(52 days)
The Durex Condom is used for contraception and for Prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted diseases).
This condom is made of a natural rubber latex sheath, which completely covers the penis with a closely fitted membrane. This condom is nipple-ended with minimal dimensions of Width: 52 mm, Length: 160 mm min., Thickness: 0.03 mm min.
This document is a 510(k) summary for a Durex Lubragel Male Latex Condom and does not contain information about the acceptance criteria or a study proving that a device meets those criteria. It is a notification of intent to market a medical device, asserting substantial equivalence to a predicate device.
Therefore, I cannot provide the requested table and study details.
Here's why the provided text doesn't contain the requested information:
- Type of Document: This is a 510(k) premarket notification. Its primary purpose is to demonstrate that a new device is "substantially equivalent" to a legally marketed predicate device, not to present a comprehensive study proving specific performance acceptance criteria for a novel device.
- Focus on Equivalence: The document explicitly states that the device "has the same technological characteristics as the predicate device," "has the same dimensions, the same physical properties, is manufactured on identical manufacturing equipment utilizing the same raw materials and formulation." The only difference noted is the substitution of an alternative lubricant.
- No Performance Study Details: There is no mention of a performance study with a test set, ground truth, experts, or sample sizes. The claim for the device's performance relies on its similarity to the predicate device and conformance with ASTM standards.
- No AI Component: The request specifically asks about "human readers improve with AI vs without AI assistance" and "standalone (i.e. algorithm only without human-in-the-loop performance)." This document describes a physical medical device (a condom) and has no AI component.
§ 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.