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The Respironics SleepEasy CPAP System delivers positive airway pressure therapy for the treatment of Obstructive Sleep Apnea in spontaneously breathing patients weighing over 30kg. For use in the home or hospital/institutional environment.

The Respironics SleepEasy CPAP System is a smaller and lighter microprocessor controlled blower based positive pressure system with integrated heated humidifier. The SleepEasy 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 device predicates, the SleepEasy 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.

The Respironics SleepEasy CPAP System (K091112) is a modified device, and its acceptance criteria and the study proving it meets these criteria are described as follows:

1. Table of Acceptance Criteria and Reported Device Performance

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

However, the specific acceptance criteria (e.g., precise pressure ranges, flow rates, noise levels, reliability metrics) and the detailed results of these tests are not provided within the given text. The document only states that the tests were performed and met the criteria.

Without the specific details, a table cannot be fully constructed. Based on the provided information, the table would appear as follows:

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

The document does not provide details on the sample size used for the test set or the data provenance (e.g., country of origin, retrospective or prospective nature of the test data). The verification tests are described as "design verification tests," which typically involve testing a representative sample of the manufactured device.

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

This information is not provided in the given document. The verification tests described are likely engineering design tests rather than clinical studies requiring expert-established ground truth.

4. Adjudication Method for the Test Set

This information is not provided in the given document. Given that the tests are described as "design verification tests," adjudication in the context of clinical or diagnostic performance assessment is unlikely to be relevant.

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

This information is not provided in the document. The Respironics SleepEasy CPAP System is a positive airway pressure delivery device for Obstructive Sleep Apnea, not an AI-powered diagnostic or interpretive device. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not applicable to this device type.

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

This information is not provided in the document. As this is not an AI-based or algorithm-driven diagnostic device in the sense of image interpretation or complex data analysis, the concept of a "standalone" algorithm performance study is not relevant. The device operates mechanistically to deliver positive airway pressure.

7. The Type of Ground Truth Used

The document does not explicitly state the "type of ground truth" used. For "design verification tests" of a mechanical device like a CPAP system, the "ground truth" would likely refer to established engineering and medical device standards, specifications, and performance targets (e.g., accuracy of pressure delivery, stability of flow, noise levels within acceptable limits, safety features functioning correctly). These are typically verified against calibrated measurement equipment and established protocols.

8. The Sample Size for the Training Set

This information is not provided in the document. The Respironics SleepEasy CPAP System is not an AI/machine learning device that requires a "training set" in the conventional sense. Its functionality is based on predefined engineering principles and control algorithms, not learned from data.

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

This information is not provided in the document. As noted above, the concept of a "training set" and associated "ground truth" is not applicable to this type of device.

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