(128 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, straight-walled with a contoured-bulbous section near the closed-end, which terminates with a reservoir tip. The condom has a silicone lubricant. 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 uM.
The provided text describes a 510(k) summary for a male latex condom, focusing on its substantial equivalence to predicate devices and its intended use. It does not contain information about specific acceptance criteria or a study proving the device meets those criteria in the format requested.
Therefore, I cannot extract the following information from the provided text:
- A table of acceptance criteria and the reported device performance.
- Sample size used for the test set and the data provenance.
- Number of experts used to establish the ground truth for the test set and their qualifications.
- Adjudication method for the test set.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done and its effect size.
- If a standalone performance study was done.
- The type of ground truth used.
- The sample size for the training set.
- How the ground truth for the training set was established.
The document primarily focuses on the administrative aspects of the 510(k) submission, device description, intended use, and technological characteristics, stating conformance with ASTM standard specifications D-3492 as the basis for substantial equivalence. It does not detail the specific test results or study methodologies that would lead to a "reported device performance."
§ 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.