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Polyisoprene Extra Large Condoms are used for contraception and for prophylactic purposes to help reduce the risk of pregnancy and the transmission of sexually transmitted infections (STIs).

The Polyisoprene Extra Large Condom is a male contraceptive prophylactic device made from synthetic polyisoprene rubber latex with a lubricant coating containing silicone gel with fragrance oil. The fragrance oil acts as a masking agent to minimize odor originated from the condom substrate. The condom is a fitted sheath with an integral ring at the open end and a reservoir (nipple end) at the closed end to contain semen. The condom dimensions are length 200 ± 10mm, width 60 ± 2mm, and thickness 0.070 ± 0.01mm. The condom is designed to conform to the requirements of ISO 23409:2011. This product has a 5-year shelf-life.

The provided text pertains to the 510(k) premarket notification for a medical device (Polyisoprene Extra Large Condom) and does not describe AI/ML device performance or the specific criteria and studies typically associated with such devices (e.g., studies involving human readers, ground truth establishment by experts, or training set details). The document focuses on demonstrating the substantial equivalence of the new condom to a predicate device, primarily through non-clinical performance testing and leveraging clinical testing from the predicate device.

Therefore, I cannot extract the information required to populate a table of acceptance criteria and reported device performance or answer questions regarding MRMC studies, standalone AI performance, and specifics of training/test sets as these concepts do not apply to the provided medical device submission for a condom.

The document discusses:

• Acceptance Criteria for the condom: Primarily adherence to ISO standards (ISO 23409:2011, ISO 4074:2015) for physical properties (dimensions, tensile strength, air burst, etc.), biocompatibility, barrier properties, package integrity, and shelf life.
• Performance Testing for the condom: Non-clinical tests were conducted to demonstrate compliance with the above standards and non-inferiority to natural rubber latex condoms in mechanical properties.
• Clinical Performance Testing: Leveraged from the predicate device, which demonstrated non-inferiority in breakage and slippage rates compared to a natural rubber latex condom.

Without information on an AI/ML component, the requested details about acceptance criteria, ground truth, sample sizes for AI training/testing, and expert involvement for ground truth establishment are not present in the provided text.

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