Neurophet AQUA AD Plus

K252496

Neurophet., Inc. · cleared 2026-01-29 · product code QIH · Radiology

Premarket evidence — what FDA accepted

Device typesamd
source quote (p.7)
“Neurophet AQUA AD Plus is a software device intended for the automatic labeling of brain structures, visualization, and volumetric quantification of segmented brain regions and lesions, as well as standardized uptake value ratio (SUVR) quantification using MR and PET images.”
AlgorithmAI-based modules using static deep learning technologies for segmentation and quantification.
source quote (p.9)
“Automatic segmentation and quantification of brain structures and lesions based on MR and PET image intensities using static deep learning technologies.”
Adaptive (vs locked)FDA source did not state this
PCCPFDA source did not state this
Cybersecurity addressedYes
source quote (p.17)
“"Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions", on September 27, 2023”

Validation studies (6)

Standalone

n=60 cases

endpoints: Dice Similarity Coefficient (DSC); Average Volume Difference Percentage (AVDP)

Standalone

n=136 cases

endpoints: Dice Similarity Coefficient (DSC); Average Volume Difference Percentage (AVDP); absolute lesion volume difference

Standalone

n=30 cases

endpoints: Intraclass Correlation Coefficients (ICC)

Standalone

n=176 scans

endpoints: kappa values

Standalone

n=100 scans

endpoints: Dice Similarity Coefficient (DSC)

Standalone

n=106 scans

endpoints: F1-score (DSC)

Reported performance (7 observations)

diceas written: “mean DSC for cortical regions”0.83CI 0.82-0.84
source quote (p.14)
“The evaluation results demonstrated a mean DSC of 0.83 ± 0.04 for cortical regions, corresponding to a 95% confidence interval of 0.82-0.84”
diceas written: “mean DSC for subcortical regions”0.87CI 0.86-0.88
source quote (p.14)
“and a mean DSC of 0.87 ± 0.03 for subcortical regions, corresponding to a 95% confidence interval of 0.86-0.88.”
diceas written: “overall mean DSC for lesion segmentation”0.9CI 0.89–0.91
source quote (p.14)
“the overall mean DSC for lesion segmentation was 0.90 ± 0.04 (95% CI: 0.89–0.91)”
agreement_kappaas written: “intraclass correlation coefficients (ICC)”0.993
source quote (p.14)
“intraclass correlation coefficients (ICC) ≥ 0.993 across seven Alzheimer's-relevant regions”
agreement_kappaas written: “kappa values”0.7
source quote (p.14)
“achieved kappa values that met or exceeded the acceptance criterion of к ≥ 0.70”
diceas written: “mean DSC versus expert manual segmentations”0.91CI 0.89–0.93
source quote (p.14)
“the mean DSC versus expert manual segmentations was 0.91 ± 0.09 (95% CI: 0.89–0.93)”
f1as written: “median F1-score (DSC)”0.86CI 0.824–0.902
source quote (p.14)
“the HEM-SegEngine achieved a median F1-score (DSC) of 0.860 (95% CI: 0.824–0.902)”

Each value carries its own analysis unit and task — never compare or pool across devices. Source: 510(k) summary PDF.

Predicate network

Postmarket — what happened after clearance

0
recalls in product code, 24mo
3
MAUDE reports in code, 12mo
—
vs code's own 3-yr baseline
0
drift signals on this device

Recall and MAUDE counts are product-code-level (reports aren't reliably attributable to one device); a recall is shown as device-attributed only when the recall record itself lists this clearance number. Signals are descriptive observables with sources — never a judgment that the device is unsafe or drifting. Snapshot 2026-07-08.

Reimbursement — how devices like this got paid

Not yet tracked — no payment pathway indexed for this clearance (the reimbursement corpus is a growing seed set).

Applicable FDA guidance — what the submission is measured against

FDA guidance documents and guiding principles applicable to 510(k) AI/ML devices in the Radiology panel. A curated reference index, not legal or regulatory advice — each item states its own status, and a draft is never binding.

Applicability is derived from the device's FDA advisory panel and pathway — cross-cutting guidances apply to every AI/ML device; panel-specific ones are flagged. Titles, dates, and links verified against fda.gov as of July 2026.

Constat Precedent · public FDA/CMS data · descriptive decision-support, not regulatory or reimbursement advice. Share this page: constat.dev/precedent/device/K252496