(262 days)
The Watch-PAT200U (WP200U) device is a non-invasive home care device for use with patients suspected to have sleep related breathing disorders. TheWP200U is a diagnostic aid for the detection of sleep related breathing disorders, sleep staging (Rapid Eye Movement (REM) Sleep, Light Sleep, Deep Sleep and Wake), snoring level and body position. The WP200U generates a peripheral arterial tonometry ("PAT") Respiratory Disturbance Index ("PRDI"), Apnea-Hypopnea index ("PAHI"), Central Apnea-Hypopnea index ("PAHIc"), PAT sleep staging identification (PSTAGES) and optional snoring level and body position discrete states from an external integrated snoring and body position sensor. The WP200U's PSTAGES and snoring level and body position provide supplemental information to its PRDI/PAHI/PAHIc. The WP200U's PSTAGES and snoring level and body position are 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.
PAHIc is indicated for use in patients 17 years and older. All other parameters are indicated for 12 years and older.
The Watch-PAT200U System (WP200U) is a non-invasive home care device for use with patients suspected to have sleep related breathing disorders. The WP200U is a diagnostic aid for the detection of sleep related breathing disorders [Respiratory disturbance index (RDI), apnea hypopnea index (AHI)] and sleep staging (Rapid Eye Movement (REM), Light Sleep, Deep Sleep and Wake) based on Peripheral Arterial Tonometry (PAT), a non-invasive technology. According to the physician discretion, the WP200U may be connected to an external integrated snoring and body position (SBP) sensor.
The WP200U device consists of the following: (1) a unified PAT and pulse oximeter probe which is used to detect the PAT signal and to measure blood oxygen saturation; (2) an embedded actigraph, which is used to determine periods of sleep based on the wrist: (3) external integrated snoring and body position sensor – SBP/RESBP (optional); (4) electronics, which include a controller that records the signals provided by the PAT finger probe, oximeter, actigraph and SBP/RESBP; (5) the device software; and (6) a power supply.
The subject WP200U introduces the RESBP sensor - an additional Snoring and Body Position (SBP) integrated sensor which also includes chest movement signal.
Another change in the subject WP200U is the introduction of new sleep disorder parameter - central apnea/hypopnea index (pAHIc).
The provided document gives information about the Watch-PAT200U device, focusing on its substantial equivalence to predicate devices and performance testing. However, it does not explicitly state acceptance criteria in a structured table or provide detailed information about a study that proves the device meets specific acceptance criteria in the format requested.
The document discusses a clinical study conducted to evaluate the WP200U's capability to identify central sleep apnea and Cheyne-Stokes Respiration, but it only briefly mentions "Test results demonstrated substantially equivalent performance" without detailing specific performance metrics or acceptance thresholds.
Given the limitations of the provided text, I will construct the answer based on the information that is available, and explicitly state where information is missing or not provided in the requested format.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document does not provide a table of explicit acceptance criteria with specific performance thresholds (e.g., sensitivity > X%, specificity > Y%). Instead, it states that "Test results demonstrated substantially equivalent performance" for the clinical study. This implies that the performance was deemed comparable to the predicate device or a clinical gold standard, but the numerical targets for such equivalence are not given.
Therefore, a table as requested cannot be fully constructed.
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: 72 subjects
- Data Provenance: The document states "72 subjects were evaluated in an overnight sleep study". It does not explicitly mention the country of origin or whether it was retrospective or prospective, but the description of an "overnight sleep study" suggests a prospective collection of data for the purpose of the study.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
The document states that the comparison was made against "polysomnographic (PSG) manual scoring."
- Number of experts: Not specified.
- Qualifications of experts: While it implicitly refers to qualified professionals performing PSG manual scoring (likely sleep physicians or trained sleep technologists), their specific qualifications (e.g., years of experience, board certification) are not detailed.
4. Adjudication method for the test set
The document mentions "polysomnographic (PSG) manual scoring" as the reference standard but does not specify any adjudication method (e.g., 2+1, 3+1, none) for disagreements among scorers, implying either a single scorer or an established standard procedure.
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 provided text does not mention a multi-reader multi-case (MRMC) comparative effectiveness study or any evaluation of human readers with or without AI assistance. The study described focuses on the standalone performance of the Watch-PAT200U device against PSG.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, a standalone performance evaluation was done. The clinical study evaluated the "WP200U's capability to identify central sleep apnea and Cheyne-Stokes Respiration" by comparing its output directly to polysomnographic manual scoring. This indicates testing of the device's algorithms without human intervention in the diagnostic process.
7. The type of ground truth used
The ground truth used was polysomnographic (PSG) manual scoring. PSG is considered the gold standard for diagnosing sleep disorders.
8. The sample size for the training set
The document does not provide information regarding the sample size used for the training set or development of the device's algorithms. It only describes the clinical study for evaluation/validation.
9. How the ground truth for the training set was established
Since information about a training set is not provided, how its ground truth was established is also not available in the document.
§ 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).