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The Playboy 3 Contour Condom is used for contraception and for prophylactic purposes (preventing transmission of sexually transmitted infections).

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I am sorry, but the provided text from the FDA letter about K211450 for the "Playboy 3 Contour Condom" does not contain information about acceptance criteria or a study proving the device meets those criteria, as it relates to device performance metrics typically found in AI/ML medical device submissions.

The document is a 510(k) clearance letter for a condom, outlining its regulatory classification, indications for use, and general controls. It's a standard FDA clearance document that confirms substantial equivalence to a predicate device, rather than a detailed report of performance studies against specific acceptance criteria for an AI/ML device.

Therefore, I cannot fulfill your request for:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes or data provenance.
3. Number of experts or their qualifications for ground truth.
4. Adjudication method.
5. MRMC study information or effect size.
6. Standalone performance.
7. Type of ground truth used.
8. Training set sample size.
9. How ground truth for the training set was established.

This information is typically found in pre-market submissions for AI/ML-powered medical devices, which undergo rigorous validation studies to demonstrate their diagnostic or prognostic capabilities. The provided text concerns a physical barrier contraception device, for which performance is assessed against different types of standards (e.g., burst strength, leakage, etc., though these specific tests are not detailed in this clearance letter).

Ask a specific question about this device