(120 days)
The Oves Cervical Cap is indicated for use in artificial insemination procedures in situations in which low sperm count, sperm immotility, or hostile vaginal environment have been diagnosed. The Oves Cervical Cap removes scmen from the vaginal environment and concentrates the sperm at the opening of the cervical os, thus facilitating sperm contact with cervical mucosa.
Not Found
The provided document is a 510(k) clearance letter from the FDA for the Oves Cervical Cap. This type of document does not typically contain information about acceptance criteria or specific study results showing device performance in the way a clinical study report or a premarket approval (PMA) application summary would.
The letter primarily addresses the substantial equivalence of the Oves Cervical Cap to legally marketed predicate devices and outlines the regulatory requirements, including labeling limitations. It states that the "safety and effectiveness of the Oves Cervical Cap for contraception have not been established." This indicates the device was NOT cleared for contraception, but for "artificial insemination procedures in situations in which low sperm count, sperm immotility, or hostile vaginal environment have been diagnosed."
Therefore, I cannot extract the requested information (acceptance criteria, device performance, study details, sample sizes, ground truth information, MRMC studies, or standalone performance) from this document. This kind of detail would typically be found in the 510(k) submission itself (which is not publicly available in detail) or a summary of safety and effectiveness if it were a PMA.
§ 884.5250 Cervical cap.
(a)
Identification. A cervical cap is a flexible cuplike receptacle that fits over the cervix to collect menstrual flow or to aid artificial insemination. This generic type of device is not for contraceptive use.(b)
Classification. Class II (performance standards).