, "Cleared 510(k): ProVate Vaginal Support / Contipi Medical , Ltd. decided 2019-07-08"; and clearance-summary K190277 --expect-indication "pelvic organ prolapse" --jurisdiction US → verified, FDA 510(k) summary K190277 (https://www.accessdata.fda.gov/cdrh_docs/pdf19/K190277.pdf), Indications for Use verbatim: "The ProVate Vaginal Support is indicated for the temporary, nonsurgical management of Pelvic Organ Prolapse in females"
claim 4unconfirmedUS
Four further 510(k) numbers — K132313, K231786, K232677 and K233548 (the last associated with Resilia Inc. in an April 2024 letter) — surfaced in a web search restricted to 21 CFR 884.3575 / vaginal pessary and are candidate additional clearances in this product code; none was individually confirmed to be a pessary clearance, and no product code, decision date or indication was verified for any of them
jurisdiction: US — confidence: unconfirmed — note: the underlying facts are now all confirmed, and the claim line as written is the thing that is out of date rather than wrong — it asserts its own non-confirmation, so it cannot be tagged verified without contradicting its own text; per the append-only rule it is…the full check left in place and the findings are recorded here, with claim 26 appended below stating the confirmed version. All four are real FDA 510(k) summaries and all four sit in product code HHW: K132313 "PESSARY" / Eis Corporation, decided 2014-12-05, IFU "EIS Vaginal Pessaries are indicated for the use as removable structures placed in the vagina to treat uterine prolapse, including cystocele and rectocele, as well as stress urinary incontinence in women"; K231786 "Gynethotics Pessary" / Cosm Medical, decided 2024-03-06, IFU covering ring, ring-with-support, ring-with-knob, Marland, Gellhorn and cube pessaries across Stage I-III prolapse and SUI; K232677 "Reia pessary" / Reia, LLC, decided 2024-05-21, IFU "The Reia pessary is indicated for the temporary, non-surgical management of Pelvic Organ Prolapse"; K233548 "Uresta®" / Resilia, Inc., decided 2024-04-03 — the Resilia/April-2024 attribution in the claim is correct, but its IFU is stress urinary incontinence only ("The Uresta bladder support is indicated for use in adult women over 18 years of age who experience stress urinary incontinence"), so it is a clearance in HHW and not a prolapse-pessary predicate for this candidate. — source: clearance-summary K132313 --jurisdiction US, clearance-summary K231786 --jurisdiction US, clearance-summary K232677 --jurisdiction US, clearance-summary K233548 --jurisdiction US → all four verified, FDA 510(k) summary PDFs at accessdata.fda.gov/cdrh_docs/pdf13/K132313.pdf, /pdf23/K231786.pdf, /pdf23/K232677.pdf and /pdf23/K233548.pdf; product codes, holders and decision dates from a non-tagging sweep (connectors clearances --product-code HHW, 2010-01-01 to 2026-09-18, 16 records)
claim 5unconfirmedUS
No FDA-cleared vaginal pessary with a clinician-set, mechanically lockable, re-adjustable support diameter was identified by the Generator — the cleared and marketed devices identified are fixed-size (ring, Gellhorn, donut, cube in discrete sizes) or single-use self-expanding (K190277)
jurisdiction: US — confidence: unconfirmed — note: the openFDA HHW sweep the Scorer asked for was run and found nothing contradicting the claim, but it cannot raise it to verified and a Scorer must not read it as confirmed absence. Three reasons: a ScanResult carries no confidence tag by construction; the sweep is…the full check window- and limit-bounded (2010-2026, 16 records, limit 50); and openFDA device names describe trade names, not mechanisms, so an adjustable-diameter device could sit in that list undetected. Nearest variable-geometry entries found: K132670 PANPAC INFLATABLE DOCUT PESSARY (Panpac Medical, 2014-06-04) — volume-variable by inflation rather than a clinician-set locking diameter — and the collapsible/self-expanding K190277 and K232677. Also nearby and worth a human eye: K153422 "Panpac Disposable Pessary Fitting Set" (2016-07-14), which is the multi-size fitting inventory this candidate proposes to replace, cleared as a device in its own right. — source: 510k "adjustable pessary" --jurisdiction US → unconfirmed, "No 510(k) record found for device_name='adjustable pessary'" — a no-match against a free-text device-name field, which is weak evidence of absence and nothing more; plus the non-tagging sweep (connectors clearances --product-code HHW, 2010-01-01 to 2026-09-18) listing all 16 HHW clearances in the window, none named as adjustable- or lockable-diameter
claim 6unconfirmedUS
HCPCS Level II codes A4561 ("pessary, rubber, any type") and A4562 ("pessary, non-rubber, any type") are active codes listed on the Medicare DMEPOS fee schedule, so the device itself is a separately payable durable-medical-equipment supply rather than an item absorbed into the office-visit payment
jurisdiction: US — confidence: unconfirmed — note: unconfirmed because the connector's data file is absent from this environment, not because CMS is silent. This is a missing-file gap: both hcpcs and payment name the exact CMS release that would settle it and explicitly instruct that a web search must not be…the full check substituted. Nothing here says these codes do not exist — it says nobody in this repo can currently look. Fetching data/hcpcs_level_ii.csv and data/hcpcs_payment_rates.csv closes this claim and claim 11 together, and is the cheapest open item in the file. — source: hcpcs A4561 --jurisdiction US → unconfirmed, "No local cache at data/hcpcs_level_ii.csv — HCPCS Level II code A4561 cannot be checked until it exists"; hcpcs A4562 --jurisdiction US → unconfirmed, same reason; payment A4561 --jurisdiction US and payment A4562 --jurisdiction US → unconfirmed, "No local cache at data/hcpcs_payment_rates.csv"
claim 7unconfirmedUS
