Neurophet AQUA AD Plus

Neurophet AQUA AD Plus is software that automatically segments, labels, and measures volumes of brain structures and lesions from MRI images, and calculates standardized uptake value ratios (SUVR) and Centiloid scales from PET images. The volumetric results are compared to reference percentile data to support clinical evaluation of neurodegeneration and cognitive impairment, though clinical interpretation by qualified physicians is required.

The device uses automated deep learning-based segmentation for T1-weighted, T2-FLAIR, GRE/SWI MRI sequences and amyloid PET imaging. It includes five AI modules (T1-SegEngine, FLAIR-SegEngine, PET-Engine, ED-SegEngine, HEM-SegEngine) that perform artifact correction, segmentation, lesion quantification, volume calculation, SUVR calculation, and automated Centiloid scale computation. It includes quality control checks and supports DICOM input/output on Windows-based off-the-shelf hardware.

Not stated in this summary.

Neurophet AQUA AD Plus is substantially equivalent to predicate devices NeuroQuant (K241098) and SCALE PET (K221405) because it shares identical regulatory classification, product codes, indications for use, and similar technological architecture for automated brain structure segmentation and quantification. Performance testing demonstrated that all AI modules met or exceeded predefined acceptance criteria (DSC ≥0.80–0.90 for segmentation; ICC ≥0.993 for SUVR; κ≥0.70 for Centiloid classification) across diverse scanner vendors, protocols, and patient populations, with no new safety or effectiveness concerns identified.