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This device is intended to provide continuous positive airway pressure (CPAP) for the treatment of adult Obstructive Sleep Apnea (OSA) patients who are spontaneously breathing. It is intended for use in the home or hospital/institutional environment.

XT Auto CPAP with Pressure Variation Algorithm Model 9S-005720 is intended to be used to deriving continuous positive airway pressure (CPAP) for Obstructive Sleep Apnea (OSA) in adult patients and home environment. It is a modification of XT Auto CPAP Model 9S-005200(K083656). It shares the same construction and auto adjustment algorithm with XT Auto CPAP but adds expiration pressure release with three constant levels in firmware and has the same downloading function as XT Auto CPAP. XT Auto CPAP with Pressure Variation Algorithm provides a release pressure during expiration phase; it is equivalent to Expiratory Pressure Relief (EPR) of the predicate device RESMED S8 ADVANCE (K082979).

Here's a breakdown of the acceptance criteria and study information for the Apex Medical Corp. XT Auto CPAP with Pressure Variation Algorithm 9S-005720, based on the provided text:

Acceptance Criteria and Device Performance

The provided document describes the device's characteristics and compares them to predicate devices to establish substantial equivalence, rather than setting explicit numerical acceptance criteria for clinical performance metrics. The implicit acceptance criterion is that the new device's performance characteristics are equivalent to the predicate devices, particularly regarding the new "Expiration Pressure Release" feature.

Study Information

The provided document describes a design verification testing approach to demonstrate substantial equivalence, rather than a clinical study with human subjects.

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

   • Test Set Sample Size: Not applicable in the context of human subjects or a dataset. The testing was performed on the device itself and compared to predicate device specifications and waveforms.
   • Data Provenance: The study involved "Side by side waveform testing at various pressure and frequency levels with the predicate device(s)" and "Closed-loop control analysis." This suggests the data was generated in a lab setting through device testing, not from patient data or a specific country. This is a retrospective comparison of device characteristics against pre-existing predicate specifications.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. The "ground truth" for this type of submission is the technical specifications and performance of the legally marketed predicate devices, as well as adherence to relevant standards like IEC 60601-1. Expert consensus was not used to establish the technical "ground truth" for the device's technical performance.

3. Adjudication method for the test set: Not applicable. The testing described focuses on direct technical comparisons and adherence to standards, not human interpretation requiring adjudication.

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.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: The provided information indicates standalone testing of the device's performance and its algorithm. The "Closed-loop control analysis" specifically refers to the algorithm's performance independent of human input during operation. The device itself operates semi-autonomously based on its pressure variation algorithm.

6. The type of ground truth used:

   • Technical Specifications and Performance of Predicate Devices: The primary "ground truth" was the established and legally marketed characteristics and performance of the RESMED S8 ADVANCE (K082979) and XT Auto CPAP (K083656).
   • Regulatory Standards: Adherence to standards like IEC 60601-1 & IEC 60601-1-2, FDA reviewer guidance 638.pdf, FDA Draft Reviewer Guidance for Ventilators (July 1995), and FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices (May 11, 2005) served as "ground truth" for safety and other requirements.
   • Waveform Matching: For the Expiration Pressure Release feature, the "ground truth" was the waveform of the predicate device (RESMED S8 ADVANCE) at various pressure and frequency levels.

7. The sample size for the training set: Not applicable. This device is a hardware CPAP machine with an algorithm, not a machine learning model that requires a "training set" in the traditional sense. The algorithm's design and parameters would have been developed by engineers.

8. How the ground truth for the training set was established: Not applicable. As it's not a machine learning model, there's no "training set." The device's algorithm for auto-adjustment and pressure variation would have been designed based on engineering principles and physiological understanding of OSA.

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