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The Vista Visualization System is intended for use in endoscopic procedures and all types of video assisted procedures, including general endoscopic and laparoscopic, bariatric, thoracic, anterior and posterior spinal and as an aid in visualization of cardiac structures

The Vista Visualization System is used to allow observation in body cavities, organs, or canals through manmade or natural orifices. It is designed for use in all types of endoscopic and endoscopic assisted procedures including bariatric surgeries. The system consists of the Vista StereoScope System (camera head, endoscope and a camera control unit), and the Head Mounted Display System (HMD with HMD processor). The system is designed to work with commercially available light sources, light guides, and video monitor displays.

I am sorry. The provided text describes a 510(k) summary for a medical device called the Vista Visualization System. This document focuses on the device's intended use, description, and substantial equivalence to predicate devices, but does not contain any information about acceptance criteria, performance studies, sample sizes, ground truth establishment, or expert involvement.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the provided text.

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