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Agape 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.

Agape Warming Personal Lubricant is a clear, semi-viscous personal lubricant that is compatible with condoms made of natural rubber latex and polyisoprene. 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 and supplement the body's natural lubrication. This product is sold as an over-the-counter (OTC) product in 1 fl. oz./30 mL and 2 fl. oz./60 mL sizes provided in a clear polyethylene terephthalate (PET) cylinder bottle. The 1 fl. oz./30 mL size bottles are capped with natural disc tops. The 2 fl. oz./60 mL size bottles are capped with silver disc tops. The individual bottles are hermetically sealed during the production process. This device is composed of water, Propanediol, Gluconolactone, Hydroxyethylcellulose, Sodium Benzoate, Polysorbate 20, Citric Acid and Capsicum Oleoresin.

The provided text is a 510(k) Premarket Notification for a personal lubricant. It does not describe an AI/ML-based medical device. Therefore, it does not contain the information required to answer your questions about acceptance criteria, study details, ground truth establishment, or expert consensus related to AI/ML device performance.

The document focuses on the substantial equivalence of the "Agape Warming Personal Lubricant" to a predicate device, based on standard physical, chemical, and biological testing relevant to personal lubricants.

Here's why your questions cannot be answered from this document:

• AI/ML Device: The product is a personal lubricant, not an AI/ML-driven diagnostic or therapeutic device.
• Performance Metrics: The acceptance criteria and performance data relate to physical properties (viscosity, pH, osmolality), antimicrobial effectiveness, biocompatibility, and condom compatibility, not to AI/ML performance metrics like sensitivity, specificity, AUC, or reader performance improvement.
• Ground Truth: Ground truth for a lubricant is established by laboratory assays and physical tests, not by expert consensus on images or outcomes data in the way it would be for an AI diagnostic.
• Training/Test Sets: There are no training or test sets in the AI/ML sense, as there is no algorithm being trained or evaluated for pattern recognition.
• Experts/Adjudication/MRMC Studies: These concepts are relevant to the evaluation of AI systems, particularly in medical imaging, where human readers interact with AI or human expert consensus is needed to establish a "truth" for complex interpretations. They are not applicable to the evaluation of a personal lubricant.

In summary, the provided text does not contain any information about an AI/ML device, and thus cannot be used to answer questions pertaining to its acceptance criteria or validating study.

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