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
万伟权 1王浩文 1王婷婷 1齐宏亮 1陈宏文1
作者信息
- 1. 南方医科大学南方医院 医学工程科,广东 广州 510515
- 折叠
摘要
目的 为了测试及量化不同品牌型号的超声探头性能参数,得到可量化的超声探头性能评价指标.方法 使用ProbeHunter Lite便携式测试设备对198例超声探头进行测试,对所收集探头测试数据的性能参数进行统计分析,得出影响超声探头性能关键指标的可量化参数.结果 通过分析198例超声探头数据得出灵敏度是影响超声探头性能的关键性指标,其量化指标参数为:可接受晶元与较弱晶元的灵敏度分界值为0.60,较弱晶元与无效晶元的灵敏度分界值为0.12;测试结果表明所测超声探头状态与实际临床应用表现相符,优于探头测试系统手册上建议的相对化指标参数.结论 本研究通过对不同品牌型号超声探头进行性能测试参数的分析研究,得出了超声探头性能评价指标的可量化参数,为超声探头的性能评价以及验收标准提供了参考依据.
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引用本文复制引用
基金项目
国家重点研发计划项目(2019YFC0121908)
广东省科技计划项目(2017ZC0068)
广东省自然科学基金(2017ZC0069)
国家卫生健康委员会医院管理研究所项目(20210322)
广东省医学会医学工程学分会青委会科研课题(2022-GDMAZZ-12)
出版年
2024
国家科技期刊平台
NSTL
万方数据