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The Cadwell Easy Body Position Module is intended for use to detect body positions during physiological recording. It provides output data that corresponds to five body positions (supine, prone, left side, right side and sitting up). It may be used in a clinical or ambulatory setting for both EEG and sleep disorder studies.

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The provided text is a 510(k) premarket notification letter from the FDA for a device called "EasyNet Body Position Module". This document primarily focuses on regulatory approval and does not contain the detailed information necessary to answer your request about acceptance criteria, study design, and performance metrics.

The document states the device's indications for use and general regulatory information, but it does not include:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes for test sets, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, or training set details.
3. Specific ground truth information.

Therefore, based solely on the provided text, I cannot answer the questions about the acceptance criteria and the study that proves the device meets them. This type of information is typically found in the full 510(k) submission, specifically in the performance testing sections, which are not included in this FDA decision letter.

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