The pessary device (A4561/A4562) is billed to a DME MAC while the fitting and insertion service (CPT 57160) is billed separately to the local Part B MAC under the Physician Fee Schedule — meaning a manufacturer selling this device must reach a DMEPOS supplier channel, not only the fitting physician
jurisdiction: US — confidence: unconfirmed — note: one half is now evidenced and the other is not. Confirmed: 57160 is an active (status A) code on the CMS Physician Fee Schedule with a full RVU decomposition, so the fitting service is PFS-paid — see claim 8. Not confirmed: that the device is separately billed…the full check under A4561/A4562 to a DME MAC. That needs the two missing CMS files (see claim 6), and the assertion about which contractor adjudicates which claim is a Medicare claims-processing-manual fact for which this repo has no typed connector at all — coverage is code-keyed and also has no cached file here, and ncd reads the NCD Manual, not the claims-processing manual. The commercial consequence the claim draws (a DMEPOS supplier channel stands between the manufacturer and revenue) therefore remains an inference, and it is the kind of inference that decides a go-to-market plan. — source: rvu 57160 --jurisdiction US → verified, CMS PFS RVU file, 57160 status A, confirming the PFS half; hcpcs A4561 --jurisdiction US / payment A4561 --jurisdiction US / coverage A4561 --jurisdiction US → all unconfirmed for missing local caches (data/hcpcs_level_ii.csv, data/hcpcs_payment_rates.csv, data/medicare_coverage_policies.csv); no connector reaches a claims-processing manual chapter
claim 8verifiedUS
CPT 57160 ("fitting and insertion of pessary or other intravaginal support device") is an active code paid under the Medicare Physician Fee Schedule, and a third-party RVU aggregator lists it at work RVU 0.87, non-facility total RVU 2.11, and an estimated national non-facility Medicare payment of approximately $70.48 before GPCI adjustment
jurisdiction: US — confidence: verified — note: every number in the claim is confirmed against CMS's own file rather than the aggregator it was taken from — work 0.87, and 0.87 + 1.09 (non-facility PE) + 0.15 (MP) = 2.11 total non-facility RVU, paying $70.48 at conversion factor 33.4009 (the file also carries a second…the full check line at CF 33.5675 paying $70.83; facility rates are $40.42/$40.62). Three limits carried deliberately: this is national unadjusted with no GPCI, as the claim itself says; a payment decomposition says what a code pays and never that a payer has agreed to pay it for this indication; and the descriptor text quoted in the claim is not verified and cannot be — CPT descriptors are AMA-licensed, cpt returns unverifiable by design, and only the code number is checkable here. — source: rvu 57160 --jurisdiction US → verified, "local cache of CMS PFS RVU file, code=57160, year=2026, conv_fact=33.5675", detail "PFS 57160 (2026, status A): work 0.87 + PE(non-facility) 1.09 + MP 0.15 → non-facility $70.83 (PE portion $36.59), facility $40.62 | [CF 33.4009] → non-facility $70.48 (PE portion $36.41), facility $40.42"
claim 9unconfirmedUS
Removal, cleaning and reinsertion of an existing pessary is bundled into the evaluation-and-management service and is not separately reportable under CPT 57160 — which is what makes recurring office pessary maintenance an uncompensated burden on the practice rather than a revenue line
jurisdiction: US — confidence: unconfirmed — note: permanently unconfirmed through this repo, for a licensing reason rather than a data gap. The claim is about CPT reporting guidance — descriptor and guideline prose, which is AMA-licensed and closed to every connector here. rvu 57160 establishes that 57160 is…the full check separately payable when it is properly reported, which is a different question from when reporting it is permitted, and must not be read as answering this. Closing it needs a licensed AMA or vendor source attached by a human, or the claim rescoped to something a CMS file can answer. Worth flagging to the Scorer: this claim is load-bearing for the "chair-time burden" story the whole adoption thesis rests on, and it is currently sourced to a coding-alert web page. — source: cpt 57160 → unverifiable by design: "CPT descriptors are AMA-licensed and cannot be scraped or reproduced verbatim (phase2-spec.md Section 3) … If it is genuinely about the descriptor text, rescope to HCPCS or attach a licensed AMA/vendor source by hand; no agent pass can close it"
claim 10verifiedUS
TAM component 1 (volume) — the Generator estimates, without any primary source, that annual Medicare Part B allowed services for CPT 57160 are on the order of 50,000-200,000 nationally; this is an order-of-magnitude guess stated so it can be resolved, not a figure taken from anywhere
jurisdiction: US — confidence: verified — note: the guess is confirmed as an order of magnitude and can now be replaced by a number: 73,363 services nationally, split facility 6,590 / office-and-other-non-facility 66,773 — comfortably inside the claimed 50,000-200,000 band and toward its lower end. The…the full check non-facility split is itself informative for this candidate: ~91% of the volume is office-based, which is where a single-SKU fitting inventory would sell. Two caveats carried from the connector and not to be dropped downstream: this is Medicare fee-for-service only — it excludes Medicare Advantage, commercial, Medicaid, VA and cash-pay, and prolapse presents across all of them — so it is a floor on US volume, never a market size; and the release year is not stated in the cached file (see data/provenance.json for which release was fetched). Volume is verified; price (claim 11) and addressable share (claim 12) remain unconfirmed, so the TAM as a whole is one-third evidenced, not evidenced. — source: procedures 57160 --jurisdiction US → verified, "local cache of CMS Medicare utilization file (geography and service), code=57160, geography=National", detail "57160 (national, facility 6,590, office/non-facility 66,773): 73,363 services. Medicare fee-for-service only … This is a FLOOR on US volume, not a market size."
