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.
CPT (Current Procedural Terminology) 95800, 95801, and 95806 exist and describe unattended home sleep studies distinguished by which channels are recorded
jurisdiction: US — confidence: unconfirmed — source: no primary source available (cpt 95800/95801/95806 → unverifiable: "CPT codes are AMA-licensed and cannot be scraped or reproduced verbatim (phase2-spec.md Section 3). Rescope this claim to HCPCS (Healthcare Common Procedure Coding System), or attach a licensed AMA/vendor source manually."). hcpcs,…the full checkpayment and coverage were also run on all three and returned unconfirmed — "No local cache at data/hcpcs_level_ii.csv / data/hcpcs_payment_rates.csv / data/medicare_coverage_policies.csv". Permanently unconfirmed absent a human-attached licensed AMA source; no agent pass can close this. The cache nulls are a missing-file condition, NOT evidence the codes do not exist or are not paid.
CPT 95782 and 95783 exist and describe attended polysomnography in patients younger than 6 years
jurisdiction: US — confidence: unconfirmed — source: no primary source available (cpt 95782/95783 → unverifiable, AMA-licensed, same detail as above). hcpcs/payment/coverage/procedures all returned unconfirmed on missing data/ caches. The Generator's own flag that these descriptors are a guess therefore…the full check stands uncorrected — do not read this line as any evidence the descriptors are right.
Home sleep testing in children is currently constrained by the limited availability of HSAT (home sleep apnoea test) devices with FDA (US Food and Drug Administration) clearance in pediatric populations
jurisdiction: US — confidence: refuted — note: in the load-bearing strong form this file scores against — source: FDA 510(k) (premarket notification) summary K240100 (an FDA 510(k) clearance number) (https://www.accessdata.fda.gov/cdrh_docs/pdf24/K240100.pdf); also K254042, K250460, K231546, K222331, K223675; roster from openFDA device/510k product_code:"MNR"…the full check 2020-08-24..2026-08-23 (38 clearances, none truncated). Verification route: classification --device-name "ventilatory effort recorder" → product code MNR, Class II (FDA device class II), regulation 868.2375 (openFDA device/classification product_code=MNR) — the launch product code the Generator did not name, now established; regulation 868.2375 → verified (eCFR versioner title-21, issue 2026-08-19). Then clearances --product-code MNR --since 6y and clearance-summary on all 38 hits. What the Indications for Use actually say: SNAP Diagnostics SAM Model 9-10000 (K240100, cleared 2024-06-04, MNR) states verbatim "The target population consists of patients who are suspected of apnea and/or complain about snoring. The majority of the test procedures will take place at the patient's home... Both pediatric and adult patients may be tested." — an explicit, un-age-floored pediatric indication on a home airflow/effort/position recorder. The WatchPAT family (K254042, K250460, K231546, K222331, K223675) is cleared "for 12 years and older" for all parameters except pAHIc (17+). This refutes the premise as the file relies on it — predicate_or_analog says "The Generator could not identify any device carrying a pediatric OSA (obstructive sleep apnoea) indication", and the Factor 1/8 narrative restates claim 3refuted as "no HSAT device carries a pediatric OSA indication". Both are contradicted by primary source. Two things it does NOT refute, and a reader must not over-read: (a) the weaker literal reading "limited availability" survives — 1 of 38 carries an explicit pediatric indication and 5 more reach only to 12, so nothing found covers ages 5-11 with an explicit age-banded pediatric OSA indication; (b) the causal half ("home sleep testing in children is constrained by this") is a market-behaviour claim no connector answers. Note the finding cuts in both directions the file itself identified: it weakens the whitespace/TAM story while strengthening the 510(k) branch of the regulatory fork, since a pediatric-indicated MNR predicate demonstrably exists. Data quality caveats on the sweep: K233501 returned unconfirmed (no posted summary), K243092 and K243268 returned only Form 3881 cover-page boilerplate, and K242290/K242424/K223573/K210593/K222950 yielded no age language — for those eight, absence of a pediatric indication was not established, it was simply not readable.
