(86 days)
Bioteque's vaginal pessaries are indicated as removable devices placed in the vaginal cavity to provide a non-surgical alternative for the treatment of organ prolapse and to relieve the symptoms of pelvic relaxation with and without urinary incontinence.
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I am sorry, but the provided text does not contain the information requested in your prompt regarding acceptance criteria and a study proving device performance. The text is a 510(k) clearance letter from the FDA for a Bioteque Vaginal Pessary, indicating that the device is substantially equivalent to a legally marketed predicate device.
The letter discusses regulatory aspects, such as compliance with the Federal Food, Drug, and Cosmetic Act, and general controls provisions. It also includes the specific indications for use of the Bioteque Vaginal Pessary. However, it does not detail any specific acceptance criteria for performance, nor does it describe a study that was conducted to demonstrate the device meets such criteria. Therefore, I cannot accurately fill in the table or answer the specific questions about sample sizes, expert qualifications, adjudication methods, or types of ground truth.
§ 884.3575 Vaginal pessary.
(a)
Identification. A vaginal pessary is a removable structure placed in the vagina to support the pelvic organs and is used to treat conditions such as uterine prolapse (falling down of uterus), uterine retroposition (backward displacement), or gynecologic hernia.(b)
Classification. Class II (performance standards).