LumiNE US; Lumi
Augmedit B.V.LumiNE US is a visualization software designed to help neurosurgeons and medical professionals prepare for surgery by converting 2D MRI and CT images into 3D models using AI-based segmentation. It enables visualization through augmented reality using head-mounted displays, assisting in understanding brain tumors and anatomy before surgery. The software is not intended for diagnostic use but to support surgical planning by providing enhanced image insights.
Intended Use
The LumiNE US software is intended for the visualization of medical images to provide insights in anatomy and pathology in preparation of surgical treatment, allowing conversion of 2D medical images into 3D models and visualization via augmented reality for neurosurgeons and medical professionals. It uses MRI and/or CT images and is not intended for diagnostic use.
Technology
LumiNE US uses a cloud-based platform connected to Microsoft HoloLens 2 to visualize 3D virtual images from MRI and CT data with semi-automatic segmentation algorithms based on machine learning (nnUnet). It allows manipulation and surgical planning of 3D models including annotations and sharing functionalities.
Performance
Nonclinical testing demonstrated that LumiNE US software performs as intended with high accuracy of semi-automatic segmentation compared to manual segmentation by clinical experts. Testing included visual quality, DICOM visualization, latency, multiple scanner variants, and usability assessments. The segmentation algorithm showed non-inferior accuracy on a diverse US test dataset, meeting defined Dice similarity and Hausdorff distance metrics.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
1/12/2024
8 months - 2
FDA Approval
9/10/2024
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