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The Zeus™ Male Condom Applicator facilitates correct positioning (donning) of a male latex condom prior to sexual intercoursc. The condom is used for contraceptive and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted infections).

The Zeus™ Male Condom Applicator is a bell shaped pouch that is open at one end and closed at the other. It is molded from polyethylene plastic. The applicator is designed to hold a latex condom in place for correct donning onto an erect penis. All surfaces and edges of the applicator are rounded to prevent damage to condom. Silicone or water-based lubricant is added to the condom prior to packaging. Approximately 2.5 inches of the condom is unrolled and lies nestled, but not firmly held, within the walls of the applicator. The width of the applicator at the point where the condom is attached is 54mm thus enabling a 52mm (nominal width) condom to be held prior to use without imparting a permanent stretch to the condom. The applicator and condom are packaged and sealed in an aluminum foil wrapper. The applicator and attached condom are removed together from the package prior to use. The user cups the device in either hand and then, during the application process, squeezes the edges of the applicator which forces the sides to bellow-out, and thus opens the attached condom The device is centered over the head of the penis and is lowered to a point that the penis makes contact with the interior condom wall. The user then uses his thumb to unroll the condom from the applicator and onto the penis. The user continues to unroll the bead as far down the penis as possible. The applicator is removed from the penis and discarded (prior to intercourse).

I apologize, but the provided text only describes an "Abbreviated 510(k) Notification for a Male Condom Applicator" and an FDA clearance letter. It does not contain information about a study that proves the device meets specific acceptance criteria in the manner of an AI/ML medical device.

Therefore, I cannot extract the information required for the requested table and descriptions regarding acceptance criteria, study details, sample sizes, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies.

The document describes a physical medical device (condom applicator) and its "technological characteristics" and "stability," but not the performance of an algorithm or AI system.

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