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The CrossFAST™ Integrated Microcatheter Guide Extension System is intended to be used in conjunction with quide catheters to access discrete regions of the coronary and/or peripheral vasculature, and to facilitate placement of interventional devices.

CrossFAST™ Integrated Microcatheter Guide Extension System (GES) ("Device" or "CrossFAST" (GES") is intended to be used in conjunction with guide catheters to access discrete regions of the coronary and/or peripheral vasculature, and to facilitate placement of interventional devices. It is intended for use in a cardiac catheterization laboratory by physicians trained in percutaneous, intravascular techniques and procedures. CrossFAST™ GES consists of two catheters: an Inner Catheter. The Outer Catheter is intended to act as an extension to a traditional guide catheter (i.e., "guide extension") and to facilitate delivery of interventional devices within the target vasculature. The Inner Catheter is intended to be pre-loaded into the user and to provide additional support to the Outer Catheter during delivery. Once assembled, the Inneyond the Outer Catheter tip. After the Outer Catheter has been delivered to the target vasculature, the Inner Catheter is removed from the passage of interventional devices. The Device is designed for use in vessels larger than 2.5mm and is not for use in the venous system. The Device is single use and provided sterile via Ethylene Oxide (EO) sterilization. The Device is compatible with standard, off-the-shelf 0.014" lumen inner diameter (ID) and minimum 180cm length guidewires and a minimum 100cm length 6F guide is intended for use with a hemostasis valve.

The provided text does not contain information about the acceptance criteria and study proving device performance for a device involving AI or machine learning. The submission is for a "CrossFAST™ Integrated Microcatheter Guide Extension System," which is a physical medical device (catheter) used in interventional procedures. The performance testing outlined is for mechanical, material, and biocompatibility properties of the catheter, not for an algorithm's performance.

Therefore, I cannot provide the requested information regarding AI/ML device acceptance criteria, performance studies, sample sizes, expert qualifications, or ground truth establishment based on the provided text.

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