(254 days)
AH! YES® OB COCO: A personal lubricant, for vaginal and penile application, intended to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. AH! YES® OB COCO is not compatible with natural rubber latex, polyurethane or polyisoprene condoms.
AH! YES OB COCO is a non-sterile, plant-oil based personal lubricant that consists primarily of sunflower oil and fractionated coconut oil and is not compatible with condoms. It is neither a contraceptive nor a spermicide. The formulation is an opaque paste that melts at body temperature. The product is packaged in a polyethylene single use applicator.
I apologize, but the provided text from the FDA 510(k) premarket notification for "AH! YES OB COCO Personal Lubricant" does not contain any information about acceptance criteria or a study proving the device meets those criteria in the context of an AI-powered medical device or diagnostic tool.
This document pertains to a medical device (a personal lubricant) that does not involve AI or algorithms requiring the types of studies you've requested (e.g., MRMC, standalone algorithm performance, expert consensus for ground truth on imagery).
Therefore, I cannot fulfill your request for the specific information regarding AI device acceptance criteria and study details. The document primarily focuses on:
- Substantial equivalence to a predicate device based on similar indications for use and technological characteristics.
- Non-clinical performance testing for biocompatibility, shelf-life, and condom compatibility for a physical product.
If you can provide a document that discusses an AI-powered medical device, I would be happy to analyze it for the information you've 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.