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The WatchPAT300 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 PRDIPAHIC. 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 subject WatchPAT300 (WP300) is identical in its intended use and indications for use to the cleared predicate WP200U (K203839) and the cleared predicate WP300 (K180775). The subject WP300 combines the software arrhythmia feature of the WP200U cleared predicate (K203839) into the WP300 cleared predicate (K180775).

The subject WP300 consists of: A wrist worn Control Unit, Actigraphy (in the Control Unit), Wrist Strap, Power Supply (battery), uPAT probe, Chest sensor (optional), Tamper-Proof Bracelet (optional), and Management and Analysis Software (SW).

The subject WP300, like the predicate WP200U and predicate WP300, uses the same offline Management and Analysis Software (SW). The 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 arrhythmia detection is not intended for use in life supporting or sustaining systems or monitor and alarm devices. It provides the sleep physician with additional information to that of the WP300 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.

The provided text describes a 510(k) premarket notification for the WatchPAT300 (WP300) device, focusing on the addition of an arrhythmia detection feature previously cleared in the Watch-PAT200U (WP200U). The key argument for substantial equivalence is that the new software feature does not alter the technological characteristics or principles of operation, and hardware differences do not raise new safety or effectiveness concerns.

However, the document specifically states regarding performance data: "SW verification and validation was performed on the subject WP300 device with the SW containing the additional arrhythmia feature as per the FDA guidance for the Content of Premarket Submissions for Software Contained in Medical Devices". It also mentions that "Bench testing was previously conducted on the predicate WP300 (in K180775) to show that the acquisition system of the WP300 and WP200U are generating the same input signals to the analysis algorithms. Specifically, the equivalence of the PAT and the actigraphy signals which are used in the newly added arrhythmia algorithm were tested. This testing provides evidence that the WP300 signals are equivalent to the WP200U signals."

The document focuses on demonstrating substantial equivalence based on the technological characteristics and intended use being largely the same as predicate devices, with the new arrhythmia feature adopting a previously cleared algorithm. It does not provide specific acceptance criteria or an explicit study proving that the device meets those acceptance criteria through clinical performance metrics (e.g., sensitivity, specificity, accuracy) for the arrhythmia feature in a clinical setting. Instead, the argument relies on the equivalence of signals and the prior clearance of the arrhythmia algorithm in a different device.

Given the information provided in the document:

1. A table of acceptance criteria and the reported device performance:
   The document mentions "The testing and acceptance criteria are the same as those in the predicate devices." However, it does not explicitly list these acceptance criteria or the reported performance data against them for the new arrhythmia feature in the WP300, beyond stating that signals are equivalent to a predicate device. The comparison table (page 6) highlights the identical intended use, user population, environment, and channels, and that the arrhythmia flagging output is "Same as WP200U". This implies that the performance of the arrhythmia feature is expected to be consistent with the WP200U, for which the algorithm was previously cleared.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
   Not explicitly stated for the arrhythmia feature's performance with the WP300. The document indicates "SW verification and validation was performed" and "Bench testing was previously conducted", but details on sample size, data provenance (e.g., countries, retrospective/prospective nature of a clinical test set) are not provided for the arrhythmia performance specifically.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
   Not provided. The document focuses on "SW verification and validation" and "Bench testing," not a clinical performance study with expert interpretation of ground truth.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
   Not provided. This would typically be relevant for clinical studies establishing ground truth, which is not detailed for the arrhythmia feature's performance in the WP300 submission.

5. 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 MRMC study is mentioned. The arrhythmia feature is described as "informational use only, to flag patients suspected of having arrhythmias," and "aiding the physician to decide if further arrhythmia investigation is needed," rather than a tool for direct improvement of human reader performance or diagnostic efficacy.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
   The document states that "Bench testing was previously conducted... to show that the acquisition system of the WP300 and WP200U are generating the same input signals to the analysis algorithms." This implies a standalone evaluation of signal acquisition equivalence. For the arrhythmia algorithm itself, it's integrated software. The performance of the arrhythmia algorithm as cleared in the WP200U would have undergone standalone evaluation at that previous clearance, but specific standalone performance metrics for this particular submission (K222331) are not provided beyond the signal equivalence testing.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
   Not explicitly stated for the arrhythmia feature's performance in this submission. For prior clearance of the algorithm in the WP200U, a ground truth would have been established (likely clinical diagnosis by experts for arrhythmia detection), but details are absent here for the WP300.

8. The sample size for the training set:
   Not provided.

9. How the ground truth for the training set was established:
   Not provided.

In summary, the provided FDA 510(k) submission primarily leverages the fact that the new arrhythmia software feature was already cleared in a predicate device (WP200U) and that the WP300's hardware can generate equivalent input signals for this algorithm. Therefore, the submission does not detail new clinical performance studies or specific acceptance criteria met for the performance of the arrhythmia feature itself within this specific application. It relies on the substantial equivalence principle, asserting that no new questions of safety or effectiveness are raised.

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