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A Latex Rubber Condom is intended to be worn over the male penis during acts of vaginal intercourse to aid in the prevention of pregnancy and spread of sexually transmitted diseases.

Latex Rubber Condom

I am sorry, but the provided documents (FDA 510(k) clearance letters and "Indications For Use" forms) do not contain the specific information required to answer your request regarding the acceptance criteria and the study that proves a device meets those criteria.

These documents are primarily concerned with the regulatory clearance of the Durex® Ultra Comfort Latex Rubber Condoms, establishing substantial equivalence to a predicate device, and outlining its intended "Indications For Use."

The detailed information you are asking for, such as:

1. A table of acceptance criteria and reported device performance
2. Sample size used for the test set and data provenance
3. Number of experts and their qualifications for ground truth
4. Adjudication method
5. Multi-reader multi-case (MRMC) comparative effectiveness study details
6. Standalone performance
7. Type of ground truth used
8. Training set sample size
9. How ground truth for the training set was established

...would typically be found in the premarket notification (510(k) submission itself, which includes detailed testing protocols, results, and often references to specific standards (e.g., ISO standards for condoms). The clearance letters only provide a summary of the FDA's decision based on that submission.

Therefore, I cannot provide an answer based on the given text.

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