qER-CTA (v1.0)

qER-CTA is a notification-only, parallel workflow tool for use by hospital networks and trained clinicians to identify and communicate images of specific patients to a specialist, independent of the standard of care workflow. qER-CTA uses a deep learning algorithm to analyze images for findings suggestive of a pre-specified clinical condition and to notify an appropriate medical specialist in parallel to standard of care image interpretation. Identification of suspected findings is not for diagnostic use beyond notification. Specifically, the device analyses CT angiogram images of the brain acquired in the acute setting and sends notifications to a neurovascular specialist that a suspected large vessel occlusion has been identified, recommending review of those images. Images can be previewed through a mobile application. qER-CTA is intended to analyze the internal carotid artery (ICA) and M1 segment of the middle cerebral artery (MCA) for LVOs on CTA scans of adults (≥ 22 years of age). Images previewed through the mobile application are compressed and for informational purposes only, not intended for diagnostic use beyond notification. Notified clinicians are responsible for viewing non-compressed images on a diagnostic viewer, conducting appropriate patient evaluation, and engaging in relevant discussions with the treating physician before making care-related decisions or requests. qER-CTA is limited to the analysis of imaging data and should not be used as a substitute for full patient evaluation or relied upon to make or confirm a diagnosis.