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Intended Use

QP-Brain® is a medical imaging processing application intended for automatic labeling and volumetric quantification of segmentable brain structures and white matter hyperintensities (WMH) from a set of adults and adolescents 18 and older MR images. Volumetric measurements may be compared to reference percentile data. The application is used by clinicians with proper training, as a support tool in assessment of structural MRIs. Patient management decisions should not be based solely on the results of the device.

Technology

QP-Brain® uses automated pipelines on 3D T1-weighted MRI scans for brain segmentation and volumetry. When T2 FLAIR images are available, it employs AI to identify white matter hyperintensities. Outputs include segmentation overlays and volumetric reports compatible with DICOM PACS systems. It integrates normative brain volume comparison by age and gender and supports longitudinal monitoring.

Performance

Software verification and validation were conducted following FDA recognized standards. Performance was compared to manual expert segmentation for brain segmentation and white matter hyperintensities. Dice scores for brain tissues ranged from 0.955 to 0.994, and WMH segmentation showed increasing accuracy with lesion size. Results demonstrated safety and effectiveness comparable to predicate devices.

View FDA documentation

Predicate Devices

No predicate devices specified

Device Timeline

  • 1

    Submission

    7/27/2023

    4 months
  • 2

    FDA Approval

    12/13/2023

Other devices from Quibim S.L.

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