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Synthetic Polyisoprene Lubricated Male Condom - 5 Senses is used for contraception and for prophylactic purposes to help reduce the risk of pregnancy and the transmission of sexually transmitted infections (STI's).

The Synthetic Polyisoprene Lubricated Male Condom – 5 Senses is a male contraceptive and prophylactic device made from synthetic rubber polyisoprene latex with a lubricant coating containing silicone gel with flavor and sensate. The subject condom is provided in a variety pack which includes three variants; Cooling, Tingling, and Warming.

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 190±10mm, width 53±2mm, and thickness 0.065-0.075mm. The condom is designed to conform to the requirements of ISO 23409:2011. This product has a 3-year shelf-life.

The provided text is related to the FDA 510(k) premarket notification for a medical device: "Synthetic Polyisoprene Lubricated Male Condom - 5 Senses." It describes the device, its intended use, comparison to a predicate device, and performance data.

However, the document does not contain any information about an AI/ML device, nor does it mention anything related to acceptance criteria for an AI/ML model, a study proving an AI/ML device meets acceptance criteria, sample sizes for test or training sets for AI, expert involvement in ground truth establishment for AI, or MRMC studies for AI.

Therefore, I cannot fulfill your request for information related to an AI/ML device's acceptance criteria and study data based on the provided text.

The closest relevant information from the document pertains to device performance testing for a physical medical device (condom):

• Performance Testing Standards: ISO 23409:2011 ("Male Condoms - Requirements and test methods for condoms made from synthetic materials") and the FDA Guidance Document, "Testing guidance for Male Condoms Made from New Material (Non-Latex)."
• Performance Results: "Results of testing showed that the mechanical properties of the subject device were equivalent to the predicate device."
• Shelf-life testing: Demonstrated a three-year shelf-life, including assessment of mechanical burst properties.
• Biocompatibility Testing: Conducted in accordance with ISO 10993-1, including Cytotoxicity, Sensitization, Irritation (Dermal, Vaginal, Penile in Rabbits), and Acute Systemic Toxicity tests.

This information is for a physical product, not a software or AI/ML device.

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