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ArtiSential Laparoscopic Instruments-Electrodes, Monopolar Series (Hand-controlled) are indicated for cutting and coagulation in endoscopic, gynecological, and general abdominal and thoracic and general laparoscopic procedures.

It uses the principle of applying high-frequency currents from the electrode to the human body to generate heat by bioimpedance when radio frequency (RF) energy from the electrosurgical unit applies an electric current to the electrode part, and using the generated heat to incise cellular tissues and cause coagulation. It is composed of a end-tip, Φ5, Φ8 diameter shaft, grip part, and electrosurgical unit connection electrode plug.

The provided text is a 510(k) summary for the ArtiSential Laparoscopic Instruments-Electrodes. This document describes the device, its intended use, and its substantial equivalence to a predicate device. However, it does not contain information about acceptance criteria and study results for device performance related to a diagnostic or AI-powered medical device.

The document primarily focuses on the physical and functional aspects of the laparoscopic instruments. Specifically, it mentions:

• Principles of operation: How the device uses high-frequency currents for cutting and coagulation.
• Components: End-tip, shaft, grip part, electrosurgical unit connection electrode plug.
• Minor differences from predicate: COAG/CUT button, cable, and connector.
• Non-Clinical and/or Clinical Tests: Thermal spread testing (in accordance with FDA guidance) and Trocar Compatibility Testing (in accordance with FDA Usability guidance).

Because the device is an electrosurgical instrument and not an AI-powered diagnostic tool, the typical "acceptance criteria" and "study proving the device meets the acceptance criteria" as described in your prompt (e.g., related to sensitivity, specificity, human reader improvement with AI assistance, ground truth establishment) are not applicable to this type of medical device submission.

Therefore, I cannot extract the information requested in your prompt based on the provided text. The document confirms the device's classification as Class II, product code GEI (Electrosurgical Cutting And Coagulation Device And Accessories), and its substantial equivalence to a predicate device (K230498). The studies performed (thermal spread and trocar compatibility) are standard for this type of device to demonstrate safety and effectiveness for surgical use.

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