(197 days)
Unicare is intended to provide electrical stimulation and neuromuscular re-education for the purpose of rehabilitation of weak pelvic floor muscles for the treatment of stress, urge and mixed urinary incontinence in women and to maintain urinary continence in women.
Unicare is battery powered, single-channel, home-use electrical pelvic floor muscle stimulator. The device is supplied with a non-sterile, reusable (single-patient use) vaginal probe and self-adhesive electrodes which connect to the control unit by cable and plugs. The vaginal probe is inserted into the vagina. The optional self-adhesive electrodes is placed on patients' intact skin and is used for the treatment of only urge urinary incontinence in women. Electrical stimulation is delivered via the vaginal probe or the self-adhesive electrodes to the pelvic floor muscles. This electrical muscle stimulation works as a rehabilitation and training for pelvic floor muscles for the treatment of stress, urge and mixed urinary incontinence in women. The level of electrical stimulation of the Unicare can be controlled by the end user using manual push-button controls. This device is intended for over the counter (OTC) use.
The provided document does not contain information related to software-based medical devices that would involve acceptance criteria, study details (sample size, data provenance, expert ground truth, adjudication, MRMC studies, standalone performance), or training set information as typically found for AI/ML-driven diagnostics.
The document is an FDA 510(k) clearance letter for a non-implanted electrical continence device called "Unicare." This device is a hardware product that provides electrical stimulation for pelvic floor muscles. The "Non-Clinical Testing" section lists various engineering and safety tests performed on the device (biocompatibility, electrical safety, electromagnetic compatibility, software verification/validation, battery life), but these are standard engineering tests for hardware and software aspects of a physical device, not performance studies for an AI/ML algorithm or diagnostic tool.
Therefore, I cannot extract the requested information regarding acceptance criteria and studies for device performance in the context of AI/ML or diagnostic accuracy from this document. The information requested (e.g., sample size for test set, data provenance, expert adjudication, MRMC studies, ground truth types) is specific to studies evaluating the performance of diagnostic algorithms, particularly those involving image analysis or similar AI/ML applications, which is not applicable to the "Unicare" device described.
§ 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).