(268 days)
M. Dior Brand Latex Condoms are intended to prevent pregnancy, HIV/AIDS, and other sexually transmitted infections. The device is for over the counter use.
The condoms are made of a natural rubber latex sheath, which completely covers the penis with a closely fitted membrane. This condom is designed to conform to the standards including ASTM D3492 and ISO 4074. The condoms are smooth surface straight walled nipple-end (SWNE) style within ASTM standard specifications D-3492 Table 1 requirements, e.g., minimum length 160 mm, maximum width 54 mm, and minimum thickness of 30 µM.
This document describes a 510(k) submission for "M. Dior Brand or Private Label Latex Condoms for Men." This is a medical device, and the provided text is a summary of the submission, a letter of clearance from the FDA, and an indications for use statement. These documents do not contain the type of specific study data (acceptance criteria, sample sizes, expert qualifications, etc.) that would typically be found in a clinical trial report or a performance validation study for an AI/ML device.
The information provided focuses on demonstrating substantial equivalence to a predicate device based on technological characteristics and adherence to established standards for condoms (ASTM D3492 and ISO 4074), rather than a study proving performance against specific acceptance criteria in the context of an AI/ML device.
Therefore, I cannot extract the requested information. The document does not describe a study involving an AI/ML device or present acceptance criteria in the manner requested.
§ 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.