Search Results

The Atrium Advanta™ SST Bifurcated Graft is intended for use in arterial vascular reconstruction, segmental bypass, and for arteriovenous vascular access. Insufficient data is available at this time to support Atrium Advanta™ SST Bifurcated Graft use in aortocoronary bypass applications or for use as a patch.

Not Found

This document is an FDA 510(k) clearance letter for a medical device called the "Atrium Advanta™ SST Bifurcated Graft." It does not contain information about acceptance criteria, device performance studies, or details relevant to AI/ML device evaluations.

The letter explicitly states: "We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976..."

This indicates that the clearance is based on substantial equivalence to a predicate device, not on a new study proving specific acceptance criteria for performance. The 510(k) process typically relies on demonstrating that a new device is as safe and effective as a legally marketed predicate device, rather than requiring extensive clinical trials or performance studies with predefined acceptance criteria as would be expected for a novel AI/ML device.

Therefore, I cannot provide the requested information based on the provided text. The document is a regulatory clearance notice and does not include the technical study details you are asking for.

Ask a specific question about this device