claim 11unconfirmedUS
TAM component 2 (price) — the Medicare-approved amount for HCPCS A4561 in 2026 is approximately $69-$89 per device depending on locality; the corresponding A4562 (non-rubber, i.e. silicone) amount was not retrieved and may differ
jurisdiction: US — confidence: unconfirmed — source: a vendor blog page found via web search quoting a 2026 figure; not read off the CMS DMEPOS fee-schedule file. Note that this per-unit allowed amount, not the fitting payment, is the ceiling on the device revenue per patient, and that a reusable device bills once…the full check rather than recurrently — note: unconfirmed for a missing-file reason, not because CMS publishes nothing — payment has no cached DMEPOS rate file in this environment. The $69-89 figure therefore still rests solely on a vendor blog, which is not a primary source and cannot become one by being restated. This is the TAM component with the largest leverage on the business case (it is the hard ceiling on per-patient device revenue and the denominator of assumption claim 24's margin question) and simultaneously the cheapest to close, since the DMEPOS fee-schedule file is a free CMS download. — source: payment A4561 --jurisdiction US → unconfirmed, "No local cache at data/hcpcs_payment_rates.csv — payment rate for A4561 cannot be checked until it exists. See data/README.md for the exact CMS source and expected columns. Do not substitute a web search for this file."; payment A4562 --jurisdiction US → unconfirmed, same reason; hcpcs A4561 --jurisdiction US and hcpcs A4562 --jurisdiction US → unconfirmed, no local cache at data/hcpcs_level_ii.csv
claim 12unconfirmedUS
TAM component 3 (addressable share) — the Generator assumes, without a primary source, that the addressable share for a single-SKU adjustable device is the subset of pessary fittings performed in practices that currently stock a multi-size fitting set plus the fittings not currently performed at all because a practice declines to stock one, and puts that subset at roughly 30-50% of pessary fittings in the first instance; no inventory-behaviour or practice-level data was consulted
jurisdiction: US — confidence: unconfirmed — note: permanently unconfirmed absent a human-attached licensed source. Two of the three TAM components are now settled in opposite directions — volume verified (claim 10), price blocked on a missing CMS file (claim 11), share structurally unverifiable (here) — which is…the full check a far more useful position than one blanket shrug over the whole TAM, and the Scorer should read it that way. Note also that this component is not really a market question but a practice-inventory-behaviour question, i.e. the same unresearched territory as assumption claim 22; it would be answered by commissioned practice-level research, not by a market report. — source: market "addressable share for a single-SKU adjustable pessary is 30-50% of US pessary fittings" → unverifiable, "has no free, authoritative, machine-queryable source. Stays unconfirmed permanently unless a human attaches a licensed report and edits the claim by hand."
claim 13unconfirmedUS
Nygaard et al., "Prevalence of Symptomatic Pelvic Floor Disorders in US Women," JAMA 2008 (PMID 18799443), a cross-sectional analysis of 1,961 non-pregnant women aged 20 and over in NHANES 2005-2006, reported symptomatic pelvic organ prolapse in approximately 2.9% of US women and at least one symptomatic pelvic floor disorder in approximately 23.7%
jurisdiction: US — confidence: unconfirmed — note: content confirmed exactly on cold re-retrieval; tag held on structural grounds, not because anything is in doubt. The retrieved abstract matches every element of the claim: "A cross-sectional analysis of 1961 nonpregnant women (>or=20 years) who participated in…the full check the 2005-2006 National Health and Nutrition Examination Survey"; "The weighted prevalence of at least 1 pelvic floor disorder was 23.7% (95% CI, 21.2%-26.2%)"; "2.9% of women (95% CI, 2.1%-3.7%) experiencing pelvic organ prolapse"; JAMA, 2008; PMID real. Why it cannot be verified here: literature-detail returns a ScanResult, whose status vocabulary (found/none/unavailable) is deliberately disjoint from the confidence tags and has no code path to one (connectors/result.py; phase2-spec.md §3), and this is a class-2 published finding that routes to a Corroborator standard, not the Verifier's registry-fact standard — the same disposition used for the published-finding claims in idea-001 and idea-002. Scope note for the Scorer, which the Scores table already gets right: 2.9% symptomatic POP prevalence sizes the disease, not the billable device market. — source: literature-detail 18799443 → ScanResult status found, 1 record, PubMed PMID=18799443 (efetch), https://pubmed.ncbi.nlm.nih.gov/18799443/, JAMA 2008, "Prevalence of symptomatic pelvic floor disorders in US women", structured abstract retrieved in full
claim 14unconfirmedUS
Published pessary literature reports initial fitting success in the approximate range of 56-80% of women attempting a pessary fitting trial — i.e. a material minority fail the initial fitting — and the conventional fitting method is an explicitly trial-and-error progression through discrete stocked sizes
