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StrokeSENS LVO is a radiological computer-aided triage and notification (CADt) software indicated for use in the analysis of CTA head images. The device is intended to assist hospital networks and trained clinicians in workflow triage by flagging and communication of suspected positive findings of Large Vessel Occlusion (LVO) in head CTA images. StrokeSENS LVO uses a software algorithm to identify suspected LVO findings. In the case of a suspected LVO, the system will send a notification to a pre-configured destination(s), notifying the clinicians of the existence of a suspected LVO that requires review. The notification system is intended to be used in parallel to the standard of care workflow to notify clinicians of the existence of a potential LVO earlier than being notified as part of the standard of care workflow. Notifications may include a compressed preview of images. Notifications are meant for informational purposes only and are not intended for diagnostic use beyond notification. The StrokeSENS LVO device does not alter the original medical image and is not intended to be used as a diagnostic device. The results of StrokeSENS LVO are intended to be used in conjunction with other patient information and based on professional judgement, to assist with triage / prioritization of medical images. Notified clinicians are responsible for viewing full images per standard of care.

StrokeSENS LVO is intended to assist hospital networks and trained clinicians in workflow triage by flagging and communication of suspected positive findings of Large Vessel Occlusion (LVQ) in head CTA images. StrokeSENS LVO uses a software alqorithm based on machine learning to identify suspected LVO findings. In the case of a suspected LVO, the system will send a notification to a preconfigured destination(s), notifying the clinicians of a suspected LVQ that requires review. StrokeSENS LVO DICOM-compliant software system consists of two main components: 1) the StrokeSENS LVO Processing Engine and 2) a compatible Radiological Software Platform: - 1. The StrokeSENS LVO Processing Engine is responsible for receiving, processing, and analyzing image data and communicating results. Primarily, the Processing Engine consists of a software algorithm (a sequence of instructions/operations) that is responsible for analyzing contrast-enhanced CT (CTA) image data of the head to identify characteristics that are consistent with LVO. The software algorithm is a binary classifier, providing a binary output of either positive or negative for suspected LVO, based on a pre-defined threshold. The output is returned to the Radiological Software Platform for the purposes of triage and notification. The Processing Engine is integrated into, or installed adjacent to, a compatible Radiological Software Platform. - 2. The compatible Radiological Software Platform is configured to retrieve/receive contrast-enhanced head CT (CTA) images from the CT scanner or PACS, and automatically transmit, or make available, a copy of the image data for processing and analysis by the LVO Processing Engine. After successful processing of a case via the StrokeSENS LVO Processing Engine, the results are returned to the Radiological Software Platform for the intended purpose of triage and notification.