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Love Alchemy's Love Lotion 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 not for use with condoms.

Love Alchemy's Love Lotion 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. Love Lotion ingredients are Shea Butter, Coconut Oil, Grapeseed Oil, Lavender Oil, Orange Peel Oil, Jasmine Oil, Sandalwood Oil, Patchouli Oil and Ylang-Ylag Oil. Device specifications are color, odor, appearance, viscosity, total aerobic microbial count, total yeast and mold count, absence of pathogenic microorganisms (P. aeruginosa, S. aureus and C. albicans) and antimicrobial effectiveness.

The provided document is a 510(k) summary for a personal lubricant, "Love Alchemy's Love Lotion," and therefore does not contain information related to an AI/ML medical device. As such, the requested details regarding acceptance criteria for an AI device, sample size for test sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth establishment, and training set size are not applicable and cannot be extracted from this document.

The document discusses the substantial equivalence of the lubricant to a predicate device based on non-clinical performance testing.

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