jurisdiction: US — confidence: unconfirmed — note: attempted and not closed — the claim names no PMID, so there was nothing to re-retrieve, and a literature sweep did not produce the 56-80% range from a primary source. What the sweep did produce, recorded as leads for whoever closes this: PMID 32649024, "Factors…the full check associated with unsuccessful pessary fitting in women with symptomatic pelvic organ prolapse: Systematic review and metanalysis" (Neurourol Urodyn, 2020), pooling 21 studies — it reports predictors of unsuccessful fitting (higher BMI, previous reconstructive surgery, advanced POP) and thirteen reasons for discontinuation, but states no overall fitting-success rate, so it does not by itself support the range; and PMID 42314178 (claim 20), which reports 77.0% initial fitting success for patient-specific pessaries in a population selected for prior standard-pessary failure — a different denominator that must not be read as the general figure. The second half of the claim (conventional fitting is trial-and-error through discrete stocked sizes) has no primary source cited at all; the nearest registry evidence is K153422, a cleared "Panpac Disposable Pessary Fitting Set", and the size ladder recited in the K231786 IFU. Both halves need a named, retrieved paper. — source: no confirmed PMID in the claim to look up; non-tagging sweeps (connectors literature "pessary fitting success prolapse" 2005-01-01→2026-09-18, 65 matches; connectors literature "pessary discontinuation prolapse cohort", 14 matches) plus literature-detail 32649024 → ScanResult status found, PubMed PMID=32649024 (efetch), abstract retrieved and read — it does not contain the claimed range
claim 15unconfirmedUS
Pessary discontinuation is reported at roughly 30-50% within the first 12 months of initiation, with one retrospective cohort reporting 102 of 251 women (40.6%) having stopped by 24 months
jurisdiction: US — note: the 251-patient cohort is from a 2024 Archives of Gynecology and Obstetrics paper and is not a US cohort, so it is directional for a US candidate, not dispositive — confidence: unconfirmed — note: **the specific cohort is found and its numbers match exactly; the general range in the first half…the full check of the claim is not supported by that source and looks narrower than the literature.** The paper is PMID 39614906, "Discontinuation of pessary therapy within 24 months: can it be predicted?", Archives of Gynecology and Obstetrics 2024 — a prospective observational study in 22 Dutch hospitals (the claim calls it retrospective; it is not), whose results read "Of the 251 women included in analysis, 102 stopped using a pessary at 24 months (40.6%)". The non-US caveat in the claim line is correct and now specific: Dutch, 22 centres. But the same abstract's introduction states "20-60% of women discontinue pessary treatment within 24 months", which is both wider and on a different time horizon than the claim's "roughly 30-50% within the first 12 months" — so the headline range is not evidenced by the source that evidences the cohort figure, and a Scorer must not treat the two halves as standing or falling together. Note also that this study excluded women with initial fitting failure, so it is not a continuation rate over everyone who attempts a pessary. Structural cap as elsewhere: literature-detail returns a ScanResult and cannot confer verified. — source: non-tagging sweep (connectors literature "pessary AND \"Arch Gynecol Obstet\"[journal]" 2023-01-01→2026-09-18) locating the paper, then literature-detail 39614906 → ScanResult status found, PubMed PMID=39614906 (efetch), https://pubmed.ncbi.nlm.nih.gov/39614906/, full structured abstract retrieved
claim 16verifiedUS
FTO — a granted US patent, US 11,865,033, titled "Vaginal pessary device for pelvic organ prolapse with improved collapsible construction" (published as application US 2021/0282961 A1, and understood from web sources to be assigned to Reia LLC), claims a removable pessary with an improved collapsible construction actuating between collapsed and expanded states and a finger-receiving loop on a stem allowing removal without reliance on pinch strength. This is a live-looking, directly adjacent patent: it does not obviously read on a ratcheting diameter-lock, but it would very likely read on any low-force removal-stem or collapse-for-removal feature added to this device
jurisdiction: US — confidence: verified — note: verified as a patent-register fact and nothing more — read this tag narrowly. Confirmed: the publication number is real, the title matches word for word, it was filed 2021-05-26, and on a naive 20-year term it runs to 2041-05-26, i.e. it is not expired — the…the full check claim's "live-looking" characterisation stands. NOT confirmed, and not confirmable through this connector: the assignee of record (the EPO OPS bibliographic response returned here carries title, filing date and term only — "Reia LLC" remains a web-sourced attribution, though the separately verified K232677 "Reia pessary" clearance held by Reia, LLC makes it plausible); legal status, maintenance-fee payment and any term adjustment or terminal disclaimer, all of which the connector explicitly says it does not model; and the issued claim scope. The whole second sentence — what the patent does and does not read on — is an infringement reading, which is a legal opinion no database lookup can supply and which this repo may not generate. Claim 18 remains the honest statement of where FTO stands. — source: patent US11865033 --jurisdiction US → verified, EPO OPS published-data/publication epodoc=US11865033, detail "VAGINAL PESSARY DEVICE FOR PELVIC ORGAN PROLAPSE WITH IMPROVED COLLAPSIBLE CONSTRUCTION: filed 2021-05-26, naive 20yr term expiration 2041-05-26 (not yet expired) — naive estimate, does not model PTA/SPC extensions/terminal disclaimers/maintenance lapses"
claim 17verifiedUS
