(269 days)
Indicated for thoracic reconstruction procedures for replacement of the thoracic aorta in cases of aneurysm, dissection, or coarctation.
Indicated for repair or replacement of damaged and diseased vessels of the abdomen in cases of aneurysmal or occlusive disease.
Indicated for the repair or replacement of damaged and diseased thoracic aorta in cases of aneurysm, dissection or coarctation.
Indicated for repair or replacement of damaged and diseased vessels of the abdomen and thoracic aorta in cases of aneurysm, dissection or coarctation.
Repair or replacement of damaged and diseased vessels of the thoracic aorta in cases of aneurysm, dissection or coarctation.
Gelweave branched vascular prostheses, including Siena™ vascular prostheses can also be used for debranching, i.e. reconstruction of the aortic vessels and associated Hybrid procedures. Hybrid procedures are defined as a treatment combination employing open surgical debranching with endovascular aortic repair.
Gelweave™ vascular prostheses are gelatin sealed woven polyester grafts, designed for vascular repair.
The Vascutek Gelweave polyester vascular graft family, which is the subject of this pre-market notification, is based on woven polyester textile technology.
The provided document is a 510(k) Summary for the Vascutek Gelweave™ Vascular Grafts. It discusses substantial equivalence to previously marketed devices and the non-clinical testing performed. However, it does not contain the specific information required to answer your request regarding acceptance criteria and performance studies of a medical device AI/ML algorithm.
The document pertains to a physical medical device (Gelweave Vascular Grafts) and its material change (new gelatin supplier), not an AI/ML system. Therefore, details like AI model performance, sample sizes for test/training sets, expert ground truth establishment, MRMC studies, or standalone algorithm performance are not applicable and not present in this document.
In summary, none of the requested information to describe the acceptance criteria and study proving device meets the acceptance criteria for an AI/ML device is available in the provided text.
§ 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.”