Alzevita

Alzevita is a cloud-based, AI-powered medical image processing software that performs fully automated segmentation and volumetric measurement of the hippocampus from high-resolution T1-weighted brain MRI scans. It is intended for use by neurologists and radiologists to enable comparison of hippocampal volume against a normative dataset from healthy control subjects aged 55-90 years acquired on 1.5T/3T MRI scanners.

Alzevita is a Software as a Medical Device (SaMD) using advanced 3D U-Net++ deep learning methodology, whereas the predicate NEUROShield uses DeepNet/U-Net methodologies. Both are fully automated, geometry-based brain analytics tools accessible via web browser on standard hardware. Alzevita accepts compressed DICOM or NIfTI files; NEUROShield requires uncompressed DICOM. Both provide hippocampal volumetric measurements with automated quality control and require clinician review.

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Alzevita is substantially equivalent to NEUROShield (K220034) in intended use, design, and performance. Both are Class II medical image processing software for automated hippocampal segmentation and volumetric quantification. Validation testing on 298 ADNI subjects demonstrated Alzevita achieved Dice scores ≥0.85, Hausdorff distances ≤1.6 mm, and correlation ≥0.82 across diverse subgroups (clinical, gender, MRI strength, slice thickness, geographic region), meeting or exceeding predefined acceptance criteria and demonstrating equivalent accuracy and reliability.