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The VasoView 5 Harvesting Cannula has applications in minimally invasive surgery and is primarily indicated for patients undergoing endoscopic surgery for vessel harvesting. It is indicated for cutting tissue and controlling bleeding through coagulation in general and cardiothoracic surgery including minimally invasive direct coronary artery bypass (MIDCAB), lower extremity and thoracoscopic procedures. Lower extremity procedures include tissue dissection/vessel harvesting along the saphenous vein for use in coronary artery bypass grafting and peripheral artery bypass. Thoracoscopic procedures include exposure and dissection of structures external to the parietal pleura, including nerves, blood vessels and other tissues of the chest wall.

The VasoView 5 Harvesting Cannula is a disposable device designed to perform endoscopic vessel isolation and division of vessel branches. The device has a tubular cannula for introduction of instrumentation into the surgical site with a proximal handle to hold and control the device during procedures. A lumen of the cannula allows insertion of an endoscope for illumination and visualization of the procedure. Opening, closing, extension and retraction of the scissors blades is actuated via controls on the handle.

The provided text is a 510(k) summary for the VasoView™ 5 Harvesting Cannula. It describes the device, its intended use, and its substantial equivalence to predicate devices. However, this document does not contain the specific information required to complete the table or the detailed study information as requested in the prompt.

The document states: "All necessary testing was performed on the VasoView 5 Harvesting Cannula to ensure that the product is substantially equivalent to the predicate devices and to ensure that the modified dimensions do not have a significant effect on safety and effectiveness."

This indicates that testing was done, but the details of the acceptance criteria, reported performance, study methodologies, ground truth establishment, or sample sizes are not provided in this summary.

Therefore, I cannot fill out the requested table and answer the study-related questions based on the provided text.

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