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The Osmanthus and Gobon condom is used for contraception and frunea.chylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted diseases).

This condom is made of a naural rubber latex sheath, which completely covers the penis with a closely fitted membrane. This condom (include a brief description of the vondom, such as, a straight-walled, nipple-end, nominal length, nominal width, nominal thickness, etc]. See Tab 1

The provided text is related to a 510(k) submission for male latex condoms and does not contain information about the acceptance criteria or a study proving the device meets those criteria. The document is essentially a 510(k) summary and the FDA's clearance letter.

Therefore, I cannot extract the requested information as it is not present in the provided text. The document states that the condom has the “same technological characteristics as the predicate condom” and that it is in “conformance with the five Latex Condom Standard D3492”. However, it does not detail:

1. A table of acceptance criteria and the reported device performance: This would typically include specific thresholds for burst pressure, tensile strength, freedom from holes, etc., and the actual values achieved by the device.
2. Sample sizes used for the test set and the data provenance: How many condoms were tested, and where did they come from?
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This is not relevant for a physical device like a condom where ground truth is typically established by laboratory testing against engineering parameters, not expert consensus on images or diagnoses.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Again, not relevant for this type of device testing.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not relevant for this type of device.
6. If a standalone performance (i.e., algorithm only without human-in-the-loop performance) was done: Not relevant as this is not an AI/algorithm-based device.
7. The type of ground truth used: For physical characteristics, ground truth refers to validated measurement methods (e.g., ASTM standards for burst pressure or absence of holes).
8. The sample size for the training set: Not applicable for this type of device; there is no "training set" in the context of AI/ML.
9. How the ground truth for the training set was established: Not applicable.

The document refers to "Latex Condom Standard D3492" but does not elaborate on the specific acceptance criteria within that standard or the study results demonstrating adherence to it.

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