标准解读

《T/SCGS 313011-2024 肺癌免疫治疗人工智能辅助决策软件算法性能测试方法》是一项针对肺癌免疫治疗领域中使用的人工智能辅助决策软件的性能测试标准。该标准详细规定了如何对这类软件进行系统性的评估,以确保其在实际应用中的准确性和可靠性。

标准首先明确了适用范围,指出其适用于基于机器学习、深度学习等技术开发的肺癌免疫治疗辅助决策软件产品。接着定义了一系列关键术语和缩略语,为后续内容的理解奠定基础。

在测试方法部分,标准提出了多种评价指标来衡量软件性能,包括但不限于准确性、敏感性、特异性以及预测值等统计学参数。此外,还强调了数据集的选择对于测试结果的重要性,建议采用多中心、多样化的临床数据作为输入,以提高测试结果的普遍适用性。

关于测试流程,标准给出了详细的步骤指导,从准备阶段的数据收集与预处理开始,经过模型训练、验证直至最终的性能评估,每个环节都有具体的操作指南。特别地,标准还提到了需要考虑不同患者群体之间的差异性,在设计实验时应尽可能涵盖广泛的病例类型。

最后,该文件还讨论了一些潜在的影响因素及其控制措施,比如过拟合问题、数据偏倚等,并提供了相应的解决方案或建议。通过遵循这些指导原则,开发者可以更有效地优化自己的AI系统,同时监管机构也能依据此标准对市场上相关产品进行公正合理的审查。


如需获取更多详尽信息,请直接参考下方经官方授权发布的权威标准文档。

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文档简介

ICS01.100.01

CCSJ04

团体标准

T/SCGS313011—2024

肺癌免疫治疗人工智能辅助决策

软件算法性能测试方法

Algorithmperformancetestmethodsforartificialintelligence⁃assisted

decision⁃makingsoftwareforlungcancerimmunotherapy

2024⁃03⁃11发布2024⁃03⁃11实施

中国图学学会发布

中国标准出版社出版

T/SCGS313011—2024

目次

前言··························································································································Ⅲ

1范围·······················································································································1

2规范性引用文件········································································································1

3术语和定义··············································································································1

4测试指标·················································································································3

4.1概述·················································································································3

4.2C⁃Index·············································································································3

4.3Kaplan⁃Meier曲线································································································3

4.4Log⁃rankP·········································································································3

4.5混淆矩阵···········································································································3

4.6准确性··············································································································3

4.7敏感度··············································································································4

4.8特异度··············································································································4

4.9阳性预测值········································································································4

4.10阴性预测值·······································································································4

4.11约登指数··········································································································4

4.12ROC曲线·········································································································4

4.13组间相关性系数·································································································4

4.14Kappa系数·······································································································5

5测试方法·················································································································5

5.1通则·················································································································5

5.2算法应用场景与测试方法······················································································5

5.3算法质量特性与测试方法······················································································5

6测试流程·················································································································6

6.1通则·················································································································6

6.2测试前的准备·····································································································6

6.3测试过程中的记录·······························································································7

6.4测试后的整理·····································································································7

7测试要求·················································································································7

7.1测试环境···········································································································7

7.2测试人员···········································································································7

7.3测试参数···········································································································7

7.4测试数据···········································································································7

T/SCGS313011—2024

7.5测试类型···········································································································9

7.6测试报告···········································································································9

8测试结果的判定······································································································10

8.1通则················································································································10

8.2单个指标测试····································································································10

8.3整体测试··········································································································10

附录A(资料性)常见测试指标的计算公式和使用总结·······················································11

A.1C⁃Index···········································································································11

A.2Log⁃rankP·······································································································11

A.3混淆矩阵·········································································································11

A.4准确性············································································································11

A.5敏感度············································································································11

A.6特异度············································································································12

A.7阳性预测值······································································································12

A.8阴性预测值······································································································12

A.9约登指数·········································································································12

A.10组间相关性系数·······························································································12

A.11Kappa系数·····································································································13

A.12评估指标使用总结····························································································13

附录B(资料性)测试数据集描述样例············································································14

B.1数据集适用范围································································································14

B.2数据的获取······································································································14

参考文献····················································································································16

T/SCGS313011—2024

前言

本文件按照GB/T1.1—2020《标准化工作导则第1部分:标准化文件的结构和起草规定》的规

定起草。

请注意本文件的某些内容可能涉及专利。本文件的发布机构不承担识别专利的责任。

本文件由北京航空航天大学提出。

本文件由中国图学学会归口。

本文件起草单位:北京航空航天大学、中国科学院自动化研究所、同济大学附属上海市肺科医院、

北京大学人民医院、中国医学科学院肿瘤医院深圳医院、广东省人民医院、中国医科大学附属盛京医

院、空军军医大学西京医院。

本文件主要起草人:牟玮、何秉羲、杜洋、陈昶、周健、梁颖、姜磊、石喻、康飞、蒋涛、佘云浪、方梦捷、

曹偲芳、邹锐阳、卢一诺、田捷。

T/SCGS313011—2024

肺癌免疫治疗人工智能辅助决策

软件算法性能测试方法

1范围

本文件规定了对采用人工智能技术的肺癌免疫治疗人工智能辅助决策软件的测试要求和测试

方法。

本文件适用于针对接受肺癌免疫治疗患者的肺癌影像为CT(ComputeaTomography,计算机断层

扫描)和PET(PositronEnissionTomography,核医学检查方法)电子发射断层显像

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