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The Eclipse 2000™ is intended for use in general surgery, including thoracic and abdominal surgeries. This includes the incision, excision, vaporization or coagulation of soft tissue and firm cartilage:

• . cholecystectomy
• lysis of adhesions .
• herniorrhaphy .
• sessile polyps of the intestine and colon .
• hemorrhoidectomy .
• condyloma .
• appendectomy ●

The Eclipse Model 2000™ laser system is designed to be easy to operate and userfriendly. It features a security keyswitch and simple one-button start-up. Energy output is controlled by the Power thumbwheel adjustment. Energy is delivered through the Eclipse delivery system only when:

• 1. the laser is in Ready mode,
• 2. the Foot Pedal is depressed, and
• 3. the delivery system is properly installed in the laser aperture.

A variety of disposable fiber optic delivery systems in a range of sizes, designs and configurations is available from Eclipse. A fiber optic delivery system must be used to delivery laser energy to the treatment site.

The provided text describes a medical device, the Eclipse Model 2000™ laser system, and its intended use and safety information. However, it does not contain any information about acceptance criteria, device performance, a study conducted to prove performance, sample sizes, ground truth establishment, or any of the other specific details requested in your prompt regarding a study.

Therefore, I cannot fulfill your request for a table of acceptance criteria, study details, or information about MRMC studies, standalone performance, or training set specifics based on the provided text.

The document is a "Summary of Safety and Effectiveness" which typically focuses on the device's design, how it works, and safety precautions, rather than detailed study results for performance metrics against pre-defined acceptance criteria.

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