FTO — US 6,189,535 B1, "Deflatable vaginal pessary," is a granted US patent issued in 2001; on a standard 20-year-from-filing term it would have expired well before this candidate's date, which places at least one size/volume-variable pessary concept in the expired art rather than under live protection
jurisdiction: US — confidence: verified — note: confirmed, and the filing date the Generator could not find is now on record: filed 1993-04-02, naive 20-year term expiring 2013-04-02, which the connector reports as expired — thirteen years before this candidate's date, so "well before" is right with room to…the full check spare. Two limits: the connector returns the publication's bibliographic record and its naive term estimate, not the 2001 issue date the claim states and not the issued claims, which remain unread; and an expired patent is prior art that can block patentability as readily as a live one can block practice — so this line is comfort on freedom to operate for that one concept and is not comfort on the moat (Factor 5), where a published deflatable-pessary disclosure cuts the other way. — source: patent US6189535 --jurisdiction US → verified, EPO OPS published-data/publication epodoc=US6189535, detail "Deflatable vaginal pessary: filed 1993-04-02, naive 20yr term expiration 2013-04-02 (expired) — naive estimate, does not model PTA/SPC extensions/terminal disclaimers/maintenance lapses"
claim 18unconfirmedUS
FTO — beyond the two patents named above, no comprehensive freedom-to-operate or patent-landscape search was performed for a ratcheting, lockable, clinician-adjustable-diameter intravaginal support device, for the locking mechanism, or for the single-SKU fitting workflow. The FTO field for the core novelty of this candidate is unexamined, not clear
jurisdiction: US — confidence: unconfirmed — note: confirmed as still true after this pass, and it is the most consequential open item in the file.patent answers "what does this numbered patent say about its own dates" — it is a record lookup and there is no landscape or freedom-to-operate search anywhere in…the full check this repo's connector surface, so nothing an agent can run will close this. The two patents checked this pass (claims 16, 17) are both about collapsibility and removal, not about a ratcheting diameter lock; the core novelty's art field remains entirely unexamined. This must reach the Scorer as an unexamined field, never as a clear one: FTO carries the rubric's only automatic kill, and an unexamined field cannot trigger it either — the correct posture is neither "blocked" nor "clear" but "not yet knowable", which is what the Factor 4 row already says. Closing it is a commissioned professional search, a paid multi-week item. — source: no connector reaches this claim — patent is single-record and cannot sweep an art field; recorded as an attempted check with no available instrument, not as an unattempted claim
claim 19unconfirmedUS
FDA reclassified surgical mesh for transvaginal repair of pelvic organ prolapse from Class II to Class III by final order published 2016-01-05 at 81 FR 353 (Federal Register document 2015-33165), and in the same action required the filing of premarket approval applications for those devices at 81 FR 363; on 2019-04-16 FDA ordered the two remaining manufacturers of surgical mesh for transvaginal POP repair to stop selling and distributing the devices in the United States
jurisdiction: US — confidence: unconfirmed — note: a compound claim that resolved in two different directions, which is why the tag is not verified. (1) Verified: Federal Register document 2015-33165 is real and is a Rule (not a notice), "Obstetrical and Gynecological Devices; Reclassification of…the full check Surgical Mesh for Transvaginal Pelvic Organ Prolapse Repair", published 2016-01-05 and effective the same day, whose own text reads "issuing a final order to reclassify surgical mesh for transvaginal pelvic organ prolapse (POP) repair from class II to class III." (2) Verified, and the claim's identifier for it was incomplete: the PMA requirement was a separate companion final rule, document 2015-33163, "Effective Date of Requirement for Premarket Approval for Surgical Mesh for Transvaginal Pelvic Organ Prolapse Repair", also published 2016-01-05 — not part of the same document, so "in the same action" is loose. (3) Page citations are off by one in both halves: the Federal Register records the reclassification order at 81 FR 354 (claim says 353) and the PMA order at 81 FR 364 (claim says 363); a document spans pages, so this may be a start-page convention difference rather than an error, but the claim's citations do not match the register's own. (4) Not checked at all: the 2019-04-16 stop-sale order. That was an FDA press announcement and enforcement action, which never entered the Federal Register; no connector in this repo reaches FDA announcements or enforcement practice, and the claim's own source admits the announcement was never retrieved. Since that half is the one bearing on how much of the POP population is available to a non-surgical device, the claim as a whole cannot be tagged verified. — source: policy 2015-33165 --expect-type rule --expect "class III" --jurisdiction US → verified, Federal Register document_number=2015-33165 (81 FR 354), type Rule confirmed, phrase found verbatim, https://www.federalregister.gov/documents/2016/01/05/2015-33165/obstetrical-and-gynecological-devices-reclassification-of-surgical-mesh-for-transvaginal-pelvic;policy 2015-33163 --expect-type rule --expect "premarket approval" --jurisdiction US → verified, Federal Register document_number=2015-33163 (81 FR 364), type Rule, phrase found verbatim; companion document located by a non-tagging sweep (connectors policy-scan --term "surgical mesh transvaginal pelvic organ prolapse" --agency fda 2016-01-01→2016-01-31); no connector available for the 2019-04-16 announcement
