(274 days)
The Male Latex Condom is used for contraception and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted infections).
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I am sorry, but the provided text does not contain information about the acceptance criteria for a device, nor does it describe a study proving a device meets any such criteria.
The document is an FDA 510(k) clearance letter for a "Male Latex Condom" (K203536). It states that the device is substantially equivalent to legally marketed predicate devices and is cleared for marketing. It also outlines regulatory requirements such as registration, labeling, and good manufacturing practices. The "Indications for Use" section specifies that the condom is for contraception and prophylactic purposes.
Therefore, I cannot provide the requested information, including:
- A table of acceptance criteria and reported device performance
- Sample sizes and data provenance
- Number and qualifications of experts for ground truth
- Adjudication method
- MRMC comparative effectiveness study results
- Standalone algorithm performance
- Type of ground truth used
- Training set sample size and ground truth establishment
§ 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.