(422 days)
The Pelvifine Pelvic Muscle Trainer (Model: KM518) is a non-implanted muscle stimulator designed to treat stress, urge and/or mixed urinary incontinence in women. It applies stimulation to the pelvic floor muscles and surrounding structures to improve strength and support.
The Pelvifine Pelvic Muscle Trainer is a product designed to give women the opportunity to strengthen their pelvic floor muscles. This device is a dual-channel stimulator combining several treatment programs into one unit. Channel B is for the Junior User (who use the device no more than 5 times) and Channel A is for the Senior User (who use the device more than 5 times). It offers full control of Pulse Widths, Rates, Ramp up times, and Work/Rest cycles.
The provided text is a 510(k) Summary for the Pelvifine Pelvic Muscle Trainer. It describes the device, its intended use, and a comparison to predicate devices to demonstrate substantial equivalence for regulatory approval.
However, this document does not contain information about clinical study acceptance criteria, device performance results from a clinical study, sample sizes for test or training sets, ground truth establishment, expert qualifications, or MRMC studies. The "Test Summary" section explicitly states that the device was evaluated by lab bench testing and usability testing, not clinical studies assessing its efficacy in treating urinary incontinence.
Therefore, I cannot fulfill your request for the comprehensive information about acceptance criteria and a study proving the device meets them, as the provided document does not contain this type of data.
The relevant section, "6. Test Summary," states:
"The Pelvifine Pelvic Muscle Trainer (Model: KM518) has been evaluated the safety and performance by lab bench testing and usability testing as following:
- Electrical safety test according to IEC 60601-1 and IEC 60601-2-10 standards
- Electromagnetic compatibility test according to IEC 60601-1-2 standard
- Biocompatibility test according to ISO 10993-5 and ISO 10993-10 standards
- Usability test according to IEC 62366 standard
- Software verification and validation test according to the requirements of the FDA "Guidance for Pre Market Submissions and for Software Contained in Medical Devices"
- The waveform test report has also been conducted to characterize the output specifications of the device according to Guidance for Transcutaneous Electrical Nerve Stimulator for Pain Relief Intended for Over the Counter Use and Guidance for Powered Muscle Stimulator for Muscle Conditioning"
This clearly indicates a focus on technical and safety performance, not clinical efficacy. The substantial equivalence argument relies on the similarity of the new device's technical specifications and intended use to those of already approved predicate devices, rather than on proving its therapeutic effectiveness through a new clinical trial.
§ 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).