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Durex Play ™ Temptations Assorted Lubricants are intended as moisturizers for vaginal dryness and personal lubrication of the vaginal entry to enhance condom use and to facilitate ease and comfort during intimate sexual activity.

Durex Play™ Temptations Assorted personal lubricants are clear, colorless, water soluble personal lubricants.

This appears to be a 510(k) premarket notification for a personal lubricant, not a study describing acceptance criteria and device performance. The provided text details the submission information, general device information, predicate devices, device description, intended use, and a letter from the FDA stating substantial equivalence.

Therefore, the requested information regarding acceptance criteria, device performance, study details (sample sizes, data provenance, expert qualifications, adjudication methods, MRMC study, standalone performance, ground truth), and training set information is not available in the provided document.

The document primarily focuses on demonstrating that the "Durex Play™ Temptations Assorted Lubricants" are substantially equivalent to already legally marketed predicate devices, which is the basis for a 510(k) clearance. Clinical studies with performance metrics as typically required for AI/ML devices are not part of this type of submission.

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