Registered clinical trials exist evaluating home sleep apnea testing in children and adolescents, including ClinicalTrials.gov NCT03748771 (a ClinicalTrials.gov registration number) ("Validation of ApneaLink Air Home Sleep Testing in the Diagnosis of Obstructive Sleep Apnea in Adolescent Children") and NCT05382754 ("Home Apnea Testing in CHildren Trial")
jurisdiction: US — confidence: unconfirmed — source: ClinicalTrials.gov NCTId=NCT03748771 and NCTId=NCT05382754, both retrieved via trial-detail. Both records exist and the titles match the claim verbatim. The tag is nonetheless unconfirmed for a structural reason, not an evidentiary one: trials/trial-detail…the full check is a Stage 0 ScanResult, whose status vocabulary (found/none/unavailable) is deliberately disjoint from confidence tags; connectors/result.py gives ScanResult no to_claim_line() and the records self-stamp requires_stage_3_verification: true. There is no ConnectorResult-producing connector for ClinicalTrials.gov in this repo, so no Stage 3 tag can be issued here without inventing one. Registry facts as retrieved, recorded so the Scorer need not re-pull them: NCT03748771 — status COMPLETED, hasResults=true, sponsor ResMed (INDUSTRY), INTERVENTIONAL/SINGLE_GROUP, enrollment 20 (ACTUAL), population ALL 12-17 years, primary outcome "Accuracy of HST Compared to ALT and PSG (polysomnography)", exclusions Down syndrome/Prader-Willi/craniofacial/congenital heart disease. NCT05382754 — status RECRUITING, hasResults=false, sponsor Children's Hospital of Philadelphia (OTHER), RANDOMIZED/CROSSOVER/double-masked, enrollment 317 (ESTIMATED — a registered target, not anyone enrolled), population ALL 5-12 years, primary outcome "Proportion of participants with diagnosis of OSA on both HSAT and PSG". Consistent with the claim's own scope limit, nothing here reports what either study found; NCT05382754 has posted no results at all, and NCT03748771's posted results were not retrieved or appraised.
TAM (total addressable market) component 1 — annual US volume of attended pediatric polysomnography, measured as claims volume for the pediatric PSG codes
jurisdiction: US — confidence: unconfirmed — source: no primary source available (procedures 95782, procedures 95783 → "No local cache at data/medicare_procedure_volumes.csv — procedure volume cannot be checked until it exists. See data/README.md... Do not substitute a web search for this file."). Two independent…the full check reasons this stays open: the cache file is absent, and the Scorer's own wrong-denominator warning is correct — Medicare FFS (fee-for-service) excludes Medicare Advantage (Medicare Advantage), commercial, Medicaid, VA and cash-pay, and children aged 5-17 are essentially absent from Medicare FFS entirely. Even with the cache present, a procedures result here would be a floor on a population that barely intersects the target, not a market size, and a null must not be scored as evidence of a small market. Still no number stated by the Generator.
TAM component 2 — realistic net price per pediatric home test to the ordering practice or sleep lab, assumed by the Generator at $150-$300 per study including scoring
jurisdiction: US — confidence: unconfirmed — source: no primary source available (market → unverifiable: "has no free, authoritative, machine-queryable source. Stays unconfirmed permanently unless a human attaches a licensed report and edits the claim by hand"; payment on the sleep codes → unconfirmed, missing…the full check data/hcpcs_payment_rates.csv). Remains a Generator assumption anchored to an unverified adult price.
TAM component 3 — addressable share assumption: the initial obtainable segment is children referred for suspected OSA who currently wait for an in-lab pediatric bed, assumed at 30-50% of pediatric PSG referral volume
jurisdiction: US — confidence: unconfirmed — source: no primary source available (market → unverifiable, same detail). The underlying "in-lab pediatric capacity is the rate limiter" premise is likewise unsourced and no connector reaches it.
Payer coverage claim — commercial and Medicaid medical policies generally do not cover home sleep apnea testing in patients under 18, restricting HSAT to adults
jurisdiction: US — confidence: unconfirmed — source: no primary source available (coverage 95800/95801/95806/95782/95783 → all unconfirmed, "No local cache at data/medicare_coverage_policies.csv"; adoption on the same claim → unverifiable). Nothing was searched, so this is a missing-file null and must not be…the full check read as evidence either that the exclusion exists or that it does not. Note also that coverage verifies existence of an NCD (national coverage determination)/LCD, not its stance, and reaches only Medicare — the claim is about commercial and Medicaid policies, which no connector in this repo touches at all. Factor 2's load-bearing claim therefore remains exactly as unsourced as the Generator left it; closing it needs human-attached named payer policy PDFs read for the exact exclusion wording.
Conditional structure of the reimbursement claim, stated separately because it is what actually matters: if the coverage exclusion above is real and if it is written as an age restriction rather than a device-clearance restriction, then FDA clearance alone does not unlock payment and a policy-change campaign is a second, serial go-to-market cost
jurisdiction: US — confidence: unconfirmed — source: no connector applies. This is a conditional over claim 8unconfirmed, whose antecedent is itself unconfirmed on a missing cache file; the "age restriction vs clearance restriction" distinction lives in payer policy prose that no connector in this repo can reach. Correctly…the full check self-described as not independently checkable. Worth flagging to the Generator: the finding on claim 3refuted (a pediatric-indicated MNR device already exists, K240100) bears directly on the second antecedent and may make this conditional resolvable sooner than the file assumes.
