idea-008 · feasibility 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 engineers who have to devascularise a grade III pedicle with radiofrequency energy and stop before the sphincter.
How to read this: every slide is a condition, not a conclusion. A bracketed claim reference points into knowledge-base/candidates/idea-008.md — the number is the claim's position in its ## Claims list, the tag is copied from it and never adjusted here. A [no claim] marker means nothing in the file speaks to the condition at all. See docs/deck-spec.md.
What changed since the 2026-08-25 build: the clinical target this device has to beat is now quantified [claim 59: unconfirmed], [claim 60: unconfirmed], the incumbent modality is shown to be improving on its own [claim 62: unconfirmed], and the comparator trade-off is mapped across 14 treatments [claim 61: unconfirmed]. None of it is engineering evidence, and all of it changes what the bench package has to be written against. Rebuilt from the file, not patched.
Would have to be true: Bipolar radiofrequency energy would have to reach the submucosal pedicle of a grade II and grade III internal hemorrhoid through a disposable applicator with impedance-based dosimetry and automatic cutoff, deployed through a single-use anoscope, in an office, without sedation.
Where it stands: No energy parameters, impedance thresholds, cutoff criteria or safe-depth target appear anywhere in the file [no claim], so this deck states none. What is verified is the regulatory envelope: 21 CFR 878.4400 and product code GEI [claim 16: verified], [claim 17: verified], the Part 876 route resolved to named regulations [claim 18: verified], codes and panels re-established independently [claim 45: verified], and a four-clearance history for a bipolar RF applicator treating internal hemorrhoids [claim 40: verified]. The anoscope half of the kit has an established, separately cleared class [claim 22: verified] and a recent cleared product spanning grade III [claim 44: verified], [claim 55: verified].
What would settle it: The verbatim IFUs and summary text of the nearest predicates for the parameters FDA has already accepted in this anatomy [claim 40: verified], [claim 20: verified]; then IEC 60601-2-2 for the electrosurgical envelope. Neither produces the dosimetry spec — that is an internal engineering document nobody has drafted.
If it's false: There is no specification for the one feature the entire product is differentiated by, and Factor 6 has nothing to be scored on beyond the fact that the modality is cleared territory [claim 40: verified].
Would have to be true: Controlled thermal devascularisation of the pedicle would have to produce durable results at grade III, where the incumbent modalities are said to fall short, without pain, bleeding, or thermal injury beyond the target.
Where it stands: The premise "incumbent modalities fall short at grade III" is no longer an assertion. Rubber band ligation at grade III was not noninferior to hemorrhoidectomy on 12-month quality-adjusted life years, with 47.5% recurrence against 6.1% [claim 59: unconfirmed]; within office ligation, grade III recurrence was 32.8% against 14.6% at grade I-II [claim 60: unconfirmed]. The alternative that does work carries the cost this device is meant to avoid: across 79 randomized trials (n=9,232), closed hemorrhoidectomy had the lowest recurrence of 14 treatments but the hemorrhoidectomy and stapled options had the highest rates of postprocedural bleeding, urinary retention and bowel incontinence [claim 61: unconfirmed]. That is a well-specified engineering target: match surgical durability at grade III without acquiring the surgical complication profile. One caution belongs in the spec: a modified ligation technique has been reported to cut 3-month recurrence to 5.4% from 13.6% and eliminate delayed massive bleeding [claim 62: unconfirmed] — the bar may be rising without new hardware. This device's own durability remains unbacked [claim 33: unconfirmed].
What would settle it: Ex vivo thermal-spread mapping with histology at defined impedance endpoints, then an animal sphincter-injury study — the package the capital claim already contemplates [claim 14: unconfirmed] — and, separately and later, a comparative durability study at grade III powered against [claim 59: unconfirmed] rather than against a general claim of improvement.
If it's false: The device does at grade II what a cleared bipolar RF applicator has done since 2012 [claim 40: verified], [claim 52: verified], with a per-case cost attached — and Factor 6 loses the only thing that distinguishes it.
