(353 days)
Crème de la Femme Feminine Lubricant is a personal lubricant, for penile and/or vaginal application, intended to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. This product is not compatible with natural rubber latex, polyurethane, and polyisoprene condoms.
Crème de la Femme Feminine Lubricant is a non-sterile, mineral oil based personal lubricant designed to supplement the body's own natural lubrication fluids, and to enhance the ease and comfort of intimate sexual activity. The product is provided in a low-density polyethylene tube with a white polypropylene screw on the cap. The device will be supplied with an applicator. Its specifications include appearance, color, odor, pH, viscosity, antimicrobial effectiveness (USP), total aerobic microbial count (USP), total yeast and mold count (USP, and absence of pathogenic organisms (USP). The lubricant is not a spermicide or contraceptive. The device is not compatible with natural rubber latex, polyisoprene or polyurethane condoms.
I am sorry, but the provided text from the FDA 510(k) Premarket Notification for "Crème de la Femme Feminine Lubricant" does not contain information about a study proving that an AI/ML-enabled medical device meets specific acceptance criteria related to its performance in tasks such as image analysis or diagnostic aid.
The document describes a medical device, a personal lubricant, and focuses on its substantial equivalence to a predicate device. The performance testing detailed in the document relates to:
- Biocompatibility: Cytotoxicity, Sensitization, Vaginal Irritation, Acute Systemic Toxicity.
- Condom Compatibility: Demonstrated non-compatibility with certain condom types.
- Shelf-Life: Stability testing.
These are standard tests for a Class II medical device like a personal lubricant, demonstrating its safety and effectiveness for its intended use.
Therefore, I cannot fulfill your request to describe acceptance criteria and a study proving an AI/ML device's performance, as the provided text pertains to a completely different type of medical device and its associated testing.
§ 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.