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The Stardust II is indicated for use by Health Care Professionals to aid in the diagnosis of sleep-related breathing disorders in adult patients weighing more than 30kg in the home, hospital or other clinical setting.

The Stardust II is intended for use during sleep disorder studies to detect up to 5 physiological signals: percent SpO2 (functional), pulse rate, oral/nasal airflow, respiratory effort and body position (i.e., supine or non-supine).

The Respironics Stardust II records physiological signals acquired during sleep and uses proprietary algorithms to determine and report the following respiratory waveforms and events:

Airflow* Effort SpO2 Pulse rate Apnea Hypopnea Desaturation

*Nasal airflow can be acquired with a pressure cannula or thermistor sensor.

The Stardust II can also interface with various Respironics pressure therapy devices to report available device/patient information (i.e., event flags and real time streamed data). When used with these devices, the Stardust II is not intended to be a diagnostic application, but rather a portable recorder to assess the quality of the at home titration of an auto-titrating device and determine if there are still events occurring and to assess the therapeutic benefit of the already diagnosed OSA patient.

The provided document for the Respironics Stardust II (K021845) does not contain detailed information about specific acceptance criteria or the study that proves the device meets these criteria in the format requested. The document is a 510(k) summary, which primarily focuses on demonstrating substantial equivalence to a predicate device.

Here's what can be extracted and what is missing, based on your request:

1. Table of Acceptance Criteria and Reported Device Performance:

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

However, it does not provide a table with specific acceptance criteria (e.g., accuracy thresholds for SpO2, airflow, etc.) nor the reported device performance measurements against those criteria.

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

This information is not provided in the document. The document mentions "design verification tests," but does not specify the sample size of patients or data samples used for these tests, nor the country of origin of the data, or whether it was retrospective or prospective.

3. Number of Experts Used to Establish Ground Truth and Qualifications:

This information is not provided in the document. The document refers to the device aiding "Health Care Professionals to aid in the diagnosis of sleep-related breathing disorders," implying clinical validation, but it doesn't detail how ground truth was established for any test sets.

4. Adjudication Method for the Test Set:

This information is not provided in the document.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

This information is not provided in the document. The filing is for a device to aid in diagnosis, but it does not detail any studies comparing human readers with and without AI assistance.

6. Standalone (Algorithm Only) Performance:

The document states: "The Respironics Stardust II records physiological signals acquired during sleep and uses proprietary algorithms to determine and report the following respiratory waveforms and events: Airflow, Effort, SpO2, Pulse rate, Apnea, Hypopnea, Desaturation."

This indicates that the device has an algorithmic component that processes signals and determines events, suggesting a standalone algorithmic function. However, specific standalone performance metrics (e.g., sensitivity, specificity, accuracy) are not provided for these algorithms.

7. Type of Ground Truth Used:

This information is not explicitly stated in the document for any test sets. Given the device's intended use for diagnosing sleep-related breathing disorders, ground truth would typically be established by polysomnography (PSG) scored by a sleep expert, or clinical diagnosis. However, this is not described as part of the "design verification tests."

8. Sample Size for the Training Set:

This information is not provided in the document. The document mentions "proprietary algorithms" but does not detail their development or any training data used.

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

This information is not provided in the document.

Summary of available information regarding acceptance criteria and studies:

The provided 510(k) summary indicates that design verification tests were conducted, and "All tests were verified to meet the required acceptance criteria." However, the document does not disclose the specific acceptance criteria themselves, nor the detailed results of these tests, nor the methodologies, sample sizes, or ground truth establishment relevant to those tests.

The focus of this 510(k) is demonstrating substantial equivalence to predicate devices (Respironics Stardust and Respironics REMstar Auto) based on similar operating principles, technology, and manufacturing processes, rather than providing detailed clinical performance data from new studies.

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