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The Watch-PAT200U (WP200U) device 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, sleep staging (Rapid Eye Movement (REM) 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"), 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 WP200U's PSTAGES and SBP provide supplemental information to its PRDI/PAHI. The WP200U'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 WP200U is indicated for use in patients 12 years of age or greater.

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 motion of the wrist; (3) external integrated snoring and body position sensor — SBP (Optional); (4) electronics, which include a controller that records the signals provided by the PAT finger probe, oximeter, actigraph and SBP; (5) the device software; and (6) a power supply.

The provided text describes the Watch-PAT200U (WP200U) device and outlines its substantial equivalence to a predicate device, primarily focusing on the expansion of its intended use to include an adolescent population (12 to 17 years old). The document highlights performance data and clinical studies used to support this expanded indication.

Here's an attempt to extract the requested information, understanding that certain details like specific acceptance criteria numerical values for RDI/AHI or the number of experts for polysomnography scoring are not explicitly stated in this document.

1. Table of Acceptance Criteria and Reported Device Performance

Notes on Acceptance Criteria: The document implies that the device is acceptable if its performance in the adolescent population is comparable to its already cleared performance in adults, and demonstrates accuracy suitable for a "diagnostic aid." The specific numerical thresholds for "high correlation" or "reasonable agreement" are not explicitly defined as acceptance criteria but are demonstrated by the reported study results.

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

• Test Set Sample Size: "Data from adolescence patients (12 to 17 years old) was pooled from 3 prospective clinical studies sponsored by Itamar of a broader age range population." The precise number of adolescent patients (12-17 years old) is not explicitly stated from the total 'broader age range population' in these 3 prospective studies. However, a separate published study mentioned prior to the main clinical studies analyzed 17 children with OSA (age range 5 to 17 years old), but this appears to be a separate smaller study contributing to the literature review, not the primary "test set" for the current submission.
• Data Provenance: Prospective clinical studies sponsored by Itamar. The country of origin is not specified, but Itamar Medical, Ltd. is based in Caesarea, Israel.

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

The ground truth for the test set was established by Polysomnography (PSG) manual scoring. The document states: "The purpose of the studies was to compare the efficacy of the WP to the manual scoring of the PSG for aiding in the diagnosis of SDB."

• Number of Experts: Not specified.
• Qualifications of Experts: The document refers to "manual scoring of the PSG," which implies scoring by trained polysomnography technologists or sleep medicine physicians, but their specific qualifications (e.g., years of experience, certifications) are not detailed.

4. Adjudication Method for the Test Set

The document states "manual scoring of the PSG," but it does not specify an adjudication method (e.g., 2+1, 3+1, none) for resolving discrepancies in PSG scoring if multiple scorers were involved.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study evaluating human readers with and without AI assistance was not explicitly described in the provided text. The study focused on the standalone performance of the device (WP200U) against PSG as the gold standard.

6. Standalone Performance Study (Algorithm Only Without Human-in-the-Loop Performance)

Yes, a standalone performance study was conducted. The clinical studies described compared the WP200U's output (PRDI, PAHI, and sleep stages) directly against the manual scoring of simultaneous in-lab polysomnography (PSG). This assesses the algorithm's performance without direct human intervention in the device's diagnostic output generation or interpretation, beyond the initial use setup.

7. Type of Ground Truth Used

The primary ground truth used was expert-scored Polysomnography (PSG). The studies compared the WP200U's sleep indices and sleep stages with those "generated by the manual scoring of the PSG."

8. Sample Size for the Training Set

The document does not explicitly state the sample size for a training set. The clinical study details describe a "test set" used for evaluating the device's performance in adolescent patients. Given that no modifications were made to the algorithm (the "PAT technology or the algorithm for the detection of sleep related breathing disorders" was identical to the predicate K133859), it's highly probable that the training of the algorithm occurred much earlier, prior to the K133859 submission, and is not detailed here. This submission focuses on validating the existing algorithm for an expanded age group.

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

This information is not provided in the document. As mentioned above, the algorithm itself was part of the predicate device (K133859) and its training data and ground truth establishment would have been detailed in that prior submission. The current document focuses on validating the existing algorithm for a new patient population.

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