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The TCVS VirtuoSaph™ Endoscopic Vein Harvesting Disposable System has applications in minimally invasive surgery allowing access for endoscopic saphenous vein harvesting (commonly known as EVH) including tissue dissection and vessel harvesting along the saphenous vein for use in coronary artery bypass grafting.

The VirtuoSaph System is composed of a Trocar, two rods: the Dissector Rod (to dissect the saphenous yein (SV) and tributaries), and the Harvesting Rod (to transect and cauterize the branches and allow harvesting of the SV).

This is a 510(k) premarket notification for a medical device called the VirtuoSaph™ Endoscopic Vein Harvesting Disposable System. This type of submission is for demonstrating substantial equivalence to a predicate device, not for proving the device meets acceptance criteria through a clinical study in the way a PMA (Premarket Approval) might require.

Therefore, the provided document does not contain the information requested in points 1-9 regarding acceptance criteria, study details, sample sizes, expert involvement, or adjudication methods for demonstrating device performance against specific metrics.

This document is a regulatory approval notification, and it focuses on:

• Device Identification: Proprietary Name, Common Name, Classification, Product Code.
• Predicate Device: Vaso-View™ Dissection / Vessel Harvesting System and Olympus Endoscopic System for Vessel Harvesting.
• Intended Use/Indications for Use: The device is for minimally invasive endoscopic saphenous vein harvesting (EVH), including tissue dissection and vessel harvesting along the saphenous vein for use in coronary artery bypass grafting.
• Device Description: Composed of a Trocar, a Dissector Rod, and a Harvesting Rod.
• Summary of Comparative Technological Characteristics with Predicate Device: Mentions intended use, system components, target patient population, two-rod system, CO2 delivery, and sterilization method. The document states to "See Section 9.0" for details, but this section is not included in the provided text.
• FDA Clearance: A letter from the FDA stating that the device is substantially equivalent to legally marketed predicate devices.

In summary, the provided document does not contain a study report or data on acceptance criteria and device performance as typically expected from a clinical trial or a more rigorous performance study. The FDA clearance is based on substantial equivalence, not a direct demonstration of meeting predefined acceptance criteria for performance metrics via a detailed study as outlined in your request.

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