Acorn 3D Software (AC-SEG-4009); Acorn 3DP Model (AC-101-XX)

K234009

Mighty Oak Medical · cleared 2024-07-12 · product code QIH · Radiology

Premarket evidence — what FDA accepted

Device typehardware with ml
source quote (p.4)
“Acorn Segmentation is intended for use as a software interface and image segmentation system for the transfer of CT or CTA medical images to an output file. Acorn Segmentation is also intended for measuring and treatment planning. The Acorn Segmentation output can also be used for the fabrication of physical replicas of the output file using additive manufacturing methods, Acorn 3DP Models.”
Algorithmmachine learning based auto-segmentation
source quote (p.6)
“Acorn Segmentation contains both machine learning based auto-segmentation as well as semi-automatic and manual segmentation tools. The auto-segmentation tool is only intended to be used for thoracic and lumbar regions of the spine (T1-T12 and L1-L5).”
Adaptive (vs locked)FDA source did not state this
PCCPYes
source quote (p.1)
“FDA's substantial equivalence determination also included the review and clearance of your Predetermined Change Control Plan (PCCP).”
Cybersecurity addressedNo

Validation studies (1)

Bench

sample size not stated

endpoints: Accuracy of automatic segmentation for its intended use on Thoracic (T1-T12) and Lumbar (L1-L5) anatomy; Accuracy of semi-automatic and manual segmentation methods for their intended for use on musculoskeletal and craniomaxillofacial anatomy

Reported performance (1 observation)

diceas written: “Dice-Sorenson coefficient”0.93
source quote (p.6)
“Testing of automatic, semi-automatic, and manual segmentation methods each exceeded an average Dice-Sorenson coefficient of 0.93.”

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) K252103 (decision 2025-12-02) from Mighty Oak Medical for a matching device line ("Acorn 3D Software (AC-SEG-4009); Acorn 3DP Model (AC-101-XX)") — a new clearance for the same line is a change event. The newer clearance's parsed summary mentions a PCCP.

    first seen 2026-07-08 · k_number:K252103

  • re_clearance

    The FDA AI/ML device list shows a newer 510(k) K251532 (decision 2025-11-03) from Mighty Oak Medical for a matching device line ("Acorn 3D Software (AC-SEG-4009); Acorn 3DP Model (AC-101-XX)") — a new clearance for the same line is a change event.

    first seen 2026-07-08 · k_number:K251532

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/K234009