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 typesamd

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.”

Algorithmmachine learning based auto-segmentation as well as semi-automatic and manual segmentation tools

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 addressedFDA source did not state this

Validation studies (2)

Bench

sample size not stated

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

Bench

sample size not stated

endpoints: geometric accuracy of physical replicas

Reported performance (1 observation)

diceas written: “average 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

recalls in product code, 24mo

MAUDE reports in code, 12mo

—

vs code's own 3-yr baseline

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). 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).