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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).

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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:

1. A table of acceptance criteria and the reported device performance.
2. Sample size used for the test set and the data provenance.
3. Number of experts used to establish the ground truth for the test set and their qualifications.
4. Adjudication method for the test set.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done and its effect size.
6. If a standalone performance study was done.
7. The type of ground truth used.
8. The sample size for the training set.
9. 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."

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