(90 days)
This device is to be used for biofeedback applications.
Not Found
The provided document is an FDA 510(k) clearance letter for the Delsys Inc. Bagnoli-4 EMG System, stating that the device is substantially equivalent to legally marketed predicate devices for biofeedback applications. This document does not contain information on acceptance criteria, a study proving the device meets acceptance criteria, sample sizes, ground truth establishment, expert qualifications, or comparative effectiveness studies (MRMC).
Therefore, I cannot provide the requested information based on the input document. The letter is a regulatory approval, not a scientific study report.
§ 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.