Moat lever — the defensible asset is the pediatric concurrent-PSG validation dataset and the pediatric scoring algorithm derived from it, plus the cleared pediatric indication itself, since a payer persuaded to cover pediatric HSAT will likely condition coverage on a device cleared for that age range
jurisdiction: US — confidence: unconfirmed — source: no primary source available (adoption on the payer-drafting half → unverifiable: "asserts what clinicians, payers, or patients would do... Do NOT substitute a model's own estimate of stakeholder behaviour"). No verifier judgement was substituted. Two…the full check primary-source facts materially pressure the first half and are recorded here rather than scored: ResMed has already run an adolescent HSAT-vs-PSG validation study (NCT03748771, COMPLETED, 12-17 years, results posted), and CHOP is running one in the 5-12 band (NCT05382754, 317 estimated); and a competitor already holds an explicit pediatric IFU (instructions for use) (K240100). Whether that erases the dataset moat is a Scorer judgement, not a Verifier finding.
Mechanism and clinical risk — the dominant risk is false negatives. Pediatric OSA presents with lower AHI, more partial obstruction and arousal-based events than adult OSA, and an unattended cannula-and-belt montage without EEG cannot see arousals or normalise by true sleep time
jurisdiction: US — confidence: unconfirmed — source: no Stage 3 connector applies. literature is a Stage 0 scan and structurally cannot emit a confidence tag (connectors/result.py), and the AASM pediatric scoring rules are licensed and human-attached. This remains Generator clinical reasoning. Closing it requires…the full check a human read of the AASM pediatric scoring manual plus appraised concordance data — note NCT03748771 has posted results that bear on it and were deliberately not appraised here.
Capital intensity and time-to-revenue — the dominant cost is a prospective multi-site validation study with concurrent in-lab PSG as reference standard in several hundred children, which the Generator estimates at mid-single-digit millions and 2-4 years before first revenue
jurisdiction: US — confidence: unconfirmed — source: no connector applies; no patent, market or CMS (Centers for Medicare & Medicaid Services) route reaches a cost estimate, and MDUFA decision-time reports are not connector-served. Unbenchmarked, as the Generator states. Pointer for whoever benchmarks it: NCT05382754 is a 317-child concurrent-PSG crossover…the full check study that has been RECRUITING since registration and was still recruiting at last update 2026-04-21 — a realized-duration datapoint, but a Stage 0 scan pointer, not verification of the estimate.
Competitive intensity — the adult HSAT incumbents (ResMed, ZOLL/Itamar, Philips) hold cleared platforms that are one validation study away from this indication, so the competitive question is not whether they can follow but whether the pediatric segment is large enough for them to bother
jurisdiction: US — confidence: unconfirmed — note: (weakest-link tag on a compound claim — the first half verified, the second half is permanently unverifiable; Generator should split this into two claim lines) — source, first half, all verified: ResMed — openFDA device/510k k_number=K061405 (ApneaLink,…the full check 2006-07-25) and k_number=K143272 (ApneaLink Air, 2015-04-30); Itamar/ZOLL — k_number=K223675 (WatchPAT ONE), k_number=K250460 (WatchPAT400), k_number=K254042 (WatchPAT SW), all MNR, all cleared to 12 years and older; Philips — k_number=K090484 (ALICE PDX, Respironics Inc., Sleep & Home Respiratory Group, 2009-06-26). Correction to predicate_or_analog: "Alice NightOne" is not a device name in openFDA's 510(k) index — 510k "Alice NightOne" returned unconfirmed and 510k "Alice NightOne" --applicant Philips and 510k "Alice" --applicant Philips both returned refuted; the Philips platform of record is ALICE PDX under the Respironics applicant name. The web-search-sourced analog name was wrong; the underlying incumbent claim is right. Second half (whether incumbents will bother) — adoption → unverifiable, permanently. Also note the first half now understates the position: ResMed has not merely could follow, it has already completed an adolescent validation study (NCT03748771). IFU caveat: clearance-summary on K143272 and K090484 both returned unconfirmed — "found no 'Indications for Use' heading... Read it directly rather than treating the indication as absent" — so the cleared age ranges of ApneaLink Air and Alice PDx were not established and must not be recorded as adult-only.
Assumption, not a fact: the idea depends on pediatric sleep physicians accepting an unattended study as sufficient for a tonsillectomy decision in an otherwise-healthy child. There is no connector for clinician acceptance and no primary research behind this belief; if specialists continue to require in-lab PSG before surgery, a cleared and covered device still has no referral flow
jurisdiction: US — confidence: unconfirmed — source: no primary source available (adoption → unverifiable, permanently, absent human-attached primary research). No verifier opinion was substituted for the missing research. The nearest checkable proxy the connector suggests is live: NCT05382754's secondary outcomes…the full check include "Association between therapeutic decision from HSAT compared to PSG" and "Proportion of participants who prefer HSAT to PSG" — i.e. a registered study is measuring close to exactly this, and has posted no results.
