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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, 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"), 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 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 Watch-PAT200U is identical to the already cleared Watch-PAT200S-3 except for Itamar Medical pulse oximetry which replaces the existing Nonin pulse oximeter.

Here's a summary of the acceptance criteria and the study proving the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Sample Size: Eleven (11) healthy adult volunteer subjects.
• Data Provenance: The study was clinical, meaning prospective patient data was collected specifically for this evaluation. It was conducted in CLINIMARK Laboratories, implying a controlled laboratory setting. The country of origin is not explicitly stated for the subjects, but the applicant's address is Caesarea, Israel, and the contact person is in Washington, DC, USA. The study was performed to US FDA guidance.

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

The document does not explicitly state the number of experts or their qualifications for establishing ground truth for the test set. However, the ground truth for SpO2 accuracy was established by CO-Oximetry for arterial blood samples, which is a highly accurate and accepted reference method in clinical practice, typically operated by trained medical laboratory professionals.

4. Adjudication Method for the Test Set:

No adjudication method (e.g., 2+1, 3+1) is mentioned. The ground truth was established by direct physical measurement (CO-Oximetry of arterial blood samples) rather than expert interpretation of data.

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

No MRMC comparative effectiveness study was done. The study focused on the standalone accuracy of the device's pulse oximeter component against a reference standard, not its impact on human reader performance.

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

Yes, a standalone study was performed. The clinical study directly evaluated the SpO2 accuracy of the Itamar Medical Pulse Oximetry system (WP200U) against CO-Oximetry, without involving human interpretation of the device's output to establish the primary metric.

7. Type of Ground Truth Used:

The ground truth used was objective physical measurement: CO-Oximetry of arterial blood samples.

8. Sample Size for the Training Set:

The document does not provide information specific to a training set or its sample size. The focus is on the clinical validation of the device's pulse oximetry component, which implies that the algorithm for oxygen saturation calculation was already developed and this study served as a validation "test set."

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

The document does not detail how the ground truth for any potential training set was established. It only describes the ground truth for the clinical validation study as CO-Oximetry. The text mentions a "new algorithm to calculate oxygen saturation" was incorporated into the software, but it doesn't describe the development or training process for this algorithm.

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