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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 clinical diagnosis and evaluation by polysomnography based on the patient's test score.

The ApneaLink recorder is a two-channels battery-powered respiratory pressure sensor and oximetry system and provides recordings of respiratory pressure, 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 again is connected to the ApneaLink recorder. After recording, the ApneaLink recorder must be returned to the physician. With the ApneaLink Software installed on a personnel computer the physician has the possibility to generate a report with the recorded and analyzed data.

Acceptance Criteria and Study Details for ApneaLink (K061405)

The provided document (K061405) for the ApneaLink device is a 510(k) Premarket Notification. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting detailed clinical study data to prove the device meets specific acceptance criteria in the way a de novo or PMA submission might.

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 explicitly list the specific acceptance criteria or provide the detailed results of these tests that would typically be presented in a clinical performance study.

Given the context of a 510(k) for a "Ventilatory Effort Recorder" and its intended use as a screening device for sleep apnea, the "acceptance criteria" would likely relate to the device's ability to accurately record respiratory nasal pressure and blood oxygen saturation, and to provide a "test score" that can be used to determine the need for clinical diagnosis. The substantial equivalence argument relies on the device being similar in intended use, operating principle, and technology to the predicate devices (microMESAM Basic-Set K040576 and Compass M10 System K041724).

Therefore, based solely on the provided text, a table of acceptance criteria and reported performance cannot be fully constructed with quantitative measures as they are not detailed in this public summary. The document focuses on regulatory compliance and substantial equivalence rather than a clinical performance study with specific metrics.

Here's an attempt to answer the questions based on the available information, noting where information is not provided:

1. Table of Acceptance Criteria and Reported Device Performance

As noted above, the specific quantitative acceptance criteria and their corresponding reported performance are not explicitly detailed in the provided 510(k) summary. The document broadly states that "All tests confirmed the product met the predetermined acceptance criteria." These criteria would likely be related to the accuracy and reliability of measuring respiratory nasal pressure and blood oxygen saturation for screening purposes, consistent with predicate devices.

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

The document does not specify a sample size for a clinical "test set" or its data provenance (country of origin, retrospective/prospective). The submission describes "Design and Verification activities" and "All tests," which typically refer to internal engineering and functional testing, rather than a clinical performance study with human subjects.

3. Number of Experts and Qualifications for Ground Truth

The document does not mention the use of experts to establish ground truth for a test set in the context of a clinical performance study. For a 510(k), ground truth for performance claims is often established through comparison to a well-accepted and legally marketed predicate device, or by relying on existing scientific literature for the underlying technology.

4. Adjudication Method

As no clinical test set requiring expert ground truth is described, an adjudication method for such a set is not mentioned.

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

There is no mention of an MRMC comparative effectiveness study in the provided document. The submission focuses on substantial equivalence of the device itself (hardware and basic functionality) as a screening tool, not on the impact of AI assistance on human readers.

6. Standalone Performance Study (Algorithm Only)

The provided text does not describe a standalone algorithm-only performance study. While the device does generate a "test score" based on recorded data, the details of how this score is derived and its standalone diagnostic performance are not elaborated. The submission is for a "Ventilatory Effort Recorder" used as a "screening device to determine the need for clinical diagnosis and evaluation by polysomnography," implying the output is for physician interpretation, not a definitive diagnosis by the device itself.

7. Type of Ground Truth Used

The type of "ground truth" for the device's main function (recording respiratory nasal pressure and blood oxygen saturation) would typically be established by comparison to reference gold standard sensors or established polysomnography (PSG) equipment during the device development and verification stages. However, this specific detail is not provided in the 510(k) summary. Given the device's intention to screen for the need for PSG, PSG itself would be the ultimate clinical ground truth for sleep apnea diagnosis.

8. Sample Size for the Training Set

The document does not specify a sample size for a "training set." The ApneaLink is a device that records physiological signals; it is not explicitly described as employing a machine learning algorithm that requires a dedicated training set in the context of this 510(k) summary. The "test score" it generates is likely based on pre-defined algorithms rather than a trained AI model.

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

Since no explicit "training set" or AI/ML algorithm requiring one is described in the provided summary, the method for establishing its ground truth is not applicable/not provided.

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