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The ApneaLink™ Plus device is indicated for use by Health Care Professionals (HCP), where it may aid in the diagnosis of sleep disordered breathing for adult patients. Apneal ink Plus recred the following data: patient respiratory nasal airflow, snoring, blood oxygen saturation, pulse and respiratory effort during sleep. The device uses these recordings to produce a report for the HCP that may aid in the diagnosis of sleep disordered breathing or for further clinical investigation.

The performance and functional characteristics of ApneaLink Plus includes all the user-friendly features of the predicate devices. The ApneaLink Plus is a further development of the previously submitted device Apneal.ink (K070263). This submission addresses the expanded Indications for Use of Apnealink by including AASM criteria for detecting hypopneas and a respiratory effort sensor to differentiate between central, obstructive and mixed apneas.

The ApneaLink Plus recorder is a 3-channel battery-powered respiratory pressure sensor and oximetry system. ApneaLink Plus provides recordings of respiratory pressure, respiratory effort, pulse rate and oxvaen saturation during sleep. The phvsician 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 Plus recorder and the respiratory effort sensor 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, pulse oximetry module and respiratory effort sensor. The disposable plastic nasal cannula is connected to the ApneaLink Plus 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 Plus recorder. The respiratory effort sensor is connected to the ApneaLink Plus recorder and held in place by the belt. After recording, the ApneaLink Plus recorder must be returned to the physician. With the ApneaLink Plus Software installed on a personnel computer the physician can generate a report with the recorded and analyzed data to aid in the diagnosis of sleep disordered breathing. The recordings and the report can be sent via email to further clinical investigation.

The provided 510(k) summary for KOS-3575 (ApneaLink Plus) does not contain a detailed study with acceptance criteria and reported device performance in the format requested. The document primarily focuses on demonstrating substantial equivalence to predicate devices and expanding the indications for use.

While it states "All tests confirmed the predetermined acceptance criteria," it does not provide the specific criteria or the results of these tests. It also lacks information regarding the sample size, data provenance, ground truth establishment for test and training sets, expert qualifications, adjudication methods, or MRMC studies.

Therefore, many of the requested fields cannot be filled directly from the provided text.

Here is a summary of what can be extracted and what is missing:

1. Table of acceptance criteria and the reported device performance

• Missing: The document states "All tests confirmed the predetermined acceptance criteria," but 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)

• Missing: No information regarding the sample size or provenance of data used for testing is provided.

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)

• Missing: No information on experts or ground truth establishment for a test set is provided.

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

• Missing: No information on adjudication methods is provided.

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

• Missing: There is no mention of an MRMC comparative effectiveness study. The device is intended to "aid in the diagnosis," implying it produces a report for a healthcare professional, but there's no study on human reader improvement with the device.

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

• Missing: While the device analyzes data and produces a report, the document does not present a standalone performance study in terms of diagnostic accuracy against a ground truth. Its role is described as aiding diagnosis by a healthcare professional.

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

• Missing: No information regarding the type of ground truth used for any testing is provided.

8. The sample size for the training set

• Missing: No information regarding a training set sample size is provided. The document describes the device's functionality rather than a machine learning model's training.

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

• Missing: No information regarding ground truth establishment for a training set is provided.

Information that is available (from the prompt, not directly in the requested format):

• Device: ApneaLink Plus
• Intended Use: To aid in the diagnosis of sleep-disordered breathing for adult patients by recording respiratory nasal airflow, snoring, blood oxygen saturation, pulse, and respiratory effort during sleep, and producing a report for healthcare professionals.
• Expanded Indications: The submission addresses expanded indications by including AASM criteria for detecting hypopneas and a respiratory effort sensor to differentiate between central, obstructive, and mixed apneas.
• Predicate Devices: ApneaLink (K070263) and Respironics Stardust II (K021845).
• Compliance: The device complies with various standards and regulations (e.g., FDA Guidance, IEC, ISO).

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