X-ray system, diagnostic, computed tomography, application program software

Intended purpose

Virtual Nodule Clinic (VNC) is a software device used in the tracking, assessment and characterization of incidentally detected pulmonary nodules. VNC includes a computer-aided diagnosis (CADx) function, available only to pulmonologists and radiologists. This automatically analyses user-selected regions of interest (ROI) within lung CT data to provide volumetric and computer analysis based on morphological characteristics. Using only imaging features extracted from the CT image data, an artificial intelligence algorithm calculates a single value, the LCP-CNN score, which is displayed to the user. The LCP-CNN score is analysed relative to LCP-CNN scores generated on a database of cases with known ground-truth using a histogram display format. The LCP-CNN score may be useful in the characterization of pulmonary nodules during image interpretation and may be used as one input to clinical decision making when following published clinical guidelines. VNC’s LCP-CNN score is indicated for the evaluation of incidentally detected solid and semi-solid pulmonary nodules of diameter 5-30mm in patients aged 35 years or above. In cases where multiple abnormalities are present, VNC’s LCP-CNN score can be used to assess each abnormality independently. Note that LCP-CNN is not indicated for lung cancer screening or for nodules of pure ground glass opacity. In addition, the validation data also excluded high contrast CT images, CT images with only calcified nodules (since these are typically considered to be benign), with implants, motion artifacts, missing slices, or cases with greater than 5 nodules. Finally, the validation data excluded patients with history of cancer of less than 5 years to avoid the presence of metastatic lesions. Users other than radiologists and pulmonologists, e.g., clinicians, nurses, nurse practitioners and navigators, may use VNC to view CT images and reports, organize patient management workflow, track patients, record management decisions and organize nodule clinics. For these users, the LCP-CNN score is unavailable.