医学图像质量控制标准验证方法及工具研究

    Research on Verification Methods and Tools for Medical Image Quality Control Standards

    • 摘要: 为解决人工智能医疗器械领域涉及图像质量控制的相关标准的验证问题,选取相关标准对象,研究标准验证的方法,通过标准文本评审、关键要素提取,对关键要素进行测试验证,分析测试结果等标准验证工作,最终给出标准验证结论。并提出验证测试工具的架构,开发相应的验证测试工具。根据标准对象提取医学图像质量作为验证要素,选择图像分割模型作为测试对象。获取基础数据集,并通过技术手段对数据集进行处理,改变数据集的质量,获得不同质量的数据集,作为模型测试的输入。输入不同的数据集分别进行模型测试,分析Dice系数、Jaccard系数、Hausdorff和ASD距离等模型测试的评价指标结果。评价指标结果显示,不同质量数据集对于模型评价结果有影响,由此得出验证结论,标准中提出的数据质量要求是科学合理可行的。研究成果可为其他数字基础设施重点领域国际标准的验证提供可行的操作框架。验证测试工具的设计开发方法也可为后续类似需求的研究提供借鉴和指导。

       

      Abstract: In order to solve the verification problem of standards related to image quality control in the field of artificial intelligence medical device, the relevant standard object is selected, the method of standard verification is studied, the framework of verification test tool is proposed, and the corresponding verification test tool is developed. In this paper, the quality of medical image is extracted as the verification factor according to the standard object. The image segmentation model is selected as the test object. The basic data set were obtained, and processed in order to obtain the data set of different quality as the input of the model test. Different data sets were input for model testing. The results of evaluation indexes such as Dice coefficient, Jaccard coefficient, Hausdorff distance and ASD distance were analysed. The evaluation index results show that different quality data sets have an impact on the model evaluation results. Further, the verification conclusion can be drawn that the data quality requirements proposed in the standard are scientific, reasonable and feasible. The research results can provide a feasible operational framework for the verification of international standards in other key areas of digital infrastructure. The design and development method of the verification test tool can also provide reference and guidance for the subsequent research of similar requirements.

       

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