BriefCase-Quantification of Midline Shift (MLS)

Aidoc Medical
BriefCase-Quantification of Midline Shift (MLS) Model Card
Product Details
Model Identifier
Manufacturer
Aidoc Medical
Product
BriefCase-Quantification of Midline Shift (MLS)
Version
Unknown
Date Cleared
11/13/2023
FDA Submission No.
Category
MIMPS
Model Characteristics
Inclusion Criteria
Non-contrast head CT Scans performed on adults/transitional adults ≥ 18 years of age Slice thickness; 0.625 mm - 5.0 mm axial slices
Exclusion Criteria
All studies that have inadequate field of view, such as studies in which the series do not contain the full skull in the slices relevant for midline shift quantification (e.g. facial fractures protocols). Studies without an axial series.
Instructions for Use
Not available
Indications for Use
Indication of Use
BriefCase-Quantification of Midline Shift (MLS) is a radiological image management and processing system software intended for automatic measurement of brain midline shift in non-contrast head CT (NCCT) images, in adults or transitional adolescents aged 18 years and older. The device is intended to assist appropriately trained medical specialists by providing the user with an automated current manual process of measuring midline shift. The device provides midline shift measurement from NCCT images acquired at a single time point, and can additionally provide an output with comparative analysis of two or more images that were acquired in the same individual at multiple time points. The device does not alter the original medical image and is not intended to be used as a diagnostic device. 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. Clinicians are responsible for viewing full images per the standard of care.
Intended User
Radiologist
Age
Adult
Anatomy
Head
Modality
CT
Output
Midline Shift 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
284
Age Range (Years)
18 - 90
Sex (%)
Female: 48
Male: 48
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 mean absolute error between the ground truth measurement and algorithm was 0.94 mm (95% CI: 0.74 mm, 1.14 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
Slice thickness; 0.625 mm - 5.0 mm axial slices
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
Midline Shift
All Products And Platforms from Aidoc Medical