BriefCase-Quantification of Abdominal Aortic Measurement (M-AbdAo-02-RT)
Contact Information
www.aidoc.com/contact-support/ or email:info@aidoc.com
Release Stage
Release Date
Version
Regulatory Approval
Please find attached the M-AbdAo-02-RT 510(k) summary.
Global Availability
US, EU (CE Marked), UK (UKCA Marked), Canada (MDEL), Israel (AMAR), UAE and South Africa.
Summary
The BriefCase-Quantification Abdominal Aortic Measurement solution is a radiological medical image management and processing device. The software consists of a single module based on an algorithm programmed component and is intended to run on a linux-based server in a cloud environment. The BriefCase-Quantification receives filtered DICOM Images, and processes them chronologically by running the algorithm on relevant series to measure the maximum abdominal aortic diameter. Following the AI processing, the output of the algorithm analysis is transferred to an image review software (desktop application), and forwarded to user review in the PACS. BriefCase-Quantification produces a preview image annotated with the maximum diameter measurement. The diameter marking is not intended to be a final output, but serves the purpose of visualization and measurement. The original, unmarked series remains available in the PACS as well. The preview image presents an unofficial measurement which is not final, and the user is instructed to review the full image and any other clinical information before making a clinical decision. The image includes a disclaimer: "Not for diagnostic use. The measurement is unofficial, not final, and must be reviewed by a radiologist." BriefCase-Quantification is not intended to evaluate post-operative aortas
Uses and Directions
Intended Use
The BriefCase-Quantification Abdominal Aortic Measurement solution is a radiological image management and processing system software indicated for use in the analysis of CT exams with contrast that include the abdominal aorta in adults or transitional adolescents aged 18 and older. The device is intended to assist appropriately trained medical specialists by providing the user with the maximum abdominal aortic diameter measurement of cases that include the abdominal aorta (M-AbdAo). BriefCase-Quantification is indicated to evaluate normal and aneurysmal abdominal aortas and is not intended to evaluate post-operative aortas.
Primary Users
The BriefCase-Quantification Abdominal Aortic Measurement solution is intended to be used by appropriately trained medical specialists. Appropriately trained medical specialists for abdominal aortic measurement include emergency physicians, radiologists, vascular surgeons, cardiothoracic surgeons, and cardiologists).
How to Use
The BriefCase-Quantification Abdominal Aortic Measurement solution produces a preview image annotated with the maximum diameter measurement. The diameter marking is not intended to be a final output, but serves the purpose of visualization and measurement. The original, unmarked series remains available in the PACS as well. The preview image presents an unofficial measurement which is not final, and the user is instructed to review the full image and any other clinical information before making a clinical decision.
Target Population
Adults or transitional adolescents aged 18 and older.
Cautioned Out-of-Scope Settings
Cautioned Out-of-Scope Settings
Results are not intended to be used on a stand-alone basis for clinical decision-making or otherwise preclude clinical assessment of cases. These measurements are unofficial, are not final, and are subject to change after review by a radiologist. For final clinically approved measurements, please refer to the official radiology report. Clinicians are responsible for viewing full images per the standard of care. Only for use by appropriately trained medical specialists. Please refer to BriefCase-Quantification User Guide (UG0010) 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.