(272 days)
Gelweave Vascular Prosthesis (with the exception of Valsalva variant) are indicated for the repair of damaged and diseased vessels of the thoracic and abdominal aorta in cases of aneurysm, dissection or occlusive disease. Branched configurations 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 Valsalva Vascular Prosthesis are indicated for the repair or replacement of damaged and diseased thoracic aorta, such as aortic root replacement in cases of aneurysm or dissection.
Gelweave™ vascular prostheses are gelatin sealed woven polyester prostheses designed for vascular repair. The Gelweave™ polyester vascular prostheses family, which is this pre-market notification, is based on woven polyester textile technology.
The provided document describes the clearance of a medical device, the Gelweave™ Vascular Prostheses, based on substantial equivalence to a predicate device. It does not contain information about the acceptance criteria or a study that proves a device meets specific performance criteria in the context of AI/ML or diagnostic performance evaluation.
Therefore, I cannot extract the requested information (performance metrics, sample sizes, ground truth establishment methods, expert qualifications, adjudication methods, or MRMC study details) from the provided text.
The document states:
- "No clinical testing was necessary to demonstrate substantial equivalence."
- "Nonclinical testing, including bench testing, shelf-life, biocompatibility testing, chemical characterization and an animal performance study, have been conducted to demonstrate equivalency."
This indicates that the clearance was based on non-clinical data and equivalence to an existing device, rather than a study evaluating diagnostic or clinical performance against specific acceptance criteria relevant to AI/ML devices.
§ 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.”