(29 days)
The Atrium Graduated Wall Flixene IFG Graft is intended for use in arterial vascular reconstruction, segmental bypass, and for arteriovenous vascular access.
Atrium Graduated Wall Flixene IFG Graft
The provided document is a 510(k) premarket notification letter from the FDA regarding a vascular graft device, not an AI/ML medical device. Therefore, it does not contain the information requested in the prompt, such as acceptance criteria for AI algorithms, sample sizes for test/training sets, expert qualifications, or details about comparative effectiveness studies.
The document discusses the substantial equivalence of the "Atrium Flixene IFG Vascular Graft" to a predicate device and its indications for use in arterial vascular reconstruction, segmental bypass, and arteriovenous vascular access.
To provide the requested information, a document describing a study conducted on an AI/ML medical device would be necessary.
§ 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.”