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The [No varticular brand name] condom is used for contraception and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted diseases).

Male Natural Rubber Latex Condom [No particular brand name]

The provided text is an FDA 510(k) clearance letter for a Male Latex Condom and does not contain the detailed information required to answer your request regarding acceptance criteria and study particulars for a medical device's performance.

Specifically, the document:

• Approves the device as substantially equivalent to a predicate device.
• Mentions regulatory class, applicable CFR sections, and general controls.
• Discusses labeling requirements for latex condoms, including expiration dating and real-time test data.
• States the Indications For Use.

However, it does not include:

1. A table of acceptance criteria or reported device performance.
2. Details about sample sizes, data provenance, number or qualifications of experts, or adjudication methods for any specific test set.
3. Information on multi-reader multi-case (MRMC) studies or standalone algorithm performance.
4. The type of ground truth used, training set sample size, or how ground truth was established for a training set.

This type of information is typically found in the 510(k) submission itself (which often includes summary data and test reports), not in the FDA's clearance letter. The clearance letter confirms that the FDA has reviewed the submission and found the device to be substantially equivalent.

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