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The Watch-PAT300 (WP300) device is a non-invasive home care device for use with patients suspected to have sleep related breathing disorders. The WP300 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 WP300 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 WP300's PSTAGES and snoring level and body position provide supplemental information to its PRDI/PAHI/PAHIc. The WP300'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-PAT300 System (WP300) is a non-invasive home care device for use with patients suspected to have sleep related breathing disorders. The WP300 is a diagnostic aid for the detection of sleep related breathing disorders (RDI, AHI and AHIc) and sleep staging (REM Sleep, Light Sleep, Deep Sleep and Wake) based on Peripheral Arterial Tonometry (PAT), a non-invasive technology. The WP300 can be connected to an external integrated sensor snoring and body position (SBP/RESBP) for recording snoring, body position and chest movement (in RESBP sensor only) data.

The WP300 device consists of the following: (1) Same unified finger PAT probe that was used in WP200U is used to measure the PAT and oximeter signals; (2) an embedded actigraph which provides a signal that is used to determine periods of sleep/wake based on the motion of the wrist: (3) Electronics, which include a microprocessor that records the information supplied by the uPAT finger probe, actigraph and chest movement; (4) snoring and body position sensor (SBP/RESBP sensors same sensors as in the WP200U) and (5) the device software.

The subject WP300 is an improved version of the predicate WP200U device (K161579) and introducing hardware changes to its components and new external design. The modifications made in order to upgrade the hardware (HW) components of the device, reduce the size of the WP200U device, improve the data download speed of the device, modify the materials in the wrist strap and update the device appearance. None of these changes alter the fundamental operation of the device or its principles of operation. Moreover, the modified system, the WP300 maintains the full capabilities of the cleared WP200U (K161579) and provides the user with the same output information, i.e. pRDI, pAHI, pAHIc, pSTAGES, snoring and body position, remain the same.

The provided document describes the Watch-PAT300 (WP300) device and its substantial equivalence to a predicate device. This device is a non-invasive home care device for detecting sleep-related breathing disorders, sleep staging, snoring level, and body position.

1. Table of Acceptance Criteria and Reported Device Performance:

The document primarily focuses on demonstrating substantial equivalence to the predicate WP200U device, rather than defining new acceptance criteria for the WP300. The performance testing section mentions only one specific performance metric for which acceptance criteria are explicitly stated: SpO2 accuracy.

Other aspects of performance for pRDI, pAHI, pAHIc, and pSTAGES are implied to be equivalent to the predicate device because the underlying algorithms and PAT technology remain unchanged.

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

For the SpO2 accuracy study:

• Sample Size: Eleven healthy adult volunteer subjects.
• Data Provenance: Not explicitly stated, but the study was performed in CLINIMARK Laboratories. Further details (e.g., country of origin, retrospective/prospective) are not provided in this document. Given it involved healthy adult volunteers in a laboratory setting, it was a prospective study.

For the substantial equivalence of the main algorithms (pRDI, pAHI, pAHIc, pSTAGES):

• There is no specific new clinical study with a defined test set sample size mentioned for these parameters. The claim is based on the fact that "There were no modifications to the PAT technology or the algorithms for the detection of sleep related breathing disorders and sleep staging." and "The modified acquisition system was designed and verified to give the same input signals to the algorithm as the predicate WP200U." This implies reliance on the performance data of the predicate device (WP200U).

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

• SpO2 Accuracy Study: The ground truth for SpO2 accuracy was established by arterial blood samples assessed by CO-Oximetry, which is an objective measurement. No human experts were involved in establishing this specific ground truth.
• Other Parameters (pRDI, pAHI, pAHIc, pSTAGES): As no new clinical study for these parameters on the WP300 is described, there's no information on experts for a new test set's ground truth. For the predicate device, such an evaluation would typically involve polysomnography (PSG) scored by board-certified sleep physicians/technicians, but this document does not detail the predicate's ground truth method.

4. Adjudication Method for the Test Set:

• SpO2 Accuracy Study: Adjudication methods are not applicable here, as ground truth was established by CO-Oximetry, an objective measurement.
• Other Parameters: Not applicable, as no new test set is described.

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

• No MRMC comparative effectiveness study is mentioned in this document. The submission is focused on demonstrating substantial equivalence of a modified device (WP300) to its predicate (WP200U), primarily through hardware modifications not affecting core algorithms.

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

• The documentation suggests that the core algorithms (for pRDI, pAHI, pAHIc, pSTAGES) themselves were not re-evaluated in a standalone study for the WP300, as they were unchanged from the predicate.
• The SpO2 accuracy study evaluates the device's sensor performance, which is a standalone measurement of the device's capability to measure blood oxygen saturation, rather than an "algorithm only" study in the context of diagnostic interpretation.

7. Type of Ground Truth Used:

• SpO2 Accuracy Study: Objective measurement using arterial blood samples assessed by CO-Oximetry. This is a direct physiological measurement establishing a "gold standard" for blood oxygen saturation.
• Other Parameters (pRDI, pAHI, pAHIc, pSTAGES): Not explicitly stated for WP300, as the algorithms are unchanged from the predicate. Typically, for sleep disorder diagnosis, the ground truth would be established by Polysomnography (PSG), scored according to recognized criteria (e.g., AASM guidelines).

8. Sample Size for the Training Set:

• The document does not describe the training set size for the WP300's algorithms, as the algorithms were not modified. The algorithms for pRDI, pAHI, pAHIc, and pSTAGES are stated to be the same as those in the predicate WP200U. Therefore, the training for these algorithms would have been performed prior to the predicate's clearance.

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

• Not described in this document, as the algorithms were adopted from the predicate device without modification.

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