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3T Medical Systems vessel cannulas are indicated for use during open-heart surgery or in vascular surgery to help check for leaks in a harvested vein which will be used for a graft.

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This document is a 510(k) clearance letter from the FDA for a medical device called "3T Vessel Cannulas." It addresses the regulatory classification and marketing authorization of the device.

Based on the provided text, there is no information regarding the acceptance criteria of the device, any study proving it meets acceptance criteria, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details.

The document is purely a regulatory letter stating that the FDA has determined the device is substantially equivalent to legally marketed predicate devices and can therefore be marketed. It defines the "Indications For Use" but does not provide any performance metrics or study results.

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