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For the percutaneous introduction of various types of cardiovascular catheters to all heart chambers, including the left atrium via transseptal perforation / puncture.

The Thomas Medical Products Inc. 6 French Braided Guiding Introducer(s) are designed to provide a conduit to deliver diagnostic and therapeutic catheters to specific heart chambers and locations in the heart. The sheath may be used for percutaneous entry. Each 6 F Braided Guiding Introducer consists of the following: a sheath, a dilator, and a "J" tip guidewire. In addition, a standard 12 cc syringe, a 18 gage XTW introducer needle, and a pre-dilator may also be packaged with the 6 F Braided Guiding Introducer Kit.

This is a 510(k) summary for a medical device (6 French Braided Guiding Introducer) and not a study describing AI/ML device performance. Therefore, I cannot provide the requested information regarding acceptance criteria and study details as it pertains to AI/ML devices.

The document discusses the substantial equivalence of a new medical device to a legally marketed predicate device, focusing on its intended use and technological characteristics. There is no mention of AI, machine learning, or algorithms, nor does it present any performance data in the context of acceptance criteria for such technologies.

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