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The Atrium Advanta™ T-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™ T-Graft use in aortocoronary bypass applications or for use as a patch.

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This document is a 510(k) premarket notification decision letter from the FDA to Atrium Medical Corporation regarding their Atrium Advanta™ T-Graft. It does not contain primary study data or detailed acceptance criteria for the device's performance.

Therefore, I cannot provide the requested information, which includes:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes, data provenance, number of experts, and adjudication methods for a test set.
3. Information on multi-reader multi-case studies or standalone algorithm performance.
4. Type of ground truth used.
5. Sample size and ground truth establishment for a training set.

This document merely confirms that the FDA has reviewed the 510(k) submission and determined the device to be substantially equivalent to legally marketed predicate devices for the stated indications for use. It lists the regulation number, regulation name, and product code, and outlines general regulatory provisions. It does not disclose the specific studies or data submitted to demonstrate substantial equivalence or the acceptance criteria used in those studies.

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