Rapid Aneurysm Triage and Notification

RapidAI
Rapid Aneurysm Triage and Notification Model Card
Product Details
Model Identifier
Manufacturer
RapidAI
Product
Rapid Aneurysm Triage and Notification
Version
Unknown
Date Cleared
07/27/2023
FDA Submission No.
Category
CADt
Model Characteristics
Inclusion Criteria
The module shall detect unruptured saccular brain aneurysms greater than or equal to 4 mm in size within the following anatomical region: � Internal Carotid Artery (ICA): ophthalmic segment to ICA terminus � Middle Cerebral Artery (MCA): M1 segment through M1/M2 bifurcation � Anterior Cerebral Artery (ACA): A1 and A2 segments � Anterior Communicating Artery (ACOM) � Posterior Communicating Artery (PCOM) � Posterior Cerebral Artery (PCA): P1 segment � Vertebral Artery (VA): intracranial portion of the VA through the vertebrobasilar (VB) junction � Basilar Artery (BA)
Exclusion Criteria
� The module shall process only CTA datasets with a patient position of �headfirst supine�. � The module shall process only a series within CTA datasets comprised only of axial slices. � The module shall process only CTA datasets with Z FOV (cranio-caudal transverse anatomical coverage) greater than or equal to 90 mm � The module shall process only CTA datasets with in-plane pixel spacing (X & Y resolution): 0.2 � 1.0 mm � The module shall process only CTA datasets with in-plane X FOV: 160-400mm. � The module shall process only CTA datasets with in-plane Y FOV: 160-400 mm � The module shall process only CTA datasets with Z slice spacing of 0.2 � 1.25 mm � The module shall process only CTA datasets with data acquired at x-ray tube voltage 80kVp140kVp, as reported in the input data DICOM header � The module shall process only CTA datasets consisting of input slices of continuous order without gaps. � The module shall process only CTA datasets where the images belong to a single series (i.e., identical SeriesInstanceUID DICOM tag value for all images). � The module shall not process CTA datasets where the DICOM tags �ImagePositionPatient� (IPP), �ImageOrientationPatient� (IOP), or �PixelSpacing� are missing � The module shall only process a single series per study, being the largest available that passes the above requirements. � The module shall accept input files within a parent folder named by a unique identifier for the case. � The module shall accept axial-oblique CTA datasets with an oblique plane of ? 35 degrees. � Cases with significant motion and/or imaging artifacts.
Instructions for Use
Not available
Indications for Use
Indication of Use
Rapid Aneurysm Triage and Notification (ANRTN) is a radiological computer-assisted triage and notification software device for analysis of CT images of the head. The device is intended to assist hospital networks and trained radiologists in workflow triage by flagging and prioritizing studies with suspected saccular aneurysms during routine patient care. Rapid ANRTN uses an artificial intelligence algorithm to analyze images and highlight studies with suspected saccular aneurysms in a Stand-Alone Performance application for study list prioritization or triage in parallel to ongoing standard of care. The device generates compressed preview images that are meant for informational purposes only and not intended for diagnostic use. The device does not alter the original medical image and is not intended to be used as a diagnostic device. Analyzed images are available for review through the PACS, email and mobile application. When viewed the images are for informational purposes only and not for diagnostic use. The results of Rapid ANRTN, in conjunction with other clinical information and professional judgment, are to be used to assist with triage/prioritization of saccular aneurysm cases. Radiologists who read the original medical images are responsible for the diagnostic decision. Rapid ANRTN is limited to analysis of imaging data and should not be used in lieu of full patient evaluation or relied upon to make or confirm diagnosis. Rapid ANRT is limited to detecting saccular aneurysms at least 4mm in diameter in adults.
Intended User
Radiologist
Age
Adult
Anatomy
Head
Modality
CT
Output
Highlight studies with suspected saccular aneurysms
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
266
Age Range (Years)
21 - 99
Sex (%)
Female: 56
Male: 33
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
Positive: 57% Negative: 43%
Scanner Manufacturer(s)
Canon\Toshiba;GE;Philips;Siemens
Scanner Model(s)
Unknown
No. of Sites
Unknown
Model Accuracy
Unknown
Model Sensitivity
93
Model Specificity
86
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
Unknown
Contrast Use
Unknown
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
Email
Unknown
Additional Details
Related Use Cases
Unknown
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