Guidance for Performance Evaluation for Fluorescence Guided Surgery Systems

Evaluation for Fluorescence Guided Surgery Systems

Abstract

The last decade has seen a large growth in fluorescence guided surgery (FGS) imaging and interventions. With the increasing number of clinical specialties implementing FGS, the range of systems with radically different physical designs, image processing approaches and performance requirements is expanding.  This variety of systems makes it nearly impossible to specify uniform performance goals, yet at the same time, utilization of different devices in clinical trials indicates some need for common knowledge bases and a quality assessment paradigm to ensure that effective translation occurs. It is feasible to identify key fundamental image quality characteristics and corresponding objective test methods that should be determined such that there are consistent conventions across a variety of FGS devices.  This report outlines test methods, tissue simulating phantoms and suggested guidelines, as well as personnel needs and professional knowledge bases that can be established.  This report frames the issues with guidance and feedback from related societies and agencies having vested interest in the outcome, coming from an independent scientific group formed from academics and international federal agencies for the establishment of these professional guidelines.