(178 days)
The PelvX Donut Vaginal Pessary is a vaginal pessary intended for support of 310 degree prolapse.
The PelvX Cube Vaginal Pessary is a vaginal pessary intended for support of 314 degree prolapse combined with rectocele and/or cystocele.
Not Found
The provided text is a 510(k) clearance letter from the FDA for the PelvX Donut and PelvX Cube Vaginal Pessaries. This document does not contain information about acceptance criteria or a study proving the device meets those criteria, as it is related to regulatory approval based on demonstrating substantial equivalence to a predicate device, not performance testing of an AI/ML device.
Therefore, I cannot extract the requested information regarding acceptance criteria, device performance, study details, ground truth, or training sets from this document. The questions you've asked are typically relevant to the evaluation of AI/ML-driven diagnostic or assistive devices, which is not what this document describes.
§ 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).