EFAI ChestSuite XR Pleural Effusion Assessment System
Ever Fortune.AI Co., Ltd.The EFAI ChestSuite XR Pleural Effusion Assessment System is an AI-powered software tool designed to assist radiologists by analyzing adult chest X-ray images (taken in the PA view) to identify features suggestive of pleural effusion. It provides notification through PACS/workstations to help prioritize and triage cases for review, improving workflow efficiency. The software does not highlight specific image areas but offers case-level alerts to support clinical assessment.
Intended Use
A software workflow tool designed to aid the clinical assessment of adult Chest X-Ray cases with features suggestive of pleural effusion. It analyzes chest x-ray images taken in PA position and makes case-level output available for worklist prioritization or triage. Not intended for standalone clinical decision-making or ruling out pleural effusion.
Technology
Software-only device using deep learning algorithms to automatically analyze PA chest X-rays. Operates in stages including data transfer, preprocessing, AI inference, and post-processing. Provides passive notifications to PACS/workstations for prioritization without marking specific locations on images. Packaged as a docker container for deployment on hospital servers.
Performance
Performance was validated through internal retrospective studies (1454 images) showing AUC of 0.9517, sensitivity 0.9013, and specificity 0.8869 for pleural effusion detection. Clinical standalone testing on 600 external images demonstrated high sensitivity (0.9510), specificity (0.9745), and AUC (0.9712), comparable to the predicate device HealthCXR (K192320). Average processing time was 19.6 seconds.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
7/14/2022
1 month - 2
FDA Approval
9/8/2022
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