RevealAI-Lung
Precision Medical Ventures, Inc. Dba RevealdxRevealAI-Lung is an AI-powered software designed to help radiologists assess the cancer risk of lung nodules detected on CT scans. It compares characteristics of detected nodules against a database of confirmed cases to provide a malignancy similarity score that supports clinical decision-making for incidental lung nodules.
Intended Use
RevealAI-Lung Software is a computer aided diagnostic (CADx) software application intended for the characterization of incidentally-detected lung nodules on computed tomography (CT) scans. When a nodule is identified, the Software automatically compares the nodule characteristics with a clinically established database of lung nodules and provides a similarity score to assist clinicians' assessment of patients' cancer risk.
Technology
RevealAI-Lung is a software-only device that analyzes CT images and provides a malignancy similarity index (mSI) score based on thousands of imaging features extracted from the nodule. It integrates with Medical Image Processing and Management System (MIMPS) for radiology workflow and utilizes machine learning trained on a reference dataset of nodules with confirmed diagnoses.
Performance
The device underwent nonclinical design verification and validation, including usability and cybersecurity testing, following FDA guidance. Clinical performance was evaluated in a multi-reader multi-case study with 10 radiologists reading 108 cases, showing a statistically significant improvement in malignancy discrimination (mean AUC improvement of 0.18, p<0.0001) when using RevealAI-Lung. Additional validation on external populations showed consistent AUC > 0.8 across diverse patient and scan characteristics.
Predicate Devices
No predicate devices specified
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