Critical Care Suite with Endotracheal Tube Positing AI algorithm
GE Medical Systems, LLCCritical Care Suite with Endotracheal Tube Positioning AI Algorithm is a software tool that uses AI to automatically analyze frontal chest X-rays. It detects and localizes the position of an endotracheal tube and calculates the distance between the tube tip and the carina, providing clinicians with important information on tube placement to improve patient care.
Intended Use
Critical Care Suite is a suite of AI algorithms for automated image analysis of frontal chest X-rays on digital x-ray systems. The Endotracheal Tube Positioning AI algorithm detects and localizes the tube, tip, and carina, and calculates their vertical distance.
Technology
The device employs a deep learning locked AI algorithm deployed on several computational platforms. It analyzes frontal chest X-ray images to identify and localize tube and anatomical landmarks, providing measurement quantification to aid healthcare professionals.
Performance
Verification and validation testing including risk analysis, design reviews, unit and integration testing, performance and safety testing, and simulated use testing were conducted. Clinical performance showed high accuracy with AUC of 0.9999, sensitivity 0.9941, specificity 1.0000 in detecting endotracheal tube and anatomical landmarks.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
4/19/2021
6 months - 2
FDA Approval
10/29/2021
Other devices from GE Medical Systems, LLC
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- Critical Care Suite with Pneumothorax Detection AI Algorithm, Critical Care Suite 2.1, Critical Care Suite2023 • 510K
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