中国医疗设备2024，Vol.39Issue(7)：90-94,5.DOI:10.3969/j.issn.1674-1633.2024.07.015
基于真实世界证据量化医用超声探头性能评价指标的研究
Study on Quantifying Performance Evaluation Indexes of Medical Ultrasonic Probes Based on Real-World Evidence
摘要
Abstract
Objective To test and quantify the performance parameters of different brands and models of ultrasonic probes,and to obtain quantifiable performance evaluation indexes of ultrasonic probes.Methods A total of 198 cases of ultrasonic probes were tested with ProbeHunter Lite portable testing equipment.The performance parameters of the collected probe data were analyzed statistically,and the quantifiable parameters affecting the performance of the ultrasonic probe were obtained.Results By analyzing the data of 198 ultrasonic probes,it was concluded that sensitivity was the key index that affects the performance of ultrasonic probes.The quantified index parameters were as follows:the sensitivity boundary between acceptable and weak ones was 0.60,and the sensitivity boundary between weak and invalid ones was 0.12.The test results showed that the state of the measured ultrasonic probe was consistent with the actual clinical application,and better than the relative index parameters suggested in the probe test system manual.Conclusion The quantifiable parameters of the ultrasonic probe performance evaluation index are obtained through the analysis of the performance test parameters of different brands and models of ultrasonic probes,which provides a reference for the performance evaluation and acceptance criteria of ultrasonic probes.关键词
超声探头/性能指标/可量化/真实世界证据Key words
ultrasonic probe/performance evaluation/quantifiable/real-world evidence分类
医药卫生引用本文复制引用
万伟权,王浩文,王婷婷,齐宏亮,陈宏文..基于真实世界证据量化医用超声探头性能评价指标的研究[J].中国医疗设备,2024,39(7):90-94,5.基金项目
国家重点研发计划项目(2019YFC0121908) （2019YFC0121908）
广东省科技计划项目(2017ZC0068) （2017ZC0068）
广东省自然科学基金(2017ZC0069) （2017ZC0069）
国家卫生健康委员会医院管理研究所项目(20210322) （20210322）
广东省医学会医学工程学分会青委会科研课题(2022-GDMAZZ-12). （2022-GDMAZZ-12）
