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AngioDynamics Angiographic Catheters are for use where angiographic diagnosis is indicated.

AngioDynamics Angiographic Catheters are sterile, single use, disposable devices designed to delivery radiopaque contrast media to selected sites in the vascular system.

This document is from a 510(k) premarket notification for AngioDynamics Angiographic Catheters. It describes the device, its intended use, and provides a summary of the studies performed to demonstrate substantial equivalence to predicate devices, but it does not contain information about acceptance criteria or a study proving performance against those criteria in the context of an AI/algorithm-based medical device.

The document is a regulatory submission for physical medical devices (catheters), not a software or AI device. Therefore, the requested information regarding "acceptance criteria and the study that proves the device meets the acceptance criteria" in the context of AI/algorithm performance (e.g., sample size for test sets, ground truth establishment, MRMC studies, standalone performance) is not applicable to this document.

The "Performance Data" section in the document lists non-clinical performance and material testing (e.g., Static Pressure, Tensile, Biocompatibility), which are relevant for physical medical devices, but not for evaluating the performance of an algorithm.

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