(59 days)
The exGraft and exGraft Carbon ePTFE Vascular Grafts are indicated for use as vascular prostheses. exGraft and exGraft Carbon ePTFE Vascular Grafts are intended for use as vascular prostheses for replacement or bypass of diseased vessels in patients suffering occlusive or aneurysmal diseases, in trauma patients requiring vascular replacement, for dialysis access, or for other vascular procedures.
The exGraft and exGraft Carbon ePTFE Vascular Grafts are single use sterile vascular grafts constructed of expanded polytetrafluoroethylene (ePTFE) with a radiopaque ink applied to the surface. The exGraft Carbon ePTFE vascular grafts also contain a carbon coating impregnated into the inner surface of the graft wall.
I am sorry, but the provided text from the FDA 510(k) notification for the exGraft and exGraft Carbon ePTFE Vascular Grafts does not contain the information necessary to describe acceptance criteria or a study proving the device meets those criteria, specifically concerning performance data related to AI/algorithm performance.
The document is a 510(k) clearance letter and summary for a vascular graft, which is a physical medical device, not a software or AI-based device. Therefore, it does not involve AI performance metrics, expert adjudication for ground truth, MRMC studies, or training/test sets as would be relevant for an AI/ML device.
The "Performance Data" section (VII) in the 510(k) Summary explicitly states: "The proposed exGraft and exGraft Carbon ePTFE Vascular Grafts utilize the same performance data as the exGraft and exGraft Carbon ePTFE Vascular Grafts cleared under K202471. Additional nonclinical data related to packaging, shelf life and sterilization was provided to support substantial equivalence." This indicates that the performance data refers to the physical characteristics and safety/efficacy of the vascular graft itself, not an AI algorithm.
Therefore, I cannot provide the requested information based on the given input.
§ 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.”