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The VES 3001-m use is indicated whenever video display from an endoscope is required for more convenient viewing.

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The provided text is a 510(k) clearance letter from the FDA for a device called "VES 3001-M Complete Video Endoscopic System". This letter primarily addresses the regulatory clearance of the device and does not contain detailed information about acceptance criteria or performance studies as typically requested for AI/ML-driven devices.

Therefore, I cannot extract the requested information regarding acceptance criteria, study details, sample sizes, expert qualifications, or ground truth establishment from this document. The document confirms that the device is "substantially equivalent" to predicate devices, but does not provide specific performance metrics or the studies that would demonstrate them.

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