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Neich Modical Creation NM™ Diagnostic Catheters are designed to deliver radiopaque contrast thediturn to selected sites in the vascular system,

Creation NM™ Diagnostic Catheter

This document is a 510(k) clearance letter from the FDA for a diagnostic catheter. It does not contain information about acceptance criteria or a study proving that a device meets acceptance criteria. Therefore, I cannot provide the requested information based on the provided text.

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The Saffron NM™ Guiding Catheter is indicated for use for intravascular introduction of interventional/diagnostic devices into coronary or peripheral vascular systems.

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This document is a 510(k) clearance letter from the FDA for a medical device called the "Saffron NM™ Guiding Catheter." It is not a study demonstrating the device meets acceptance criteria.

The 510(k) process is for demonstrating substantial equivalence to a legally marketed predicate device, not for proving individual performance metrics in the same way a clinical trial for a new drug or a novel AI algorithm would.

Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert ground truth, MRMC studies, standalone performance, and training set information is not present in this document. This letter simply states that the FDA has determined the device is "substantially equivalent" to predicate devices for its stated indications for use.

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