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K-Y® Brand Intrigue™ Intense Warming Sensation is intended as a personal lubricant for penile and vaginal application compatible with latex condom.

This device is a personal lubricant compatible with latex condom.

The provided document is a 510(k) Summary for a medical device called "K-Y® Brand Intrigue™ Intense Warming Sensation," which is a personal lubricant. It does not include information about a study involving an AI/algorithmic device with acceptance criteria, ground truth, or expert review in the manner typically described for such technologies.

The performance data mentioned in the document relates to laboratory testing, pre-clinical evaluations, and human use to demonstrate equivalence to a predicate device. This is a very different type of evaluation than what is requested in the prompt for an AI-powered device.

Therefore, I cannot provide the requested information. The document focuses on demonstrating substantial equivalence of a personal lubricant to a legally marketed predicate device based on its physical and performance characteristics, and its safety for human use and compatibility with latex condoms. It does not involve AI or algorithms that would require the specified acceptance criteria and ground truth methodologies.

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