CINA-iPE

AVICENNA.AI
CINA-iPE Model Card
Product Details
Model Identifier
Manufacturer
AVICENNA.AI
Product
CINA-iPE
Version
Unknown
Date Cleared
03/13/2024
FDA Submission No.
Category
CADt
Model Characteristics
Inclusion Criteria
Contrast-enhanced CT scans (not dedicated CTPA protocol) of the lung
Exclusion Criteria
Unknown
Instructions for Use
Not available
Indications for Use
Indication of Use
CINA-iPE is a radiological computer-aided triage and notification software indicated for use in patients undergoing contrast-enhanced CT scans (not dedicated CTPA protocol) for other clinical indications than pulmonary embolism suspicion, including at least a part of the lung. The device is intended to assist hospital networks and appropriately trained radiologists in workflow triage by flagging and communicating suspected positive findings for incidental Pulmonary Embolism (iPE). The device is indicated for adults and transitional adolescents (18 to 21 years old but treated as adults). CINA-iPE uses an artificial intelligence algorithm to analyze images and highlight cases with detected incidental PE on a standalone application in parallel to the ongoing standard of care image interpretation. The user is presented with notifications for cases with suspected incidental PE findings.The device is not designed to detect PE in subsegmental arteries. 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 diagnostic device. The results of CINA-iPE are intended to be used in conjunction with other patient information and based on their 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 appropriately trained radiologists
Age
Adult
Anatomy
Chest
Modality
CT
Output
Triage by flagging and communicating suspected positive findings for incidental Pulmonary Embolism (iPE)
Details on Training Data Sets
Details on Training Data Sets
No. of Cases
5,429
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
381
Age Range (Years)
18 - 99
Sex (%)
Female: 46
Male: 53
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: 56
International: 44
Output
Positive iPE : 47
Scanner Manufacturer(s)
Canon\Toshiba;GE;Philips;Siemens
Scanner Model(s)
Unknown
No. of Sites
Unknown
Model Accuracy
Unknown
Model Sensitivity
87
Model Specificity
92
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
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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