QOCA image Smart CXR Image Processing System
Quanta Computer Inc.QOCA image Smart CXR Image Processing System is an AI-powered software that analyzes adult chest X-rays automatically to identify suspected pneumothorax cases. It integrates with hospital PACS to notify radiologists so they can prioritize reviewing urgent cases, thus enhancing workflow efficiency. It is not a standalone diagnostic tool, but a triage aid.
Intended Use
QOCA image Smart CXR Image Processing System is a software as medical device (SaMD) that uses AI/deep learning technology to analyze chest X-ray images of adult patients to identify suspected pneumothorax cases. It integrates with PACS to automatically analyze DICOM files, marking suspected cases to alert radiologists for prioritized review. It is a triage tool, not meant to substitute clinical diagnosis or be used standalone.
Technology
The device is a web-based medical software using a locked AI algorithm for automatic analysis of PA or AP erect chest X-rays pushed from PACS. It marks suspected pneumothorax cases on a viewer page for radiologist prioritization but does not highlight specific image anomalies. It supports multiple users simultaneously and analyzes DICOM files with AI for triage notification.
Performance
Performance was validated via two pivotal studies on independent datasets from MIMIC (US) and a Taiwanese hospital. The device achieved AUC around 97-98%, sensitivity >91%, specificity >92%. It demonstrated comparable accuracy to its predicate device. Average analysis time was 4.94 seconds, facilitating rapid triage notification.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
6/27/2022
7 months - 2
FDA Approval
1/27/2023
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