(69 days)
The Watch-PAT100S (WP100S) device is a non-invasive home care device for use with patients suspected to have sleep related breathing disorders. The WP100S is a diagnostic aid for the detection of sleep related breathing disorders and rapid eye movement ("REM") sleep stages. The WP100S generates a peripheral arterial tonometry ("PAT") respiratory disturbance index ("PRDI") and PAT REM sleep stage identification ("PREM"). The WP100S's PREM provides supplemental information to its PRDI. The WP100S's PREM is not intended to be used as the sole or primary basis for diagnosing any sleep related breathing disorder, prescribing treatment, or determining whether additional diagnostic assessment is warranted. The WP100S is not indicated for children less than 17 years old. The WP100S is contraindicated for patients with latex allergy.
The WP100S uses peripheral arterial tonometry to generate apnea indices ("PRDIs") and identify REM sleep stages ("PREMs"). The device's primary components include a cleared oximeter and actigraph, an associated computer analysis program, a battery and charger, and a carrying case.
The provided text does not contain detailed acceptance criteria and a specific study proving the device meets them with the level of detail requested in the prompt. It primarily serves as a 510(k) summary and an FDA clearance letter, which focuses on demonstrating substantial equivalence to predicate devices rather than a standalone performance study against pre-defined acceptance criteria.
However, based on the available information, here's what can be extracted and inferred:
1. A table of acceptance criteria and the reported device performance
The document states, "Clinical data demonstrates that the device is as safe and effective as manual scoring of polysomnography ("PSG") and automated scoring of the BioSleep in detection REM sleep stages. Clinical data also demonstrated that the WP100S is at least as safe and effective as the Watch-PAT100 in detecting sleep apnea."
This implies that the acceptance criteria are based on equivalence to the predicate devices and manual PSG scoring. However, specific numerical thresholds (e.g., sensitivity, specificity, accuracy percentages, or correlation coefficients) for this equivalence are not provided.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| As safe and effective as manual scoring of PSG for REM detection | "the device is as safe and effective as manual scoring of polysomnography ("PSG") ... in detection REM sleep stages." (Specific metrics like sensitivity/specificity/accuracy or agreement rates are not provided in the summary) |
| As safe and effective as automated scoring of BioSleep for REM detection | "the device is as safe and effective as ... automated scoring of the BioSleep in detection REM sleep stages." (Specific metrics like sensitivity/specificity/accuracy or agreement rates are not provided in the summary) |
| At least as safe and effective as the Watch-PAT100 for detecting sleep apnea | "the WP100S is at least as safe and effective as the Watch-PAT100 in detecting sleep apnea." (Specific metrics like sensitivity/specificity/accuracy or agreement rates are not provided in the summary) |
| Does not raise new issues of safety or effectiveness | "The minor technological differences between the WP100S and its predicate devices, namely the WP100S's software modifications, raise no new issues of safety or effectiveness. Clinical data demonstrate that the WP100S is as safe and effective as its predicates." (This is a qualitative statement, no specific safety endpoints are detailed in the provided text) |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the given text. The document only mentions "Clinical data demonstrates..." without specifying the number of subjects or the study design (retrospective/prospective, country of origin).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
The ground truth for REM detection is mentioned as "manual scoring of polysomnography ("PSG")". While this implies expert involvement (sleep technologists or physicians), the number of experts and their specific qualifications are not provided.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided in the given text. For manual PSG scoring, standard adjudication methods would typically be used, but they are not detailed here.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
The document mentions "manual scoring of polysomnography" for comparison. However, it does not describe an MRMC study or any scenario where human readers used AI assistance. The WP100S is presented as a diagnostic aid that generates indices, not as a system to assist human readers in interpreting other data. Therefore, an effect size of human improvement with AI assistance is not applicable and not reported.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, the device (WP100S) is described as a "non-invasive home care device" that "generates a peripheral arterial tonometry ("PAT") respiratory disturbance index ("PRDI") and PAT REM sleep stage identification ("PREM")". This implies a standalone algorithm-only performance for generating these indices. The comparison is made between the device's output and manual PSG scoring or predicate devices' automated scoring.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The ground truth used for REM detection is "manual scoring of polysomnography ("PSG")". For sleep apnea detection, the ground truth for the Watch-PAT100 (which WP100S is compared to) would also likely be PSG, but this is not explicitly stated for WP100S's sleep apnea detection in this summary.
8. The sample size for the training set
This information is not provided in the given text.
9. How the ground truth for the training set was established
This information is not provided in the given 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 device may provide an audible or visible alarm when the respiratory rate, averaged over time, is outside operator settable alarm limits. This device does not include the apnea monitor classified in § 868.2377.(b)
Classification. Class II (performance standards).