Harmonized Technical Standard Test Methods for Quality Evaluation of Medical Fluorescence Endoscopic Imaging Systems

Fluorescence endoscopy technology utilizes a light source of a specific wavelength to excite the fluorescence signals of biological tissues. This capability is extremely valuable for the early detection and precise diagnosis of pathological changes. Identifying a suitable experimental approach and metric for objectively and quantitatively assessing the imaging quality of fluorescence endoscopy is imperative to enhance the image evaluation criteria of fluorescence imaging technology. In this study, we propose a new set of standards for fluorescence endoscopy technology to evaluate the optical performance and image quality of fluorescence imaging objectively and quantitatively. This comprehensive set of standards encompasses fluorescence test models and imaging quality assessment protocols to ensure that the performance of fluorescence endoscopy systems meets the required standards. In addition, it aims to enhance the accuracy and uniformity of the results by standardizing testing procedures. The formulation of pivotal metrics and testing methodologies is anticipated to facilitate direct quantitative comparisons of the performance of fluorescence endoscopy devices. This advancement is expected to foster the harmonization of clinical and preclinical evaluations using fluorescence endoscopy imaging systems, thereby improving diagnostic precision and efficiency.