Search Results

The Innolatex condom used for contraceptive and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted diseases)

Male Natural Rubber Latex Condom Straight side or Contoured or Flared in Shape, either Textured or Non-textured, Lubricated or Non-lubricated, Non-color or Colored and Flavored or Non-flavored

The provided text is a 510(k) premarket notification approval letter for a male natural latex condom. It does not contain information about the acceptance criteria and study proving device performance as typically expected for an AI/ML medical device. This document is a regulatory approval for a physical medical device (condom), not a software or AI-based device, and therefore the requested information categories (e.g., sample size for test set, number of experts for ground truth, MRMC study, training set) are not applicable.

The letter confirms that the device, a "Male Natural Latex Condom," is substantially equivalent to legally marketed predicate devices for contraceptive and prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted diseases). This substantial equivalence determination is based on the device meeting established performance standards for condoms, which are physical tests rather than AI/ML performance metrics.

Therefore, I cannot provide a table of acceptance criteria and reported device performance or information regarding studies in the context of an AI/ML device, because this document pertains to a traditional medical device.

Ask a specific question about this device