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The TROJAN™ Fire & Ice male natural rubber latex condom with lubricant is used for contraception and for prophylactic purposes (to prevent pregnancy and the transmission of sexually transmitted infections).

The TROJAN™ Fire & Ice lubricated male natural rubber latex condom is made of a natural rubber latex sheath, which completely covers the penis with a fitted membrane, and a lubricant applied directly to the exterior of the condom that creates a perception of warming and cooling. The condom is bulbous shaped and smooth (no ribs) with a reservoir tip and meets the specifications of ASTM D3492-16. The condom has a nominal length of 185 mm and a nominal flat width of 54 mm, measured 30 mm from the open end. The bulbous part at the closed end of the condom has a flat width of 65 mm.

This document is a 510(k) Pre-Market Notification from the FDA regarding a new condom (TROJAN™ Fire & Ice lubricated male natural rubber latex condom). It is not a medical AI/software device and therefore does not contain information on acceptance criteria and validation studies for AI/ML algorithms.

The request asks for information relevant to the validation of a medical device software/AI, such as acceptance criteria, study methodologies, sample sizes for training and testing, ground truth establishment, expert qualifications, and MRMC studies. This type of information is found in clearances for AI/ML medical devices, which the provided document is not.

Therefore, I cannot fulfill the request using only the provided text. The document details the clearance of a physical medical device (a condom) and its non-clinical performance testing (physical testing, shelf-life, biocompatibility), which are entirely different from the validation of a software algorithm.

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