idea-015 · desirability deck
Every slide states a condition that would have to be true, then reports where it stands using the candidate file's own claim and its own confidence tag. A deck never upgrades a tag, invents a number, or recommends anything, and there is no ask slide.
The chair: the user. There are two here, and both have to say yes. One is the fitting clinician (gynecologist, urogynecologist, women's-health NP), who has to change how a fitting visit runs. The other is the woman with symptomatic stage II-III anterior or apical prolapse who has chosen not to have surgery, and who has to wear the thing.
How to read this: every slide is a condition, not a conclusion. A bracketed claim reference points into knowledge-base/candidates/idea-015.md. The number is the claim's position in its ## Claims list, and the tag is copied from that claim as it stands at build time, never adjusted here. A [no claim] marker means nothing in the file speaks to the condition. Where another lens holds a condition, this deck points at that deck rather than restating it. See docs/deck-spec.md.
What the file looks like from this chair. Every claim in the file about what a person would do is unconfirmed. That covers the two the Generator wrote (clinician stocking, and continued use after in-visit adjustment) and all six desirability conditions earlier deck builds put on record (claims 27, 28, 29, 38, 39, 40). The Verifier took all eight through a pass on 2026-09-29. Each came back unconfirmed because adoption returns unverifiable by design and no connector reads patient or clinician behaviour, not because anything showed them false. This build appended nothing: every condition below already has a claim line. The rubric scores no factor for whether anyone wants this device, so none of that shows up in a score.
Would have to be true: At the office fitting visit, a material share of women with symptomatic stage II-III prolapse would have to leave without a retained, comfortable pessary because the first sizes a clinician takes from a stocked set do not fit. The problem the device solves would have to be a failure at fitting, not one that happens weeks later.
Where it stands: The fitting visit is real and mostly in the office. Medicare fee-for-service billed 73,363 pessary fitting services (CPT (Current Procedural Terminology) 57160) in the year the file read, about 91% of them non-facility. That is a floor on US volume, not a market claim 10verified. How often a fitting fails is not established. The 56-80% initial-success range has no retrieved primary source, and the meta-analysis the Verifier found reports predictors of failure but no overall rate claim 14unconfirmed. The one retrieved success figure (77.0%) comes from a population already selected for failing a standard pessary, so it is a different denominator claim 20unconfirmed. Nothing in the file shows directly that fitting is trial-and-error through discrete sizes. The nearest evidence is a cleared multi-size fitting set, K153422 (an FDA 510(k) clearance number), recorded in a claim's note claim 5unconfirmed. Some of the failure is later, not at fitting: 40.6% of 251 Dutch women stopped by 24 months, in a cohort that excluded initial fitting failures claim 15unconfirmed. The file sizes the disease at 2.9% symptomatic prolapse prevalence, which sizes the condition and not the fitting population claim 13unconfirmed.
What would settle it: A named, retrieved primary cohort reporting the overall initial fitting-success rate across all women who attempt a pessary, brought to the Corroborator via literature-detail on its PMID (PubMed identifier). The Verifier's sweep for claim 14unconfirmed found leads (PMID 32649024) but not this figure. For the trial-and-error half, a published description of fitting practice, or a human reading of a society fitting protocol.
If it's false: If fitting mostly succeeds and the losses come later, an in-visit adjustment fixes the smaller problem. Slide 2's behaviour change then buys little. The Factor 6 premise that the problem is real rests on claims 14 and 15, and it thins. The viability deck's reachable-share condition (Slide 3 there) loses its rationale.
Would have to be true: A fitting clinician would have to stop withdrawing a pessary that doesn't fit and trying the next size. Instead they would adjust and lock the same device in the same visit, write the set diameter in the chart, and re-set it from the chart at follow-up. The practice would have to stop stocking a multi-size fitting set because of this.
Where it stands: Both halves are behaviour claims with no evidence. Switching fitting method and charting the diameter claim 27unconfirmed. Stocking one adjustable SKU instead of a fitting set, and practices that don't fit pessaries today starting to claim 22unconfirmed. The Verifier recorded both as unreachable by any connector. The observable version of the behaviour, fewer device insertions per fitting visit, is a comparative claim about an unbuilt, untested device, and the Verifier found no connector for it claim 40unconfirmed. Whether the diameter can be adjusted with the device still in place is an engineering condition. It is held on Slide 2 of the feasibility deck claim 36unconfirmed.
What would settle it: Structured interviews or a survey of fitting clinicians across gynecology, urogynecology and NP practice, on current fitting workflow and inventory, run by a human. No connector reaches it: adoption returns unverifiable by design. claim 40unconfirmed needs a fitting study counting insertions per visit, adjustable device against a multi-size set, on a prototype. The file records none.
