The “Artificial Intelligent Medical Device Innovation and Cooperation Platform” was established in July 2019 as a subordinate unit under the CMDE (Center for Medical Device Evaluation) of NMPA (National Medical Products Administration). The CMDE announced their recent developments on July 30, 2020:
Online public service platform (pilot phase) and database for the performance evaluation of AI medical devices
- The online platform is currently available only for the performance evaluation of AI medical devices detecting diabetic retinopathy in conventional colour fundus photography.
- The online platform provides access to a database of real-world data collected from 8 provinces, equivalent to 15,000 photographs of the eye fundus (including different retinopathy types, after laser surgery conditions, and low-quality image references).
- The database can form into sub databases according to the different intended use of AI softwares to determine:
- The type of diabetic retinopathy
- The photo quality of the eye fundus
- The need for hospital transfer
The performance index and testing methods for AI medical devices
Currently only available for AI medical devices:
- detecting diabetic retinopathy in conventional colour fundus photography; and
- detecting lung nodules in chest CT scans
The performance index and testing methods serve as a guideline for the “Artificial Intelligent Medical Device Innovation and Cooperation Platform” in their future developments of the AI medical device field.
By Jacky Li. Contact Cisema if you would like to learn more.