BriefCase-Pulmonary Embolism Triage

Aidoc Medical
BriefCase-Pulmonary Embolism Triage Model Card
Product Details
Model Identifier
Manufacturer
Aidoc Medical
Product
BriefCase-Pulmonary Embolism Triage
Version
2
Date Cleared
08/26/2022
FDA Submission No.
Category
CADt
Model Characteristics
Inclusion Criteria
Scans performed on adults/transitional adults ≥ 18 years of age. CT pulmonary angiogram (CTPA) with a 64-slice scanner or higher. Slice thickness 0.5 mm – 3.0 mm.
Exclusion Criteria
All studies that are technically inadequate, including studies with motion artifacts, severe metal artifacts, sub-optimal 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 CTPA 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 Pulmonary Embolism (PE) 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 notifications for cases with suspected PE 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
Medical professionals
Age
Adult
Anatomy
Chest
Modality
CT
Output
Pulmonary Embolism (Triage)
Details on Training Data Sets
Details on Training Data Sets
No. of Cases
Unspecified
Age Range (Years)
Unspecified
Sex (%)
  • Female: Unspecified
  • Male: Unspecified
  • Unknown: Unspecified
Output
Unspecified
Race (%)
  • White: Unspecified
  • Black or African American: Unspecified
  • American Indian or Alaska Native: Unspecified
  • Asian: Unspecified
  • Native Hawaiian or Other Pacific Islander: Unspecified
  • Unknown: Unspecified
Ethnicity (%)
  • Hispanic or Latino: Unspecified
  • Not Hispanic or Latino: Unspecified
  • Unknown: Unspecified
Geographic Region (%)
  • USA: Unspecified
  • International: Unspecified
  • Unknown: Unspecified
Scanner Manufacturer(s)
Unspecified
Scanner Model(s)
Unspecified
Model Performance
Study Type
Performance Testing Type
Stand-Alone Performance
Standalone Model Performance
Reference Standard (Ground Truth)
Interpretation by Reviewing Clinician
No. of Cases
499
Age Range (Years)
18 - 90
Sex (%)
Female: 48
Male: 51
Unknown: 1
Race (%)
  • White: Unspecified
  • Black or African American: Unspecified
  • American Indian or Alaska Native: Unspecified
  • Asian: Unspecified
  • Native Hawaiian or Other Pacific Islander: Unspecified
  • Unknown: Unspecified
Ethnicity (%)
  • Hispanic or Latino: Unspecified
  • Not Hispanic or Latino: Unspecified
  • Unknown: Unspecified
Geographic Region (%)
USA: 100
International: 0
Output
PE present: 42
Scanner Manufacturer(s)
Canon\Toshiba;GE;Philips;Siemens
Scanner Model(s)
Unspecified
No. of Sites
6
Model Accuracy
Unspecified
Model Sensitivity
95%
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
0.5-3.0mm
Contrast Use
With Contrast
MRI Field Strength
Unspecified
Reconstruction Kernel Used
Not Applicable
Alternative Choices
Alternative Choices
Previous Version(s)
Unspecified
Contact Information
Contact Information
Point of Contact Name
Unspecified
Additional Details
Related Use Cases
Pulmonary Embolism
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