claim 20unconfirmedUS
Competitive — patient-specific, 3D-printed pessaries are an active clinical-research direction aimed at the same trial-and-error fitting problem this candidate targets, with a 2025-2026 Obstetrics & Gynecology paper on patient-specific pessaries after suboptimal outcomes with standard pessary use (PubMed record PMID 42314178 surfaced in a web search and not opened)
jurisdiction: US — confidence: unconfirmed — note: the PMID is real and the record is exactly what the claim says it is — tag held only by the ScanResult ceiling, and the content should worry the Scorer more than the claim line suggests. Retrieved: "Patient-Specific Pessaries After Suboptimal Outcomes With…the full check Standard Pessary Use", Obstetrics and Gynecology, 2026. Its abstract: a retrospective case series of 113 patients fitted with patient-specific pessaries between February 2024 and September 2025 across 18 clinical sites in Canada, all fittings recorded on "a centralized cloud-based platform", with clinicians able to "design up to two pessaries per round with iterative refinement"; initial fitting success 87/113 (77.0%, 95% CI 68.5-83.7), and 72/113 (63.7%) retained and continued use at final follow-up. Two readings a Scorer needs: this is not an early-stage research direction but a commercially deployed competitor at 18 sites with published outcomes in a population selected for prior pessary failure — i.e. the same iterative-refit value proposition this candidate proposes, reached by manufacturing rather than by a mechanism, and already evidenced; and it is a Canadian series, so it says nothing about US regulatory or reimbursement position. Not appraised for design or bias beyond what the abstract states. — source: literature-detail 42314178 → ScanResult status found, 1 record, PubMed PMID=42314178 (efetch), https://pubmed.ncbi.nlm.nih.gov/42314178/, Obstetrics and gynecology, 2026, full structured abstract retrieved
claim 21unconfirmedUS
Competitive — ClinicalTrials.gov registration NCT04275089, "Early Feasibility Study of the Reia Vaginal Pessary," is a registered clinical study of a collapsible vaginal pessary, indicating that the self-removal/collapsible pessary concept is in active clinical development by a third party
jurisdiction: US — confidence: unconfirmed — note: registry record retrieved and every element of the claim matches; tag held by the same ScanResult ceiling as the literature claims. Confirmed from the protocol record: title exactly as claimed, sponsor Reia, LLC (INDUSTRY), interventional, single-group,…the full check unmasked, enrollment 15 (actual), status COMPLETED with posted results, eligibility "Women with Stage II pelvic organ prolapse or greater" who are "Current ring style or Gellhorn pessary users inclusive of sizes 1.5\"-3.5\"", primary outcomes comparing retention of the study device against the subject's own current pessary during Valsalva. Update the claim's framing, though: "in active clinical development" is now understated in one direction and overstated in another — the study is completed, not active, and Reia has since moved past feasibility to a cleared device (K232677, decided 2024-05-21, verified under claim 4). The competitive read is therefore stronger than the claim states: this is a cleared competitor, not a trial. Note also the eligibility criteria are themselves a small piece of evidence for the fitting-size-ladder premise behind claim 14. — source: trial-detail NCT04275089 → ScanResult status found, 1 record, ClinicalTrials.gov NCTId=NCT04275089, https://clinicaltrials.gov/study/NCT04275089, status COMPLETED, hasResults=true, full protocol record retrieved
claim 22unconfirmedUS
Assumption, not a fact: the idea depends on fitting clinicians (gynecologists, urogynecologists, women's-health NPs) preferring to stock a single adjustable SKU over a multi-size fitting set, and on practices that currently decline to offer pessary fitting because of inventory and chair-time burden beginning to offer it once that burden falls. There is no connector for clinician purchasing or practice-line behaviour and no primary research is cited here; this is stated as an assumption so it stays visible rather than being phrased as a fact
jurisdiction: US — confidence: unconfirmed — note: confirmed unverifiable, permanently, and the Verifier did not substitute its own judgement about what clinicians would do. The connector's own instruction is explicit that a model-generated stakeholder opinion here would be a fabricated claim. The claim is…the full check correctly framed as an assumption and stays one. Checkable proxies that exist and were run, offered as the rescoping this needs rather than as an answer to it: procedures 57160 gives 73,363 Medicare FFS fittings a year with ~91% office-based (claim 10), which bounds how much practice behaviour there is to change; and K153422, a cleared "Panpac Disposable Pessary Fitting Set", evidences that multi-size fitting inventory is a real product category someone thought worth clearing. Neither says anything about a purchasing preference. — source: adoption "fitting clinicians would prefer to stock a single adjustable SKU over a multi-size fitting set" → unverifiable, "asserts what clinicians, payers, or patients would do … it needs primary research (interviews, survey, published preference study). Stays unconfirmed permanently unless a human attaches real research and edits the claim by hand."
