Initial situation
A startup with its own development of neural network analysis of CT scans applied for registration of a SaMD solution. At the time of work in Russia there was no established practice of registering systems based on deep learning. It was necessary to justify the risk class, develop a methodology for validating the algorithm, and undergo clinical evaluation using Russian data.
What we did
- Product classification and justification for risk class 2a
- Preparation of an algorithm validation protocol with AUC, sensitivity and specificity metrics
- Organization of clinical evaluation on a dataset of 4,800 studies from 6 medical centers
- Development of a plan for post-registration monitoring of the quality of the algorithm
- Support of extended examination in Roszdravnadzor and presentation at the specialized commission
Issued Registration Certificate
The registration certificate has been received. This is one of the first precedents for registering SaMD of this class in Russia. Based on our methodology, the customer subsequently registered 2 more models from his line in half the time.