BriefCase- Triage for RibFx

Aidoc Medical
BriefCase- Triage for RibFx Model Card
Product Details
Model Identifier
Manufacturer
Aidoc Medical
Product
BriefCase- Triage for RibFx
Version
Unknown
Date Cleared
12/11/2024
FDA Submission No.
Category
CADt
Model Characteristics
Inclusion Criteria
● CT images with or without contrast that include the ribs ● Single energy exams ● Performed on CT scanners with 64 or greater number of detectors ● Scans performed on adults/transitional adults ≥ 18 years of age ● Slice thickness; 0.5 mm to 5.0 mm axial slices
Exclusion Criteria
All studies that are technically inadequate, including studies with motion artifacts, severe metal artifacts, or inadequate field of view
Instructions for Use
Not available
Indications for Use
Indication of Use
BriefCase-Triage is a radiological computer aided triage and notification software indicated for use in the analysis of CT images with or without contrast that include the ribs, 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 communicating suspect cases of three or more acute Rib fracture (RibFx) pathologies. BriefCase-Triage uses an artificial intelligence algorithm to analyze images and highlight cases with detected findings in parallel to the ongoing standard of care image interpretation. The user is presented with notifications for cases with suspected RibFx 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 BriefCase-Triage 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.
Intended User
Radiologist
Age
Adult
Anatomy
Chest
Modality
CT
Output
Rib Fracture (Triage)
Details on Training Data Sets
Details on Training Data Sets
No. of Cases
Unknown
Age Range (Years)
Unknown
Sex (%)
Female: 58
Male: 42
Output
RibFx present: 61% RibFx absent: 39%
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
Scanner Manufacturer(s)
Canon\Toshiba;GE;Philips;Siemens
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
308
Age Range (Years)
20 - 90
Sex (%)
Female: 47
Male: 53
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
International: 0
Output
RIbFx present:32
Scanner Manufacturer(s)
Canon\Toshiba;GE;Philips;Siemens
Scanner Model(s)
Unknown
No. of Sites
5
Model Accuracy
Unknown
Model Sensitivity
95
Model Specificity
95
Additional Performance Metrics
AUC: 97.2% (95% CI: 95.5%-99.0%),
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
Slice thickness; 0.5 - 5.0 mm axial
Contrast Use
Without and with contrast
MRI Field Strength
Unknown
Reconstruction Kernel Used
Not Applicable
Alternative Choices
Alternative Choices
Previous Version(s)
Unknown
Predicate Device(s)
Unknown
Contact Information
Contact Information
Point of Contact Name
Unknown
Additional Details
Related Use Cases
Unknown
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