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The Microthin Natural Rubber Latex Condom is used for contraception and prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted infections).

The Microthin Natural Rubber Latex Condom is a male contraceptive made of natural rubber latex that completely covers the penis with a closely fitted membrane sheath. The condom is provided lubricated with silicone oil. The condom is straight-walled, with a smooth surface and a reservoir (nipple end) at the closed end to contain semen. The condom dimensions are length 170mm ± 10mm, width 52 ± 2mm, and thickness 0.035mm ± 0.005mm. The condom conforms to the recognized standards ASTM D3492-16 Standard Specification for Rubber Contraceptives (male condoms) and ISO 4074:2015 Natural Rubber Latex Condoms - Requirements and test methods. The condom has a 5-year shelf-life.

The provided text is related to a 510(k) premarket notification for a medical device (Microthin Natural Rubber Latex Condom). It details the device's characteristics, comparison to a predicate device, and summaries of non-clinical performance testing. However, it does not contain information about a study proving the device meets acceptance criteria in the context of an AI/ML powered medical device, which is what your request is specifically asking for.

The request asks for details about:

• A table of acceptance criteria and reported device performance (in the context of AI performance metrics like sensitivity, specificity, AUC).
• Sample size used for the test set and data provenance.
• Number of experts and their qualifications for ground truth establishment.
• Adjudication method for the test set.
• MRMC comparative effectiveness study details.
• Standalone performance.
• Type of ground truth used (e.g., pathology, outcomes data).
• Sample size for the training set.
• How ground truth for the training set was established.

None of this information is present in the provided document, as it is describing a physical product (a condom) and not an AI/ML device.

The document does mention "acceptance criteria" in the context of a physical product's performance validation (e.g., airburst specifications, biocompatibility), but these are not the kind of acceptance criteria you are asking for (which are relevant to AI/ML performance).

Therefore, I cannot fulfill your request for information related to an AI/ML powered medical device study based on the provided text.

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