Would have to be true: A 510(k) against a cleared bipolar RF hemorrhoid device would have to carry this, with bench dosimetry and animal thermal-spread data and no pivotal trial — including the grade III half of the indication.
Where it stands: The predicate ground is settled and favourable as far as it goes: five predicates named by K-number, the De Novo fork's premise refuted [claim 46: refuted], the panel question refuted as having moved against the frontmatter [claim 19: refuted], and a predicate with a checked Indications for Use in hand [claim 20: verified]. The boundary is equally settled and is the problem: every located bipolar/RF IFU stops at grade II [claim 42: verified], [claim 52: verified], and the only grade-III-spanning predicate is a 2003 device in another panel [claim 53: verified], whose current commercial status is unchecked [claim 54: unconfirmed]. Whether FDA accepts grade II and III on that footing is unresolved [claim 51: unconfirmed], and no product code for this device itself has been established [claim 23: refuted] — the refutation covers the "nothing found in openFDA" half only.
What would settle it: An FDA pre-submission that puts the grade III indication and the predicate strategy in front of the review division — a human act, and the only thing that settles [claim 51: unconfirmed]. Then the special controls under the identified regulation to scope the bench, biocompatibility and human-factors package. Note the design lever the file already names: narrowing to grade I-II makes the predicate match exact; keeping grade III makes it a cross-code argument.
If it's false: Factor 7's calendar and cost [claim 14: unconfirmed] change category — a clinical study enters the critical path — and the indication that the candidate's own scope note calls its entire premise has to be either evidenced expensively or narrowed away.
Would have to be true: Impedance-based dosimetry would have to predict depth of thermal injury in hemorrhoidal submucosa well enough to devascularise the pedicle and stop before the sphincter complex or the rectal wall — at the larger, more vascular grade III pedicle, not just the grade II one.
Where it stands: Unbacked [claim 31: unconfirmed], and the Verifier's position is that no connector answers bench physics. The week's evidence does not touch it directly and sharpens why it matters: the entire commercial case now rests on beating a measured 47.5% recurrence at grade III [claim 59: unconfirmed], and the only way this device does that is by delivering a dose the incumbent modalities cannot deliver consistently. The failure mode on the other side is unchanged and severe — thermal injury beyond the target, at an anatomy where the complication profile of over-treatment is exactly what makes hemorrhoidectomy unattractive [claim 61: unconfirmed], [claim 12: unconfirmed].
What would settle it: Ex vivo thermal-spread mapping with histology at defined impedance endpoints, on tissue that includes a grade III-sized pedicle, then animal data — the point being to characterise the cutoff, not merely to pass it. That is bench work, and what happens after it is a Tier 3 decision this repo does not make.
If it's false: The differentiator becomes a marketing feature on a commodity generator, Factor 5's only asserted defensible assets go with it [claim 10: unconfirmed], and the one rare serious complication has no mitigation behind it.
Would have to be true: Thermal spread, cutoff behaviour and applicator geometry would all have to be characterised on the bench, against a written acceptance criterion, before any animal or patient work.
Where it stands: No acceptance criterion exists [no claim], and the bench conditions are this deck's own write-back [claim 31: unconfirmed], [claim 32: unconfirmed]. What the week supplied is the number the criterion should be derived against: a durability target set by [claim 59: unconfirmed] and [claim 60: unconfirmed], and a safety ceiling set by the complication profile the alternative carries [claim 61: unconfirmed]. Writing the acceptance criterion is now a tractable task rather than an open one.
What would settle it: A safe-depth specification derived from sphincter and rectal-wall anatomy at the treatment site, then ex vivo mapping against it across the grade II and grade III pedicle range. No animal is needed for the first pass.
If it's false: The animal work is spent characterising a device whose limits were never defined, the submission inherits the ambiguity, and Factor 6 stays unscoreable on anything except other people's clearances.
Would have to be true: An applicator carrying dosimetry electronics would have to be manufacturable inside the disposable cost the economics allow — and the kit would have to stay a kit.
