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

Orange colored condoms with orange scents

The provided document is a 510(k) premarket notification letter from the FDA regarding a condom, specifically "Orange colored condoms with orange scents." This document does not contain information about a medical device that utilizes AI, machine learning, or complex imaging. Therefore, it does not include the details typically found in an acceptance criteria and study report for such devices.

The request asks for specific information related to the performance evaluation of a device, including:

1. A table of acceptance criteria and reported device performance.
2. Sample size and data provenance.
3. Number and qualifications of experts for ground truth.
4. Adjudication method.
5. MRMC study details and effect size.
6. Standalone performance.
7. Type of ground truth.
8. Training set sample size.
9. Ground truth establishment for training set.

None of this information is available in the provided FDA 510(k) clearance letter for the condom.

To fulfill the request, one would need a performance study report for an AI/ML medical device, which is not what has been provided.

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