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
基本信息
- 批准号:10932644
- 负责人:
- 金额:$ 39.99万
- 依托单位:
- 依托单位国家:美国
- 项目类别:
- 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:
- 关键词:AmericanArtificial IntelligenceComputer softwareData SetData Storage and RetrievalDigital Imaging and Communications in MedicineElementsEvaluationFoodGoalsHealthcareManufacturerMarketingMedical DeviceMedicineModelingNamesNomenclaturePerformancePharmaceutical PreparationsPhaseProcessQualifyingRadiation therapyResourcesRoleServicesSmall Business Innovation Research GrantSoftware ToolsStandardizationStructureTest ResultTestingValidationcloud basedcohortdata communicationdesignhealth datapost-marketprogramstooltool developmenttreatment planningusability
项目摘要
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。
项目成果
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