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The AXS Vecta Intermediate Catheter is indicated for use in facilitating the insertion and guidance of appropriately sized interventional devices into a selected blood vessel in the neurovascular system. The AXS Vecta Internediate Catheter is also indicated for use as a conduit for retrieval devices.

The AXS Vecta 46 Intermediate Catheter is a single lumen, flexible, variable stiffness catheter. It has a radiopaque marker band on the distal end and a Luer hub at the proximal end. The AXS Vecta 46 Intermediate Catheter shaft has a lubricious hydrophilic coating at the distal 25cm) to reduce friction during use. It is packaged with one hemostasis valve, and one peel-away introducer.

The provided text does NOT describe an AI/ML powered medical device, therefore, a detailed response regarding acceptance criteria for such a device, including sample size, expert ground truth, MRMC study, and training set information, cannot be extracted.

The document discusses the substantial equivalence of the AXS Vecta 46 Intermediate Catheter to existing predicate devices. This is a physical medical device (a catheter) and its clearance is based on bench testing (simulated use, burst testing, particulate testing), animal studies, and shelf-life testing, not on AI/ML performance metrics.

Therefore, I cannot fulfill the request to describe the acceptance criteria and study proving an AI/ML device meets acceptance criteria based on this input. The information requested (e.g., number of experts for ground truth, adjudication methods, MRMC studies, training set details) is specific to AI/ML device evaluations and is not relevant or present in this document about a physical catheter.

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