If it's false: If clinicians keep their fitting sets and use the device only as one more option, the single-SKU inventory argument goes. That argument is the viability deck's reachable-share condition claim 12unconfirmed. The device is then a ring with a mechanism added, competing in a category where one 510(k) (premarket notification) already covers a full multi-shape, multi-size line (viability Slide 6).
Would have to be true: Four more parties would have to agree. The patient would have to accept a device with a mechanical ratcheting joint as readily as a one-piece silicone ring. A woman who has already failed a conventional fitting would have to agree to another attempt, not give up on pessaries. A DMEPOS (durable medical equipment, prosthetics, orthotics and supplies) supplier would have to stock and dispense the device, or the fitting practice would have to be that supplier. And a practice that does not fit pessaries today would have to decide that this device makes it worth starting.
Where it stands: Patient acceptance of a jointed device: no evidence, and the Verifier found no connector claim 28unconfirmed. Failed-fit patients agreeing to another attempt: the Verifier returned it unverifiable, needing primary patient research, and substituted no synthetic opinion claim 39unconfirmed. That the device reaches revenue through a DMEPOS supplier and not only through the fitting clinician is half-evidenced: the fitting half is confirmed, the device-billing half is not claim 7unconfirmed. Whether the practice can itself be the supplier resolved only in part: 42 CFR 424.57(a) defines a DMEPOS supplier as an entity or individual "including a physician", but whether a given practice meets the supplier standards and accreditation, and which contractor the device claim goes to, are open. Held on Slide 1 of the viability deck claim 42unconfirmed. New practices taking up fitting is part of the stocking assumption claim 22unconfirmed. Payer coverage is held on Slide 2 of the viability deck.
What would settle it: Patient-preference research, such as interviews or a published preference study, including women with a prior fitting failure. A human would have to run or attach it, since adoption cannot. For the supplier link, a human reading of the DME MAC (durable medical equipment Medicare administrative contractor) supplier manuals and the 42 CFR 424.57(c) and 424.58 standards and accreditation rules against a real practice.
If it's false: If patients refuse the joint, the device has no wearer, whatever clinicians think. If failed-fit women won't try again, the most motivated group (the one the patient-specific competitor in claim 20unconfirmed targets) is not reachable. If no supplier dispenses it and the practice can't, the device can't be billed at all, and Slide 4's cost question is moot.
Would have to be true: The patient's out-of-pocket cost would have to be no higher than for a conventional silicone pessary. The clinician's unpaid chair time per patient, across fitting and maintenance visits, would have to go down, not up. A diameter that has to be re-set at follow-up would have to add no unpaid work.
Where it stands: Patient out-of-pocket cost is not read by any connector. The Verifier's nearest fact: under Medicare fee-for-service, a silicone pessary of either design dispensed under A4562 (a HCPCS code for a supply) by an assigning supplier carries the same allowed amount, so Medicare coinsurance on the device would be the same. Non-assigned pricing, deductibles, the fitting-visit share and every non-Medicare plan are unread claim 29unconfirmed. The price the file first carried for the device is refuted. The vendor-blog range of $69-$89 per device does not describe A4561, which the July 2026 DMEPOS fee schedule prices at $28.43-$29.45 non-rural. The silicone code, A4562, is $70.81-$73.34, so the $89 upper end is supported for neither code claim 11refuted. Beneficiary coinsurance comes out of that Medicare allowed amount. Whether this device would be billed under A4562 at all is unconfirmed: the A4562 descriptor ("Pessary, reusable, non rubber, any type") is verified and a silicone device matches its text, but a descriptor match is not an assignment, no coding determination has been made, and no coverage policy in the cached index names A4562 (see viability Slide 2) claim 41unconfirmed. On the clinician side, the fitting service pays about $70.48 non-facility, national and unadjusted claim 8verified. The claim that routine removal, cleaning and reinsertion is bundled into the office visit, and so unpaid, is permanently unconfirmed here. It rests on AMA-licensed CPT guidance claim 9unconfirmed. The Verifier noted that the whole "chair-time burden" story rests on that claim.
What would settle it: For claim 9unconfirmed, a licensed AMA/CPT coding source attached by a human. For out-of-pocket cost, plan cost-sharing data, which no connector reaches (a human with a claims dataset could). For claim 41unconfirmed, a DMEPOS coding verification for the device, which needs a device to exist.
If it's false: If maintenance is separately paid, the practice's unpaid-burden motive (claim 22unconfirmed) weakens and adoption has to rest on fitting outcomes alone. If the adjustable device costs the patient more, or lands outside A4562, it competes against a cheaper ring on a benefit that pays the same.
