(172 days)
Condoms are latex sheaths, intended to completely cover the penis during sexual intercourse for contraception and prophylaxis, an 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.
Caution Condoms - Male latex condoms lubricated, with and without Nonoxynol-9
This document is a 510(k) clearance letter for "Caution Condoms - Male latex condoms, lubricated, with and without Nonoxynol-9." It does not contain information about acceptance criteria or a study proving the device meets those criteria, as typically found in a clinical study report or performance evaluation document for a diagnostic or AI-based device.
The letter confirms that the FDA has reviewed the 510(k) notification and determined that the device is "substantially equivalent" to legally marketed predicate devices. This determination is based on the device's indications for use and general controls, rather than a specific performance study against defined acceptance criteria in the manner requested.
Therefore, I cannot extract the information requested in your prompt regarding acceptance criteria and performance study details from this document. The document primarily concerns regulatory clearance for a medical device (condoms) based on substantial equivalence, not a detailed performance study with specific metrics, sample sizes, or ground truth establishment relevant to the provided questions.
§ 884.5310 Condom with spermicidal lubricant.
(a)
Identification. A condom with spermicidal lubricant is a sheath which completely covers the penis with a closely fitting membrane with a lubricant that contains a spermicidal agent, nonoxynol-9. This condom is used for contraceptive and prophylactic purposes (preventing transmission of venereal disease).(b)
Classification. Class II (performance standards).