Children referred for suspected obstructive sleep apnea wait long enough for an in-lab pediatric bed that families would accept a home study instead
jurisdiction: US — confidence: unconfirmed — source: deck-surfaced assumption (desirability deck, 2026-08-24) — never checked; adoption → unverifiable: "asserts what clinicians, payers, or patients would do; no primary research, interviews, or survey provided. Requires human-attached primary research (published…the full check preference study, revealed-behaviour data) to resolve. No verifier opinion substituted."
A child aged 5 through 17 will tolerate a nasal cannula, thermistor, effort belts and an oximeter probe overnight at home well enough to produce a scorable study on the first attempt, at a failure rate comparable to adult home testing
jurisdiction: US — confidence: unconfirmed — source: deck-surfaced assumption (desirability deck, 2026-08-24) — never checked; adoption → unverifiable: adoption/stakeholder-preference claims require primary research (survey, published preference study, or clinical trial). No connector reaches this. Must rescope to…the full check checkable proxy or attach human-provided primary research.
Otolaryngologists will accept an unattended home study as sufficient basis for an adenotonsillectomy decision in an otherwise-healthy child
jurisdiction: US — confidence: unconfirmed — source: deck-surfaced assumption (desirability deck, 2026-08-24) — never checked; adoption → unverifiable: clinician acceptance claim. No primary research. The registered trial NCT05382754 includes "Association between therapeutic decision from HSAT compared to PSG" as a…the full check secondary outcome (status RECRUITING, not yet posted). Closest checkable proxy exists but results not yet published.
A commercial or Medicaid payer will change a pediatric home-sleep-testing coverage policy on the strength of a cleared pediatric indication plus a published concurrent-PSG validation study
jurisdiction: US — confidence: unconfirmed — source: deck-surfaced assumption (viability deck, 2026-08-24) — never checked; adoption → unverifiable: payer policy drafting claim. No primary research or named payer policy provided. Requires human-attached named payer coverage policies read for language precedent…the full check (e.g., policies that condition payment on age-specific FDA clearance).
A pediatric home study at the assumed price is cheaper to the payer than in-lab pediatric polysomnography by a margin large enough to motivate a policy change
jurisdiction: US — confidence: unconfirmed — source: deck-surfaced assumption (viability deck, 2026-08-24) — never checked; market → unverifiable: cost-comparison claim requires human-attached licensed payer data (e.g., MarketScan contracted rates, Medicaid T-MSIS allowed amounts) and actual HSAT device cost data.…the full check No connector reaches proprietary pricing.
An unattended montage without EEG can reproduce pediatric AHI thresholds to a level of agreement with concurrent in-lab polysomnography that a pediatric sleep physician would accept for a treatment decision
jurisdiction: US — confidence: unconfirmed — source: deck-surfaced assumption (feasibility deck, 2026-08-24) — never checked; literature is a Stage 0 scan, not a Stage 3 connector, and cannot emit a confidence tag. AASM pediatric scoring rules are licensed (human-attached). Registered trial NCT05382754 is measuring…the full check this (secondary outcome "Proportion of participants with diagnosis of OSA on both HSAT and PSG") but results not yet posted. Closest checkable proxy is live but unresolved.
Effort belts, airflow sensors and oximetry probes can be sized and fitted across the 5-to-17 age range without fragmenting into separate device configurations
jurisdiction: US — confidence: unconfirmed — source: deck-surfaced assumption (feasibility deck, 2026-08-24) — never checked; device-engineering claim. No primary source reachable by connector. Requires human-attached technical specifications and manufacturing process document or clinical-trial enrollment data showing…the full check fit across age range.
Pulse oximetry on a sleeping child at home achieves signal quality sufficient for event scoring despite motion artifact
jurisdiction: US — confidence: unconfirmed — source: deck-surfaced assumption (feasibility deck, 2026-08-24) — never checked; device-engineering/clinical claim. No primary source reachable by connector. Requires human-attached validation data (e.g., from an internal bench test, clinical trial, or published methods…the full check paper).
No live, enforceable US patent blocks a pediatric-indicated unattended multi-channel home sleep recorder or the pediatric scoring algorithm applied to its output
jurisdiction: US — confidence: unconfirmed — source: deck-surfaced assumption (feasibility deck, 2026-08-24) — never checked; patent requires specific patent numbers; none provided. Prerequisite is a patent search (CPC A61B5/0816, A61B5/087, A61B5/4818; assignees ResMed, Philips, Itamar, Nox Medical; claims live…the full check past ~2032). Each candidate number then goes through patent <number>. No claim numbers in this file yet to verify.
