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

9S-007XXX series are intended to provide continuous positive airway pressure for the treatment of adult obstructive sleep apnea (OSA) in home care environment. A built-in heated humidifier of 9S-007xxx series is designed to increase the humidity of the air from the CPAP thereby relieving the symptoms of a dry nose and throat resulting from constant airflow that some patients may experience.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Apex Medical Corp. iCH CPAP 9S-007XXX device:

1. Table of Acceptance Criteria and Reported Device Performance

The provided documentation does not explicitly detail specific quantitative acceptance criteria or corresponding reported device performance values in a table format. Instead, it relies on a comparison to a predicate device and adherence to established regulatory standards and testing procedures.

The text states: "Above tests were verified to meet the required acceptance criteria." This indicates that the device did meet criteria, but the specific numerical values of these criteria are not provided in this summary.

Here's a generalized table based on the information available:

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

The document describes design verification tests performed on the new device, comparing it to predicate devices. However, it does not provide details on:

• Sample size: No specific number of devices or test iterations is mentioned for any of the verification tests (safety, EMC, vapor/particle, firmware).
• Data Provenance: The document doesn't specify the country of origin of the data or whether the data was retrospective or prospective. Given that these are design verification tests, they would be conducted in a controlled lab or manufacturing environment.

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

The document does not describe the use of human experts to establish "ground truth" for the test set. The tests performed are engineering and regulatory compliance validations (e.g., electrical safety, electromagnetic compatibility, firmware functionality, particle emissions). These would be evaluated against pre-defined engineering specifications, regulatory standards, and established laboratory protocols, rather than expert consensus on diagnostic accuracy.

4. Adjudication Method for the Test Set

As the "test set" consists of engineering and regulatory compliance tests, there is no mention of an adjudication method (like 2+1 or 3+1). The "ground truth" here is objective compliance with specified standards or successful execution of pre-defined procedures.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

No MRMC study was performed or mentioned. This submission is for a CPAP device, which is a therapeutic device for sleep apnea, not an AI-powered diagnostic or assistive tool for human readers. Therefore, the concept of human readers improving with AI assistance is not applicable to this device or its submission.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This device is not an algorithm or AI system. It is a physical medical device (CPAP machine). Therefore, a standalone algorithm performance study is not applicable. The performance is assessed based on its physical and electrical characteristics as per the verification tests.

7. The Type of Ground Truth Used

For the design verification tests (safety, EMC, vapor/particle, firmware), the "ground truth" is based on:

• Regulatory Standards: IEC 60601-1, IEC 60601-1-2.
• Environmental Standards: EPA PM2.5, EPA TO-15.
• FDA Guidance Documents: FDA reviewer guidance 638.pdf, "Guidance for FDA Reviewers and Industry Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices."
• Predicate Device Testing Procedures: The testing procedures established and validated for the APEX MEDICAL XT Auto CPAP MODEL 9S-005200 (K083656) and APEX MEDICAL HumidCare Heated Humidifier MODEL 9S-004 (K062664).

Essentially, the ground truth is compliance with established engineering, safety, and regulatory benchmarks.

8. The Sample Size for the Training Set

This device does not use machine learning or AI algorithms that require a "training set." Therefore, this question is not applicable.

9. How the Ground Truth for the Training Set Was Established

As there is no training set for this device, this question is not applicable.

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