Acorn 3D Software (AC-SEG-4009); Acorn 3DP Model (AC-101-XX)
K252103Mighty Oak Medical · cleared 2025-12-02 · product code QIH · Radiology
Premarket evidence — what FDA accepted
Device typehardware with ml
source quote (p.7)
“Acorn 3D Software is a standalone modular software package.”
Algorithm3D U-Net machine learning model
source quote (p.12)
“The Acorn 3D Segmentation module automates the segmentation of particular anatomy (listed in IFU) by implementing a 3D U-Net machine learning model.”
Adaptive (vs locked)No
source quote (p.12)
“In accordance with the PCCP, all algorithm modifications will be trained, tuned, and locked prior to release of the software.”
PCCPYes
source quote (p.12)
“Mighty Oak Medical will make future algorithm improvements under a Predetermined Change Control Plan (PCCP; cleared as part of K234009 – no changes made to the PCCP as part of K252103).”
Cybersecurity addressedFDA source did not state this
Validation studies (2)
Bench
sample size not stated
endpoints: Target Registration Error (TRE)
Standalone
n=111 cases
endpoints: DICE similarity coefficient (DSC)
Reported performance (3 observations)
diceas written: “Mean DSC (Vertebral Model, In-House)”0.9331
source quote (p.13)
“Mean DSC 0.9331”
diceas written: “Mean DSC (Vertebral Model, VERSE '20)”0.94451
source quote (p.13)
“0.94451”
diceas written: “Mean DSC (Sacral Model, In-House)”0.9663
source quote (p.13)
“0.96630”
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). 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).