Assessment — idea-001

Prescription home intravaginal NMES (neuromuscular electrical stimulation) device for stress urinary incontinence, rented under HCPCS (Healthcare Common Procedure Coding System) E0740, whose stimulation fires on a voluntary pelvic floor contraction and is withheld on a Valsalva or abdominal brace. A two-channel trigger does the withholding: pelvic floor EMG from the probe, plus an abdominal surface-EMG reference the woman places herself (pivot P2 the discriminating trigger).

This file carries no confidence tags. It cites them: [claim N: tag] reads claim N of the candidate file with the tag it carries there, and check_assessment.py refuses a citation that disagrees. It moves no score, no stage: and no status:.

Restated from scratch on 2026-10-01 against P2 the discriminating trigger, as the spec requires after a pivot. The P1 commercially-insured first assessment rested on a bet, "enough better than the existing open-loop devices", whose comparison claim 167refuted removed. Its text is in git history. Pillar ids are kept where the new pillar is the closest successor to an old one, so the four analog-case rows filed for B1 The discriminating trigger works in the…, B2 What the manufacturer collects per…, B4 Prescribers will send a woman home with a… and B5 Women will start an intravaginal home… still point at the right question. Where the proposition changed, the change is in ## Regrades. The candidate was read as it stands after the Verifier's P2 the discriminating trigger pass (claims 168–208) and the impact reviews IR-57 claim 191 came back refuted to IR-76 claim 85. It has 209 claims. One of them, claim 209unverified, was drafted today for B1 The discriminating trigger works in the… through append_assessment_claims.py and is registered as A117.

The bet

A urogynecologist or pelvic floor physical therapist prescribes a woman with stress urinary incontinence a home stimulator after she has failed four weeks of pelvic muscle exercise. A DME supplier rents it to her under E0740, and Medicare or a commercial plan pays the supplier a fixed monthly allowable claim 9verified, claim 193verified. The prescriber picks it instead of a cleared single-channel EMG-triggered device: the MyOnyx is listed and offered for US sale claim 167refuted, K243079 is cleared for prescription home use claim 153verified, and K220161 is cleared over the counter. The reason to pick it is that those triggers fire on the pelvic floor channel alone claim 202verified. Pelvic floor EMG also rises on a strain claim 150unconfirmed, so they may stimulate the manoeuvre the therapy exists to correct. This device withholds stimulation when the abdominal reference says she is straining. The shape is chosen because it is the only answer on the record to the specific failure IR-56 claim 167 came back refuted found: the closed loop is sold already, and a differentiator has to name something the sold implementation does not do. The bet is that the withhold is real in these women, that she can run it alone at home, that no incumbent already does it, and that the rental money clears the cost of an extra electrode every session.

The neighbouring shapes it is not. Each survives a different pillar's failure, and that is why they are written down.

• The supervised adjunct for Oxford 0–1 women (Clinical's shape). It survives B1 The discriminating trigger works in the…'s self-placement half failing. It gives up the home benefit, the coverage precondition, and the setting where a second channel is worth most.
• A single-channel ETS me-too, competing on channel and price. It survives B3 The discriminating trigger is a difference… failing. IR-56 claim 167 came back refuted recorded that it does not answer the failure, and at a fixed allowable it competes only on share.
• The data and app layer (RTM (remote therapeutic monitoring), practice fees). It survives B1 The discriminating trigger works in the… and B3 The discriminating trigger is a difference… failing together. The MyOnyx already records EMG through an app claim 154verified, and nobody is shown to pay for the stream.
• Biofeedback without stimulation (Regulatory's Option 2 the adherence device rather than the…). It survives B6 No live US patent stops P2 from shipping and B8 The route is one 510. It loses the home payment route, because home biofeedback is excluded claim 58verified.
• The manometric trigger (Option 3 the manometric trigger). It survives B6 No live US patent stops P2 from shipping only if pressure escapes the grants, and it needs the same reference channel to discriminate (IR-48 claims 151 and 159).
• Sell rather than rent (Option 4 sell rather than rent) and Medicare-first (Option 1 unwind P1). These are payer and asset decisions that move B2 What the manufacturer collects per… and B9 Payment reaches this device as billed and leave B1 The discriminating trigger works in the… and B3 The discriminating trigger is a difference… where they are.

Pillars

Eight. Each is a separate way this fails, and consequence is graded against the business. Claims a pillar is cited on only because the assumption register requires a home for them are listed in ## Regrades. None of them moves a band.

