三维超声成像性能试验方法解析

Analysis of Performance Test Methods for Three-Dimensional Ultrasonography

三维超声成像分为三维重建超声成像和实时三维超声成像。三维超声成像比二维超声成像能够提供更加丰富的空间信息,在临床上常用于心肌损伤检测、胸腹部体内肿瘤检测、以及妊娠期胎儿体征评估等方面。三维数据采集方法使用到的有自由臂系统、机械定位系统以及二维面阵探头等。三维超声成像的常见性能指标包括探测深度、盲区、侧向分辨力、轴向分辨力、几何位置精度、三维体积重建偏差等。结合医药行业标准YY/T1279-2015对三维超声成像性能试验的具体操作方法进行图示解析,以期对规范注册申请人注册自检工作、确保相关产品医疗器械注册检验工作有序开展中有所帮助。

Three dimensional ultrasound imaging is divided into three-dimensional reconstruction ultrasound imaging and real-time three-dimensional ultrasound imaging.Three dimensional ultrasound imaging can provide more abundant spatial information than two-dimensional ultrasound imaging,and is often used clinically for detection of myocardial injury,detection of tumors in the chest and abdomen,and evaluation of fetal signs during pregnancy.The data acquisition methods that have been used include free arm systems,mechanical positioning systems,and two-dimensional area array probes.Common performance indicators of 3D ultrasound imaging include detection depth,blind zone,lateral resolution,axial resolution,geometric position accuracy,and 3D volume reconstruction error.Based on the medical industry standard YY/T1279-2015,this paper illustrated the specific operation methods of three-dimensional ultrasonic imaging performance test.It is hoped that it will be helpful in regulating the registration self-inspection of registration applicants and ensuring the orderly development of the registration and inspection of related products and medical devices.