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

SuperSlyde is an anhydrous, non-sterile, clear, silicone-soluble liquid for use as a personal lubricant. It is made of dimethicone and dimethiconol. The specifications for SuperSlyde include appearance, color, odor, viscosity, total aerobic microbial count per USP , total yeast and mold count per USP and absence of pathogenic organisms per USP . Osmolality, pH and antimicrobial effectiveness test parameters are not applicable because the subject lubricant is non-aqueous based formulation. The product is packaged in a polyethylene terephthalate (PET) bottle with a screw-on, press-top polypropylene (PP) in volumes of 100ml, 250ml and 400ml.

This document is a 510(k) summary for the SuperSlyde Personal Lubricant. It does not describe an AI medical device or a study proving its performance against acceptance criteria in the manner typically expected for AI/ML devices. Instead, it's a regulatory submission for a personal lubricant, focusing on its substantial equivalence to a predicate device based on material composition and physical/chemical properties.

Therefore, I cannot provide the information requested in the prompt, as the prompt's assumptions of an "AI device," "test set," "training set," "ground truth," "experts," and "comparative effectiveness study" are not applicable to the submitted document.

The document discusses the following:

• Device: SuperSlyde Personal Lubricant
• Regulation: Classified under Condom (21 CFR§ 884.5300), Product Code NUC (lubricant, personal)
• Predicate Device: Wet Platinum Premium Lubricant (K130012)
• Performance Testing Summary:
  • Biocompatibility: Tested per ISO 10993-5:2009, ISO 10993-10:2010, ISO 10993-11:2006. Found to be biocompatible.
  • Condom Compatibility: Evaluated per ASTM D7661-10. Compatible with natural rubber latex condoms, but not with polyisoprene and polyurethane condoms.
  • Shelf Life Testing: Demonstrated the device meets specifications over its proposed shelf life.

These tests are standard for a personal lubricant to demonstrate safety and effectiveness for its intended use, not for an AI/ML device's diagnostic or predictive performance.

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