(211 days)
The UROSTYM™ Biofeedback and Stimulation Probes are indicated for use in Treating urinary incontinence by way of re-education and stimulation. The UROSTYM non-implanted electrical Stimulation applied to the pelvic floor musculature and surrounding Pelvic Structures for therapy in the Treatment of urinary Incontinence. The probes are provided for single patient use/disposable. The non-steril probes are for office use under the direction of a physican or licensed health care professional.
UROSTYM™ Biofeedback and Stimulation Device - Vaginal Probe Models 3AT2B and TP2B
I'm sorry, but the provided text from the FDA letter and the "Indications For Use" form for the UROSTYM™ Biofeedback and Stimulation Device does not contain any information about acceptance criteria or a study proving that the device meets those criteria. The document is an FDA 510(k) clearance letter, which states that the device is substantially equivalent to legally marketed predicate devices.
Therefore, I cannot provide the requested table or the details about a study, sample sizes, expert qualifications, ground truth, or MRMC studies, as this information is not present in the provided text.
§ 876.5320 Nonimplanted electrical continence device.
(a)
Identification. A nonimplanted electrical continence device is a device that consists of a pair of electrodes on a plug or a pessary that are connected by an electrical cable to a battery-powered pulse source. The plug or pessary is inserted into the rectum or into the vagina and used to stimulate the muscles of the pelvic floor to maintain urinary or fecal continence. When necessary, the plug or pessary may be removed by the user. This device excludes an AC-powered nonimplanted electrical continence device and the powered vaginal muscle stimulator for therapeutic use (§ 884.5940).(b)
Classification. Class II (performance standards).