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Lubrease is a personal lubricant for vaginal application, intended to moisturise and lubricate to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication.

This product is NOT compatible with latex or synthetic condoms

Lubrease is a single use applicator containing 1.6ml water based lubricating gel. The applicator is designed to lock after the gel has been applied to prevent inadvertent re-use of the applicator.

The provided text does not contain information about acceptance criteria or a study proving the device meets them. The document is a 510(k) summary for a personal lubricant, and it explicitly states:

"Curves Limited has not performed any clinical trials on Lubrease and there are consequently no financial implications to be considered in accordance with 21 CFR 54."

This indicates that no clinical trials or studies were conducted to assess the performance of the device against specific criteria for regulatory submission. The submission relies on demonstrating substantial equivalence to predicate devices (Aquagel K951431 and Rephresh K021737) based on technological characteristics and intended use, rather than presenting performance data from its own studies.

Therefore, I cannot provide the requested information in a table or answer the specific questions about acceptance criteria, study details, sample sizes, expert qualifications, or ground truth establishment, as this information is not present in the provided document.

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