(217 days)
The Incontinence Probes are intended to provide electromyographic 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.
The Incontinence Probe models PE0001, PE0002, PE0004, PE0005, PE0006, PE0007 , PE0008, PE0009, and PE0010 are stand-alone probes/electrodes, which can be placed inside the adult rectum or female vagina to transmit electrical stimulation signals or pelvic floor EMG signals when connected to pelvic electrical stimulators or EMG biofeedback devices during the treatment of urinary incontinence . All the models are reusable for a single patient except PE0003, which is a disposable vaginal probe. The probes are not packaged with specific floor muscle stimulators and EMG/biofeedback equipment but are compatible with low-frequency (less than 1000Hz working frequency) stimulators or EMG/biofeedback devices that meet the standards of IEC 60601-1, IEC 60601-1-2 and IEC 60601-2-10 and use 2.0 DIN connection. The probes are made of S304 stainless steel and Acrylonitrile-Butadiene-Styrene (ABS). The probes are designed for use in home or clinic by a single user. The probes do not require sterilization but need cleaning for reuse according to the cleaning instructions provided in the instructions for use manual.
The provided text is related to the 510(k) premarket notification for the "Incontinence Probe" by Shenzhen Med-link Electronics Tech Co., Ltd. It details the device description, indications for use, comparison with a predicate device, and non-clinical testing conducted to demonstrate substantial equivalence.
However, the provided text does not contain information about acceptance criteria or a study proving that a device meets specific acceptance criteria in the context of diagnostic performance (e.g., sensitivity, specificity, accuracy) typically associated with AI/ML devices.
Instead, the acceptance criteria and testing described are focused on device safety and performance characteristics for a physical medical device (an incontinence probe), not an AI/ML diagnostic tool.
Therefore, I cannot provide the requested information about acceptance criteria and a study proving device diagnostic performance, as the document is about a different type of device and testing.
The document covers:
- Non-clinical testing for a physical device (Incontinence Probe).
- Tests performed include: Biocompatibility (cytotoxicity, sensitization, irritation), Shelf-life validation, Electrical Safety (IEC 60601-1), and Performance Bench Testing (visual testing, electrical output verification, cable dielectric strength, lead wire contact resistance, ANSI/AAMI EC53).
- The "acceptance criteria" here are implicitly tied to the standards cited (e.g., ISO 10993 for biocompatibility, IEC 60601-1 for electrical safety, ANSI/AAMI EC53 for lead wires), meaning the device passed these standard tests as acceptable.
If the request was based on a misunderstanding of the device type, and the intent was to find information on a diagnostic AI device, this document does not contain that information.
§ 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).