Optellum Virtual Nodule Clinic

Primary DI

+B816VNC2P20

Basic UDI-DI Code

++B816VNC2P0YT

Reference

2.2.2

Device Types

None provided

Regulation

Eu Mdr

Classification

Eu Md Class 2b

Status

On The Market

Manufacturer

Optellum Ltd

The device is a software device used in the tracking, assessment and characterization of pulmonary nodules. The device 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. The LCP-CNN score is indicated for the evaluation of solid and semi-solid pulmonary nodules of diameter 5-30 mm 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. LCP-CNN is not indicated 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 the device 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.

Other on-the-market devices with the same classification (Eu Md Class 2b) and regulation (EU MDR).