(29 days)
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 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:
- Acceptance criteria and reported device performance: The letter does not detail the specific performance metrics or thresholds the device needed to meet.
- Sample size and data provenance for a test set.
- Number and qualifications of experts for ground truth establishment.
- Adjudication method.
- Multi-Reader Multi-Case (MRMC) comparative effectiveness study.
- Standalone algorithm performance.
- Type of ground truth used (pathology, outcomes data, etc.) for testing.
- Sample size for the training set.
- 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.
§ 870.3450 Vascular graft prosthesis.
(a)
Identification. A vascular graft prosthesis is an implanted device intended to repair, replace, or bypass sections of native or artificial vessels, excluding coronary or cerebral vasculature, and to provide vascular access. It is commonly constructed of materials such as polyethylene terephthalate and polytetrafluoroethylene, and it may be coated with a biological coating, such as albumin or collagen, or a synthetic coating, such as silicone. The graft structure itself is not made of materials of animal origin, including human umbilical cords.(b)
Classification. Class II (special controls). The special control for this device is the FDA guidance document entitled “Guidance Document for Vascular Prostheses 510(k) Submissions.”