BriefCase-Quantification of the Abdominal Aortic Measurement (M-AbdAo)

Aidoc Medical
BriefCase-Quantification of the Abdominal Aortic Measurement (M-AbdAo) Model Card
Product Details
Model Identifier
Manufacturer
Aidoc Medical
Product
BriefCase-Quantification of the Abdominal Aortic Measurement (M-AbdAo)
Version
2
Date Cleared
05/15/2024
FDA Submission No.
Category
MIMPS
Model Characteristics
Inclusion Criteria
CT scans with contrast that include the abdominal aorta Performed on CT scanners with 64 or greater number of detectors Scans performed on adults/transitional adults ≥ 18 years of age Slice thickness; 0.6 mm - 5.0 mm axial slices
Exclusion Criteria
Delayed contrast studies
Instructions for Use
Not available
Indications for Use
Indication of Use
Briefcase-Quantification 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 (M­AbdAo ). Briefcase-Quantification is indicated to evaluate normal and aneurysmal abdominal aortas and is not intended to evaluate postoperative aortas. The Briefcase-Quantification 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.
Intended User
Unknown
Age
Unknown
Anatomy
Abdomen
Modality
CT
Output
Abdominal Aortic Measurement
Details on Training Data Sets
Details on Training Data Sets
No. of Cases
Unknown
Age Range (Years)
Unknown
Sex (%)
  • Female: Unknown
  • Male: Unknown
  • Unknown: Unknown
Output
Unknown
Race (%)
  • White: Unknown
  • Black or African American: Unknown
  • American Indian or Alaska Native: Unknown
  • Asian: Unknown
  • Native Hawaiian or Other Pacific Islander: Unknown
  • Unknown: Unknown
Ethnicity (%)
  • Hispanic or Latino: Unknown
  • Not Hispanic or Latino: Unknown
  • Unknown: Unknown
Geographic Region (%)
  • USA: Unknown
  • International: Unknown
  • Unknown: Unknown
Scanner Manufacturer(s)
Unknown
Scanner Model(s)
Unknown
Model Performance
Study Type
Performance Testing Type
Stand-Alone Performance
Standalone Model Performance
Reference Standard (Ground Truth)
Interpretation by Reviewing Clinician
No. of Cases
162
Age Range (Years)
Unknown
Sex (%)
Female: 53
Male: 47
Race (%)
  • White: Unknown
  • Black or African American: Unknown
  • American Indian or Alaska Native: Unknown
  • Asian: Unknown
  • Native Hawaiian or Other Pacific Islander: Unknown
  • Unknown: Unknown
Ethnicity (%)
  • Hispanic or Latino: Unknown
  • Not Hispanic or Latino: Unknown
  • Unknown: Unknown
Geographic Region (%)
USA: 100
Output
Unknown
Scanner Manufacturer(s)
Canon\Toshiba;GE;Philips;Siemens
Scanner Model(s)
Unknown
No. of Sites
6
Model Accuracy
Unknown
Model Sensitivity
Not provided
Model Specificity
Not provided
Additional Performance Metrics
The algorithm performance showed that the mean absolute error between the ground truth measurement and algorithm was 1.52 mm (95% CI: 1.20 mm, 1.83 mm).
Reader Study Performance
No. of Readers
N/A
No. of Cases
N/A
No. of Sites
N/A
Output
N/A
Age Range (Years)
N/A
Sex (%)
  • Female: N/A
  • Male: N/A
  • Unknown: N/A
Race (%)
  • White: N/A
  • Black or African American: N/A
  • American Indian or Alaska Native: N/A
  • Asian: N/A
  • Native Hawaiian or Other Pacific Islander: N/A
  • Unknown: N/A
Ethnicity (%)
  • Hispanic or Latino: N/A
  • Not Hispanic or Latino: N/A
  • Unknown: N/A
Geographic Region (%)
  • USA: N/A
  • International: N/A
  • Unknown: N/A
Scanner Manufacturer(s)
N/A
Scanner Model(s)
N/A
Model Accuracy
N/A
Model Sensitivity
N/A
Model Specificity
N/A
Model Limitations, Warnings, & Precautions
Model Limitations, Warnings, & Precautions
Supported Scanner Manufacturer(s)
All
Slice Thickness
0.6 mm - 5.0 mm axial slices
Contrast Use
With Contrast
MRI Field Strength
Unknown
Reconstruction Kernel Used
Unknown
Alternative Choices
Alternative Choices
Previous Version(s)
Unknown
Contact Information
Contact Information
Point of Contact Name
Unknown
Additional Details
Related Use Cases
Unknown
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