(90 days)
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.
§ 884.5300 Condom.
(a)
Identification. A condom is a sheath which completely covers the penis with a closely fitting membrane. The condom is used for contraceptive and for prophylactic purposes (preventing transmission of sexually transmitted infections). The device may also be used to collect semen to aid in the diagnosis of infertility.(b)
Classification. (1) Class II (special controls) for condoms made of materials other than natural rubber latex, including natural membrane (skin) or synthetic.(2) Class II (special controls) for natural rubber latex condoms. The guidance document entitled “Class II Special Controls Guidance Document: Labeling for Natural Rubber Latex Condoms Classified Under 21 CFR 884.5300” will serve as the special control. See § 884.1(e) for the availability of this guidance document.