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The NeoGuide Endoscopy System is intended to provide visualization and diagnostic / therapeutic access to the adult lower gastrointestinal tract (including, but not limited to, the anus, rectum, sigmoid colon, colon, cecum and ileocecal valve) for endoscopy and endoscopic surgery.

The NeoGuide colonoscope is manually inserted and withdrawn by the physician, who steers and controls it using the electromechanical controls located at the handle. The colonoscope distal tip is equipped with a CCD camera and fiber optic illumination bundles for procedural illumination and includes a standard tool channel for therapeutic procedures. Valves control insuflation air, water irrigation, and suction. The NeoGuide Colonoscope incorporates fifteen active electro-mechanically controlled segments, not including the tip. During a procedure, the segments shape conforms to the path defined by the physician as the tip is manually steered but electromechanically controlled through the colon lumen. Each of the active segments uses four control cables to articulate in the up/down and left/right directions. This mechanism of action is the same as the mechanism used in conventional colonoscope steerable tips. The NeoGuide Endoscopy System displays a graphical representation of the system interpretation of the tip movements commanded by the physician and the depth of insertion of the colonoscope into the patient.

I am sorry, but the provided text does not contain any information about acceptance criteria, device performance, a study, or any of the other specific details requested. The document is a 510(k) premarket notification summary and an FDA clearance letter for the NeoGuide Endoscopy System.

It describes the device, its intended use, and compares it to predicate devices to establish substantial equivalence. However, it does not include data from a performance study against specific acceptance criteria.

Therefore, I cannot provide the requested information based on the given input.

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