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JO H2O Personal Lubricant is a water-based personal lubricant, for penile 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, polyurethane, and polyisoprene condoms.

JO H2O Water Based Personal 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 compatible with natural rubber latex, polyurethane, and polyisoprene condoms.

JO H2O Water Based Personal Lubricant is a clear, colorless, semi-viscous personal lubricant that is compatible with condoms made of natural rubber latex, polyurethane, and polyisoprene. The device is a non-sterile lubricant, for penile and/or vaginal application, to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. The product is provided in Polyethylene (PET) bottles with Polypropylene caps. The individual bottles are sealed using an induction seal constructed of aluminized mylar. There is a 16 fl. Oz./480 mL bottle with a different configuration consisting of a clear Polyethylene (PET) bottle with a Polypropylene lotion pump. This bottle is fitted with a shrink band.

The provided document is a 510(k) premarket notification for a medical device, specifically a personal lubricant, and as such, it does not describe an AI medical device or include the typical acceptance criteria and study designs associated with such devices. Therefore, I cannot extract the information requested about acceptance criteria, test set details, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details as they pertain to an AI device.

The document discusses the substantial equivalence of the "JO H2O Water Based Personal Lubricant" to a predicate device based on:

1. Biocompatibility studies: Acute systemic toxicity, vaginal irritation, cytotoxicity, and guinea pig maximization sensitization testing according to FDA recognized ISO 10993 standards. These tests demonstrate the safety of the device.
2. Shelf life study: A three-year real-time aging study evaluated parameters like appearance, color, odor, pH, osmolality, viscosity, specific gravity, microbial counts, absence of pathogens, and antimicrobial effectiveness.
3. Condom Compatibility: Evaluation with natural rubber latex, polyisoprene, and polyurethane condoms per ASTM D7661-10.

Without the context of an AI medical device, the specific questions about acceptance criteria related to AI performance metrics (e.g., sensitivity, specificity, AUC), test/training set characteristics for AI, expert involvement in ground truth, or comparative effectiveness studies with AI assistance are not applicable to this document.

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