openFDA's device/classification record ties product code MNR (Ventilatory Effort Recorder, the launch product code for this candidate) to 21 CFR (Title 21 of the Code of Federal Regulations) 868.2375, but the eCFR text at 21 CFR 868.2375 describes a 'breathing (ventilatory) frequency monitor' respiratory-rate alarm device and does not contain the phrase 'ventilatory effort recorder' — a mismatch between the classification database's regulation_number field and the codified CFR text
jurisdiction: US — confidence: verified — source: eCFR versioner title-21, issue 2026-08-27, section=868.2375; verified text: "§ 868.2375 Breathing frequency monitor. (a) Identification. A breathing (ventilatory) frequency monitor is a device intended to measure or monitor a patient's respiratory rate." The actual…the full check eCFR text at 868.2375 describes a breathing frequency monitor for respiratory rate, not a ventilatory effort recorder. The mismatch between openFDA's regulation_number field and the codified text is confirmed.
A recall (Z-0031-2022, Nox Medical Nox T3s Recorder, product code MNR, status Terminated, initiated 2021-09-07) was issued for 'error in the device firmware results in the inaccurate detection of device position,' related 510(k) K082113
jurisdiction: US — confidence: verified — source: openFDA device/recall product_res_number=Z-0031-2022; recall confirmed with date 2021-09-07, status Terminated, reason: "Error in the device firmware results in the inaccurate detection of device position", related 510(k) K082113, product code MNR.
The AASM's 2017 Position Paper states that use of a home sleep apnea test is not recommended for the diagnosis of obstructive sleep apnea in children, citing an inability to identify literature on HSAT devices that monitor CO2 or detect arousals — measurements the task force viewed as critical in pediatric populations
jurisdiction: US — confidence: verified — source: PubMed PMID (PubMed identifier)=28877820 (efetch); Journal of Clinical Sleep Medicine 2017; title "American Academy of Sleep Medicine Position Paper for the Use of a Home Sleep Apnea Test for the Diagnosis of OSA in Children"; verified text: "Use of a home sleep apnea test is not…the full check recommended for the diagnosis of obstructive sleep apnea in children."
A 2012 AAP technical report reviewing 3,166 titles (350 included, level II-IV evidence) found pediatric OSAS prevalence ranged from 0% to 5.7% across the reviewed literature, with obesity as an independent risk factor, and found most diagnostic screening tests had low sensitivity and specificity
jurisdiction: US — confidence: verified — source: PubMed PMID=22926176 (efetch); Pediatrics 2012 Technical Report; title "Diagnosis and management of childhood obstructive sleep apnea syndrome"; verified text: "A total of 3166 titles were reviewed, of which 350 provided relevant data. Most articles were level II…the full check through IV. The prevalence of OSAS ranged from 0% to 5.7%, with obesity being an independent risk factor. Most diagnostic screening tests had low sensitivity and specificity."
A 2026 systematic review of pediatric HSAT-versus-PSG concordance found only 3 of 9 included studies used simultaneous HSAT and PSG testing, and in one of the largest such studies mean AHI was 2.5±3 (HSAT) versus 2.7±2.9 (PSG), p>0.05
jurisdiction: US — confidence: verified — source: PubMed PMID=42165382 (efetch); Pediatric Pulmonology 2026 Systematic Review; title "Reliability of Home Sleep Apnea Test as a Diagnostic Modality in Children With Obstructive Sleep Apnea- a Systematic Review"; verified text: "A total of nine studies were included in…the full check this review. Of these, only three studies employed simultaneous HSAT and PSG testing... In one of the largest studies comparing HSAT with PSG, the mean AHI observed was 2.5 ± 3 for HSAT and 2.7 ± 2.9 for PSG (p > 0.05)"
In a non-US (Australian) study of 47 children aged 5-16 undergoing home Type-2 polysomnography compared against in-laboratory Type-1 PSG, acceptable recordings were obtained for every home study attempted, with a 6.6% false-positive rate and 3% false-negative rate for OSA diagnosis
jurisdiction: US — confidence: verified — source: PubMed PMID=34323688 (efetch); Journal of Clinical Sleep Medicine 2022; title "Comparison of home ambulatory type 2 polysomnography with a portable monitoring device and in-laboratory type 1 polysomnography for the diagnosis of obstructive sleep apnea in children";…the full check verified text: "47 participants (ages 5-16) had T1PSG in the sleep laboratory and T2PSG performed at home. Acceptable recordings were obtained for every home T2PSG... false-positive rate of 6.6% and false-negative rate of 3%." NOTE: Claim text specifies non-US jurisdiction but claim line tags jurisdiction: US; this inconsistency should be resolved by the Generator.
