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The CrossCath Support Catheter is intended for use in small vessel or superselective anatomy for diagnostic and interventional procedures, including peripheral use.

CrossCath Support Catheters are single lumen intravascular catheters, designed to support a wire guide during access of vasculature, allow for exchange of wire guides, and provide a conduit for the delivery of saline solutions or diagnostic contrast agents.

CrossCath Support Catheters are available in 12 different configurations. All models have three radiopaque markers spaced equally along the distal shaft to aid in estimating length within the vascular system. The distal radiopaque marker is positioned approximately 3 millimeters from the catheter tip. Each model has a smaller distal portion for passing through smaller vasculature and a larger proximal portion for additional support. The distal 40 to 60 centimeters of each configuration are hydrophilically coated.

I am sorry, but the provided text does not contain the information required to answer your request. The document is a 510(k) premarket notification for a medical device (CrossCath Support Catheter) that focuses on demonstrating substantial equivalence to a predicate device. It describes the device, its intended use, and indicates that testing (specifically flow rate measurement) was performed to support the modification.

However, it does not include any details about acceptance criteria or a study that proves the device meets those criteria in the context of an AI/algorithm-driven device performance study. The questions you've asked (e.g., sample size for test set, number of experts for ground truth, MRMC study, standalone performance, training set details) are highly relevant to the validation of AI/ML-based medical devices, but are not applicable to the traditional 510(k) submission described in this document for a physical catheter.

Therefore, I cannot populate the table or answer the specific questions about device performance validation as requested, as the necessary information is not present in the provided text.

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