Rapid MLS

RapidAI
Rapid MLS Model Card
Product Details
Model Identifier
Manufacturer
RapidAI
Product
Rapid MLS
Version
Unknown
Date Cleared
05/28/2025
FDA Submission No.
Category
MIMPS
Model Characteristics
Inclusion Criteria
Non-Contrast CT images
Exclusion Criteria
Unknown
Instructions for Use
Not available
Indications for Use
Indication of Use
The Rapid MLS software device is designed to measure the midline shift of the brain from a NCCT acquisition and report the measurements. Rapid MLS analyzes adult cases using machine learning algorithms to identify locations and measurements of the expected brain midline and any shift which may have occurred. The Rapid MLS device provides the user with annotated images showing measurements. Its results are not intended to be used on a stand-alone basis for clinical decision-making or otherwise preclude clinical assessment of NCCT cases.
Intended User
Medical professionals
Age
Adult
Anatomy
Head
Modality
CT
Output
Visual output containing a color overlay image displaying the difference between the expected and indicated brain midline at the Foramen of Monro; and a text file output (json format) containing the quantitative measurement
Details on Training Data Sets
Details on Training Data Sets
No. of Cases
162
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)
Unknown
No. of Cases
153
Age Range (Years)
26 - 93
Sex (%)
Female: 56
Male: 44
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: 84
International: 15
Output
Unknown
Scanner Manufacturer(s)
Canon\Toshiba;GE;Philips;Siemens
Scanner Model(s)
Unknown
No. of Sites
13
Model Accuracy
Unknown
Model Sensitivity
Not provided
Model Specificity
Not provided
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)
Unknown
Slice Thickness
Unknown
Contrast Use
Without contrast
MRI Field Strength
Unknown
Reconstruction Kernel Used
Unknown
Alternative Choices
Alternative Choices
Previous Version(s)
Unknown
Predicate Device(s)
Unknown
Contact Information
Contact Information
Point of Contact Name
Unknown
Email
Unknown
Additional Details
Related Use Cases
Unknown
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