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The SleepScreen and ApnoeScreen Cardio are portable physiological signal recording devices intended to be used for testing patients suspected of having sleep-related breathing disorders. They are intended to be used under the direction of a physician. The devices may be used in the home, clinic, doctor's office or hospital.

The SleepScreen and ApnoeScreen Cardio, or any of the accessories supplied with it, are not to be used, alone or in combination, as an apnea monitor or as a component in an apnea monitoring system.

The SleepScreen and ApnoeScreen Cardio, or any of the accessories supplied with it, are not to be used, alone or in combination, as a life support device, a life support system, or as a critical component in a life support device or life support system.

The SleepScreen and ApnoeScreen Cardio are non-life-supporting portable physiological signal recording devices intended to be used for testing patients 7 years and older suspected of having sleep-related breathing disorders. The SleepScreen and ApnoeScreen Cardio are intended to measure and record oxygen saturation, pulse rate, body position, snoring, respiratory airflow, respiratory effort, PLM, EEG, EMG, EOG and ECG data. The devices may be used in the home, clinic, doctor's office or hospital.

The SleepScreen and ApnoeScreen Cardio are not intended for use as an apnea monitor or as a component in an apnea monitoring system. Additionally, the SleepScreen and ApnoeScreen Cardio are not intended to be used alone or in combination with another product as a life support device, a life support system, or as a critical component to a life support device or system. There is no claim of compatibility with diagnostic imaging equipment.

The ApnoeScreen Cardio is the ApnoeScreen Pro (K000396) with the addition of two AC channels. The additional AC channels may be used to record electro-oculargram (EOG), electromyogram (EMG), electroencephalogram (EEG) and/or electrocardiogram (ECG).

The SleepScreen is the ApnoeScreen Pro (K000396) with the addition of eight AC channels. The additional AC channels may be used to record electrooculargram (EOG), electromyogram (EMG), electroencephalogram (EEG) and/or electrocardiogram (ECG).

The provided document, K021138, for the SleepScreen and ApnoeScreen Cardio devices, describes their intended use and comparison to a predicate device but does not contain detailed information regarding specific acceptance criteria for performance metrics, the results of a formal clinical study to prove these criteria, or any of the detailed aspects of such a study as requested in the prompt.

Instead, the document states:

"Summary of Performance Testing: Performance testing was conducted in the laboratory to confirm compliance to device specifications; all functions were verified to operate as designed and intended, and measured parameters met required ranges and accuracies. Testing to internationally accepted standards for electrical safety and electromagnetic compatibility were performed: the SleepScreen/ApnoeScreen Cardio complied with the requirements of these standards."

This statement indicates that laboratory-based performance testing was conducted against device specifications and international standards for electrical safety and electromagnetic compatibility. However, it does not provide the specific numerical acceptance criteria or the reported performance data in a quantifiable manner, nor does it detail a clinical study as typically understood for AI/algorithm-based devices.

Therefore, most of the requested information cannot be extracted from this document, as it pertains to a traditional medical device submission focusing on hardware functionality, safety, and equivalence to a predicate device, rather than the performance of an algorithm against ground truth data.

Based on the provided text, here's what can be inferred or explicitly stated:

1. Table of Acceptance Criteria and Reported Device Performance: This information is not provided in a quantifiable table format. The document generally states that "measured parameters met required ranges and accuracies" and that the device complied with electrical safety and electromagnetic compatibility standards, but no specific numerical targets or results are given.

2. Sample size used for the test set and the data provenance: This information is not provided. The "performance testing" described appears to be laboratory-based functional testing, not a clinical study with a defined patient test set.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This information is not provided. As no clinical test set is detailed, the concept of establishing ground truth by experts is not addressed.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: This information is not 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: This information is not provided. The device is a physiological signal recording device, not an AI-assisted diagnostic tool as implied by an MRMC study.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: This information is not provided. The device is described as recording physiological signals, implying human interpretation of these signals for diagnosis. It is not an AI algorithm performing standalone diagnoses.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): This information is not provided.

8. The sample size for the training set: This information is not provided. The device does not appear to involve machine learning or AI that would require a "training set."

9. How the ground truth for the training set was established: This information is not provided.

In summary, the provided document is a 510(k) premarket notification for a physiological signal recording device. It focuses on demonstrating substantial equivalence to a predicate device and confirming basic laboratory performance, electrical safety, and electromagnetic compatibility. It does not detail the type of clinical performance study or AI algorithm validation that would require the specific information requested in the prompt.

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