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Nulatex Natural Male Latex Condom is used for contraception and prophylactic purposes. (To help prevent pregnancy and transmission of sexually transmitted infection)

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The provided document is an FDA 510(k) premarket notification approval letter for a male latex condom. It does not contain information about the acceptance criteria and study data for a medical device's performance characteristics beyond the general statement of substantial equivalence to predicate devices.

Therefore, I cannot extract the specific information requested about acceptance criteria, device performance, sample sizes, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details from this document. This kind of information is typically found in the submission package that precedes the approval letter, which is not provided here.

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The Nulatex Male Natural Rubber Latex condom is used for contraception and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted infections).

Male Latex Condom. (No Particular Brand Name) Natural Smooth, Natural Ribbed, Natural Studded(Dotted), Natural 3 in 1, Natural ultrathin, Pink Smooth, Pink Ribbed, Pink Studded(Dotted),Pink 3 in 1, Pink Ultrathin with/or without Strawberry flavored.

The provided text is a 510(k) substantial equivalence determination letter from the FDA for a Male Latex Condom. It does not contain information about acceptance criteria, device performance, or a study report as typically found in submissions for AI/ML-powered medical devices.

Therefore, I cannot extract the requested information regarding acceptance criteria, study details, sample sizes, ground truth establishment, or expert involvement. The document only confirms that the device is substantially equivalent to legally marketed predicate devices for contraception and prevention of sexually transmitted infections.

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This [MULTIPLE BRAND] latex condom has the same intended use as the predicate condom. The condom is used for contraception and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted diseases).

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I am sorry, but the provided text does not contain information about acceptance criteria or a study proving a device meets those criteria. The document is an FDA 510(k) clearance letter for male natural rubber latex condoms. It indicates that the device has been found substantially equivalent to a legally marketed predicate device for contraception and prophylactic purposes.

The document discusses:

• The trade name of the device and its classification.
• The regulatory framework for medical devices.
• The intended use of the condom.

It does not include:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes or data provenance for any study.
3. Details about experts or ground truth establishment.
4. Adjudication methods.
5. MRMC comparative effectiveness studies.
6. Standalone algorithm performance.
7. The type of ground truth used.
8. Training set sample sizes or ground truth establishment for a training set.

Therefore, I cannot answer your request based on the provided input.

Ask a specific question about this device