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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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Based on the provided document, which is an FDA 510(k) clearance letter for the HardCover Condoms™ Male Latex Condoms, there is no information available regarding acceptance criteria, device performance studies, or the methodologies used to establish ground truth.

The document is a regulatory approval letter, confirming that the device is "substantially equivalent" to legally marketed predicate devices. This means the FDA has determined that the new device is as safe and effective as a legally marketed device and does not require a new Premarket Approval (PMA) application.

The letter explicitly states: "Although supporting data is not to be provided in your 510(k) submission, 801.435(j) requires that you maintain this data and that it be available for inspection by FDA." This indicates that while design and performance testing were conducted by the manufacturer, the detailed results and methodologies are not part of this public clearance letter.

Therefore, I cannot provide the requested information for the following points as they are not contained within the provided text:

1. A table of acceptance criteria and the reported device performance: Not present.
2. Sample sized used for the test set and the data provenance: Not present.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not present.
4. Adjudication method: Not present.
5. If a multi-reader, multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not present (and not applicable as this is not an AI/software device).
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not present (and not applicable as this is not an AI/software device).
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not present.
8. The sample size for the training set: Not present.
9. How the ground truth for the training set was established: Not present.

The only performance-related requirement mentioned in the document is about expiration dating for latex condoms and spermicidal lubricant shelf life, which must be "supported by test data developed under the conditions specified in 801.435(d)". However, the specifics of these tests and their acceptance criteria are not detailed in this letter.

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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).

Not Found

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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