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For use as a personal lubricant to lubricate condoms and help ease insertion of tampons and douches. For OTC use.

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The provided document is a 510(k) clearance letter from the FDA for a device called "Summer's Eve® Lubricating Jelly." This letter indicates that the device has been found substantially equivalent to a legally marketed predicate device.

However, the document does not contain any information regarding acceptance criteria, device performance studies, sample sizes, expert qualifications, ground truth establishment, or multi-reader multi-case studies. The letter is a regulatory approval document and not a technical study report.

Therefore, I cannot provide the requested information based on the input document. The information in the input pertains to the regulatory clearance of a medical device, not a detailed technical evaluation of its performance against specific acceptance criteria.

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