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The SENDERO MAX Delivery Catheter is intended for the peripheral vasculature for the infusion of diagnostic and therapeutic agents.

The SENDERO MAX Delivery Catheter is a single lumen, variable stiffness catheter with a radiopaque marker on the shaped distal end and a Luer-lock hub on the proximal end. A hydrophilic coating on the catheter shaft reduces friction during navigation through the vasculature. The device is delivered to the target location using standard interventional techniques (e.g. use of guide wire, etc.) under fluoroscopic guidance. Once at the target location, the lumen of the device allows for the introduction of diagnostic and therapeutic agents into the peripheral vasculature.

This document is a 510(k) summary for the SENDERO MAX Delivery Catheter, a medical device. It describes the device's indications for use, technological characteristics, and performance testing conducted to demonstrate its substantial equivalence to a predicate device. This type of document is a regulatory submission to the FDA, not a study report. Therefore, it does not contain the information required to answer your specific questions about acceptance criteria for an AI/CADe device or a study proving its performance.

The questions you've asked (about acceptance criteria, sample sizes, ground truth, experts, MRMC studies, standalone performance, and training sets) are typically relevant for AI/CADe devices or clinical studies used to prove the performance and safety of a device.

This document pertains to a physical medical device, specifically a catheter, not an AI or software device. The "performance testing" described (dimensional, coating, burst pressure, tensile strength, etc.) are standard engineering and material tests for physical medical devices to ensure they meet design specifications and regulatory requirements.

Therefore, it is not possible to answer your questions using the provided document because the device described is a physical catheter, not an AI/CADe device, and the document is a regulatory summary, not a clinical study report.

The document states: "No clinical studies were required." This further confirms that this submission does not contain the kind of study data you are asking about for AI/CADe performance.

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