Notice on the Meeting for Construction of AI Standard Testing Dataset (Fundus Part) by the Opto-Mechatronics Division of NIFDC
On the evening of December 24, VCBeat learned from the Division of Optical and Mechanical Instruments at the National Institutes for Food and Drug Control (NIFDC) that the division would convene a meeting on the development of AI standard test datasets (fundus portion). The full notice is provided below.
To all relevant medical device manufacturers:
The application of artificial intelligence in medicine is developing extremely rapidly, posing challenges to quality assessment and regulation.The AI Group of the Optical, Mechanical, and Electrical Division at the National Institutes for Food and Drug Control (NIFDC) will convene a discussion meeting in early January 2018 on the development plan for standard test datasets (fundus component). The aim is to establish “scientific, independent, impartial, and authoritative” test datasets and objective evaluation methods, thereby advancing pre-market quality assessment of products. Representatives from enterprises are now being invited to attend the meeting.。
Eligibility Criteria: (1) AI software for screening/lesion identification of fundus diseases (such as diabetic retinopathy) has been fully developed, and is expected to have undergone or has already completed registration testing at the National Institutes for Food and Drug Control (NIFDC); (2) Willingness to participate in the construction of standard test datasets and provide annotated images as required.
Qualified enterprises are requested to send the company name, names of attendees, mobile phone numbers, and photos of the product interface to the following email address by December 28, 2017: wanghao@nifdc.org.cn. Contact person: Dr. Wang Hao; Tel: 010-53852531, 15311357806.
We will notify you of the specific meeting time and location by phone.
Thank you for your attention.
Optoelectromechanics AI Group
NIFDC
National Institutes for Food and Drug Control (NIFDC), a public institution directly under the China Food and Drug Administration, is the statutory body and highest technical arbitration authority for quality inspection of food, drugs, and medical devices in China.。
The predecessor of the National Institutes for Food and Drug Control (NIFDC) was the Institute of Pharmaceutical and Food Inspection and the Institute of Biological Products Control, both established in 1950 under the Ministry of Health. In 1961, these two institutes were merged to form the National Institute for the Control of Pharmaceutical and Biological Products (NICPBP) under the Ministry of Health. In 1998, upon the establishment of the State Drug Administration, NICPBP was transferred in its entirety from the Ministry of Health to the State Drug Administration. In 2010, it was renamed the National Institutes for Food and Drug Control, concurrently bearing the title of the Center for Medical Device Standards Management of the State Food and Drug Administration, and used the name “National Institute for the Control of Pharmaceutical and Biological Products” for external purposes. In 2015, the China Food and Drug Administration officially established the National Institutes for Food and Drug Control (Center for Medical Device Standards Management of the China Food and Drug Administration).
The National Institutes for Food and Drug Control (NIFDC) undertakes, in accordance with the law, registration testing, import inspection, supervisory testing, and safety evaluation of products across multiple fields, including food (including food additives and health foods), drugs, cosmetics, medical devices, and related packaging materials and containers. It organizes the formulation and revision of national and industry standards for medical devices. The NIFDC is responsible for the research, preparation, calibration, distribution, and management of national drug reference standards and microbial strains used in production and testing. It also conducts consistency evaluations for generic drugs and other related technical research.
Recent Work Updates of the AI Group in the Optoelectromechanical Laboratory
As a national technical support institution for regulatory oversight, the National Institutes for Food and Drug Control (NIFDC) has undertaken the evaluation and research of medical artificial intelligence product quality. Leveraging its extensive expertise in medical device software testing, the Optoelectromechanical Laboratory has established a dedicated AI team to carry out this work.
On November 16, 2017, the AI Group of the Optoelectromechanics Division announced its recent work activities, as detailed below:
1. Undertook dozens of medical AI products, primarily involving auxiliary diagnosis for diabetic retinopathy screening, lung cancer screening, skin cancer screening, brain tumor diagnosis, chest X-ray imaging, and fracture diagnosis.
2. Held multiple thematic technical seminars on products. For each product, in-depth discussions were conducted with corporate engineers regarding data composition, data structure, algorithmic frameworks, model optimization, and clinical application.
3. Continued discussions with the Center for Drug Evaluation, the Chinese Academy of Sciences, and industry technical experts on product quality evaluation methods. Medical artificial intelligence products differ from traditional medical device software; conventional testing methods cannot comprehensively evaluate product quality, particularly regarding focal issues such as the quality of training datasets, robustness of algorithmic models, and risks associated with real-time iteration of algorithmic frameworks. The research team is reaching a preliminary consensus with these experts.