(131 days)
The exGraft and exGraft Carbon ePTFE Vascular Grafts are indicated for use as vascular prostheses.
The exGraft and exGraft Carbon ePTFE Vascular Grafts are intended for use as subcutaneous arteriovenous conduits for blood access, bypass, or reconstruction of peripheral arterial blood vessels.
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 outer surface. The exGraft Carbon ePTFE vascular grafts also contain a carbon coating impregnated into the inner surface of the graft wall.
The provided text describes the 510(k) summary for the exGraft and exGraft Carbon ePTFE Vascular Grafts. While it details the device and its comparison to predicate devices, it does not contain information about a study involving AI or human readers for diagnostic purposes.
The performance data section outlines:
- Biocompatibility Evaluation: Conducted according to ISO 10993-1, including tests for cytotoxicity, sensitization, irritation, acute systemic toxicity, material-mediated pyrogen testing, implantation, and hemocompatibility. It also mentions chemical characterization and toxicological risk assessment for subacute/subchronic systemic toxicity, chronic systemic toxicity, genotoxicity, and carcinogenicity.
- Bench Testing: Included probe burst strength, suture retention strength, longitudinal tensile strength, circumferential tensile strength, water entry pressure, microscopic porosity, strength after repeated puncture, kink radius, ink thickness, accelerated ink wear, and MRI safety evaluation.
Therefore, I cannot provide the requested information regarding acceptance criteria, study details, sample sizes, expert involvement, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details because this information is not present in the provided document.
The document describes the physical and chemical testing of a vascular graft device, not the performance of a diagnostic AI system.
§ 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.”