(233 days)
When used in accordance with manufacturer's instruction, condoms are effective form of contraception. If used properly, latex condoms will help to reduce the risk of transmission of HIV infection (AIDS) and many other sexually transmitted diseases, including chlamydia, genital warts, gonorthea, hepatitis B and syphilis.
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I apologize, but the provided text relates to an FDA 510(k) clearance letter for a "SURE" Condom (Natural Rubber Latex Contraceptive) from 1999. This document does not contain information about the acceptance criteria and study details for a device in the context of modern AI/medical device evaluations as described in your request.
The letter pertains to regulatory clearance for a physical contraceptive product, not an AI-powered diagnostic or therapeutic device. Therefore, I cannot extract the requested information such as test set sample sizes, expert qualifications for ground truth, or multi-reader multi-case studies, as these concepts are not applicable to the content of this document.
§ 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.