FDA-Approved Artificial Intelligence and Machine Learning (AI/ML)-Enabled Medical Devices: An Updated Landscape
Terminology: Features - "These features include the date of approval, the number of days taken to obtain clearance, clearance type (approval path), regulation panel, decision type, the name of the manufacturing company that filed for clearance, the country where the manufacturing company is based, device name, device medical specialty, device type, and recall history as shown in Figure 1." Trial - "Additionally, wherever available, we also gathered clinical trial information such as study type, sampling method, age group of subjects, criteria for inclusion, the number of clinical trial locations, and the names of the countries where the clinical trials were conducted."