(66 days)
The LifeStyles NRL Textured Condom is used for contraception and prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted infections).
The LifeStyles® NRL Textured Condom is indicated for contraception and for prophylactic purposes (to help reduce the risk of pregnancy and the transmission of sexually transmitted infections). The condom is a single use device made of a noncolored natural rubber latex sheath that covers the penis with a closely fitted membrane. The condom is textured with dots along its straight shaft, includes a reservoir tip at the closed end to contain semen, and is coated with a silicone lubricant. The LifeStyles® NRL Textured Condom has a nominal length of 190 mm, width of 53 mm, and thickness of 0.08 mm. Each condom is packaged individually in laminate foils that are secondarily packaged in cardboard shelf boxes.
The provided text describes the 510(k) premarket notification for a medical device, specifically a condom. It details the device's characteristics, comparison to a predicate device, and non-clinical performance testing. However, the request asks for information related to a study proving a device meets acceptance criteria for an AI/algorithm-based medical device, including details like sample sizes, expert ground truth establishment, MRMC studies, and training set information.
The provided document does not contain any information about an AI/algorithm-based medical device study. The "LifeStyles® NRL Textured Condom" is a physical medical device, not an AI or algorithm-driven one. Therefore, I cannot extract the requested information from the given text as it is not present.
The document discusses:
- Device Name: LifeStyles® NRL Textured Condom
- Regulation: 21 CFR § 884.5300 Condom, Class II
- Performance Testing: Biocompatibility (cytotoxicity, sensitization, irritation, acute systemic toxicity), Physical Property Testing (conformance to ASTM D3492-16 and ISO 4074:2015 for parameters like lubricant quantity, length, width, thickness, burst volume, burst pressure), and Shelf-Life (5 years based on accelerated stability).
These are all standard tests for a physical condom and do not relate to the evaluation of an AI or algorithm.
§ 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.