EFAI Chestsuite XR Malpositioned ETT Assessment System (ETT-XR-100)
Ever Fortune.AI, Co., Ltd.The EFAI Chestsuite XR Malpositioned ETT Assessment System (ETT-XR-100) is software that assists medical professionals by automatically analyzing chest X-ray images to detect misplaced endotracheal tubes. It uses deep learning to flag suspicious cases and prioritize them in the workflow, helping radiologists review these urgent cases more quickly. The software provides alerts when the tube tip is positioned too high, too low, or incorrectly and supports clinical decision-making by improving triage efficiency.
Intended Use
Radiological computer-aided triage and notification software indicated for use in the analysis of chest X-ray (CXR) images in adults to assist in workflow triage by flagging suspected positive cases of vertically malpositioned endotracheal tube (ETT) relative to the carina.
Technology
Uses deep learning algorithms to automatically analyze chest radiographs (AP view) and notify PACS/workstations of cases with suspected malpositioned ETT for prioritized review. It provides case-level outputs and does not mark specific image regions. The algorithm assesses the vertical position of the ETT distal tip relative to the carina but does not account for patient positioning or esophageal intubation and operates solely on single lumen ETTs.
Performance
A retrospective, blinded, multisite clinical validation on 940 chest X-ray studies demonstrated sensitivity of 0.890 and specificity of 0.935 in detecting malpositioned ETTs. Performance was consistent across demographic subgroups and complex cases. The average processing time was 2.49 minutes per study. Testing conformed to FDA software guidance and IEC 62304 standards.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
9/18/2024
5 months - 2
FDA Approval
2/20/2025
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