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Mega Big Boy condom is used for contraceptive and prophylactic purpose (to help prevent pregnancy, HIV/ADS and the transmission of sexually transmitted infections).

This condom is made of a natural rubber latex sheath, which completely covers the penis with a closely fitted membrane. This condom is smooth surface, flared at the closed end with reservoir tip, silicone lubricated condom with nominal length 200 mm, nominal flat width 57 mm, and nominal thickness of 0.065 mm. The air burst pressure is > 1 kPa and air burst volume is > 19 dm3. It is lubricated with silicone (viscosity 350 cps) and cornstarch is used as a dressing material. This condom conforms to current established national standard ASTM D3492: 2008.

The provided text is a 510(k) summary for a male latex condom called "Mega Big Boy Condom." It does not describe a study involving an AI/Machine Learning device or a diagnostic/screening technology. Therefore, I cannot extract the information required to populate the requested sections about acceptance criteria, study design, ground truth establishment, or human-in-the-loop performance, as this type of information is not present in the provided document.

The document focuses on demonstrating substantial equivalence of the "Mega Big Boy Condom" to a predicate device (TROJAN EXTRA LARGE LATEX CONDOM) based on technological characteristics and performance standards for condoms (e.g., air burst pressure, air burst volume, shelf life, biocompatibility testing).

Therefore, I must state that the requested information (acceptance criteria for an AI device, study details for its performance, expert adjudication, etc.) cannot be extracted from the provided text.

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