(202 days)
Indicated for extra anatomical vascular repair, primarily for axillo-femoral bypass and femoro- popliteal reconstruction.
Gelsoft Plus ERS grafts are an externally reinforced (ERS), gelatin-sealed, knitted polyester grafts.
Vascutek's polyester vascular prosthesis family is based on a polyester textile technology. The starting point for all products is polyester yarn. This is fabricated into tubular form by knitting. This is referred to as the base fabric and exists in a variety of designs to meet particular end uses. Further processing is designed to retain the tubular form of the graft e.g. crimping and addition of an external polypropylene support. In Gelsoft Plus ERS, this external polypropylene support is to provide kink resistance and a smooth flow surface for extra-anatomical applications. The polypropylene support may be peeled where it extends to the ends of the prosthesis, in order to facilitate the fashioning of the anastomosis. Additional branches are also attached in a variety of configurations. The last process is impregnation with a bovine derived gelatin sealant. This process fills the gaps between threads of the polyester base graft and eliminates the need for pre-clotting of the graft prior to implant.
The provided text is a 510(k) summary for the Vascutek Gelsoft Plus ERS Vascular Graft. This document outlines the device's characteristics, intended use, and claims of substantial equivalence to a predicate device. However, it does not describe a study involving AI, human readers, or image analysis for detection or diagnostic purposes.
The section "The nonclinical testing performed, including physical bench, biocompatibility, chemical characterisation and an animal performance study, have demonstrated that the device is substantially equivalent to the predicate device" refers to engineering and animal studies to demonstrate the physical and biological properties of the vascular graft itself, not a performance study of a diagnostic AI system.
Therefore, the information required to answer the requested questions about acceptance criteria for an AI device performance, sample sizes, ground truth establishment, expert adjudication, or MRMC studies for AI is not present in the provided text.
Based on the provided text, the device is a vascular graft, not an AI-powered diagnostic device. The acceptance criteria and studies described relate to the physical and biological performance of the graft material, not an AI's diagnostic performance.
§ 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.”