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The ONE Nitrile Condom is used for contraception and for prophylactic purposes (to help reduce the risk of pregnancy and the transmission of sexually transmitted infections).

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I apologize, but the provided FDA 510(k) clearance letter for the ONE Nitrile Condom does not contain any information about acceptance criteria or a study proving the device meets those criteria, as typically found for AI/medical imaging devices.

The document primarily focuses on regulatory approval, substantial equivalence to a predicate device, and general controls for medical devices. It outlines:

• The FDA's determination of substantial equivalence for the ONE Nitrile Condom (K243967).
• Regulatory classifications (Class II, Product Code MOL).
• Applicable regulations (e.g., Quality System regulation, UDI Rule).
• General information about FDA oversight of medical devices.
• The intended use of the device (contraception and STI prevention).

Therefore, I cannot extract the detailed information requested in your prompt (e.g., acceptance criteria table, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types) because it is not present in this specific FDA clearance letter for a condom.

These types of details are typically found in regulatory submissions for AI-enabled medical devices or diagnostic tools, which undergo rigorous performance validation studies. A condom, while a medical device, is evaluated based on different performance metrics (e.g., burst strength, freedom from holes, dimensions) that are validated through standard tests rather than AI-specific evaluations.

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The ONE Nitrile Condom is used for contraception and for prophylactic purposes (to help reduce the risk of pregnancy and the transmission of sexually transmitted infections).

Not Found

I am sorry, but the provided text is a 510(k) clearance letter for a medical device (ONE Nitrile Condom). This document does not contain the specific information needed to answer your request regarding acceptance criteria, study details, sample sizes, ground truth establishment, or multi-reader multi-case studies for a device's performance.

The letter confirms the device's clearance for marketing and provides regulatory information, but it does not delve into the technical validation studies that would include acceptance criteria and performance data.

Ask a specific question about this device