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ApneaLink records patient respiratory nasal pressure and blood oxygen saturation during sleep. The device is intended for use as a screening device to determine the need for further clinical diagnosis based on the patient's test score. ApneaLink reports apneas, hypopneas, flow limitation, snoring, SpO2 and the probability of Cheyne-Stokes respiration breathing patterns within the recording.

The performance and functional characteristics of the ApneaLink includes all the user-friendly features of the predicate device. The ApneaLink is a further development of the previous submitted device ApneaLink (K061405). This submission addresses the expanded indications for use of the Apneal.ink by analyzing the flow signal for periods of Cheyne-Stokes respiration breathing patterns.

The ApneaLink recorder is a two-channel battery-powered respiratory pressure sensor and oximetry system and provides recordings of respiratory flow, pulse rate and oxygen saturation during sleep. The physician prescribed device will help to recognize sleep-related respiratory disorders and lead to comprehensive clinical diagnosis and therapy. The patient may perform the recording at home by himself. The ApneaLink recorder must be fastened with the re-usable belt on the patient's chest. All relevant respiratory information during sleep will be collected via nasal cannula and pulse oximetry module. The disposable plastic nasal cannula is connected to the ApneaLink recorder and fixed at the patient's nose. The oximetry sensor is connected to the XPOD and fixed at the patient's finger. The XPOD is connected to the ApneaLink recorder, After recording, the Apneal.ink recorder is returned to the physician. With the Apneal.ink Software installed on a personnel computer the physician has the possibility to generate a report with the recorded and analyzed data. For further clinical diagnosis the physician has the possibility to send the recording and the report via email to the sleep laboratory/hospital.

The provided text is a 510(k) Premarket Notification for the ApneaLink device, primarily focused on establishing substantial equivalence to a predicate device for an expanded indication (analysis of Cheyne-Stokes respiration breathing patterns). It does not contain detailed information about specific acceptance criteria, performance studies, or ground truth establishment in the way typically expected for a dedicated performance study report.

Here's a breakdown of the available information based on your request, highlighting what is present and what is missing:

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

This information is not explicitly provided in the given text.
The document states: "Design and Verification activities were performed on the ApneaLink as a result of the risk analysis and product requirements. All tests confirmed the product met the predetermined acceptance criteria." However, it does not list these criteria or the specific performance metrics achieved.

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

This information is not provided in the given text.

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 provided in the given text.

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

This information is not provided in the given text.

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

This information is not provided in the given text. The document refers to the device as a "screening device to determine the need for further clinical diagnosis" and generating a report for a physician to use for "further clinical diagnosis," suggesting a human-in-the-loop scenario, but no MRMC study or effectiveness data is presented. This is an algorithm-only device (standalone) that reports data to a physician.

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

Yes, based on the description, the ApneaLink operates as a standalone device that records and analyzes data to generate a report. The text states:

• "ApneaLink reports apneas, hypopneas, flow limitation, snoring, SpO2 and the probability of Cheyne-Stokes respiration breathing patterns within the recording."
• "With the ApneaLink Software installed on a personnel computer the physician has the possibility to generate a report with the recorded and analyzed data."

This implies the algorithm performs the analysis autonomously to produce the report. However, no specific standalone performance metrics (e.g., sensitivity, specificity against a reference standard) are provided in this document.

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

This information is not provided in the given text.

8. The sample size for the training set

This information is not provided in the given text.

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

This information is not provided in the given text.

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