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The Karl Storz Video Lower G.I. Endoscope System is intended to be used by physician / endoscopist in the visual examination and treatment of the lower digestive tract including the anus, rectum, colon and ileocecal valve. The Karl Storz Video Lower G.I. Endoscope System is intended to provide optical visualization via a video monitor and therapeutic access to the lower digestive tract.

The Karl Storz Video Lower G.I. Endoscope System includes flexible endoscopes with distal-CCD chip technology which connects to the Karl Storz Camera Control Processor treatment of the lower digestive tract. The flexible video endoscopes contain an image module, air/water insufflation, jet nozzle, suction, and illumination light and biopsy channels. The Karl Storz Video Lower G.I. Endoscope System is a Class II device under 21CFR876.1500, Endoscope and accessories.

This appears to be a 510(k) summary for a medical device submitted to the FDA, specifically for the Karl Storz Video Lower G.I. Endoscope System.

Based on the provided text, there is no information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert involvement, or multi-reader multi-case studies.

The document primarily focuses on:

• Applicant and contact information.
• Device identification (common name, trade name, indication for use).
• Device description (flexible endoscopes with distal-CCD chip technology, image module, air/water insufflation, jet nozzle, suction, illumination light, and biopsy channels).
• Regulatory classification (Class II, 21CFR876.1500).
• FDA's substantial equivalence determination letter.

Therefore, I cannot provide the requested information as it is not present in the given text.

Medical devices like endoscopes typically have performance criteria related to optics (resolution, field of view, illumination), mechanical properties (insertion tube flexibility, angulation, working channel dimensions), and electrical safety. However, these specific details or any studies validating them are not described in this 510(k) summary. The FDA's substantial equivalence determination is based on the device being similar enough to a previously cleared predicate device, implying its safety and effectiveness are comparable without necessarily requiring new clinical performance studies for every aspect.

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