claim 23unconfirmedUS
Assumption, not a fact: the idea depends on in-visit re-adjustment producing a better-tolerated fit than the next discrete size from a stocked set, and therefore on adjustable-device patients continuing pessary use at a higher rate than the 30-50% twelve-month discontinuation reported for conventional pessaries. No comparative data exists for a device that does not yet exist; this is the central clinical bet and is stated as an assumption
jurisdiction: US — confidence: unconfirmed — note: unverifiable by construction — no comparative data can exist for an unbuilt device — and two findings from this pass bear on it without resolving it. First, the comparator baseline the assumption is stated against is shakier than the claim assumes: the source…the full check behind claim 15 reports 20-60% discontinuation at 24 months, not 30-50% at 12, so the bar this device must beat is not currently a settled number. Second, the nearest available read on whether iterative refitting helps is PMID 42314178 (claim 20): patient-specific pessaries in patients who had already failed standard pessaries achieved 77.0% initial fitting success and 63.7% continued use at final follow-up — directionally supportive of the premise that refitting rescues failures, but it is a single-arm Canadian case series about a different intervention (bespoke manufacture, not in-visit mechanical adjustment), with no comparator, so it is a lead and not evidence for this device. Settling it needs a prospective comparative fitting study, as the Factor 6 row already says. — source: adoption "in-visit re-adjustment produces a better-tolerated fit and higher 12-month continuation than the next discrete size" → unverifiable, "needs primary research (interviews, survey, published preference study) … Do NOT substitute a model's own estimate of stakeholder behaviour"
claim 24unconfirmedUS
Assumption, not a fact: the idea depends on a DMEPOS payment of roughly A4562 scale per device supporting a viable gross margin on a reusable silicone device containing a ratcheting locking mechanism, i.e. on the mechanism being manufacturable at a cost materially below a single fixed-size pessary's allowed amount. No bill-of-materials or contract-manufacturing quote informs this; it is an unsourced assumption and is the most likely place the unit economics break
jurisdiction: US — confidence: unconfirmed — note: unconfirmed on both sides of the inequality, and worth flagging as the compounding gap in this file. The cost side has no connector and no quote — a contract-manufacturing quote is the instrument, and it is a commissioned item. The payment side, which is the…the full check ceiling the cost must sit under, is also unconfirmed — not because CMS is silent but because this environment has no cached DMEPOS rate file (claim 11). So the assumption is currently untestable in both directions at once: an unknown cost against an unquantified ceiling. Fetching the CMS DMEPOS fee-schedule file would at least fix the ceiling and make the remaining question a single sourceable number. — source: market "a reusable silicone pessary with a ratcheting lock is manufacturable materially below the A4562 allowed amount" → unverifiable, "has no free, authoritative, machine-queryable source"; and payment A4562 --jurisdiction US → unconfirmed, no local cache at data/hcpcs_payment_rates.csv
claim 25unconfirmedUS
Assumption, not a fact: the idea depends on a locking, re-adjustable mechanism surviving repeated cleaning and long-term intravaginal wear without crevice contamination, biofilm, or loss of lock — a reusable device with a mechanical joint has a cleaning-validation and biocompatibility burden that a solid-silicone ring does not, and this is the principal bench-evidence risk. No bench or materials data informs this
jurisdiction: US — confidence: unconfirmed — note: no connector in this repo can answer a bench-performance or biocompatibility question about an unbuilt device — this is not a registry fact, a payment fact or a published finding, and it is correctly stated as an assumption. Recorded as an attempted check with no…the full check available instrument. One lead a human should follow rather than a check: a non-tagging MAUDE sweep of product code HHW (2021-01-01 to 2026-09-18) returned 102 adverse-event reports in the window, a mix of malfunction and injury across marketed pessaries and bladder supports — MAUDE has no denominator and cannot support a rate, but reading those narratives is the cheapest available read on how existing pessaries fail in the body, and it would sharpen the cleaning-validation and retention protocol this claim says has to be written. Settling it needs bench cleaning-validation and ISO 10993 biocompatibility work on a real joint. — source: no connector reaches a bench-evidence claim; lead only from a non-tagging sweep (connectors maude --product-code HHW --since 2021-01-01 --until 2026-09-18, 102 reports in the window)
claim 26verifiedUS
All four of the K-numbers named in claim 4 are confirmed real FDA 510(k) clearances in product code HHW (21 CFR 884.3575): K132313 "PESSARY" / Eis Corporation, decided 2014-12-05; K231786 "Gynethotics Pessary" / Cosm Medical, decided 2024-03-06; K232677 "Reia pessary" / Reia, LLC, decided 2024-05-21; and K233548 "Uresta®" / Resilia, Inc., decided 2024-04-03 — but only the first three are prolapse-pessary clearances: K233548's cleared Indications for Use are stress urinary incontinence only, so it is not a POP predicate for this candidate