In a non-US (Québec, Canada) retrospective quality-improvement study of 82 consecutive pediatric adenotonsillectomy patients over 22 months, mean referral-to-consultation delay was 9.0±7.0 months and total referral-to-surgery delay was 15.2±8.6 months, substantially exceeding the region's pediatric surgical access targets
jurisdiction: US — confidence: verified — source: PubMed PMID=42480311 (efetch); International Journal of Pediatric Otorhinolaryngology 2026; title "Reducing referral-to-consultation delays in pediatric obstructive sleep apnea through standardized triage: A regional quality improvement initiative"; verified text: "n =…the full check 82) quantified referral-to-consultation (Wait-1)... Mean Wait-1 was 9.0 ± 7.0 months... total referral-to-surgery delay was 15.2 ± 8.6 months... Wait-1 substantially exceeded benchmarks." NOTE: Claim text specifies non-US jurisdiction but claim line tags jurisdiction: US; this inconsistency should be resolved by the Generator.
Parents would prefer a home sleep apnea test to an in-lab polysomnography study for their child — unanswerable directly; the nearest revealed-behaviour twin found is claim 38unverified (a non-US pediatric adenotonsillectomy cohort's referral-to-consultation and referral-to-surgery delays), which quantifies the burden of the in-lab pathway but not any preference for or uptake of a home alternative. A US-specific PSG no-show, cancellation, or dropout rate was searched for directly this pass and not found (not merely not searched)
jurisdiction: US — confidence: unconfirmed — source: research lane, from dossier pediatric-obstructive-sleep-apnea-testing §9 (2026-08-27) — evidence class 3 (stakeholder future); adoption → unverifiable: "asserts what clinicians, payers, or patients would do... Requires primary research (preference study,…the full check revealed behaviour, interviews)." The nearest candidate is NCT05382754's secondary outcome "Proportion of participants who prefer HSAT to PSG" (registered but results not yet posted). Rescope to use revealed-behaviour proxy (wait-time data per claim 38unverified) rather than stated preference assertion.
A pediatric home sleep apnea test would win a material share of the addressable pediatric PSG referral pool (the population assumed at 30-50% of pediatric PSG referral volume currently waiting for an in-lab bed) by year 3 of commercial availability
jurisdiction: US — confidence: unverified — source: business-case assumption (2026-09-03) — never checked; recorded so the Verifier can see it
At a net price of $150-300 per pediatric home sleep study, the device generates a positive gross margin to the manufacturer after cost of goods, cloud scoring, and customer support
jurisdiction: US — confidence: unverified — source: business-case assumption (2026-09-03) — never checked; recorded so the Verifier can see it
Following FDA clearance, a payer-policy-change campaign to remove or narrow an age-based exclusion on pediatric home-sleep-apnea-testing coverage is affordable and completes within a calendar a single company can finance
jurisdiction: US — confidence: unverified — source: business-case assumption (2026-09-03) — never checked; recorded so the Verifier can see it
The regulatory, clinical-validation, and go-to-market cost and calendar for the De Novo (De Novo classification request) branch of this candidate's regulatory fork materially exceed the mid-single-digit-millions, 2-4-year estimate the candidate file states for the 510(k) branch
jurisdiction: US — confidence: unverified — source: business-case assumption (2026-09-03) — never checked; recorded so the Verifier can see it
A well-capitalized incumbent adult home-sleep-apnea-test manufacturer would pay a royalty or transfer price for a licensed pediatric scoring algorithm and concurrent-PSG validation dataset sufficient to sustain a standalone licensing business
jurisdiction: US — confidence: unverified — source: business-case assumption (2026-09-03) — never checked; recorded so the Verifier can see it
A child referred for suspected obstructive sleep apnea undergoes between 1.0 and 1.3 diagnostic sleep studies per year, i.e. repeat and post-adenotonsillectomy re-testing adds no more than 30% to study volume over the referred population
jurisdiction: US — confidence: unverified — source: market-model leg assumption (2026-09-11) — never checked; recorded so the Verifier can see it
The US resident population aged 5 to 13 years was 36,232,804 at July 1, 2025, per Census Bureau Vintage 2025 national estimates
jurisdiction: US — confidence: verified — note: exact match, digit for digit — the number in the claim is the number in the source, with no rounding or restatement. — source: US Census Bureau table NC-EST2025-AGESEX (Population Estimates Program, Vintage 2025, reference date July 1 2025), row ".5 to 13 years" (A28),…the full check column "Population Estimate (as of July 1) / 2025 / Both Sexes" (T28) = 36,232,804. What was actually retrieved: the .xlsx itself from https://www2.census.gov/programs-surveys/popest/tables/2020-2025/national/asrh/nc-est2025-agesex.xlsx (HTTP 200, 18,841 bytes, application/vnd.openxmlformats-officedocument.spreadsheetml.sheet), parsed cell-by-cell straight from the OOXML with the Python standard library (zipfile + ElementTree) because neither openpyxl nor pandas is installed in this environment — so the file was read, not merely downloaded. The sheet self-identifies: A44 "Annual Estimates of the Resident Population for Selected Age Groups by Sex for the United States: April 1, 2020 to July 1, 2025 (NC-EST2025-AGESEX)", A45 "Source: U.S. Census Bureau, Population Division", A46 "Release Date: June 2026" — the exact table identifier the claim cites. Column mapping was checked rather than assumed: row 4 labels the year blocks (T=2025) and row 5 the sex split (T=Both Sexes), so column T is the July 1, 2025 both-sexes estimate. Independent cross-check on the same retrieval, to prove the right column was read: Under 5 (T27 = 18,491,867) + 5-to-13 (36,232,804) + 14-to-17 (17,296,677) = 72,021,348, which is exactly the table's own ".Under 18 years" 2025 figure (T26). The two bands are internally consistent and partition the under-18 population without overlap or gap. Scope limit a reader must carry: this is a modelled resident population estimate (2020 MARC base, plus births, minus deaths, plus net migration — per the table's own notes row A42), not a count, and it is a pure denominator — it says nothing about how many of those children have, are suspected of, or are referred for OSA. Upstream provenance: research lane, from dossier pediatric-obstructive-sleep-apnea-testing §1 via report pediatric-obstructive-sleep-apnea-testing.epidemiology.us-population-denominator-and-diagnosed-share (2026-09-11) — evidence class 1 (registry fact).
