AIDOC BriefCase
Description
BriefCase is a radiological computer-assisted triage and notification software device. The software is based on an algorithm programmed component and is intended to run on a linux-based server in a cloud environment. The BriefCase receives filtered DICOM Images, and processes them chronologically by running the algorithms on each series to detect suspected cases. Following the AI processing, the output of the algorithm analysis is transferred to an image review software (desktop application). When a suspected case is detected, the user receives a pop-up notification and is presented with a compressed, low quality, grayscale image that is captioned “not for diagnostic use, for prioritization only” which is displayed as a preview function. This preview is meant for informational purposes only, does not contain any marking of the findings, and is not intended for primary diagnosis beyond notification. Presenting the users with worklist prioritization facilitates efficient triage by prompting the user to assess the relevant original images in the PACS. Thus, the suspect case receives attention earlier than would have been the case in the standard of care practice alone. https://www.accessdata.fda.gov/cdrh_docs/pdf23/K230020.pdf
Detailed example
When a suspected case is detected, the user receives a pop-up notification and is presented with a compressed, low quality, grayscale image that is captioned “not for diagnostic use, for prioritization only” which is displayed as a preview function. This preview is meant for informational purposes only, does not contain any marking of the findings, and is not intended for primary diagnosis beyond notification.
AI / analytics pattern
Computer Vision: AI that processes and interprets visual data (e.g., images and videos).
Automation level / stage
c) Deployed – The use case is being actively authorized or utilized to support the functions or mission of an agency.
Expected benefit
Presenting the users with worklist prioritization facilitates efficient triage by prompting the user to assess the relevant original images in the PACS. Thus, the suspect case receives attention earlier than would have been the case in the standard of care practice alone.
Controls / human review
ATO: Not reported; PIA: Not published