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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 analyzes user-selected regions of interest (RO) 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 analyzed 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 nor is it indicated for nodules of pure ground glass opacity. In addition, high contrast CT images were not used in clinical validation (as measured as >300HU median attenuation in the aortic arch) and the validation data also excluded CT images with only calcified nodules (since these are typically considered to be benign), with implants, motion artifacts, 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, 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.

VNC is a software only device which consists of two main components: a web application accessed via standard desktop web browsers and the LCP-CNN machine learning model. Virtual Nodule Clinic (VNC) is a software application designed for trained medical professionals in the clinical management of patients with pulmonary nodules. VNC includes a computer-aided diagnosis (CADx) function to assist pulmonologists and radiologists in the assessment and characterization of incidentally detected pulmonary nodules using CT image data. VNC has two main functions: - A CADx function to assist radiologists and pulmonologists in clinical decision making by providing a score using machine learning (namely the LCP-CNN algorithm, Lung Cancer Prediction Convolutional Network). Also note that the output of the CADx function is referred to synonymously in this document as either "Optellum LCP Score" or "LCP-CNN score", depending on context. - . A management function to allow users to easily track patients that need to be under management follow-up for indeterminate pulmonary nodules (IPNs). VNC consists of two main software components: - . A web application deployed on a virtual server within a hospital datacenter; - The LCP-CNN module deployed on a GPU-equipped server on hospital premises or in the cloud. VNC is connected to two other IT systems in the hospital: a DICOM-compatible Picture Archiving and Communication System (PACS) for accessing images and to the Radiology Information System (RIS) or reporting system for accessing the clinical reports.