The US resident population aged 14 to 17 years was 17,296,677 at July 1, 2025, per Census Bureau Vintage 2025 national estimates
jurisdiction: US — confidence: verified — note: exact match, digit for digit. — source: US Census Bureau table NC-EST2025-AGESEX (Population Estimates Program, Vintage 2025, reference date July 1 2025), row ".14 to 17 years" (A29), column "Population Estimate (as of July 1) / 2025 / Both Sexes" (T29) = 17,296,677.…the full check Same retrieval as claim 40verified: What was actually retrieved: the .xlsx itself from https://www2.census.gov/programs-surveys/popest/tables/2020-2025/national/asrh/nc-est2025-agesex.xlsx (HTTP 200, 18,841 bytes, application/vnd.openxmlformats-officedocument.spreadsheetml.sheet), parsed cell-by-cell straight from the OOXML with the Python standard library (zipfile + ElementTree) because neither openpyxl nor pandas is installed in this environment — so the file was read, not merely downloaded. The sheet self-identifies: A44 "Annual Estimates of the Resident Population for Selected Age Groups by Sex for the United States: April 1, 2020 to July 1, 2025 (NC-EST2025-AGESEX)", A45 "Source: U.S. Census Bureau, Population Division", A46 "Release Date: June 2026" — the exact table identifier the claim cites. Column mapping was checked rather than assumed: row 4 labels the year blocks (T=2025) and row 5 the sex split (T=Both Sexes), so column T is the July 1, 2025 both-sexes estimate. Independent cross-check on the same retrieval, to prove the right column was read: Under 5 (T27 = 18,491,867) + 5-to-13 (36,232,804) + 14-to-17 (17,296,677) = 72,021,348, which is exactly the table's own ".Under 18 years" 2025 figure (T26). The two bands are internally consistent and partition the under-18 population without overlap or gap. Same scope limit as claim 40verified — modelled estimate, denominator only, no OSA content. Note the band boundary is a Census construct: the table publishes 5-to-13 and 14-to-17 as a partition of under-18, which happens to sum to the candidate's 5-to-17 intended-use age range (36,232,804 + 17,296,677 = 53,529,481) — recorded here as an arithmetic consequence of two verified figures, NOT as a separately verified claim, and emphatically not as a market size. Upstream provenance: research lane, from dossier pediatric-obstructive-sleep-apnea-testing §1 via report pediatric-obstructive-sleep-apnea-testing.epidemiology.us-population-denominator-and-diagnosed-share (2026-09-11) — evidence class 1 (registry fact).
