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These multiple-brand condoms are used for contraception and for prophylactic purposes to help prevent pregnancy and the transmission of sexually transmitted diseases and HIV (AIDS).

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I am sorry, but the provided text does not contain the information requested in your prompt regarding acceptance criteria and a study proving a device meets them. The document is a 510(k) clearance letter from the FDA for "HardCover Condoms™ Male Latex Condoms," dated June 17, 1999.

It primarily discusses:

• The FDA's determination of substantial equivalence for the device.
• Regulatory classifications and general controls.
• Labeling requirements for latex condoms, specifically regarding expiration dating (21 CFR 801.435).
• Contact information for FDA offices.
• The product's indications for use: contraception and prevention of sexually transmitted diseases and HIV.

There is no mention of:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes for test sets or data provenance.
3. Number or qualifications of experts for ground truth.
4. Adjudication methods.
5. MRMC comparative effectiveness studies.
6. Standalone algorithm performance.
7. Type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

The letter pertains to regulatory clearance based on substantial equivalence to predicate devices, not on a detailed performance study as you've outlined for AI/ML device evaluations. The only "test data" mentioned is for supporting the expiration date as per 21 CFR 801.435, and it explicitly states that this data is not to be provided in the 510(k) submission itself but must be maintained by the manufacturer.

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