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I am sorry, but the provided text from the FDA letter (K171213) does not contain information about the acceptance criteria or a study that proves the device meets those criteria for the "One Touch Condom with Benzocaine."
The text is a standard FDA 510(k) clearance letter, which states that the device is substantially equivalent to a predicate device and can be marketed. It outlines the regulatory framework, general controls, and other requirements for the manufacturer. It does not include specific performance data, study designs, or acceptance criteria.
Therefore, I cannot provide the requested information based on the input text.
§ 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.