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The Elliquence Electrodes are intended for use by a physician familiar with resection, incision, and hemostasis in soft tissue surgical procedures. The types of surgery intended are: General surgery, Laparoscopic procedures, Endoscopic procedures, Open abdominal, Orthopedic coagulation, Thorascopic coagulation, Neurosurgical coagulation, Gynecological coagulation, (except for use in female sterilization), Ear, Nose, Throat coagulation.

The elliguence family of electrodes is a collection of monopolar electrodes which are used in association with an electrosurgical generator, elliquence Surgi-Max (K100390). The electrical power operating at radio frequency (RF) is transferred to tissue at the surgical site via the active tip of the electrode. The time-varying voltage produced by RF electrical power source yields a predetermined electrosurgical effect, such as tissue cutting or coaqulation.

The elliquence electrodes are composed of SUS 303 stainless steel, ABS plastic, TEFLON heat shrink tubing, tungsten, brass alloys, and PFA. The basic design of the electrodes consists of an insulated shaft with an uninsulated active tip.

All elliquence electrodes share the same materials, design principle, and operating principle, but are available in various shaft and tip configurations in order to satisfy different user preferences. There are eight shaft form "families" which vary in length (1.9 cm to 60 cm), shape (straight, angled, bayonet, and curved), diameter (1/16" and 3/32"), and malleability: (1) FlexTrode Malleable Electrodes, (2) Depth Gauge FlexTrodes, (3) Clear-Vu Bayonet Electrodes, (4) Empire microlncision Needle Electrodes, (5) MicroFibre Electrode, (6) Standard Electrode, (7) Medical Electrode, and (8) Surg-e Tip Electrode. The electrode tips are available in three fundamental configurations: (1) loop (round loop, diamond loop, and triangle loop), (2) ball, and (3) blade (fine wire, needle, and spatula).

This document describes the 510(k) premarket notification for Elliquence Electrodes. However, it does not describe a study related to an AI/ML device that has acceptance criteria and performance data in the way requested in the prompt.

The document discusses:

• Device: Elliquence Electrodes, intended for electrosurgical cutting and coagulation.
• Regulatory Pathway: 510(k) substantial equivalence to predicate devices.
• Testing: Primarily non-clinical bench tests (Hipot, Drop, Pull, Lateral heat spread, Bend tests), Biocompatibility (ISO 10993), Electrical Safety (IEC 60601 series), and Sterilization/Shelf Life (ISO 11135-1, ISO 11137-1).
• Key finding: "Clinical testing was not performed for the elliquence electrodes. The elliquence electrodes do not differ from the predicate devices in fundamental scientific technology or intended use."

Therefore, I cannot provide the requested information about acceptance criteria and a study proving the device meets it in the context of an AI/ML device, a test set, expert ground truth, MRMC studies, or training sets, because this document describes a traditional medical device (electrosurgical electrodes) and not an AI/ML-driven diagnostic or assistive device. The "acceptance criteria" here are related to engineering performance, biocompatibility, and electrical safety, not diagnostic performance metrics like sensitivity, specificity, or AUC.

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