qXR-PTX-PE
Qure.ai TechnologiesqXR-PTX-PE is an AI-powered software that assists radiologists by automatically analyzing adult chest X-rays to detect signs of pleural effusion and pneumothorax. It helps prioritize cases by providing case-level outputs within the existing PACS/workstation without altering images or providing direct clinical diagnosis, thereby improving workflow efficiency.
Intended Use
qXR-PTX-PE is a radiological computer-assisted triage and notification software that analyzes adult chest X-ray images for the presence of pre-specified suspected critical findings (pleural effusion and/or pneumothorax). qXR-PTX-PE uses an artificial intelligence algorithm to analyze images for features suggestive of critical findings and provides case-level output available in the PACS/workstation for worklist prioritization or triage. It is a passive notification tool and not intended as a standalone clinical decision tool.
Technology
The device processes frontal chest X-ray images in DICOM format using an AI algorithm trained on diverse international datasets. It analyzes images to detect features suggestive of pleural effusion and pneumothorax and provides prioritized case-level outputs through integrations with PACS/workstations without modifying original images. Notifications are passive and meant to assist workflow prioritization.
Performance
Clinical studies on retrospective chest X-rays from diverse U.S. hospitals demonstrated high accuracy in detecting pleural effusion and pneumothorax, with AUC > 0.98, sensitivity > 94%, and specificity > 94%. Performance was consistent across age, gender, and imaging device subgroups. The average time to analyze and notify was about 10 seconds, comparable to predicate devices.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
3/31/2023
4 months - 2
FDA Approval
8/22/2023
Other devices from Qure.ai Technologies
- qCT LN Quant2024 • 510K
- qXR-LN2023 • 510K
- qXR-CTR2023 • 510K
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