GyriCalc (Version 1.0.0)

GyriCalc is automated software that analyzes 3D T1 MRI brain images from children aged 24-36 months to automatically label, visualize, and measure brain structures. It produces a PDF report with segmented color overlays and morphometric data including volume, surface area, and gyrification measurements for clinical assessment by qualified clinicians.

Both GyriCalc and predicate NeuroQuant use automatic segmentation and quantification of brain structures from 3D T1 MRI images, but GyriCalc adds surface area and gyrification index measurements whereas NeuroQuant only provides volume. GyriCalc uses deep learning-based segmentation (FreeSurfer's SynthSeg) versus NeuroQuant's atlas-based approach. GyriCalc outputs PDF reports only, while NeuroQuant supports DICOM output format.

Not stated in this summary.

Both devices perform identical core functions—automatic labeling, visualization, and quantification of brain structures from 3D T1 MRI images—with equivalent processing architectures (preprocessing, segmentation, measurement, reporting). The additional technological characteristics (surface area and gyrification measurements) do not raise new safety or effectiveness questions because they are supplementary measurements supported by clinical performance testing showing Dice scores of 92-99% for segmentation accuracy. GyriCalc's exclusion of lesion quantification is not a safety concern because lesion detection is explicitly outside its stated indications for use.