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Somnolyzer 24X7 is a computer program (software) intended for use as an aid for the diagnosis of sleep and respiratory disorders.

Somnolyzer 24X7 is intended to be used for analysis (automatic scoring and manual rescoring), display, redisplay (retrieve), summarize, reports generation and networking of data received from monitoring devices typically used to evaluate sleep and respiratory related sleep disorders.

This device is to be used under the supervision of a physician.

Somnolyzer 24X7 is a software system for automatic analysis of sleep, respiratory and movement information recorded during sleep studies. It processes information recorded during sleep by electrodes and sensors attached to the body. It generates reports that include quantitative sleep, breathing and motion parameters, used to evaluate sleep and respiratory-related disorders.

The provided text is a 510(k) summary for the Somnolyzer® 24X7. While it states that "Clinical performance testing was conducted" and mentions "Performance Data," it does not provide specific details regarding acceptance criteria, the study design, sample sizes, expert qualifications, or ground truth establishment.

Therefore, I cannot populate the table or answer most of your detailed questions based solely on the provided text. The document focuses on the regulatory submission, intended use, and substantial equivalence to a predicate device, rather than a detailed report of the device's performance study.

Here's what I can extract and what is missing:

Acceptance Criteria and Reported Device Performance

Study Details (Based on available information)

1. Sample size used for the test set and the data provenance:
* Test Set Sample Size: Not specified.
* Data Provenance: Not specified (e.g., country of origin, retrospective or prospective).

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
* Number of Experts: Not specified.
* Qualifications of Experts: Not specified.

3. Adjudication method for the test set:
* Not specified.

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:
* Not specified. The document states the device is an "aid for the diagnosis" and "automatic scoring and manual rescoring," implying human oversight, but doesn't detail a comparative effectiveness study with and without AI assistance for human readers.

5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
* The device performs "automatic analysis of sleep, respiratory and movement information" and "automatic scoring," implying standalone algorithmic function. However, the document also states it's an "aid" and allows "manual rescoring," and is to be "used under the supervision of a physician." A dedicated "standalone performance" study result or methodology is not detailed.

6. The type of ground truth used:
* Not specified. (e.g., expert consensus, pathology, outcomes data, etc.)

7. The sample size for the training set:
* Not specified.

8. How the ground truth for the training set was established:
* Not specified.

Conclusion:
The provided 510(k) summary indicates that clinical performance testing was conducted for the Somnolyzer® 24X7, but it does not include the detailed results, acceptance criteria, or specifics of the study methodology required to answer the questions comprehensively. Such details are typically found in the full 510(k) submission, particularly in performance data sections that are often proprietary and not fully disclosed in the public summary.

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