(277 days)
The ExTT-101 is used for assessing the strength of pelvic floor muscles, teaching pelvic floor muscle exercises and for providing feedback during pelvic floor muscle exercises.
Not Found
The provided text is a 510(k) clearance letter from the FDA for a medical device called ExTT-101 Perineometer. This document does not contain any information about acceptance criteria, device performance studies, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or training/test set details.
The letter is primarily focused on:
- Confirming that the device is "substantially equivalent" to legally marketed predicate devices.
- Listing the indications for use of the device.
- Outlining the regulatory responsibilities of the manufacturer (e.g., registration, labeling, good manufacturing practice, adverse event reporting).
- Providing contact information for various FDA offices.
Therefore, I cannot fulfill your request for the specific details about acceptance criteria and study design/results based on the provided input.
§ 884.1425 Perineometer.
(a)
Identification. A perineometer is a device consisting of a fluid-filled sack for intravaginal use that is attached to an external manometer. The devices measure the strength of the perineal muscles by offering resistence to a patient's voluntary contractions of these muscles and is used to diagnose and to correct, through exercise, uninary incontinence or sexual dysfunction.(b)
Classification. Class II (performance standards).