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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 re-scoring), 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 is a polysomnography scoring application that provides automated 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 then generates results that include quantitative sleep, breathing and motion parameters, used to evaluate sleep and respiratoryrelated disorders. Somnolyzer 24x7 scoring is applicable to adult patient populations only.

Somnolyzer 24x7 version 2.5 provides an update to the currently released Somnolyzer 24x7 (K083620), which enables Somnolyzer to score sleep recordings according to the American Academy of Sleep Medicine (AASM) Manual 2007 and 2012 editions.

Here's an analysis of the provided information regarding the Somnolyzer 24x7, focusing on acceptance criteria and the study used to demonstrate compliance.

Based on the provided text, there is no explicit table of acceptance criteria or a detailed study description with performance metrics for the Somnolyzer 24x7. This submission (K131994) is a 510(k) for a modified device, and the primary claim is substantial equivalence to a previously cleared predicate device (Somnolyzer 24x7, K083620).

The submission relies on a non-clinical test approach, specifically focusing on verification and validation activities to ensure the modifications did not adversely affect safety and effectiveness.

Here's what can be extracted and inferred from the text regarding the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

As stated, no explicit table of acceptance criteria or detailed performance metrics are provided in the document. The submission focuses on verification that the modifications performed as intended and did not impact safety and effectiveness.

The document implicitly states that "Testing confirmed that the Somnolyzer 24x7 software version 2.5 performs equivalently to the device predicate Somnolyzer 24x7 software (K083620). All tests had passing results or minor resolved defects." This implies the acceptance criteria were met, but the specific criteria and performance values are not detailed.

Inferred "Acceptance Criteria" (based on nature of submission):

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

• Sample Size for Test Set: Not specified. The document mentions "automated validation testing compared the performance of human manual scoring against Somnolyzer 24x7 version 2.5 and previous versions of Somnolyzer," but does not provide details on the number of cases or studies used.
• Data Provenance: Not specified. The country of origin of the data (e.g., retrospective or prospective) is not mentioned.

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

• Number of Experts: Not specified. The document refers to "human manual scoring" as the benchmark for automated validation testing but doesn't quantify how many human scorers were involved or how their results were consolidated.
• Qualifications of Experts: Not specified. The qualifications of the "human manual scorers" are not detailed (e.g., board-certified sleep physicians, polysomnographic technologists, experience level).

4. Adjudication Method for the Test Set

• Adjudication Method: Not specified. Given that multiple "human manual scorers" may have been involved in establishing the benchmark (though not quantified), the method for resolving discrepancies or establishing a consensus (e.g., 2+1, 3+1) is not mentioned. It's possible a single expert's scoring was used as the ground truth if only one manual scorer was involved, or if the "previous versions of Somnolyzer" acted as a reference point.

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

• No MRMC study was done or reported. The submission does not mention a comparative effectiveness study involving human readers with and without AI assistance to quantify an effect size of improvement. The testing compared the algorithm's performance to human scoring, not human performance with/without the algorithm.

6. Standalone Performance Study

• Yes, a standalone algorithm performance evaluation was done. The "automated validation testing" involved comparing the performance of the Somnolyzer 24x7 version 2.5 (algorithm only) against human manual scoring. This is a standalone performance assessment for the algorithm.

7. Type of Ground Truth Used

• Expert Consensus / Expert Interpretation. The "human manual scoring" served as the ground truth against which the automated scoring algorithm's performance was compared. This indicates an expert interpretation or potentially an expert consensus if multiple human scorers were used. The document does not mention pathology or outcomes data as ground truth.

8. Sample Size for the Training Set

• Not applicable / Not specified. This submission is for modifications to an existing device. The training set for the original Somnolyzer 24x7 (K083620) is not discussed, and there is no indication that the modifications (which primarily involve updating algorithms to AASM rules) required a new or re-training with a distinct training set. The changes were algorithmic adjustments rather than training a new deep learning model from scratch.

9. How Ground Truth for the Training Set Was Established

• Not applicable / Not specified. Similar to the above, as this is a modification submission focused on rule implementation rather than re-training a new model, the establishment of ground truth for a training set is not discussed. For the original predicate device, it is presumed to have been established through expert manual scoring in accordance with relevant sleep scoring guidelines at that time.

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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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