CINA-ASPECTS

AVICENNA.AI
CINA-ASPECTS Model Card
Product Details
Model Identifier
Manufacturer
AVICENNA.AI
Product
CINA-ASPECTS
Version
Unknown
Date Cleared
03/15/2024
FDA Submission No.
Category
CADx
Model Characteristics
Inclusion Criteria
Non-contrast head CT
Exclusion Criteria
Unknown
Instructions for Use
Not available
Indications for Use
Indication of Use
CINA-ASPECTS is a computer-aided diagnosis (CADx) software device used to assist the clinician in the assessment and characterization of brain tissue abnormalities using CT image data. The Software automatically reorients images, segments and analyzes ASPECTS Regions of lnterest (ROIs). CINAASPECTS extracts image data for the ROI(s) to provide analysis and computer analytics based on morphological characteristics. The imaging features are then synthesized by an artificial intelligence algorithm into a single ASPECT (Alberta Stroke Program Early CT) Score. CINA-ASPECTS is indicated for evaluation of patients presenting for diagnostic imaging workup with known MCA or ICA occlusion, for evaluation of extent of disease. Extent of disease refers to the number of ASPECTS regions affected which is reflected in the total score. This device provides information that may be useful in the characterization of early ischemic (acute) brain tissue injury during image interpretation. CINA-ASPECTS provides a comparative analysis to the ASPECTS standard of care radiologist assessment using the ASPECTS region definitions and highlighting ROIs and numerical scoring. Limitations: 1. CINA-ASPECT is not intended for primary interpretation of CT images. It is used to assist physician evaluation. 2. CINA-ASPECT has been validated in patients with known MCA or ICA unilateral occlusion prior to ASPECTS scoring. 3. CINA-ASPECTS is not suitable for use on brain scans displaying neurological pathologies other than acute stroke, such as tumors or abscesses, traumatic brain injuries, hemorrhagic transformation and hematoma. 4. Use of CINA-ASPECT in clinical settings other than brain ischemia within 12 hours from time last known well, caused by known ICA or MCA occlusions has not been tested. 5. CINA-ASPECTS has only been validated and is intended to be used in patient populations aged over 21. 6. CINA-ASPECTS has been validated and is intended to be used with images acquired with Canon Medical Systems Corporation, GE Healthcare, Philips Healthcare and Siemens Healthineers scanners.
Intended User
Physician
Age
Adult
Anatomy
Head
Modality
CT
Output
ASPECT Score
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
200
Age Range (Years)
Unknown
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
Unknown
Scanner Manufacturer(s)
Canon\Toshiba;GE;Philips;Siemens
Scanner Model(s)
Unknown
No. of Sites
5
Model Accuracy
Unknown
Model Sensitivity
Not provided
Model Specificity
Not provided
Reader Study Performance
No. of Readers
8
No. of Cases
200
No. of Sites
Unknown
Output
Unknown
Age Range (Years)
Unknown
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)
Unknown
Scanner Model(s)
Unknown
Model Accuracy
Unknown
Model Sensitivity
Not provided
Model Specificity
Not provided
Model Limitations, Warnings, & Precautions
Model Limitations, Warnings, & Precautions
Supported Scanner Manufacturer(s)
Canon\Toshiba;GE;Philips;Siemens
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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