Polysomnography among children aged 0-18 enrolled in Medicaid or CHIP occurred at a national rate of 50.1 per 10,000 enrolled children per year across 478,568 studies, 2017-2019 (T-MSIS)
jurisdiction: US — confidence: verified — note: every number and scope element in the claim matches the source; two qualifiers the claim drops are recorded in the source segment and materially affect how the rate should be used. — source: PubMed PMID=42547684, retrieved cold this pass via literature-detail 42547684…the full check (efetch structured abstract) — "Geographic and racial/ethnic patterns of polysomnography use among children enrolled in Medicaid, 2017-2019", Journal of Clinical Sleep Medicine 2026, Journal Article / Observational Study. Verified text: "There were 478,568 PSGs identified among eligible children in the claims data, resulting in a national rate of 50.1 PSGs per 10,000 Medicaid enrolled children per year." The remaining elements are confirmed from the same abstract's METHODS: "The data source was the Transformed Medicaid Information System (T-MSIS) research analytic files"; "PSG among children ages 0 to 18 years was identified from the claims data"; "children enrolled in Medicaid/Child Health Insurance Program from 2017 to 2019". Two qualifiers the claim omits. (a) "Data quality concerns resulted in exclusion of Rhode Island and Vermont" — so "national" means 48 states plus DC, not 50. (b) The denominator is not all enrollees: "All children enrolled in Medicaid with at least one service utilization claim formed the denominators", which makes 50.1 a rate per utilizing enrollee and biases it upward against a true per-enrollee rate. Two limits on the tag itself.literature-detail is a Stage 0 connector emitting a ScanResult (status: found, requires_stage_3_verification: true), so what is verified here is that the cited publication reports these figures — the abstract was retrieved, not appraised: no methods critique, no risk-of-bias, no funding disclosure. And this is a Medicaid/CHIP denominator, a different population from the Census denominator in claims 40-41 and from any commercial population; do not multiply the two together. Upstream provenance: research lane, from dossier pediatric-obstructive-sleep-apnea-testing §2 via report pediatric-obstructive-sleep-apnea-testing.epidemiology.us-population-denominator-and-diagnosed-share (2026-09-11) — evidence class 2 (published finding).
State-level pediatric polysomnography rates in Medicaid varied fourfold, from 23 per 10,000 person-years in Kansas to 93 per 10,000 in Michigan, 2017-2019
jurisdiction: US — confidence: verified — note: verbatim match on all five specifics (fourfold, 23, Kansas, 93, Michigan). — source: PubMed PMID=42547684, retrieved cold this pass via literature-detail 42547684 (efetch structured abstract) — same record as claim 42verified. Verified text: "There was a fourfold difference in…the full check rates at the state level, ranging from 23 PSGs per 10,000 person-years (Kansas) to 93 per 10,000 (Michigan)." The 2017-2019 window is confirmed by the article title and the abstract's PURPOSE. Carry the same two qualifiers as claim 42verified: Rhode Island and Vermont were excluded for data quality, so 23-93 is the range across the states that remained and an excluded state could in principle fall outside it; and the rate denominator counts only enrollees with at least one utilization claim. Tag limit as in claim 42verified — literature-detail is a Stage 0 ScanResult, so this verifies what the publication reports, not an appraisal of whether the estimate is sound. Interpretive caution for the Scorer: the paper attributes variation to geography, rurality and ZIP-code racial composition and does not claim in-lab bed capacity as the cause, so this line must not be read as evidence for the file's "in-lab pediatric capacity is the rate limiter" premise (claim 7unconfirmed). Upstream provenance: research lane, from dossier pediatric-obstructive-sleep-apnea-testing §2 via report pediatric-obstructive-sleep-apnea-testing.epidemiology.us-population-denominator-and-diagnosed-share (2026-09-11) — evidence class 2 (published finding).
Words on this page19 abbreviation(s) and code(s), with what each stands for — copied from _shared/plain-language.md
21 CFR
Title 21 of the Code of Federal Regulations — the US food-and-drug rulebook; a number after it is one regulation, often the one that classifies a device type
510(k)
premarket notification — the FDA route for a device shown to be as safe and effective as one already on the market; months, no clinical trial as a rule
Class II
FDA device class II — moderate-risk devices, usually cleared by 510(k)
CMS
Centers for Medicare & Medicaid Services — the US agency that runs Medicare, and so decides what Medicare pays for
CPT
Current Procedural Terminology — the US billing codes for what a clinician does; owned by the American Medical Association
De Novo
De Novo classification request — the FDA route for a new, lower-risk device with no comparable product to point at; longer than a 510(k), usually needs clinical data
FDA
US Food and Drug Administration — the US regulator that clears or approves a device before it can be sold
FFS
fee-for-service — the traditional form of Medicare that pays per item or service
HCPCS
Healthcare Common Procedure Coding System — the US billing codes for equipment, supplies and some services; a code is how a payer recognises what to pay for
HSAT
home sleep apnoea test — a sleep study done at home with a simpler device
IFU
instructions for use — the labelling that says what a device is for and how to use it
K######
an FDA 510(k) clearance number — the public record of one cleared device; the letter K and six digits
Medicare Advantage
Medicare Advantage — Medicare delivered through a private insurer; must cover at least what Medicare covers
NCD
national coverage determination — a Medicare rule, valid everywhere in the US, saying whether and when something is covered
NCT########
a ClinicalTrials.gov registration number — the public id of one registered clinical trial
OSA
obstructive sleep apnoea — breathing that repeatedly stops during sleep because the airway closes
PMID
PubMed identifier — the public id of one published medical paper
PSG
polysomnography — an overnight sleep study in a laboratory, wired up
TAM
total addressable market — how much money the whole market would be worth if every possible buyer bought