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The LifeStyles® Zero® condom is used for contraception and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted diseases).

This condom is made of a natural rubber latex sheath, which completely covers the penis with a closely fitted membrane. The device is a straight-walled, cylindrical, lubricated condom with a reservoir tip. The device is designed to conform to the specifications of ASTM D3492, Standard Specification for Rubber Contraceptives (Male Condoms) and is provided in a foil package.

The provided text is a 510(k) summary for a medical device (condom) seeking substantial equivalence to a predicate device. It does not describe an AI/ML powered device, and therefore the information requested in the prompt (acceptance criteria, study details, human reader improvement, standalone performance, ground truth, training set size, etc.) is not present in the document.

The document focuses on comparing the new device's technical characteristics with a predicate device to demonstrate substantial equivalence, rather than providing performance metrics against specific acceptance criteria for an AI/ML algorithm.

Therefore, I cannot fulfill your request using the provided input.

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