(137 days)
The Love Lockers condom, when properly used, are highly effective against pregnancy although no contraceptive can guarantee 100% effectiveness.
This condom is made of a natural rubber latex sheath, which completely covers the penis with a closely fitted membrane. This condom has the specification as enclosed in Annexure I & IV.
The provided text does not contain information about the acceptance criteria or a study proving that a device meets those criteria. Instead, the document is a 510(k) summary for a "Latex Condom" called "Love Lockers," outlining its classification, predicate device, description, intended use, and technological characteristics. It also includes an FDA clearance letter for the device.
Therefore, I cannot provide the requested table, sample sizes, expert information, adjudication methods, MRMC study details, standalone performance, ground truth types, or training set information as this data is not present in the provided text.
§ 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.