Critical Care Suite
GE Medical Systems, LLC.Critical Care Suite is an AI-powered software by GE Medical Systems designed to analyze frontal chest X-ray images and detect pneumothorax, a potentially life-threatening condition. It flags suspicious images in the image management system to help radiologists prioritize urgent cases, improving workflow efficiency and patient care. The software runs seamlessly without delaying image processing and helps reduce the report turnaround time for critical chest X-rays.
Intended Use
Critical Care Suite is a computer aided triage and notification device that analyzes frontal chest x-ray images for the presence of prespecified critical findings (pneumothorax). Identifies images with critical findings to enable case prioritization or triage in the PACS/workstation. Intended for notification only and does not provide diagnostic information beyond the notification. Indicated for adult-size patients.
Technology
Critical Care Suite employs AI-based image analysis algorithms including a Quality Care Suite for input validation and a PTX Classifier to detect pneumothorax on frontal chest X-rays. It integrates with Digital Projection Radiographic Systems and PACS, runs on multiple platforms (on premise or cloud), and produces passive notifications for prioritization without affecting image acquisition or transfer times.
Performance
Performance testing showed ROC AUC of 0.96 for pneumothorax detection with high sensitivity (84.3%) and specificity (93.5%). Clinical evaluation on 804 chest X-rays demonstrated consistent performance across views, manufacturers, and data sources. The software does not delay image acquisition or transfer and enables immediate prioritization in PACS. Non-clinical and clinical tests confirmed safety, reliability, and workflow integration.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
11/19/2018
8 months - 2
FDA Approval
8/12/2019
Other devices from GE Medical Systems, LLC.
- SIGNA MAGNUS2024 • 510K
- Sonic DL2023 • 510K
- Critical Care Suite with Pneumothorax Detection AI Algorithm, Critical Care Suite 2.1, Critical Care Suite2023 • 510K
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