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The Respironics REMstar Pro M Series CPAP System delivers positive airway pressure therapy for the treatment of Obstructive Sleep Apnea in spontaneously breathing patients weighing over 30kg.

The Respironics REMstar Pro M Series CPAP System is a smaller and lighter microprocessor controlled blower based positive pressure system with integrated heated humidifier. The REMstar Pro M Series CPAP System also includes the flex therapy feature cleared in K021861 which provides the patient with additional comfort by easing the transition from the end of inspiration to the beginning of exhalation. Like its predicate, the REMstar Pro M Series CPAP System is intended for use with a patient circuit that is used to connect the device to the patient interface device (mask). A typical patient circuit consists of a six-foot disposable or reusable smooth lumen 22mm tubing, an exhalation device, and a patient interface device.

This document describes the 510(k) summary for the Respironics REMstar Pro M Series CPAP System. It is a premarket notification to the FDA to demonstrate substantial equivalence to a previously cleared predicate device.

Based on the provided text, a formal study to prove the device meets acceptance criteria, in the sense of a clinical trial with specific performance metrics and statistical analysis, was not performed or reported in this 510(k) summary.

Here's an analysis of the requested information based only on the provided text:

1. A table of acceptance criteria and the reported device performance

The document states: "Design verification tests were performed on the Respironics REMstar Pro M Series CPAP System as a result of the risk analysis and product requirements. All tests were verified to meet the required acceptance criteria."

However, the document does not provide a table of specific acceptance criteria or the reported device performance metrics from these design verification tests. It only generally states that the tests met the criteria.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not provide any information regarding the sample size used for the design verification tests (e.g., number of devices tested), the country of origin of the data, or whether it was retrospective or prospective.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not applicable as the document describes design verification tests for a medical device (CPAP system) and not an AI or diagnostic imaging device that would require expert-established ground truth for a test set. The "ground truth" for a CPAP system's performance would typically be based on engineering specifications and physical measurements, not expert consensus on interpretations.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not applicable for the same reasons as point 3.

5. 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

An MRMC study was not done and is not applicable for this type of device (CPAP system). This is not an AI-assisted diagnostic or interpretative device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This information is not applicable as the device is a physical CPAP system, not an algorithm, and its performance is inherently "standalone" in that it performs its function (delivering positive airway pressure) without direct continuous human interpretation loops.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

As indicated in point 3, the concept of "ground truth" as typically used in AI/diagnostic studies is not directly applicable here. For design verification of a CPAP system, the "ground truth" or reference for meeting acceptance criteria would be based on:

• Engineering specifications: The device is expected to deliver specific pressure, flow, and other parameters within defined tolerances.
• Performance standards: Compliance with relevant national and international standards for medical devices.
• Risk analysis requirements: Addressing identified risks through specific design and testing.

8. The sample size for the training set

This information is not applicable as the device is not an AI system that requires a "training set."

9. How the ground truth for the training set was established

This information is not applicable for the same reason as point 8.

Summary from the provided text:

The 510(k) summary for the Respironics REMstar Pro M Series CPAP System indicates that "Design verification tests were performed... All tests were verified to meet the required acceptance criteria." However, it does not provide details about these tests, such as:

• Specific acceptance criteria values (e.g., pressure output range, noise levels, temperature control).
• The results of these tests (e.g., actual measured pressure output, actual noise levels).
• The number of units tested (sample size).
• The methodology of these tests.

The submission focuses on demonstrating substantial equivalence to a predicate device (Respironics REMstar Pro with C-Flex CPAP System K021861) based on shared intended use, operating principles, technology, and manufacturing processes, and the general statement that design modifications had "no impact on the safety and effectiveness" as evidenced by meeting acceptance criteria in internal design verification. This is typical for a 510(k) clearance, which is not a full clinical trial.

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