BriefCase-Malpositioned Endotracheal Tube Triage

Aidoc Medical
BriefCase-Malpositioned Endotracheal Tube Triage Model Card
Product Details
Model Identifier
Manufacturer
Aidoc Medical
Product
BriefCase-Malpositioned Endotracheal Tube Triage
Version
Unknown
Date Cleared
11/18/2022
FDA Submission No.
Category
CADt
Model Characteristics
Inclusion Criteria
Frontal Chest X-ray protocol. Images performed on adults/ transitional adults ≥ 18 years of age
Exclusion Criteria
All x-ray images that have inadequate field of view. The device does not provide results when the carina is not well-visualized on the x-ray image.
Instructions for Use
Not available
Indications for Use
Indication of Use
BriefCase is a radiological computer-aided triage and notification software indicated for use in the analysis of frontal chest X-ray (CXR) images in adults or transitional adolescents aged 18 and older. The device is intended to assist hospital networks and appropriately trained medical specialists in workflow triage by flagging and communicating suspected positive cases of vertically malpositioned endotracheal tube (ETT) in relation to the carina. Findings are flagged when the ETT distal tip is assessed as being more than 5 cm above the carina, less than 2 cm above the carina, or when it is below the carina (i.e., in the right or left mainstem bronchus). The device assesses solely the vertical position of the ETT distal tip relative to the carina, does not factor patient positioning, and cannot detect esophageal intubation. The device does not provide results when the carina is not well visualized on the x-ray image. The device does not discriminate types of ETTs, as such a properly positioned double lumen ETT may trigger a false prioritization alert. BriefCase uses an artificial intelligence algorithm to analyze images and highlight cases with detected findings on a Stand-Alone Performance application in parallel to the ongoing standard of care image interpretation. The user is presented with notifications for cases with suspected findings. Notifications include compressed preview images that are meant for informational purposes only and not intended for diagnostic use beyond notification. The device does not alter the original medical image and is not intended to be used as a diagnostic device.
Intended User
Medical professionals
Age
Adult
Anatomy
Chest
Modality
XRAY
Output
Malpositioned Endotracheal Tube (ETT) (Triage)
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
921
Age Range (Years)
18 - 90
Sex (%)
Female: 41
Male: 59
Unknown: 0
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: 100
International: 0
Output
Positive: 19
Scanner Manufacturer(s)
Canon\Toshiba;Philips;Siemens;Carestream
Scanner Model(s)
Unknown
No. of Sites
5
Model Accuracy
Unknown
Model Sensitivity
86
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)
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
Additional Details
Related Use Cases
Placement of Endotracheal Tube
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