(90 days)
JO Coconut Hybrid Warming Personal Lubricant is a personal lubricant for penile, anal and/or vaginal application, intended to lubricate and moisturize, 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.
JO Coconut Hybrid Warming Personal Lubricant is a clear, viscous personal lubricant that is compatible with natural rubber latex and polyisoprene condoms. This product is not compatible with polyurethane condoms. This device is a non-sterile personal lubricant for penile, anal and/or vaginal application, intended to lubricate and moisturize, to enhance the ease and comfort of intimate sexual activity supplement the body's natural lubrication.
JO Coconut Hybrid Warming Personal Lubricant is sold as an over-the-counter (OTC) product in a 1 fl. oz./ 30 mL and 4 fl. oz./ 120 mL size. This product is provided in a clear polyethylene terephthalate (PET) cylinder bottle. The 1 fl. oz/ 30 mL size bottle is capped with natural disc tops. The 4 fl. oz/ 120 mL is capped with silver disc tops. The individual bottles are hermetically sealed during the production process.
This device is composed of Water (Aqua), Propylene Glycol, Caprylic/Capric Triglyceride, Cocos Nucifera (Coconut) Oil, Flavor (Aroma), Phenoxyethanol, Polyacrylate 13, Cellulose Gum, Raphanus Sativus (Radish) Seed Extract, Niacin, Polyisobutene, Polysorbate 20, Dipropylene Glycol, Vanillyl Butyl Ether,PEG-45M, Butyrospermum Parkii (Shea) Butter Extract, Ethyl Menthane Carboxamide, Methyl Diisopropyl Propionamide, Polysorbate 80, Caprylyl Glycol, Phenethyl Alcohol, Ethylhexylglycerin, Beeswax, Glyceryl Stearate, Hydroxypropylcellulose, Menthyl Lactate, PEG-100 Stearate, Stearamidopropyl Dimethylamine Lactate, Polyquaternium-67.
The provided text is a 510(k) summary for a personal lubricant (JO Coconut Hybrid Warming Personal Lubricant). It details the device's characteristics, comparison to a predicate device, and non-clinical performance data (biocompatibility, shelf-life, and condom compatibility).
However, the text does not contain any information about an AI/ML-based medical device study. It does not mention:
- Acceptance criteria for an AI/ML model
- Sample sizes for test or training sets for AI/ML
- Provenance of data for AI/ML
- Number or qualifications of experts for AI/ML ground truth
- Adjudication methods for AI/ML ground truth
- Multi-reader multi-case (MRMC) studies
- Standalone algorithm performance
- Type of ground truth used for AI/ML (e.g., pathology, outcomes)
- How ground truth for training data was established for an AI/ML model
Therefore, I cannot fulfill your request for the tables and study details related to an AI/ML device's acceptance criteria and proven performance based on the input text. The information provided is for a traditional, non-AI medical device (a lubricant).
§ 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.