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The Watch-PAT200S-3 (WP200S-3) device is a non-invasive home care device for use with patients suspected to have sleep related breathing disorders. The WP200S-3 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 WP200S-3 generates a peripheral arterial tonometry ("PAT") Respiratory Disturbance Index ("PRDI"), Apnea-Hypopnea index ("PAHI"), PAT sleep staging identification (PSTAGES) and optional snoring level and body position discrete states from an external integrated snoring and body position (SBP) sensor. The WP200S-3's PSTAGES and SBP provide supplemental information to its PRDI/PAHI. The WP200S-3's PSTAGES and SBP 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.

The Watch-PAT200S-3 System (WP200S-3) is a non-invasive home care device for use with patients suspected to have sleep related breathing disorders. The WP200S-3 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 WP200S-3 may be connected to an external integrated snoring and body position (SBP) sensor.

The WP200S-3 device is worn on the wrist and consists of the following: (1) a finger PAT probe, which is used to detect the PAT signal; (2) an embedded pulse oximeter using a second probe that is attached to another finger, for measuring blood oxygen saturation; (3) an embedded actigraph, which is used to determine periods of sleep based on the motion of the wrist; (4) external integrated snoring and body position sensor - SBP (Optional); (5) electronics, which include a controller that records the information supplied by the PAT finger probe, oximeter, actigraph and SBP, (6) the device software; and (7) a power supply.

The Watch-PAT200S-3 is identical to the already cleared Watch-PAT200S-2 with the addition of an optional snoring level and body position sensor and the required electronic and software modification. The integrated sensor (SBP) is an optional external hardware which can be connected to the WP200S-3 device and attached to the patient's chest right under the sternal notch for recording snoring and body position signals.

Here's a breakdown of the acceptance criteria and study information for the Watch-PAT200S-3, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The provided 510(k) summary does not explicitly state quantitative acceptance criteria or detailed performance metrics against specific criteria (e.g., sensitivity, specificity thresholds). Instead, the performance testing demonstrated substantial equivalence to predicate devices and focused on the addition of the SBP sensor. The general "acceptance criteria" can be inferred to be successful completion of the described performance tests to demonstrate safety and efficacy.

2. Sample Size Used for the Test Set and Data Provenance

The document mentions "a clinical study" was performed and that "supportive clinical data" was used. However, it does not specify the sample size used for this test set nor the data provenance (e.g., country of origin, retrospective or prospective nature of the data).

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

The document does not specify the number of experts used or their qualifications for establishing the ground truth in the clinical study.

4. Adjudication Method for the Test Set

The document does not specify the adjudication method used (e.g., 2+1, 3+1, none) for the test set in the clinical study.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

The document does not mention or describe an MRMC comparative effectiveness study involving human readers with and without AI assistance. The device is described as a diagnostic aid that generates indices (PRDI, PAHI, PSTAGES) and provides supplemental information. The focus of the clinical study mentioned was on supporting the snoring level and body position claims.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Yes, the device (Watch-PAT200S-3) as a diagnostic aid that generates PRDI, PAHI, PSTAGES, and optionally snoring level and body position discrete states, operates in a standalone manner. The clinical study and performance testing would have evaluated the standalone performance of the device's algorithms to support its claims. The document implies an algorithm-only performance assessment where the device's outputs (PRDI, PAHI, etc.) are compared against a ground truth.

7. The Type of Ground Truth Used

The document explicitly states that the clinical study was conducted to support "the claim of measuring snoring level in decibels and body position." While not explicitly stated, it is highly probable that the ground truth for these measurements would have been established by reference devices or expert observation/recording (e.g., simultaneous polysomnography (PSG) recording for body position and sound level meters for snoring, or expert scoring of PSG data). For PRDI/PAHI and sleep staging, the typical ground truth in such studies is concurrently recorded, expertly scored polysomnography (PSG) data.

8. The Sample Size for the Training Set

The document does not provide any information regarding the sample size used for the training set of any algorithms within the device.

9. How the Ground Truth for the Training Set Was Established

The document does not provide information on how the ground truth for the training set (if any was used for algorithm development) was established.

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