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If used properly, condoms will help to reduce the risk of transmission of HIV infection (AIDS) and many other sexually transmitted diseases, including chlamydia, genital herpes, genital warts, gonorrhea, hepatitis B and syphilis. Condoms, when properly used, are highly effective against pregnancy although no contraceptive can guarantee 100% effectiveness. Any use of this condom for other than vaginal intercourse can increase the potential damage to the condom. For maximum pleasure and protection, it is important to follow the instructions for use included inside this package. Failure to do so may result in the loss of the benefits of the condom.

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The provided documents are a 510(k) clearance letter and an "Indications For Use" statement for a Latex Condom with Spermicidal Lubricant. These documents confirm the device has been cleared by the FDA as substantially equivalent to previously marketed devices. However, they do not contain any information regarding specific acceptance criteria, performance studies, or technical data that would describe how the device meets such criteria.

Therefore, for each of your requested points, I must state that the information is not available in the provided text.

Here's a breakdown based on your request:

1. A table of acceptance criteria and the reported device performance

   • Not Available: The provided documents do not specify any acceptance criteria (e.g., burst pressure, freedom from holes, shelf life, or spermicide effectiveness) or report specific performance metrics against such criteria.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

   • Not Available: The documents do not describe any specific test sets, sample sizes, or data provenance for performance evaluation.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

   • Not Applicable / Not Available: This type of information is typically related to diagnostic devices where expert interpretation establishes ground truth (e.g., pathology, radiology). For a condom, "ground truth" would relate to its physical properties and effectiveness, which are measured through standardized tests, not expert consensus in the same way. The documents do not describe any expert involvement in establishing ground truth.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

   • Not Applicable / Not Available: Similar to point 3, adjudication methods are relevant for subjective interpretations, often in diagnostic studies. For a physical barrier device like a condom, performance is assessed objectively via standardized tests, not through adjudication of expert opinions. The documents do not mention any adjudication method.

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 Applicable: MRMC studies are used for evaluating diagnostic imaging devices, often involving AI assistance for human readers. This device is a condom, not an AI-assisted diagnostic imaging tool. Therefore, an MRMC study is not relevant or described.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

   • Not Applicable: This question pertains to AI algorithms. The device is a latex condom with spermicidal lubricant, not an algorithm, so a standalone algorithm performance study is not relevant.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

   • Not Available / Not Applicable in the way typically asked for diagnostic devices: For a condom, ground truth would fundamentally be established through standardized physical and chemical testing (e.g., burst strength, freedom from holes, spermicide efficacy testing). The documents do not detail the specific types of ground truth used for performance assessment.

8. The sample size for the training set

   • Not Applicable / Not Available: This question is relevant to machine learning/AI models, which do not apply to this device. Also, the documents do not describe any "training set" for physical product testing.

9. How the ground truth for the training set was established

   • Not Applicable / Not Available: Similar to point 8, this question is for AI/machine learning models and does not apply to this device.

In summary, the provided FDA 510(k) clearance documentation for this condom confirms its regulatory status but does not delve into the detailed performance study data, acceptance criteria, or methodology that would be expected for a comprehensive technical report. Such information would typically be found in the manufacturer's internal test reports or the complete 510(k) submission, which is not provided here.

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