(108 days)
The Konmed Incontinence Stimulation Electrode include Vaginal Probe KM-504, KM-505, KM-506, KM-507, KM-5013 & Rectal Probe KM-502. KM-5018 are intended to provide electromyographic feedback from pelvic musculature or electrical stimulation to pelvic musculature for the purpose of rehabilitation of weak pelvic floor muscles and restoration of neuromuscular control during the treatment of urinary incontinence.
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I am sorry, but the provided text from the FDA 510(k) clearance letter for the "Konmed Incontinence Stimulation Electrode" does not contain any information about acceptance criteria or a study that proves the device meets those criteria.
This document is a standard FDA clearance letter, which primarily states that the device is substantially equivalent to legally marketed predicate devices. It discusses regulatory classifications, general controls, and other administrative requirements.
To answer your request, a document detailing the verification and validation (V&V) testing performed by the manufacturer, including specific acceptance criteria and study results, would be necessary. This information is typically found in the 510(k) submission itself, which is not fully provided here.
Therefore, I cannot populate the table or answer the specific questions about the study design, sample sizes, ground truth establishment, or expert involvement, as that data is absent from 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).