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The EES 100 with Accessories is intended to deliver argon gas for argon plasma coagulation on tissue when used in conjunction with an Electrosurgical Generator and applicators or probes.

The EES 100 is an expansion system for the electrosurgical unit (ESU). The EES 100 is not a generator. It is designed for the enhanced control of bleeding and the electrosurgical destruction of tissue in multispecialty procedures in the operating room or endoscopy suite. The EES 100 equipped with the argon module is used in combination with a high-frequency generator and an electrosurgical handpiece and the users can select appropriate operation modes: Pulse, Endo or Ar-cut mode to fulfill various argon surgical requirements.

The device consists of four major assemblies integrated into one system: Main Unit, Universal Cart, the Argon Module, Accessories. The EES 100 provides finer maneuverability and fits a variety of surgical equipments, endoscopes and instruments. The Software is equipped in the device. Dispense with setting or modification for the user. Dispense with training before using the device.

This 510(k) summary for the Medrange Corporation's Electrosurgical Expansion System (EES 100) does not contain the information requested in your prompt regarding acceptance criteria and a study proving the device meets those criteria.

Instead, the document focuses on demonstrating substantial equivalence to predicate devices based on intended use, principles of operation, technological characteristics, and functional capabilities. It primarily discusses compliance with various safety and performance standards, but it does not report on a specific study with defined acceptance criteria for the device's performance.

Therefore, I cannot provide a table of acceptance criteria and reported device performance, nor can I answer questions about sample sizes, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies, as this information is absent from the provided text.

Here's a breakdown of what is mentioned in relation to performance and testing:

• Performance Data Section:
  • States: "The Hazard Analysis of the device is in accordance with ISO 14971 Medical Application of Risk Management to Medical Devices."
  • States: "The performance of product has been tested and verified by users." (This is a general statement and does not describe a formal study with acceptance criteria).
  • States: "The Safety of General Requirement, EMC, Software, Usability and Alarm of the device are in compliance with following standards: IEC60601-1, IEC60601-1-2, IEC 60601-1-4, IEC60601-1-6, IEC60601-1-8, And the device is also in compliance with ANSI/AAMI HF18: Standard for Electrosurgical Instruments." (This indicates compliance with standards, not a study proving specific acceptance criteria laid out for the device's performance).

In summary, the provided document focuses on demonstrating that the EES 100 is substantially equivalent to existing, cleared devices by complying with general safety and performance standards for electrosurgical equipment. It does not detail a specific performance study with acceptance criteria as envisioned in your prompt for medical imaging devices or AI-powered diagnostics.

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