(15 days)
The TROJAN® THINTENSITY™ brand male latex condom is used for contraception and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted diseases).
The condoms are made of a natural rubber latex sheath, which completely covers the penis with a closely fitted membrane. The condom is smooth surfaced, straightwalled with a contoured-bulbous section near the closed-end, which terminates with a reservoir tip. The condom design is within the ASTM standard specifications D-3492, e.q., minimum length 160 mm, maximum width 54 mm, and minimum thickness of 30 µM. Each condom is lubricated with either of two varieties of lubricant, ULTRASMOOTH™ lubricant or WARM SENSATIONS™ lubricant.
I am sorry, but the provided text does not contain the detailed information required to describe the acceptance criteria and the study that proves the device meets them for the TROJAN® THINTENSITY™ brand male latex condom.
The document is a 510(k) summary and FDA clearance letter, which primarily focuses on establishing substantial equivalence to a predicate device. It briefly mentions conformance with ASTM standard specifications D-3492, but it does not provide:
- A table of specific acceptance criteria and reported device performance.
- Details about samples size, data provenance, or ground truth establishment for any testing.
- Information regarding expert involvement, adjudication methods, MRMC studies, or standalone algorithm performance.
- Specifics about training sets or how ground truth for training was established.
The document states that the device's technical characteristics are the same as the predicate and that "The condom design is within the ASTM standard specifications D-3492". This implies that adherence to the ASTM standard serves as the primary "proof" of performance for the 510(k) submission, rather than a detailed study report contained within this document.
To obtain the information requested, one would typically need to refer to the ASTM D3492 standard itself, or retrieve detailed test reports submitted as part of the full 510(k) application (which are usually not publicly available in their entirety).
§ 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.