The Covid pandemic led to oil demand contracting by 9-10 million barrels per day in 2020, but it is expected to rebound by 5-6 million barrels per day this year, a major symposium heard.
How We Develop AI for 510(k)-Cleared Devices by Grace Adams and Yujan Shrestha, MD on January 26, 2021
Want to know how we develop safe, effective, and FDA compliant machine learning algorithms? This article describes how we develop machine learning algorithms, points out common pitfalls, and makes documentation recommendations.
When developing a machine learning or AI algorithm, it’s easy to become overly focused on making the best model possible. While model performance is important, to incorporate the model into a commercial medical device, you’ll need to be able to demonstrate to the FDA that the model is safe and effective. Therefore, it’s critical to thoroughly document the algorithm’s development lineage in your design history file. The process outlined in this article will help you do this. We’ve used it to develop AI algorithms within a recently 510(k)-cleared class-II medical device for one of our clients.