(29 days)
The Atrium 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 Advanta™ Graft use in aortocronary bypass applications or for use as a patch.
Not Found
The provided document is a 510(k) clearance letter from the FDA for the Atrium Advanta™ Graft. It announces that the device has been found substantially equivalent to a legally marketed predicate device.
Crucially, this document is an approval letter, not a study report. It does not contain the detailed information requested regarding acceptance criteria, study performance, sample sizes, ground truth establishment, or expert qualifications. The letter only states that the device is "substantially equivalent" to predicate devices for its stated indications for use.
Therefore, I cannot extract the requested information from this document. To answer your questions, a separate study report or regulatory submission document detailing the device's performance data would be required.
§ 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.”