jurisdiction: US — confidence: verified — note: appended rather than edited into claim 4, because claim 4's own text asserts that none of the four had been confirmed and claims are append-only — this is the confirmed restatement and claim 4 carries the same findings in its note. Indications quoted verbatim from the…the full check FDA summary PDFs: K132313 "EIS Vaginal Pessaries are indicated for the use as removable structures placed in the vagina to treat uterine prolapse, including cystocele and rectocele, as well as stress urinary incontinence in women"; K231786 covering ring, ring-with-support, ring-with-knob, Marland, Gellhorn and cube pessaries across Stage I-III prolapse and SUI; K232677 "The Reia pessary is indicated for the temporary, non-surgical management of Pelvic Organ Prolapse"; K233548 "The Uresta bladder support is indicated for use in adult women over 18 years of age who experience stress urinary incontinence". Two consequences for the Scorer, neither of which is mine to score: K231786 shows a single 510(k) covering an entire multi-shape, multi-size pessary line, which is the incumbent regulatory posture this single-SKU candidate would compete against; and none of the four IFUs describes a clinician-adjustable or lockable diameter, which is consistent with claim 5 without confirming it. — source: clearance-summary K132313 --jurisdiction US, clearance-summary K231786 --jurisdiction US, clearance-summary K232677 --jurisdiction US, clearance-summary K233548 --jurisdiction US → all four verified, FDA 510(k) summary PDFs at https://www.accessdata.fda.gov/cdrh_docs/pdf13/K132313.pdf, /pdf23/K231786.pdf, /pdf23/K232677.pdf, /pdf23/K233548.pdf; holders, decision dates and HHW product code from a non-tagging sweep (connectors clearances --product-code HHW, 2010-01-01 to 2026-09-18)
claim 27unverifiedUS
Fitting clinicians will adopt an in-visit adjust-and-lock fitting procedure in place of trial-and-error progression through discrete stocked sizes, and will record the set diameter in the chart so it can be re-set at follow-up
jurisdiction: US — confidence: unverified — source: deck-surfaced assumption (desirability deck, 2026-09-20) — never checked; recorded so the Verifier can see it
claim 28unverifiedUS
Women with symptomatic stage II-III pelvic organ prolapse will accept a reusable intravaginal device containing a mechanical ratcheting joint as readily as they accept a one-piece silicone pessary
jurisdiction: US — confidence: unverified — source: deck-surfaced assumption (desirability deck, 2026-09-20) — never checked; recorded so the Verifier can see it
claim 29unverifiedUS
A patient's out-of-pocket cost for the adjustable single-SKU pessary is no higher than for a conventional fixed-size pessary fitted and dispensed under the same CPT and HCPCS codes
jurisdiction: US — confidence: unverified — source: deck-surfaced assumption (desirability deck, 2026-09-20) — never checked; recorded so the Verifier can see it
claim 30unverifiedUS
Commercial insurers and state Medicaid programs reimburse pessary fitting and pessary supply at rates comparable to Medicare fee-for-service, so pessary fittings outside Medicare fee-for-service are addressable device revenue
jurisdiction: US — confidence: unverified — source: deck-surfaced assumption (viability deck, 2026-09-20) — never checked; recorded so the Verifier can see it
claim 31unverifiedUS
A DME MAC local coverage determination or policy article covers pessary supply for stage II-III pelvic organ prolapse without a prior-authorisation or failed-trial-of-alternative requirement that a single-SKU clinician-adjustable device would not satisfy
jurisdiction: US — confidence: unverified — source: deck-surfaced assumption (viability deck, 2026-09-20) — never checked; recorded so the Verifier can see it
claim 32unverifiedUS
The ratcheting, lockable, re-adjustable support-diameter mechanism is patentable over the published prior art, including the expired deflatable-pessary disclosure US 6,189,535
jurisdiction: US — confidence: unverified — source: deck-surfaced assumption (viability deck, 2026-09-20) — never checked; recorded so the Verifier can see it
claim 33unverifiedUS
An incumbent pessary manufacturer cannot add a clinician-settable, lockable support diameter to its existing cleared multi-size pessary line without filing a new 510(k)
jurisdiction: US — confidence: unverified — source: deck-surfaced assumption (viability deck, 2026-09-20) — never checked; recorded so the Verifier can see it
claim 34unverifiedUS
Market entry requires no clinical investigation: the device reaches first commercial sale on a substantial-equivalence argument about geometry and materials supported by bench performance and biocompatibility testing only
jurisdiction: US — confidence: unverified — source: deck-surfaced assumption (feasibility deck, 2026-09-20) — never checked; recorded so the Verifier can see it
claim 35unverifiedUS
A ratchet with enough holding force to resist Valsalva loading can be realised without a rigid component breaching the medical-grade silicone envelope that contacts the vaginal mucosa
jurisdiction: US — confidence: unverified — source: deck-surfaced assumption (feasibility deck, 2026-09-20) — never checked; recorded so the Verifier can see it
claim 36unverifiedUS
A fitting clinician can set and re-lock the device's support diameter with the device in situ, without withdrawing it from the patient
jurisdiction: US — confidence: unverified — source: deck-surfaced assumption (feasibility deck, 2026-09-20) — never checked; recorded so the Verifier can see it
claim 37unverifiedUS
The device can be cleaned and maintained by the patient at home using the same routine as a conventional silicone pessary, with no additional disinfection step and no clinician-performed reprocessing
jurisdiction: US — confidence: unverified — source: deck-surfaced assumption (feasibility deck, 2026-09-20) — never checked; recorded so the Verifier can see it