SBIR TOPIC 454: A SOFTWARE TOOL FOR STANDARDIZATION OF RADIOTHERAPY TREATMENT PLANS FOR AI VALIDATION

SBIR 主题 454：用于 AI 验证的放射治疗计划标准化的软件工具

• 批准号: 10932644
• 负责人: JULIE SHADE
• 金额: $ 39.99万
• 依托单位: ONCOSPACE, INC.
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-08-10 至 2024-08-09
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10932644
• 关键词: American; Artificial Intelligence; Computer software; Data Set; Data Storage and Retrieval; Digital Imaging and Communications in Medicine; Elements; Evaluation; Food; Goals; Healthcare; Manufacturer; Marketing; Medical Device; Medicine; Modeling; Names; Nomenclature; Performance; Pharmaceutical Preparations; Phase; Process; Qualifying; Radiation therapy; Resources; Role; Services; Small Business Innovation Research Grant; Software Tools; Standardization; Structure; Test Result; Testing; Validation; cloud based; cohort; data communication; design; health data; post-market; programs; tool; tool development; treatment planning; usability

The goal of this proposal is to create a medical device development tool (MDDT) for use during performance evaluation of artificial intelligence (AI)-based radiotherapy software. The MDDT is intended to be used by manufacturers during external validation, whereby AI models are tested for generalizability. Test results can be used for pre-market submissions to the Food and Drug Administation (FDA) and post-market surveillance. The role of the MDDT is to standardize test datasets consisting of tens or hundreds of radiotherapy treatment plans. Functionality includes: making contoured structure names comply with American Association of Physicists in Medicine (AAPM) Task Group 263 (TG-263) nomenclature, making plan information searchable, and creation of test cohorts. The MDDT will be cloud-based, employing Microsoft Azure Health Data services. Uploaded treatment plans, and derived information such as standardized names, will be stored using HL-7 Fast Healthcare Interperability Resources (FHIR) and Digital Imaging and Communications in Medicine (DICOM). The specific aims of this Phase I project are to design and implement the data communication, data storage, and user interface elements of the MDDT, to carry out a pilot usability study, and to create a qualification plan detailing steps to qualify the tool within the FDA MDDT program.

本提案的目标是创建一个医疗器械开发工具（MDDT），用于基于人工智能（AI）的放射治疗软件的性能评价。MDDT旨在由制造商在外部验证期间使用，从而测试AI模型的可推广性。测试结果可用于向美国食品药品监督管理局（FDA）提交上市前申请和上市后监督。MDDT的作用是标准化由数十或数百个放射治疗计划组成的测试数据集。功能包括：使轮廓结构名称符合美国医学物理学家协会（AAPM）任务组263（TG-263）命名法，使计划信息可搜索，并创建测试群组。MDDT将基于云，采用Microsoft Azure Health Data服务。将使用HL-7快速医疗保健互操作性资源（FHIR）和医学数字成像和通信（DICOM）存储扩展的治疗计划和衍生信息（如标准化名称）。该I期项目的具体目标是设计和实施MDDT的数据通信、数据存储和用户界面元素，开展试点可用性研究，并创建一个鉴定计划，详细说明在FDA MDDT项目中鉴定该工具的步骤。