EFAI ChestSuite XR Pneumothorax Assessment System

“EFAI ChestSuite XR Pneumothorax Assessment System, herein referred to as EFAI PNXXR, is a radiological computer-assisted triage and notification software system.”

“EFAI PNXXR analyzes cases using an artificial intelligence algorithm to identify suspected findings. It makes case-level output available to a PACS/workstation for worklist prioritization or triage. EFAI PNXXR is not intended to direct attention to specific portions or anomalies of an image. Its results are not intended to be used on a stand-alone basis for clinical decision-making nor is it intended to rule out pneumothorax or otherwise preclude clinical assessment of X-Ray cases. The software uses deep learning techniques to automatically analyze PA chest x-rays and sends notification messages to the picture archiving and communication system (PACS)/workstation to allow suspicious findings of pneumothorax to be identified.”

“Additionally, the software validation activities were performed in accordance with IEC 62304:2006/A1:2016 - Medical device software – Software life cycle processes, in addition to the FDA Guidance documents, “Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices”(2005), and “Content of Premarket Submission for Management of Cybersecurity in Medical Devices."”