Search Results

The TROJAN® PASSION BERRY™ Gel patient lubricant is a device intended for medical purposes that is used to lubricate a body orifice to facilitate entry of a diagnostic or therapeutic device. The TROJAN® PASSION BERRY™ Gel is principally designed to help enhance the sexual experience by providing supplemental vaginal lubrication during sexual intercourse. The TROJAN® PASSION BERRY™ Gel may be used with condoms.

The TROJAN® PASSION BERRYTM Gel personal lubricant is formulated as a clear, high viscosity gel with a pink color and lubricant is lonnalise as agrance and packaged in a clear plastic 2.5 oz. tube.

The provided text is a 510(k) summary and an FDA clearance letter for a personal lubricant. It does NOT contain information about a study with acceptance criteria and device performance as typically understood for AI/ML medical devices. The document explains that the device is substantially equivalent to legally marketed predicate devices, which is the basis for its clearance, rather than proving performance against specific acceptance criteria through a clinical or algorithmic study.

Therefore, I cannot fulfill the request as it pertains to AI/ML device studies, acceptance criteria, and ground truth establishment, because the provided input document does not contain this information.

Specifically, the document focuses on:

• Predicate Device Equivalence: The primary method for clearance is demonstrating substantial equivalence to pre-amendment devices or previously cleared devices (H•R® Lubricating Jelly and TROJAN® FOR WOMEN Personal Lubricant). This typically involves comparing characteristics like intended use, technological characteristics, and safety and effectiveness profiles, rather than setting and meeting performance metrics from a new study.
• Device Description and Intended Use: Information is provided on the physical properties and intended use (supplemental vaginal lubrication during sexual intercourse, compatible with condoms).
• Regulatory Classification: The device is classified under 21 CFR §884.5300 as a Condom (later reclassified as Patient Lubricant [21 CFR §880.6375] in the summary).

The request's points, such as "sample size used for the test set," "number of experts used to establish the ground truth," "adjudication method," "multi reader multi case (MRMC) comparative effectiveness study," and "standalone performance," are all highly relevant to the evaluation of AI/ML-driven medical devices. However, this type of data is not applicable to the clearance pathway described in the provided document for a personal lubricant.

Ask a specific question about this device