(264 days)
Instinct brand condoms ( Instinct Plain, Instinct Dotted, Instinct Ultrathin) are used for contraception and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted diseases).
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This document is a 510(k) clearance letter from the FDA for INSTINCT BRAND CONDOMS. It does not contain information about a study with acceptance criteria and device performance metrics in the context of an AI/ML medical device. Therefore, I cannot extract the requested information from the provided text.
Specifically, the document pertains to a traditional medical device (condoms) and its substantial equivalence to previously marketed devices, not an AI/ML-driven device that would involve performance metrics like sensitivity, specificity, or the use of training/test sets, expert adjudication, or MRMC studies.
§ 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.