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Durex Play™ Tingling Lubricant is intended as a moisturizer 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™ Tingling personal Lubricant is a clear, colorless, spearmint scented personal lubricant composed of silicone fluid and sweetened spearmint aroma concentrate.

The provided text is a 510(k) premarket notification summary for a medical device, Durex Play™ Tingling Lubricant. This document describes the device, its intended use, and its substantial equivalence to predicate devices. It does not contain any information about acceptance criteria, a study validating performance against such criteria, or details regarding ground truth establishment, sample sizes for training/test sets, expert qualifications, or adjudication methods.

Therefore, I cannot provide the requested table and information based on the given input, as the document focuses on regulatory submission for substantial equivalence rather than a detailed performance study. The 510(k) process primarily relies on demonstrating that a new device is "substantially equivalent" to a legally marketed predicate device, often without requiring new clinical trials or detailed performance studies if equivalence can be established through design, materials, and intended use.

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