Brainomix 360 Triage Stroke

Brainomix Limited
Brainomix 360 Triage Stroke - Model Card
Product Details
Model Identifier
Manufacturer
Brainomix Limited
Product
Brainomix 360 Triage Stroke
Version
Unknown
Date Cleared
08/26/2025
FDA Submission No.
Category
CADt
Model Characteristics
Inclusion Criteria
Non-contrast head CT (NCCT) images
Exclusion Criteria
Patients with recent (within 6 weeks) neurosurgery or endovascular neurointervention or recent (within 4 weeks) previous diagnosis of stroke
Instructions for Use
Not available
Indications for Use
Indication of Use
Brainomix 360 Triage Stroke is a radiological computer aided triage and notification software indicated for use in the analysis of non-contrast head CT (NCCT) images to assist hospital networks and trained clinicians in workflow triage by flagging and communicating suspected positive findings of head NCCT images for large vessel occlusion (LVO) of the intracranial ICA and M1 or intracranial hemorrhage (ICH). Specifically, the device is intended to be used for the triage of images acquired from adult patients in the acute setting, within 24 hours of the onset of the acute symptoms, or where this is unclear, since last known well (LKW) time. It is not intended to detect symmetrical bilateral MCA occlusions. Brainomix 360 Triage Stroke uses an artificial intelligence algorithm to analyze images and highlight cases with detected NCCT LVO or ICH on the Brainomix server on premise or in the cloud in parallel to the ongoing standard of care image interpretation. The user is presented with notifications for cases with suspected LVO or ICH findings via a web user interface or mobile application. Notifications include compressed preview images that are meant for informational purposes only and are not intended for diagnostic use beyond notification. The device does not alter the original medical image, and it is not intended to be used as a primary diagnostic device. The results of Brainomix 360 Triage Stroke are intended to be used in conjunction with other patient information and based on professional judgment to assist with triage/prioritization of medical images. Notified clinicians are ultimately responsible for reviewing full images per the standard of care.
Intended User
Hospital networks and trained clinicians
Age
Adult
Anatomy
Head
Modality
CT
Output
The device flags and communicates suspected positive findings of large vessel occlusion (LVO) of the intracranial ICA and M1 or intracranial hemorrhage (ICH) on non-contrast head CT images. It provides notifications for cases with suspected LVO or ICH findings via a web user interface or mobile application.
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
Both
Standalone Model Performance
Reference Standard (Ground Truth)
Unknown
No. of Cases
608
Age Range (Years)
21 - 70
Sex (%)
  • Female: Unknown
  • Male: Unknown
  • Unknown: 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
Output
ICH positive: 49%, ICH negative: 51%
Scanner Manufacturer(s)
GE;Philips;Siemens
Scanner Model(s)
Unknown
No. of Sites
Unknown
Model Accuracy
Unknown
Model Sensitivity
ICH: 96 - 77
Model Specificity
ICH: 96 - 94
Reader Study Performance
No. of Readers
Unknown
No. of Cases
Unknown
No. of Sites
Unknown
Output
LVO positive: 41
Age Range (Years)
21 - 70
Sex (%)
  • Female: Unknown
  • Male: Unknown
  • Unknown: 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)
GE;Philips;Siemens
Scanner Model(s)
Unknown
Model Accuracy
Unknown
Model Sensitivity
69.64% (95% CI: 60.65%, 77.70%)
Model Specificity
89.57% (95% CI: 82.92%, 94.36%)
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
All Products And Platforms from Brainomix Limited