(77 days)
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.
Not Found
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.
§ 882.5050 Biofeedback device.
(a)
Identification. A biofeedback device is an instrument that provides a visual or auditory signal corresponding to the status of one or more of a patient's physiological parameters (e.g., brain alpha wave activity, muscle activity, skin temperature, etc.) so that the patient can control voluntarily these physiological parameters.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter when it is a prescription battery powered device that is indicated for relaxation training and muscle reeducation and prescription use, subject to § 882.9.