Critical Care Suite with Pneumothorax Detection AI Algorithm, Critical Care Suite 2.1, Critical Care Suite
GE Medical Systems, LLCCritical Care Suite with Pneumothorax Detection AI Algorithm by GE Medical Systems is an AI-based software tool that analyzes frontal chest X-rays to detect pneumothorax. It highlights areas of concern and provides a confidence score, helping radiologists and licensed healthcare professionals prioritize cases and accurately diagnose pneumothoraces more efficiently. The software can be integrated with existing PACS and X-ray imaging systems to streamline workflow.
Intended Use
Intended to aide a clinician in the detection and localization of a pneumothorax on frontal chest radiographic images.
Technology
Uses deep learning AI algorithms deployed on various platforms (PACS, On Premise, On Cloud, or X-ray Imaging Systems) to analyze frontal chest X-ray images. Outputs include detection flags, localization overlays, and confidence scores highlighting suspected pneumothorax.
Performance
Clinical testing included standalone performance and multi-reader multi-case study with over 12,000 training images and 804 validation images. Achieved 96.1% AUC, 84.3% sensitivity, and 93.2% specificity. Use of the AI improved reader mean AUC by 14.5%, sensitivity by 16.3% and specificity by 12.4%.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
11/21/2022
6 months - 2
FDA Approval
5/25/2023
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