• B1 The discriminating trigger works in the… The discriminating trigger works in the women this label names, at home, as she sets it up: in women with stress incontinence who have failed four weeks of exercise, a single pelvic floor EMG channel fires on a Valsalva or brace often enough to matter; a pelvic-floor-plus-abdominal detector that decides before each burst separates the two manoeuvres, and deciding only before the burst is safe; she can place the reference herself without critical use errors; and stimulating only the correct contraction gives a better continence outcome than single-channel triggering, which itself has to beat untriggered stimulation — consequence: reshaping — graded: 2026-10-01 — rests on: claim 150unconfirmed, claim 105unconfirmed, claim 176unconfirmed, claim 204unconfirmed, claim 172unconfirmed, claim 100unconfirmed, claim 207unconfirmed, claim 209unverified, claim 178unconfirmed, claim 179unconfirmed, claim 33unconfirmed, claim 91unconfirmed, claim 96unconfirmed, claim 109unconfirmed, claim 101unconfirmed, claim 103unconfirmed, claim 147unconfirmed, claim 149unconfirmed, claim 114unconfirmed, claim 145unconfirmed, claim 146unconfirmed, claim 142unconfirmed, claim 144unconfirmed, claim 102unconfirmed — settled by: literature first: REQ-0055 Search for any reported sensitivity or… and REQ-0187 Search for any reported sensitivity for any published single- or two-channel discrimination figure, REQ-0170 Search the literature for whether the wrong manoeuvre survives the failed exercise trial, REQ-0193 Search PubMed for any outcome comparison, and REQ-0181 Is an intravaginal NMES burst delivered… for whether a burst on a strain is a harm (claim 209unverified). Then a sensing-only recording in 10–15 women on a purchased two-channel unit against the pass line REQ-0189 State the acceptance criterion the P2… asks Clinical to set, and REQ-0197 Specify's formative placement study on a works-like prototype. The outcome half (claim 178unconfirmed) has no test short of a controlled comparison against single-channel triggering, which is funded and has no sponsor — cost: project — in plain words: The device's one remaining difference is that it stimulates only when a woman squeezes her pelvic floor correctly, and holds back when she strains or braces her belly instead. That has to actually work in these women, at home, with a skin electrode she sticks on herself each session, and it has to help her more than the simpler devices already sold. If it does not, what is left is a device that already exists.
• B2 What the manufacturer collects per… What the manufacturer collects per beneficiary clears what it costs to field the P2 the discriminating trigger system for that beneficiary — a returnable controller, a single-patient probe, an app pathway and a self-placed skin electrode every session — paid as E0740 capped-rental months — consequence: fatal — graded: 2026-10-01 — rests on: claim 88unconfirmed, claim 48unconfirmed, claim 111unconfirmed, claim 67unconfirmed, claim 57unconfirmed, claim 121unconfirmed, claim 87unconfirmed, claim 122unconfirmed, claim 141unconfirmed, claim 113unconfirmed, claim 117unconfirmed, claim 139unconfirmed, claim 181unconfirmed, claim 183unconfirmed, claim 208unconfirmed, claim 14unconfirmed, claim 92unconfirmed, claim 108unconfirmed, claim 116unconfirmed — settled by: REQ-0177 For the P2 device as prescribed at home… (sessions per course), then REQ-0176 Under P2 (the landed monthly electrode cost against the $74.52 rental), with REQ-0173 Retrieve deciding whether the supplier carries it inside the rental. Then the denominator this file has never had: REQ-0046 Build the market model this candidate has…'s market model and REQ-0060 When the market model REQ-0046 commissions…'s build volume by object, and the OIG supplier-acquisition-cost reports for claim 122unconfirmed's ratio — analogs: [analog: stress-urinary-incontinence.reference-products.analog-capped-rental-manufacturer-economics] — cost: project — in plain words: What Medicare pays the rental supplier each month has to cover the whole kit for one woman: a controller that comes back, a probe that does not, the app, and a fresh skin electrode every session. If the monthly payment does not cover that, nobody makes money and there is no business.
