(90 days)
The LifeStyles® Zero® condom is used for contraception and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted diseases).
This condom is made of a natural rubber latex sheath, which completely covers the penis with a closely fitted membrane. The device is a straight-walled, cylindrical, lubricated condom with a reservoir tip. The device is designed to conform to the specifications of ASTM D3492, Standard Specification for Rubber Contraceptives (Male Condoms) and is provided in a foil package.
The provided text is a 510(k) summary for a medical device (condom) seeking substantial equivalence to a predicate device. It does not describe an AI/ML powered device, and therefore the information requested in the prompt (acceptance criteria, study details, human reader improvement, standalone performance, ground truth, training set size, etc.) is not present in the document.
The document focuses on comparing the new device's technical characteristics with a predicate device to demonstrate substantial equivalence, rather than providing performance metrics against specific acceptance criteria for an AI/ML algorithm.
Therefore, I cannot fulfill your request using the provided input.
§ 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.