Intended Use

NS-HGlio is intended for the semi-automatic labeling, visualization, and volumetric quantification of high-grade brain glioma from standard MRI images of adult patients confirmed pathologically to have high-grade glioma. It is used as an additional information source by qualified clinical personnel and is not intended for primary diagnosis.

Technology

NS-HGlio operates as a software-as-a-medical-device (SaMD) taking DICOM standard MRI images as input. It employs deep learning to semi-automatically label glioma subcomponents and outputs volumetric measurements and segmented color overlays via a viewing software, with integration options to clinical PACS systems.

Performance

The device was validated on 33 subjects with 132 MRI scans from multiple vendors, using expert neuroradiologist-labeled ground truth. It achieved a mean Dice Similarity Coefficient of 0.88 (preoperative) and 0.80 (postoperative), outperforming expert averages, and an intraclass correlation coefficient (ICC) of 0.98, demonstrating high accuracy and reliability.

Predicate Devices

No predicate devices specified

Device Timeline

  • 1

    Submission

    6/15/2022

    3 months
  • 2

    FDA Approval

    9/27/2022

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