(81 days)
The intended use of this condom is for contraception and prophylactic purposes (preventing transmission of venereal disease).
A condom with silicone lubricant is a sheath which covers the penis with a closely fitted membrane
The provided text describes a 510(k) submission for latex condoms and does not contain information about an AI/ML powered medical device. Therefore, I cannot extract the requested information regarding acceptance criteria, study details, ground truth, or AI/MRMC specific information.
The document is a traditional 510(k) summary for a physical medical device (condoms), comparing it to predicate devices based on adherence to voluntary standards and physical testing, and explicitly states "Discussion of clinical tests performed: Not applicable."
As such, I cannot provide a table of acceptance criteria and device performance in the context of an AI/ML device, nor address sample sizes for test/training sets, expert qualifications, adjudication methods, or MRMC/standalone study details.
§ 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.