The Role and Requirement of Datasets in the Quality Control of Artifcial Intelligence Medical Device.
10.3969/j.issn.1671-7104.2019.01.014
- VernacularTitle:骨组织病损植入器械定制设计的审评关注点
- Author:
Hao WANG
1
;
Xiangfeng MENG
1
;
Shu LI
1
;
Haiping REN
1
Author Information
1. Division of Active Medical Device and Medical Optics, National Institutes for Food and Drug Control, Beijing, 100050.
- Publication Type:Journal Article
- Keywords:
artificial intelligence;
dataset;
medical device;
quality control
- MeSH:
Artificial Intelligence;
Data Analysis;
Equipment and Supplies;
Quality Control
- From:
Chinese Journal of Medical Instrumentation
2019;43(1):54-57
- CountryChina
- Language:Chinese
-
Abstract:
Artificial intelligence is a blooming branch of medical device. Its development and quality control all rely on high quality clinical data. Since there is no established standard or guidance yet, it is important to study how to build and utilize a dataset appropriately and scientifically, especially for the decrease of clinical trial expense. With reference to the current status of premarket review and related guidance in developed countries, this paper analyzes the role and requirement of datasets in the quality control of AI medical device, providing useful information for regulation agencies and the development of public datasets for AI.