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Astroglide® Organix® Gel 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. The product is not compatible with polyurethane condoms.

Astroglide® Organix ® Gel is non-sterile, translucent, colorless to slight yellow, water-based personal lubricant intended for penile and vaginal application 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 and is not compatible with polyurethane condoms. This product is for over-the-counter (OTC) use. Astroglide® Organix ® Gel's formulation consists of water, glycerine, xanthan gum, gellan gum, aloe barbabensis powder, chamomilla recutita (matricaria) flower extract, calendula officinalis flower extract, vaccinium macrocarpon (cranberry) fruit extract, passiflora incarnata flower extract, sodium benzoate, potassium sorbate, and citric acid. It is packaged in white LDPE tube with a screw on flip top cap comprised of polypropylene. This product is also provided in 2.5 ml foil packs.

This document is a 510(k) Premarket Notification from the FDA regarding a personal lubricant, Astroglide® Organix® Gel. It is a not a study of an AI/ML medical device. Therefore, I cannot extract the information required using the provided text.

The request asks for specific details related to the validation of an AI/ML medical device, such as acceptance criteria based on AI performance metrics (e.g., sensitivity, specificity), details about test sets (sample size, provenance, ground truth establishment, expert qualifications, adjudication methods), information on multi-reader multi-case (MRMC) studies, and details about training sets. These concepts are entirely absent from the provided document, which focuses on the chemical, physical, and biocompatibility testing of a personal lubricant to demonstrate its substantial equivalence to a predicate device.

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