(137 days)
Mighty Man (Dynamic Linkers) condom, when properly used, are highly effective against pregnancy although no contraceptive can guarantee 100% effectiveness.
This condom is made of a natural rubber latex sheath, which completely covers the penis with a closely fitted membrane. This condom has the specification as enclosed in Annexure I & IV.
The provided text is a 510(k) summary for a latex condom, and it does not contain any information about acceptance criteria, device performance studies (beyond conformance to ASTM D 3492), or details about ground truth, sample sizes, or expert adjudication specific to an AI/ML device.
Therefore, I cannot fulfill your request for the specific information regarding an AI/ML device's acceptance criteria and studies from this document. This document is related to a traditional medical device (condom) and its premarket notification to the FDA to demonstrate substantial equivalence to a predicate device.
§ 884.5300 Condom.
(a)
Identification. A condom is a sheath which completely covers the penis with a closely fitting membrane. The condom is used for contraceptive and for prophylactic purposes (preventing transmission of sexually transmitted infections). The device may also be used to collect semen to aid in the diagnosis of infertility.(b)
Classification. (1) Class II (special controls) for condoms made of materials other than natural rubber latex, including natural membrane (skin) or synthetic.(2) Class II (special controls) for natural rubber latex condoms. The guidance document entitled “Class II Special Controls Guidance Document: Labeling for Natural Rubber Latex Condoms Classified Under 21 CFR 884.5300” will serve as the special control. See § 884.1(e) for the availability of this guidance document.