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Medley 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 and polyisoprene condoms. This product is not compatible with polyurethane condoms.

Medley is a water-based personal lubricant that is non-sterile and provides lubrication during intimate sexual activity. This device is compatible with natural rubber latex and polyisoprene condoms and is not compatible with polyurethane condoms. Its formulation consists of water, hydroxyethylcellulose, xanthan gum, hyaluronic acid, Zemea propanediol, glycerin water, dimethicone, hydrogenated lecithin, sodium benzoate, potassium sorbate, and DL lactic acid. Medley is packaged in 2 fl. oz high-density polyethylene pump bottles. Medley is a personal lubricant for over-the-counter (OTC) use.

The provided text describes the 510(k) summary for a personal lubricant device named Medley. It does not contain information about a study proving the device meets acceptance criteria related to an AI/Software as a Medical Device (SaMD). The document primarily focuses on the device's physical and chemical specifications, biocompatibility, and condom compatibility based on standard testing methods for personal lubricants.

Therefore, I cannot provide a response with the requested information as it pertains to AI/SaMD performance evaluation. The document is about a physical medical device (personal lubricant), not an AI-powered diagnostic or therapeutic device.

If you have a document related to an AI/SaMD, I would be happy to analyze it for the specific criteria you've outlined.

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