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The WatchPAT™200U (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"), 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/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 (pRDI), apnea - hypopnea index (pAHI), central apnea - hypAHIc) and sleep staging (Rapid Eye Movement (REM), Light Sleep, Deep Sleep and Wake) based on Peripheral Arterial Tonometry (PAT), a non-invasive technology. In accordance with physician discretion, the WP200U may be connected to a chest sensor for measuring snoring level, body position states and chest movements.

The WP200U device consists of the following: (1) unified finger PAT probe to measure PAT and oximeter signals; (2) actigraph, which provides a signal that is used to determine periods of sleep/wake based on the motion of the wrist; (3) chest sensor to measure snoring level, body position and chest movements (optional); (4) electronics, which include a controller that records the signals provided by the uPAT finger probe, actigraph and chest sensor; (5) Tamper-Proof Bracelet (Optional); (6) power supply; (7) Wrist strap and (8) Management and Analysis Software Program.

The subject WP200U introduces new algorithms to its software allowing the identification of arrhythmia events occurred during the night - Atrial Fibrillation and Premature Beats.

Beside the introduction of the new arrhythmia information, the SW provides identical output information as that previously provided for the predicate.

The additional arrhythmia information presented by the modified WP200U device follows the AASM (American Academy of Sleep Medicine) guidelines to provide the sleep physician with information regarding cardiac events occurred during the night. The WP200U arrhythmia feature is to be used for informational use only, to flag patients suspected of having arrhythmias, thereby aiding the physician to decide if further arrhythmia investigation is needed. The device is not intended to be used as a diagnostic device for cardiac arrhythmia and it is not intended to replace traditional methods of diagnosis. The WP200U's arrhythmia detection is not intended for use in life supporting or sustaining systems or monitor and alarm devices.

The new analysis provides the sleep physician with additional information to that of the WP200U cleared capabilities of detecting sleep disorders, to be considered in conjunction with the physician's knowledge of patient background, clinical history, symptoms, and other diagnostic information.

Here's a breakdown of the acceptance criteria and the study details for the Watch-PAT200U (WP200U) device, based on the provided FDA 510(k) summary:

Acceptance Criteria and Reported Device Performance

The acceptance criteria are not explicitly stated in a detailed, quantitative table within the provided document. However, the document describes the clinical testing performed to evaluate the device's ability to identify cardiac arrhythmias (Atrial Fibrillation and Premature beats). The reported performance is generally stated as "acceptable performance" against a "Gold Standard."

Given the information, we can infer the acceptance criteria would be related to the accuracy of arrhythmia detection. The table below represents the available information and how performance against these implied criteria is reported:

Study Details that Prove the Device Meets Acceptance Criteria

1. Sample Size used for the test set and the data provenance:

   • Sample Size: One hundred and fifty-seven (157) subjects.
   • Data Provenance: The document does not explicitly state the country of origin. It indicates that subjects were evaluated in an overnight sleep study using the subject device and a single-lead ECG in a sleep lab. This suggests it was likely a prospective study.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • Number of Experts: Not explicitly stated, but the ground truth was established by "cardiologist-scored ECG channel." This implies at least one cardiologist, and potentially multiple for consensus, reviewed the ECG data.
   • Qualifications of Experts: "Cardiologist-scored." Specific years of experience are not mentioned, but a cardiologist is a highly qualified medical professional specializing in heart conditions.

3. Adjudication method for the test set:

   • The document does not explicitly describe a specific adjudication method like "2+1" or "3+1." It simply states "cardiologist-scored ECG channel" was the "Gold Standard," implying their scoring was accepted as the truth.

4. 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:

   • No, a multi-reader multi-case (MRMC) comparative effectiveness study was not explicitly done. The study focuses on the standalone performance of the device's arrhythmia detection algorithm against a gold standard, not on how human readers (physicians) might improve with AI assistance.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

   • Yes, a standalone study was done. The clinical performance testing evaluated "the capability of WP200U to identify arrhythmic events," directly comparing the device's outputs to the "Gold Standard" cardiologist-scored ECG data. This is a standalone assessment of the algorithm's performance.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

   • Expert Consensus/Diagnosis: The ground truth for arrhythmia detection was established by a "cardiologist-scored ECG channel of a polysomnography (PSG)." This falls under expert diagnosis from a recognized "Gold Standard" method.

7. The sample size for the training set:

   • The document does not provide the sample size for the training set. It only describes the clinical testing performed to evaluate the device, which would typically be a test set after training and development.

8. 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 was established, as it doesn't mention specifics about the training process or dataset.

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