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For use during diagnostic and/or surgical procedures when endoscopic video assistance is required.
For use in all types of video assisted minimally invasive procedures including: general surgery, gynecologic, thoracic, urologic, bariatric, spinal, ENT and as an aid in visualization of cardiac structures.

The Viking 3DHD Video Camera System consists of camera heads, 3D endoscopes, and a camera controller. The system can be used with commercially available light sources, light cables, 2D endoscopes, couplers, and 2D and 3D video monitors or head mounted displays.

This document is a 510(k) summary for the Viking 3DHD Video Camera System. It states that the device is substantially equivalent to legally marketed predicate devices and does not provide an independent study or specific acceptance criteria for performance metrics of the device itself.

Therefore, the requested information regarding acceptance criteria, a study proving the device meets those criteria, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, and training set details cannot be extracted from the provided text because such information is not present.

The document focuses on demonstrating substantial equivalence to existing devices, which is a regulatory pathway in the U.S. and typically means the new device has the same intended use and technological characteristics as a predicate device, and does not raise new questions of safety and effectiveness. This often relies on comparing the device's characteristics to those of the predicate rather than presenting a performance study against predefined acceptance criteria for the new device.

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