EFAI ChestSuite XR Pneumothorax Assessment System
Ever Fortune AI Co., Ltd.The EFAI ChestSuite XR Pneumothorax Assessment System is an AI-powered software tool that helps clinicians prioritize chest X-ray cases suspected of pneumothorax. It uses deep learning to analyze posteroanterior chest X-rays and provides case-level notifications in the existing PACS/workstation workflow, facilitating faster identification and assessment of patients who may have pneumothorax. It supports clinical decision-making by aiding in triage but is not intended for stand-alone diagnosis.
Intended Use
EFAI PNXXR is a software workflow tool designed to aid the clinical assessment of adult (22 years of age or older) Posteroanterior (PA) view Chest X-Ray cases with features suggestive of pneumothorax in the medical care environment, using AI to identify suspected findings and making case-level output available to PACS/workstation for prioritization or triage. It does not direct attention to specific portions or anomalies and is not for stand-alone decision-making.
Technology
EFAI PNXXR is a radiological computer-assisted triage and notification software system using deep learning to automatically analyze chest PA X-rays and provide passive notification to PACS/workstation for prioritization of cases suspicious for pneumothorax. It does not mark specific image areas and runs on a specialized server within a local hospital IT network.
Performance
A blinded, retrospective multicenter study on 800 chest X-ray cases (182 positive for pneumothorax) demonstrated the device's high sensitivity (0.97), specificity (0.98), and AUC (0.99), comparable to the predicate device red dot™ (K191556). Testing included various X-ray manufacturers and confounding conditions, showing consistent and reliable performance within approximately 23 seconds per case.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
5/31/2022
5 months - 2
FDA Approval
11/8/2022
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