ClearPoint Maestro Brain Model

K213645

ClearPoint Neuro, Inc. · cleared 2022-08-08 · product code QIH · Radiology

Premarket evidence — what FDA accepted

Device typesamd
source quote (p.3)
“ClearPoint Maestro™ Brain Model is intended for automatic labeling, visualization, volumetric and shape quantification of segmentable brain structures from a set of MR images. This software is intended to automate the process of identifying, labelling, and quantifying the volume and shape of brain structures visible in MRI images.”
Algorithmshape-constrained segmentation of sub-cortical brain regions, the hemispheres, and the cerebellum, followed by voxel-wise tissue parcellation of the hemispheres and the cerebellum into tissue types. Machine learning derived outputs.
source quote (p.5)
“NeuroQuant performs automatic segmentation and quantification of brain structures using a probabilistic neuroanatomical atlas based on MR image intensity, while ClearPoint Maestro™ Brain Model uses shape-constrained segmentation of sub-cortical brain regions, the hemispheres, and the cerebellum, followed by voxel-wise tissue parcellation of the hemispheres and the cerebellum into tissue types. However, based on the assessment of device performance, these minor differences do not affect safety and effectiveness. Machine learning derived outputs are the volumes of the gray and white matter in the cerebellum and the left and right cerebral hemispheres: Cerebellum GM, Cerebellum WM, L Cortical GM, and R Cortical GM, L Cortical WM, R Cortical WM.”
Adaptive (vs locked)FDA source did not state this
PCCPFDA source did not state this
Cybersecurity addressedFDA source did not state this

Validation studies (1)

Retrospective clinical

n=101 patients

endpoints: Dice coefficient >0.7; relative volume difference <0.3; absolute volume differences <15% between segmentation performed on two repeated scans

Reported performance (1 observation)

diceas written: “Dice coefficient”0.7
source quote (p.5)
“The means of computed Dice coefficients for 21 segmented brain structures in 101 subjects from the validation dataset were significantly greater than 70%, meeting the acceptance criteria.”

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
2
drift signals on this device
  • re_clearance

    The FDA AI/ML device list shows a newer 510(k) K243657 (decision 2025-01-24) from ClearPoint Neuro, Inc. for a matching device line ("ClearPoint System (Software Version 3.0)") — a new clearance for the same line is a change event.

    first seen 2026-07-08 · k_number:K243657

  • re_clearance

    The FDA AI/ML device list shows a newer 510(k) K233243 (decision 2023-11-27) from ClearPoint Neuro Inc. for a matching device line ("ClearPoint System (Software Version 2.2)") — a new clearance for the same line is a change event.

    first seen 2026-07-08 · k_number:K233243

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/K213645