AIDOC BriefCase

Overview

Development stage

DeployedSource: c) Deployed – The use case is being actively authorized or utilized to support the functions or mission of an agency.

High-impact designation

High-impactSource: a) High-impact

Impact justification

Not reported

Start date

Not reported

Withheld from public reporting

Not reported

Mission

Topic area

Health and Medical

Operational functions

Risk scoring and triage, Clinical and medical Derived by keyword rules; see methodology

Problem the AI is intended to solve

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

Expected benefits

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.

System outputs

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.

Technology

AI classification

Computer visionSource: Computer Vision: AI that processes and interprets visual data (e.g., images and videos).

System name(s)

Not reported

Custom-developed code

No

Public source code

Not reported

Sourcing

How it was built

Purchased from vendorSource: a) Purchased from a vendor

Vendor (as reported)

Not reported

Vendors (standardized)

None on the standard list

A vendor is the supplier named by the agency. It does not identify the underlying model or AI technology.

Data and privacy

Involves PII

Not reported

Privacy Impact Assessment

Not reported

Authorization to Operate

Not reported

Demographic features

Not reported

Training and evaluation data

Not reported

Federal Data Catalog

Not reported

Governance

0 of 8 minimum-practice questions answered. A blank answer means the agency reported nothing; it does not mean the practice is absent.

Potential impacts and how they were identified

Not reported