(73 days)
Biofeedback is to be used for muscle re-education and relaxation training
Not Found
I am sorry, but the provided text does not contain the detailed information needed to answer your request about the acceptance criteria and the study that proves the device meets them. The text is a 510(k) clearance letter from the FDA for a device named "BioTrol," indicating it's cleared for marketing.
While it mentions the device's intended use (muscle re-education and relaxation training via biofeedback) and its classification, it does not include any details about:
- Acceptance criteria: What specific performance metrics were set for the device.
- Device performance: The actual results achieved by the device in testing.
- Study design details:
- Sample size for test set or training set.
- Data provenance.
- Number or qualifications of experts.
- Adjudication methods.
- MRMC studies or effect sizes.
- Standalone algorithm performance.
- Type of ground truth used or how it was established.
This document is primarily an administrative clearance letter, not a technical report detailing the device's validation studies.
§ 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.