BriefCase-Intracranial Hemorrhage Triage

Aidoc Medical
BriefCase-Intracranial Hemorrhage Triage Model Card
Product Details
Model Identifier
Manufacturer
Aidoc Medical
Product
BriefCase-Intracranial Hemorrhage Triage
Version
Unknown
Date Cleared
05/17/2022
FDA Submission No.
Category
CADt
Model Characteristics
Inclusion Criteria
Non-enhanced head CT. Scans performed on adults/transitional adults ≥ 18 years of age. Scans performed on CT scanners with 64 or greater number of detectors. Slice thickness 0.625 mm - 5.0 mm axial.
Exclusion Criteria
All scans that are technically inadequate, including motion artifacts, severe metal artifacts, suboptimal bolus timing or an inadequate field of view.
Instructions for Use
Not available
Indications for Use
Indication of Use
BriefCase is a radiological computer aided triage and notification software indicated for use in the analysis of nonenhanced head CT images 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 communication of suspected positive findings of Intracranial hemorrhage (ICH) pathologies. Briefcase uses an artificial intelligence algorithm to analyze images and highlight cases with detected findings on a Stand-Alone Performance desktop application in parallel to the ongoing standard of care image interpretation. The user is presented with notification for cases with suspected 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 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
Trained medical specialists
Age
Adult
Anatomy
Head
Modality
CT
Output
Intracranial Hemorrhage (Triage)
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)
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
220
Age Range (Years)
20 - 90
Sex (%)
Female: 50
Male: 49
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
5
Model Accuracy
Unknown
Model Sensitivity
96
Model Specificity
94
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
0.625-5.0
Contrast Use
Without 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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