(90 days)
Not Found
The medical devices and drugs contained in The Loving Smarter- Safer Sex Kit are:
1.Latex Male Condoms
- Personal Lubricants, Water-based
I'm sorry, but the provided text "K963679 DEC 1 2 1006 ENCLOBURE C Summary of Information on Safety and Effectiveness" does not contain the detailed information necessary to describe acceptance criteria and a study proving a device meets those criteria.
The text describes a "Loving Smarter- Safer Sex Kit" which contains latex male condoms and personal lubricants. It mentions that research supports these products are safe and effective, and that they will be purchased from manufacturers and distributors and will be substantially equivalent to legally marketed products.
This information is very general and does not provide any specific quantitative acceptance criteria or details about a study that would demonstrate a device meets such criteria. For example, it doesn't mention:
- Specific performance metrics (e.g., sensitivity, specificity, accuracy, detection rate, image quality metrics).
- Thresholds for these metrics that would constitute "acceptance."
- Study design details like sample size, ground truth methods, expert qualifications, or adjudication methods.
- Comparative effectiveness studies (MRMC) or standalone performance studies for an AI-powered device.
Therefore, I cannot generate the requested table and paragraphs based on the input provided. To answer your query, I would need a summary or description of a study that includes these specific details for a device, particularly one involving AI or a complex medical device with defined performance metrics.
§ 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.