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医用荧光内镜成像系统质量评价的协调技术标准测试方法

Harmonized technical standard test methods for quality evaluation of medical fluorescence endoscopic imaging systems.

作者信息

Liu Bodong, Guo Zhaojun, Yang Pengfei, Ye Jian'an, He Kunshan, Gao Shen, Chi Chongwei, An Yu, Tian Jie

机构信息

Center for Medical Device Evaluation, National Medical Products Administration, Beijing, 100081, China.

School of Engineering Medicine and School of Biological Science and Medical Engineering, Beihang University, Beijing, 100191, China.

出版信息

Vis Comput Ind Biomed Art. 2025 Jan 10;8(1):2. doi: 10.1186/s42492-024-00184-5.

Abstract

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.

摘要

荧光内镜技术利用特定波长的光源激发生物组织的荧光信号。这种能力对于病变的早期检测和精确诊断极为有价值。确定一种合适的实验方法和指标来客观、定量地评估荧光内镜的成像质量,对于提高荧光成像技术的图像评估标准至关重要。在本研究中,我们提出了一套新的荧光内镜技术标准,以客观、定量地评估荧光成像的光学性能和图像质量。这套全面的标准包括荧光测试模型和成像质量评估方案,以确保荧光内镜系统的性能符合要求的标准。此外,它旨在通过标准化测试程序来提高结果的准确性和一致性。关键指标和测试方法的制定预计将有助于对荧光内镜设备的性能进行直接的定量比较。这一进展有望促进使用荧光内镜成像系统的临床和临床前评估的协调统一,从而提高诊断的准确性和效率。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/1344/11723869/2dc1cc8ee9f5/42492_2024_184_Fig1_HTML.jpg

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