• B3 The discriminating trigger is a difference… The discriminating trigger is a difference only this device offers, and prescribers choose it: none of the four cleared ETS products (K243079, K201014, K201290, K220161) uses a reference channel to decide when to fire; an incumbent cannot add one by a documented change, and no earlier publication already gives it away; and a prescriber who has decided on home triggered stimulation picks it over a cleared single-channel device despite the extra electrode — consequence: reshaping — graded: 2026-10-01 — rests on: claim 173unconfirmed, claim 202verified, claim 160unconfirmed, claim 199unconfirmed, claim 174unconfirmed, claim 168unconfirmed, claim 110unconfirmed — settled by: REQ-0166 Read the manufacturer labelling item (a) and REQ-0190 Read device labelling no connector reaches… item (a), the four products' labelling for how each trigger fires, which IR-58 claim 173 decided is the last commission on claim 173unconfirmed. REQ-0192 Read in full reads the two Chinese disclosures that could refute claim 199unconfirmed. REQ-0194 Run the twenty structured prescriber calls…'s twenty prescriber calls ask claims 168 and 174, and REQ-0188 Candidate claims 187 and 202 place the… asks Regulatory whether an incumbent's firmware change needs a new 510(k) — cost: cheap — in plain words: Nobody else's device uses a second, belly-worn channel to decide when to fire, an incumbent cannot bolt one on cheaply, and a prescriber who wants home stimulation would choose this one despite the extra electrode. If any of that fails, the device is one more of a kind already sold.
• B4 Prescribers will send a woman home with a… Prescribers will send a woman home with a stimulator instead of retaining her in clinic, and will produce the documented failed four-week exercise trial the indication requires — consequence: fatal — graded: 2026-10-01 — rests on: claim 24unconfirmed, claim 29unconfirmed, claim 31unconfirmed, claim 68unconfirmed, claim 93unconfirmed, claim 94unconfirmed, claim 124unconfirmed, claim 143unconfirmed, claim 157unconfirmed — settled by: REQ-0194 Run the twenty structured prescriber calls…, the twenty structured calls this line has named since 2026-09-14 and which had no request behind them until today, preceded by REQ-0062 Read the United States guideline corpus for…'s read of ACOG, AUGS and AUA/SUFU for whether any US guideline names electrical stimulation — analogs: [analog: stress-urinary-incontinence.reference-products.analog-documented-conservative-failure-prescribing] — cost: cheap — in plain words: Clinicians have to be willing to send a woman home with a stimulator instead of treating her in the clinic, and to write down the failed four weeks of exercise the coverage rule demands first. If they will not, there is no prescription and no business.
• B5 Women will start an intravaginal home… Women will start an intravaginal home device whose every session now includes placing a skin electrode, and still be using it at twelve weeks, at a recurring monthly cost share, given that a non-invasive external alternative is already on the market — consequence: fatal — graded: 2026-10-01 — rests on: claim 26unconfirmed, claim 27unconfirmed, claim 28unconfirmed, claim 59unconfirmed, claim 80unconfirmed, claim 138unconfirmed, claim 169unconfirmed — settled by: REQ-0050 Reconcile the adherence evidence for…, the published discontinuation and withdrawal figures read as one series, then a twelve-week continuation arm in the first clinical work, which now has to include placing the reference every session. REQ-0160 For app-connected home pelvic floor devices adds capture rates on app-connected home pelvic floor devices. None of it can be answered without patients — analogs: [analog: stress-urinary-incontinence.reference-products.analog-self-inserted-device-continuation] — cost: project — in plain words: A woman has to be willing to start using an internal device at home, stick on a skin electrode every session, pay a monthly share of the cost, and still be using it three months later, when a device that does not go inside the body is already on sale. If women stop, the rental income stops and there is no business.
