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This device is intended to provide continuous positive airway pressure (CPAP) for the treatment of adult obstructive sleep apnea (OSA).

XT Auto CPAP Model 9S-005200 is intended to be used to delivery continuous positive airway pressure (CPAP) for Obstructive Sleep Apnea (OSA) for adult patients in the home environment. It is a modification of CPAP XT I MODEL 9S-005 (K070609) & RT2120 (K022650). It shares the same construction with XT-I but adds pressure and flow sensor on the circuit and has same downloading function as RT2120. As for the function of auto CPAP, it refers to the predicate Resmed Autoset Spirit (K032480).

The provided text is a 510(k) summary for the Apex Medical Corp. XT Auto CPAP 9S-005200. This document focuses on demonstrating substantial equivalence to predicate devices rather than presenting a detailed study proving the device meets specific acceptance criteria with reported performance metrics.

Therefore, many of the requested details regarding acceptance criteria, study design, sample sizes, expert involvement, and ground truth establishment are not available in the provided text.

Here's an analysis based on the information provided:

Acceptance Criteria and Reported Device Performance

The document states:
"Design verification tests were performed on the new device with the predicate device(s) as a result of the risk analysis and product requirements. All tests were verified to meet the required acceptance criteria."

However, it does not explicitly list the specific acceptance criteria or the reported performance for each criterion. It only states that the tests met the criteria.

Study Details

1. Sample size used for the test set and the data provenance: Not specified. The document only mentions "design verification tests" without details on a test set size or data origin (country, retrospective/prospective).
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not specified.
3. Adjudication method (e.g. 2+1, 3+1, none) 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 applicable. This device is a CPAP machine, not an AI-assisted diagnostic tool for human readers.
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable in the context of an algorithm's performance. The "standalone" performance here would refer to the device's functional operation (e.g., pressure delivery, auto-adjustment features). The document indicates "design verification tests" were performed, implying functional validation, but no specific performance metrics are given.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not specified.
7. The sample size for the training set: Not applicable. This is a hardware device (CPAP), not an AI algorithm requiring a training set in the conventional sense.
8. How the ground truth for the training set was established: Not applicable.

Summary of Limited Information

The 510(k) summary for the XT Auto CPAP 9S-005200 focuses on establishing substantial equivalence to previously cleared predicate devices (APEX MEDICAL XT1 CPAP MODEL 9S-005, APEX MEDICAL CPAP RT 21XX, and ResMed AutoSet Spirit CPAP). The logic for equivalence is based on:

• Similar intended use
• Similar operating principle
• Similar technology
• Similar manufacturing process

The document states that "Design verification tests were performed on the new device... All tests were verified to meet the required acceptance criteria," but it does not provide specifics on these criteria, the study design, or the performance results. This type of submission typically demonstrates functional equivalence through engineering tests rather than clinical performance studies that would involve human subjects and ground truth establishment by experts for diagnostic accuracy.

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