AVIEW Lung Nodule CAD
Coreline Soft Co.,Ltd.AVIEW Lung Nodule CAD is an AI-powered software designed to help radiologists detect lung nodules on chest CT scans. It automatically identifies nodules between 3 to 20 mm in diameter, providing an additional review layer to ensure suspicious nodules are not overlooked. This tool integrates with medical imaging systems and has been clinically tested to improve detection accuracy and reduce the time radiologists spend reviewing CT scans, ultimately aiding early diagnosis of lung conditions.
Intended Use
AVIEW Lung Nodule CAD is a Computer-Aided Detection (CAD) software designed to assist radiologists in the detection of pulmonary nodules (with diameter 3-20 mm) during the review of CT examinations of the chest for asymptomatic populations. It provides adjunctive information to alert the radiologists to regions of interest with suspected lung nodules that may otherwise be overlooked. It may be used as a second reader after the radiologist has completed their initial read.
Technology
The device uses a deep convolutional neural network (CNN) based algorithm trained on chest CT images to automatically detect lung nodules sized 3 to 20 mm. It complies with DICOM standards to integrate with PACS and provides a separate user interface. The algorithm is validated on Siemens SOMATOM CT series and intended to be used with the AVIEW platform.
Performance
Clinical testing involved a multi-reader multi-case retrospective study with 11 board-certified radiologists and 151 chest CT cases, showing statistically significant improvement in lung nodule detection accuracy and reduced reading time with AI assistance. Standalone performance testing demonstrated high sensitivity (around 0.9) and specificity (around 0.7) with AUC above 0.9. Software verification and validation testing confirmed reliability and performance per predefined criteria.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
6/2/2022
8 months - 2
FDA Approval
2/24/2023
Other devices from Coreline Soft Co.,Ltd.
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