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The Cadwell EasyNet Limb Movement Module is intended for use to detect periodic limb movements for recording onto a physiological recorder. It may be used in a clinical or ambulatory setting for both EEG and sleep disorder studies.

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This looks like a 510(k) clearance letter for the Cadwell Limb Movement Module. This type of document typically does not contain the detailed information requested about acceptance criteria and specific study results. 510(k) clearances establish substantial equivalence to a predicate device, and while they might reference performance data, the granular details of the studies (like sample sizes, expert qualifications, adjudication methods, training set details, or effect sizes for AI assistance) are usually found in the original submission documents, which are not publicly available in this format.

Therefore, I cannot extract the requested information from the provided text. The document confirms that the device is cleared for marketing based on its substantial equivalence to a predicate device and its stated indications for use.

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