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The World's Best Latex Condoms are to completely cover the penis during sexual intercourse for contraception and prophylaxis, and aid to the prevention of sexually transmitted diseases (STDs). If used properly, latex condoms will help to reduce the risk of transmission of HIV infection (AIDS) and many other sexually transmitted diseases, including, chlamydia infections, genital herpes, genital warts, gonorrhea, hepatitis B, and syphilis. This product may also combine a latox condom and a spermicidal lubricant. The spermicide, nonoxynol-9, reduces the number of active sperm, thereby decreasing the risk of pregnancy if you lose your erection before withdrawal and some semen spill outside the condom. However, the extent of decreased risk has not been established. This condom should not be used as a substitute for the combined use of a vaginal spermicide and a condom.

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This document is a 510(k) clearance letter from the FDA for "World's Best Condoms." It does not contain information about acceptance criteria or a study that proves the device meets those criteria from an AI/device performance perspective.

The letter is the outcome of a regulatory review stating that the device is "substantially equivalent" to legally marketed predicate devices, meaning it has met the regulatory requirements for going to market. However, it does not describe specific performance metrics, study designs, sample sizes, or ground truth methodologies that would be typical for an AI/device performance evaluation.

Therefore, I cannot extract the requested information from the provided text.

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