Where it stands: Unbacked [claim 32: unconfirmed], and still the single most neglected item across all three of this candidate's decks and three successive builds — because it is the half of the decisive economic claim [claim 6: unconfirmed] that involves no external party at all. The kit's other half faces a cleared competitor: a single-use disposable anoscope with a hemorrhoid indication through grade III, cleared 2025-10-09 [claim 55: verified], [claim 44: verified], which makes build-versus-source a real decision and unbundling a real risk [claim 27: unconfirmed].
What would settle it: A contract-manufacturing quote against the applicator specification; then a build-versus-source decision on the anoscope against the cleared alternative.
If it's false: Either the dosimetry migrates into the console and the disposable becomes commodity — taking Factor 5 with it [claim 10: unconfirmed] — or the kit price breaks the adoption argument the whole candidate rests on [claim 15: unconfirmed], [claim 63: unconfirmed].
Would have to be true: Office RF hemorrhoid treatment with impedance-controlled coagulation would have to be buildable around whatever the incumbents hold.
Where it stands: Never examined [claim 11: unconfirmed], [claim 34: unconfirmed] — zero patents searched. Unexamined, not clear. The parties to search are better named than at any previous build: a strategic-owned bipolar RF hemorrhoid line with three clearances [claim 40: verified], [claim 52: verified], the 2003 grade-III predicate holder [claim 53: verified], and the recent disposable-anoscope entrant [claim 55: verified].
What would settle it: A CPC A61B18/12 and A61B17/12 search restricted to hemorrhoid/anorectal RF and impedance-feedback electrosurgical control, plus those assignee sweeps, producing named numbers that each go through the patent connector for family, status and expiry — and then counsel, because even a verified patent record is a database fact about dates, not an FTO opinion.
If it's false: FTO blocked is an automatic kill under the rubric, regardless of every other score. Note the asymmetry this candidate carries: its regulatory position is the best-evidenced in the knowledge base and got better again this week, while the one gate-relevant factor that could kill it outright has never been examined at all.
Every condition above with nothing verified behind it.
Sixteen verified claims, and the second and third passes improved them: the modality is cleared territory for this exact anatomy [claim 40: verified], the codes and panels are settled [claim 45: verified], the grade scope of every nearby IFU is read verbatim [claim 42: verified], [claim 52: verified], the disposable anoscope class is established and occupied [claim 44: verified], [claim 55: verified], and the ligation comparator is a separately regulated class [claim 56: verified]. Every one of them establishes what somebody else was permitted to sell. Nothing verified says the control algorithm works, what it costs, or whether anyone else owns it.
If only one thing from this chair could be checked: whether this device can be evidenced and cleared at grade III — the half of its own indication for which no bipolar or RF applicator predicate exists [claim 42: verified], [claim 51: unconfirmed].
It survives the third pass, and the week's evidence makes the reason for it much stronger. Grade III is where the engineering, the evidence and the regulatory strategy converge on one question. It is what the impedance dosimetry has to be good enough for, at the largest and most vascular pedicle [claim 31: unconfirmed]. It is the endpoint the bench and animal package has to be written against [claim 14: unconfirmed] — and that endpoint is now numeric: 47.5% 12-month recurrence for the incumbent office modality [claim 59: unconfirmed]. It is the durability argument the physician's switch depends on [claim 33: unconfirmed], [claim 63: unconfirmed]. And it is the only ground on this candidate that no verified record shows already occupied [claim 40: verified], [claim 44: verified].
The file frames the fork without resolving it and this deck does not resolve it either: narrow to grade I-II and the nearest predicate matches exactly but the product competes where a cleared bipolar RF device has been since 2012 [claim 52: verified]; keep grade III and the predicate story becomes a cross-code argument against a 2003 device in another panel [claim 53: verified], [claim 46: refuted]. What the clinical evidence adds is that the second branch is where the unmet need demonstrably is — and that a modified version of the incumbent technique is already reducing that need without any new device [claim 62: unconfirmed]. Which way the regulatory fork goes is an FDA judgement and a human decision.
Naming it is not a recommendation, a gate, or a kill.