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The Atrium (Wrapped) Advanta™ 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 (Wrapped) Advanta™ Graft use in aortocoronary bypass applications or for use as a patch.

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I am sorry, but the provided text from the FDA 510(k) notification for the Atrium Advanta™ Graft does not contain the information needed to answer the questions about acceptance criteria and a study proving a device meets those criteria.

This document is a letter from the FDA stating that the device is substantially equivalent to legally marketed predicate devices and can be marketed. It defines the "Indications for Use" for the device, but it does not include:

• A table of acceptance criteria and reported device performance.
• Details about a study (sample size, data provenance, ground truth establishment, expert qualifications, adjudication methods).
• Information on MRMC comparative effectiveness studies or standalone algorithm performance.
• Training set details.

The document pertains to regulatory clearance based on substantial equivalence, not a detailed performance study report.

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The Atrium (Wrapped) Advanta™ 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 (Wrapped) Advanta™ Graft use in aortocoronary bypass applications or for use as a patch.

Not Found

I am sorry, but the provided text is a letter from the FDA to Atrium Medical Corporation regarding the 510(k) clearance of the Atrium Advanta™ Graft. This document primarily focuses on regulatory approval based on substantial equivalence to a predicate device and states the indications for use.

It does not contain information about:

1. Acceptance criteria and reported device performance: The letter does not detail the specific performance metrics or thresholds the device needed to meet.
2. Sample size and data provenance for a test set.
3. Number and qualifications of experts for ground truth establishment.
4. Adjudication method.
5. Multi-Reader Multi-Case (MRMC) comparative effectiveness study.
6. Standalone algorithm performance.
7. Type of ground truth used (pathology, outcomes data, etc.) for testing.
8. Sample size for the training set.
9. How ground truth for the training set was established.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the provided text. This document is a regulatory approval letter, not a detailed study report or clinical trial summary.

Ask a specific question about this device