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0.04 Zero Zero Four Male Latex Condom is used for contraceptive and prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted infections).

The 0.04 ZERO ZERO FOUR Male Latex Condom is a natural rubber latex sheath, which completely covers the penis with a closely fitted membrane. The subject condom is smooth surfaced with a reservoir tip, silicone lubricated, with a nominal length of 180 mm, nominal flat width of 54 mm, and nominal thickness of 0.042 mm. This condom conforms to current established national standard ASTM D3492: 2016.

The provided text describes information for a K243584 submission of a male latex condom. However, it does not contain information regarding an AI/ML device or studies proving its performance against acceptance criteria. The acceptance criteria and studies described relate to the physical properties, shelf-life, and biocompatibility of the condom itself, not an AI system.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves an AI device meets the acceptance criteria using the provided text.

Here's what the document does discuss regarding acceptance criteria and performance of the condom:

While the document does not relate to an AI device, here's a breakdown of the condom's acceptance criteria and performance based on the provided text:

1. A table of acceptance criteria and the reported device performance (for the condom):

2. Sample size used for the test set and the data provenance:

• Physical Testing (Airburst, Water Leakage): "Three (3) lots" of condoms were tested. The specific number of condoms within each lot is not provided.
• Shelf Life: Not explicitly stated as a sample size for a test set, but stability was established from "physical testing data" over a 5-year period.
• Biocompatibility: The sample sizes for the specific biocompatibility tests (cytotoxicity, irritation, sensitization, systemic toxicity) are not provided in the summary.
• Data Provenance: Not specified, but generally, such testing is conducted by the manufacturer or a contract lab. The country of origin for the data is not mentioned. The data is retrospective in the sense that it's reported after the tests were performed.

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):

• This is not applicable as the studies relate to physical and biological testing of a condom, not the performance of an AI system where expert-established ground truth would be required. The "ground truth" here is objective measurements against established international and national standards.

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

• Not applicable as this is not an AI/ML study involving human readers.

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 as this is not an AI/ML comparative effectiveness study.

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

• Not applicable as this is not an AI/ML device.

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

• For physical tests (Air Burst, Water Leakage), the ground truth is established by objective measurements against quantitative specifications defined in standards like ASTM D3492-16.
• For biocompatibility tests, the ground truth is established by the in vitro and in vivo biological responses observed in standardized tests, interpreted against the criteria of ISO 10993 series standards.

8. The sample size for the training set:

• Not applicable as this is not an AI/ML product. There is no "training set" for a physical device like a condom.

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

• Not applicable as this is not an AI/ML product.

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