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For use in removing smoke from laser and/or electrosurgical procedures.

Edge Systems Sterile Tubing (Accessory Device Name:

This document is a 510(k) clearance letter from the FDA to Edge Systems Corporation for their "Edge Systems Sterile Tubing" device. It does not contain any information regarding acceptance criteria, device performance studies, or clinical trial data.

Therefore, I cannot fulfill your request for the detailed information outlined (table of acceptance criteria, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth details, or training set size/ground truth establishment).

The document merely states that the device is substantially equivalent to legally marketed predicate devices for its intended use: "For use in removing smoke from laser and/or electrosurgical procedures." This clearance is based on the device meeting general controls provisions and compliance with Good Manufacturing Practice for Medical Devices.

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