BriefCase-Triage for Vessel Occlusion
Contact Information
www.aidoc.com/contact-support/ or email:info@aidoc.com
Release Stage
Release Date
Version
Regulatory Approval
Please find attached the VO-01 510(k) summary.
Global Availability
US, EU (CE Marked), UK (UKCA Marked), Canada (MDEL), Australia (ARTG), New Zealand, Israel (AMAR), UAE and South Africa.
Summary
The Vessel Occlusion solution is a radiological computer aided triage and notification software indicated for use in the analysis of head CTA images in adults or transitional adolescents aged 18 and older. The device is intended to assist hospital networks and appropriately trained medical specialists in workflow triage by flagging and communication of suspected positive findings of complete Large Vessel Occlusion (LVO) - MCA-M1, PCA-P1, ACA-A1, ICA, Basilar; and Medium Vessel Occlusions (MeVO) - MCA-M2, MCA-proximal M3, PCA-P2, PCA-proximal P3, ACA-A2, ACA-proximal A3, and Vertebral-V4. The Vessel Occlusion solution uses an artificial intelligence algorithm to analyze images and highlight cases with detected findings on a standalone desktop application in parallel to the ongoing standard of care image interpretation. The user is presented with notifications for cases with suspected findings. Notifications include compressed preview images that are meant for informational purposes only and not intended for diagnostic use beyond notification. The device does not alter the original medical image and is not intended to be used as a diagnostic device. The results of The Vessel Occlusion solution are intended to be used in conjunction with other patient information and based on their professional judgment, to assist with triage/prioritization of medical images. Notified clinicians are responsible for viewing full images per the standard of care.
Uses and Directions
Intended Use
The device is intended to assist hospital networks and appropriately trained medical specialists in workflow triage by flagging and communicating suspected positive cases of Large Vessel Occlusion (LVO) - MCA-M1, PCA-P1, ACA-A1, ICA, Basilar; and Medium Vessel Occlusions (MeVO) - MCA-M2, MCA-proximal M3, PCA-P2, PCA-proximal P3, ACA-A2, ACA-proximal A3, and Vertebral-V4. pathologies.
Primary Users
The Vessel Occlusion solution is intended to be used by appropriately trained medical specialists. Appropriately trained medical specialists for VO are emergency physicians, radiologists, neurologists, neuro-surgeons, neuro-interventionalists, interventional radiologists, neuro-intensive care physicians.
How to Use
The user is presented with notifications for cases with suspected findings. Notifications include compressed preview images that are meant for informational purposes only and not intended for diagnostic use beyond notification. The desktop application feed displays all incoming suspect cases, each notified case in a line. Hovering over a line in the feed pops up a compressed, low-quality, grayscale, unannotated image that is captioned "not for diagnostic use" and is displayed as a preview function. This compressed preview is meant for informational purposes only, does not contain any marking of the findings, and is not intended for primary diagnosis beyond notification. The device does not alter the original medical image and is not intended to be used as a diagnostic device.
Target Population
patients Adults or transitional adolescents aged 18 and older.
Cautioned Out-of-Scope Settings
Cautioned Out-of-Scope Settings
Notifications include compressed preview images that are meant for informational purposes only and not intended for diagnostic use beyond notification. The device does not alter the original medical image and is not intended to be used as a diagnostic device. Only for use in workflow triage, and only for use by appropriately trained medical specialists. Please refer to BriefCase-Triage User Guide (UG0009) for further information on warnings and precautions.
EHR Compatibility
EHR-agnostic
This solution works independently of specific EHR systems and can be integrated with most healthcare IT infrastructures.