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Extra strength lubricated rubber male condom with Nonoxynol-9 for use as a contraceptive and prophylactic.

Additional Statement: "Laboratory tests of physical properties show the ExtraWear condom is stronger than the InnerWear condom. However, the breakage rate during sex has not been tested. "

Additional Statement: This condom contains a latex 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 the 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

ExtraWear™, Gentlemen's Choice™, Extra Strength Latex Condom with Nonoxynol-9

The provided document is a 510(k) premarket notification letter and the "Indications for Use" statement for a medical device (a latex condom). It does not contain information about the acceptance criteria or a study proving the device meets acceptance criteria in the manner typically described for AI/ML device evaluations. This document is from 1997, predating the widespread use of AI/ML in medical devices and the associated rigorous evaluation frameworks.

Therefore, I cannot extract the requested information regarding acceptance criteria, study details, sample sizes, ground truth, expert qualifications, or MRMC studies from these documents. The questions in the prompt are structured around modern AI/ML device validation, which is not applicable to a 1997 condom approval document.

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Extra strength nonlubricated rubber male condom for use as a contraceptive and prophylactic.
Additional Statement: "Laboratory tests of physical properties show the ExtraWear condom is stronger than required by the ASTM standard. The breakage rate during sex has not been tested."

ExtraWear™, Gentlemen's Choice™, Extra Strength ... ... Non-Lubricated Latex Condom

I am sorry, but the provided text does not contain the information required to answer your request. The document is an FDA clearance letter for a condom and does not describe any specific acceptance criteria or a study proving that a device meets those criteria. It mainly focuses on the substantial equivalence determination for the condom.

Ask a specific question about this device