• B6 No live US patent stops P2 from shipping No live US patent stops P2 the discriminating trigger from shipping: the four Reider grants do not read on a trigger that decides from EMG sensed before each burst, or a design that avoids them keeps the closed loop, and no issued or pending US claim covers withholding triggered stimulation on an abdominal reference — consequence: fatal — graded: 2026-10-01 — rests on: claim 21unconfirmed, claim 85unconfirmed, claim 195unconfirmed, claim 104unconfirmed, claim 201unconfirmed, claim 107unconfirmed, claim 198unconfirmed, claim 197unconfirmed, claim 196unconfirmed, claim 200unconfirmed — settled by: counsel's read under REQ-0048 Do the issued claims of US10307589 (accepted by Legal & IP) of the four grants' independent claims against a pre-burst design. It uses the claim text REQ-0191 From USPTO public records retrieves from USPTO, the expired alternating disclosure (REQ-0053 US6240315 and US6289245, REQ-0153 Read the full specifications of US6240315…), and K053434's possible 2006 ETS clearance (IR-75 claim 201). Then REQ-0185 A US landscape scoped to pivot P2's new…'s landscape for the withhold element — analogs: none sought, because the pillar is settled by counsel reading the issued claims of four patents and the pending claims on one element against this design; no case elsewhere can change how those claims construe — cost: project — in plain words: No patent still in force in the US can stop this device shipping: four existing patents on triggered stimulation must not cover the way this one decides to fire, and nobody may already own the idea of holding back stimulation on a belly signal. If a live patent reads on it, the device cannot be sold without a licence.
• B8 The route is one 510 The route is one 510(k) under 21 CFR 876.5320 against K243079 and K201014, and the reference channel does not push it to a De Novo, clinical performance data, a second classification regulation or a summative human-factors study — consequence: costly — graded: 2026-10-01 — rests on: claim 2verified, claim 6unconfirmed, claim 153verified, claim 154verified, claim 155unconfirmed, claim 188unconfirmed, claim 187unconfirmed, claim 189unconfirmed, claim 190unconfirmed, claim 184verified, claim 206unconfirmed, claim 192unconfirmed, claim 205unconfirmed, claim 156verified, claim 158verified, claim 165verified, claim 97unconfirmed, claim 36unconfirmed, claim 115unconfirmed, claim 161unconfirmed, claim 162unconfirmed, claim 164unconfirmed — settled by: REQ-0196 Retrieve from fda.gov and quote (the 510(k) Program guidance's decision points), REQ-0179 May the P2 abdominal reference electrode be… (whether the electrode is a third-party cleared part or sits inside this 510(k)), REQ-0183 Retrieve from fda.gov and quote (critical task) and REQ-0198 Retrieve and quote (the isolation clauses). Then an FDA pre-submission written response, the only thing that settles claims 155 and 188 — cost: project — in plain words: The regulatory route stays the quick one: a single 510(k) clearance pointing at two devices already cleared, with the extra belly electrode not forcing a slower route, a clinical study or a large human-factors study. If it does, the same business gets slower and more expensive.
• B9 Payment reaches this device as billed Payment reaches this device as billed: the PDAC codes the P2 the discriminating trigger system, reference electrode included, as one E0740 stimulator; a payer covers it at home for the women the label describes; DME suppliers carry it; and there is a commercially insured population behind the commercial policies — consequence: reshaping — graded: 2026-10-01 — rests on: claim 9verified, claim 55unconfirmed, claim 180unconfirmed, claim 56unconfirmed, claim 170unconfirmed, claim 90unconfirmed, claim 32unconfirmed, claim 86unconfirmed, claim 89unconfirmed, claim 74verified, claim 75verified, claim 129unconfirmed, claim 58verified, claim 193verified, claim 194unconfirmed, claim 182unconfirmed, claim 77verified — settled by: REQ-0172 Retrieve (the PDAC E0740 list, including which components each listed system names) and REQ-0195 Call DME suppliers that dispense home… (DME supplier calls). Then REQ-0020 Retrieve's remaining commercial policies and REQ-0154 From CMS primary sources's Medicare Advantage share. The coding determination itself needs a PDAC application on the built, cleared device — cost: cheap — in plain words: The money has to arrive the way the plan assumes: Medicare's coding contractor treats the whole kit, electrode included, as one stimulator under the existing billing code, payers cover it at home for these women, equipment suppliers agree to stock it, and enough commercially insured women exist behind the commercial policies. If not, the device is paid for differently or not at all, and the business changes shape.

