(90 days)
This product is intended for penile, vaginal and/or anal application to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. This product is compatible with natural rubber latex and polyisoprene condoms. This product is not compatible with polyurethane condoms.
K Y Grosz Jelly is a water-based personal lubricant intended for penile, vaginal and/or anal application to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. This product is compatible with natural rubber latex and polyisoprene condoms, and is not compatible with polyurethane condoms. Its formulation consists of Water, Propylene glycol, Hydroxyethylcellulose, Benzoic acid, Carbomer, Sodium hydroxide. KY Grosz Jelly may be packaged in 2 oz (57g) and 4 oz (113g) tubes composed of high-density polyethylene (HDPE) and linear low-density polyethylene (LLDPE), sealed with foil and fitted with a polypropylene (PP) cap. The individual tubes may be packaged in an outer cardboard carton. KY Grosz Jelly is a personal lubricant for over-the-counter (OTC) use.
The provided text describes the regulatory review for a personal lubricant (KY Grosz Jelly), not an AI-powered medical device. Therefore, the information required to answer your specific questions about acceptance criteria, study design, expert involvement, and ground truth for an AI device is not present in the document.
The document discusses:
- Product Name: KY Grosz Jelly
- Regulation Number: 21 CFR § 884.5300 (Condom)
- Regulatory Class: Class II
- Intended Use: Penile, vaginal, and/or anal application to moisturize and lubricate, enhance intimacy, and supplement natural lubrication. Compatible with natural rubber latex and polyisoprene condoms, not with polyurethane condoms.
- Predicate Device: KY Banksy Aloe
- Performance Testing: Shelf life, biocompatibility (cytotoxicity, vaginal irritation, sensitization, acute systemic toxicity), and condom compatibility.
No information regarding AI/ML device performance, human reader studies (MRMC), standalone algorithm performance, or the establishment of ground truth for AI model training/testing is available in this document.
Therefore, I cannot populate the table or answer the specific questions related to AI device acceptance criteria and study design based on the provided 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.