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The TeleMed Systems, Inc. Flexible Endoscopic Scissors are indicated for use for cutting of tissue when used through the working channel of a flexible or rigid endoscope.

The TeleMed Systems Flexible Endoscopic Scissors are reusable, metallic surgical scissors that may be passed through a gastrointestinal endoscope and used to incise tissue.

The provided text is a 510(k) summary for a medical device: "TeleMed Systems Flexible Endoscopic Scissors." This document is a premarket notification to the FDA, asserting substantial equivalence to existing devices.

The critical piece of information here, in the "Safety and Performance" section, explicitly states: "Substantial equivalence for these devices was based solely on design characteristics; no performance or safety data was included in this premarket notification."

This single sentence means that the submission did not include a study to prove the device meets acceptance criteria. Instead, it relied on comparing the design and characteristics of the new device to existing, legally marketed predicate devices.

Therefore, I cannot provide the requested information about acceptance criteria, device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment based on this document, because such studies were not performed or submitted as part of this particular 510(k) notification. The submission focused purely on demonstrating design equivalence to predicate devices.

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