(90 days)
Surface electromyography is a safe and effective technique for relaxation training and muscle re-education. Using internal perineometer electrodes such as the PerryVaginal: EMG biofeedback is a safe and effective technique for the assessment and treatment of pelvic floor dysfunction, monitoring the performance of Keyel exercises. The pelvic floor muscles include the Levator Ani group as well as the pubococcygeus (PC), ileococcygeus, and coccygeus. These are skeletal muscles which respond to re-education, strengthening, endurance building, and relaxation. Conditions that can be assessed or treated using this technique include: stress incontinence, mixed incontinence, and urge incontinence.
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The provided text is a 510(k) clearance letter from the FDA for a device called "Pathway TR-10, TR-10C, TR-20, TR20C." This document does not contain details about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment.
The letter focuses on the FDA's determination of substantial equivalence to a predicate device and outlines regulatory obligations for the manufacturer. The "Indications for Use" section describes what the device is intended for, but not how well it performs or how that performance was validated.
Therefore, I cannot provide the requested information based on the given input.
§ 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.