Standing

Rendered, never written: python3 engine/scripts/check_assessment.py --candidate idea-001 --render

Decision queue

Same render. Worst exposure first; inside a band, cheapest first.

Regrades

2026-10-01: the restatement against P2 the discriminating trigger. Every pillar was re-derived, and every graded: date is today. That date is after the Verifier's P2 the discriminating trigger pass, not before it. The P2 the discriminating trigger premises (claims 172, 173, 174) were registered before anyone attempted them, but the classes below were set with the tags already known, so they are reconstructions and say so. One proposition was found with no claim under it. It is now claim 209unverified, under B1 The discriminating trigger works in the…, registered as A117.

Claims cited only because the register requires a home for them. Each is a live register row whose proposition this pillar reads around rather than dies without. They are listed so a distrustful reader can strike them and recompute. Striking every one of them moves no band: the unconfirmed ones cannot move standing, and the verified ones sit beside verified claims the pillar does die without.

What this does not say

• It does not say P2 the discriminating trigger's own propositions matter less than the inherited ones. All four fatal pillars (B2 What the manufacturer collects per…, B4 Prescribers will send a woman home with a…, B5 Women will start an intravaginal home…, B6 No live US patent stops P2 from shipping) were already fatal under P1 commercially-insured first. The two propositions P2 the discriminating trigger added (B1 The discriminating trigger works in the…, B3 The discriminating trigger is a difference…) are graded reshaping. The grading an intelligent reader should argue with is B1 The discriminating trigger works in the…'s. IR-56 claim 167 came back refuted itself recorded that the shapes left below P2 the discriminating trigger "compete with a sold incumbent and do not answer the failure". If P2 the discriminating trigger's trigger does nothing in women, this is a second differentiation failure in a row, with no differentiation on the loop left at all. Calling that fatal would put B1 The discriminating trigger works in the… at critical, beside B2 What the manufacturer collects per…, B4 Prescribers will send a woman home with a…, B5 Women will start an intravaginal home… and B6 No live US patent stops P2 from shipping. The posture would not change. The queue's first band would grow from four to five, and B1 The discriminating trigger works in the… would still sort below B4 Prescribers will send a woman home with a… on cost. The class is reshaping because the business-consequence test is "is anything left to build", and three shapes are on the record. That is a judgement, it is made after the tags, and it is stated here rather than defended.
• B3 The discriminating trigger is a difference…'s moderate is arithmetic over one verified claim, not evidence of a differentiator. claim 202verified says the two summaries that describe their trigger describe a pelvic floor threshold alone. The decisive claim is claim 173unconfirmed. The other two summaries are silent, and K202648 ships a skin electrode on its EMG lead whose role nobody has read. B3 The discriminating trigger is a difference… dies on one labelling sentence. Its cost band is cheap because that sentence is one retrieval away. The band says nothing about which way the sentence reads.
• The two refuted claims sit under no pillar, and that is not burying them. claim 167refuted is the P1 commercially-insured first premise P2 the discriminating trigger is built on the refutation of. It is cited in the bet, and no P2 the discriminating trigger proposition asserts it. claim 191refuted refuted a regulatory-effort premise in the direction that helps B8 The route is one 510, and it was absorbed (IR-57 claim 191 came back refuted). It would read on B8 The route is one 510's rests on: as a hole in a proposition it does not contradict. A reader running the spec's human check ("every refuted claim happens to sit under a cosmetic one") should know that neither sits anywhere, and why.
• evidence-gated is a state, not a verdict. It says no pillar is holed and at least one fatal question is open. Nothing here is resolved. The three partial pillars (B3 The discriminating trigger is a difference…, B8 The route is one 510, B9 Payment reaches this device as billed) are partial because their verified claims are about codes, regulations and FDA summaries, which are the cheapest things to verify, and none of the three is fatal. Nothing about whether a woman, a prescriber or a supplier will do anything has a verified claim under it.
• The queue's first line is the cheapest open fatal question, not the most likely to fail. B4 Prescribers will send a woman home with a… sits first because twenty calls cost an hour each, not because prescribers are the weakest link. This file grades no probability.
• B6 No live US patent stops P2 from shipping is graded fatal with a licence route on the record. If the grants read on P2 the discriminating trigger, a licence from an inventor who has recorded no assignment claim 200unconfirmed, or waiting for the term to end in about 2036 claim 196unconfirmed, would turn "no business" into a costly one. It stays fatal because neither route is a fact here, and counsel has not read the claims.
• The coverage citations are not hidden padding, and striking them is the test. The table above lists every claim cited only because the register requires it, with the reason. A reader who strikes all of them gets the same standing, exposure and queue.
• B5 Women will start an intravaginal home… lost four cited measurements and is not weaker for it. Claims 39, 40, 42 and 99 are still in the file and still the adherence evidence. They were cited as a bibliography, and the spec's rule is that a pillar cites what it dies without.

Every claim in the candidate file, with the pillars that rest on it and the materiality it inherits from them. 115 of 218 are read by a pillar; the rest are context — true, possibly checked, and carrying nothing. That is not an insult and it is not an error: it is the only view in this repo that can tell you where the verification effort went.