Would have to be true: A fitting clinician would need to see published comparative data showing that in-visit adjustment gives a better-retained fit and higher continued use than the next discrete size. They would need this before changing method. And that comparison would have to come out in the device's favour against a baseline the literature has not fixed, and against a personalised-fit option clinicians may already have.
Where it stands: That clinicians need comparative data before switching was returned unverifiable by the Verifier, with no synthetic clinician opinion substituted claim 38unconfirmed. The comparative bet itself cannot be checked for a device that does not exist claim 23unconfirmed. The baseline is unsettled: the cohort behind claim 15unconfirmed gives 20-60% discontinuation at 24 months, not the 30-50% at 12 months the file assumes claim 15unconfirmed. A competitor already has published outcomes for the same promise of rescuing a failed fit. Patient-specific pessaries report 77.0% initial fitting success and 63.7% continued use in 113 prior-failure patients at 18 Canadian sites claim 20unconfirmed. And in the US, FDA (US Food and Drug Administration) has cleared K231786, whose summary describes "personalized configurations of certain shape features, as determined by the clinician". The Verifier calls it a probable counterexample to "no patient-specific pessary is cleared in HHW", pending a human's terminology call (held on viability Slide 6) claim 43unconfirmed.
What would settle it: claim 38unconfirmed needs clinician interviews by a human, which could also ask how clinicians see K231786's clinician-determined configurations against in-visit adjustment. claim 23unconfirmed needs a prospective comparative fitting study, which is a Tier 3 decision to commission and not something a deck or an agent can start.
If it's false: This is where the lenses pull against each other. The feasibility and viability decks carry the premise that the device reaches market on bench and biocompatibility testing alone. The precedent is mixed: K231786 (clinician-configured) cleared with no clinical testing listed, while K232677 (Reia, a novel collapsible mechanism) included a seven-site US single-arm clinical study claim 34unconfirmed. Even if FDA takes the K231786 path, a clearance with no clinical data may not be enough for clinicians who want comparative data. The study the regulator may not ask for is the one the user does. Capital to first dollar then goes up (viability Slide 4).
Would have to be true: In the first handful of simulated-use or first-in-clinic fittings, three things would have to hold. A clinician would reach a retained, comfortable fit in fewer insertions than with a fitting set. The clinician would read and chart the set diameter without prompting. And the woman would accept wearing the jointed device. The falsifying observations are the reverse: as many insertions, re-adjustment that needs the device taken out, or refusals.
Where it stands: Nothing has been observed. The file describes the device as unbuilt, so there are no comparative data claim 23unconfirmed. The fewer-insertions condition has no study behind it claim 40unconfirmed. Charting claim 27unconfirmed and patient acceptance claim 28unconfirmed have no evidence. How many fittings would count as "a handful" is not in the file, and this deck does not supply a number [no claim].
What would settle it: Before any prototype exists, clinician interviews can test claims 22, 27 and 38 at the cost of a human's time. A simulated-use fitting on a pelvic model can test claim 40unconfirmed and the in-place adjustment (feasibility Slide 2), but it needs a prototype. Anything involving a patient is past the Tier 3 line and is a human's call.
If it's false: If interviews show clinicians are content with fitting sets, the other desirability conditions don't matter much: a device nobody fits has no wearer to ask.
Every condition above with nothing verified behind it, whether a [no claim] marker or a claim still short of verified. Read this slide first. All six conditions are here. The one verified claim on Slide 1 (claim 10verified) counts fittings, which is not the same as showing that fittings fail. The one verified claim on Slide 4 (claim 8verified) prices the fitting service, not the patient's cost or the clinician's unpaid time.
Of the six conditions, five rest wholly on unconfirmed lines. The sixth rests partly on a verified count that does not bear on the condition itself. Nothing on this deck is unverified any more: the six conditions earlier builds put on record (27, 28, 29, 38, 39, 40) have all had a Verifier pass and all came back unconfirmed because nothing here can reach them, not because anything showed them false. The shorter [no claim] list is not good news. It means the deck's open questions are now on record, not that they are answered.
If only one thing from this chair could be checked: whether fitting clinicians would give up trying discrete stocked sizes in favour of adjusting and locking one device in the visit, and would stop stocking the fitting set because of it claim 27unconfirmed claim 22unconfirmed. The sharpest form of that question is whether they would need comparative clinical data before switching claim 38unconfirmed.
Why this one: the patient only ever meets this device if a clinician chooses to fit it. Out-of-pocket cost and patient acceptance matter only after that. The single-SKU premise is what the viability deck's reachable share and the product's whole difference from a fitting set rest on, and that premise is this condition. It is also the cheapest condition in the deck that could come back false, because it needs interviews and no prototype.
Naming it is not a recommendation, a gate, or a kill. It is the answer to "check what first."
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