Acorn 3D Software (AC-SEG-4009)

by Mighty Oak Medical  · Based in United States → — AI-driven pre-surgical planning for spinal deformity correction.
Neurosurgery Orthopedics Radiology
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Overview

Acorn 3D Software (AC-SEG-4009) is a modular image processing software that utilizes AI-driven automated scan segmentation and pre-correction measurements to support spinal deformity correction planning. [2, 4, 7, 8] It processes CT and CTA medical images to visualize, segment, and create detailed 3D digital models of musculoskeletal and craniomaxillofacial anatomy, including spine regions. [2, 3] The software offers machine learning-based automatic segmentation for certain vertebrae and semi-automatic/manual tools for other bones. [3] Clinicians can use these digital models for measurement, treatment planning, and can also produce physical 3D printed replicas for diagnostic purposes, enhancing surgical planning and patient care. [3] Acorn 3D Software also aligns CT and MRI data to standing X-rays to generate weight-bearing 3D models and provides hundreds of 3D spinal analytic measurements. [7, 8]

Reviewed by Pouyan Golshani, MD — Interventional Radiologist

Key Features

  • AI-driven automated scan segmentation
  • Pre-correction measurements for spinal deformity planning
  • Visualization of medical images (CT, CTA, MRI)
  • 3D digital model creation of musculoskeletal and craniomaxillofacial anatomy
  • Machine learning-based automatic segmentation for vertebrae
  • Semi-automatic/manual segmentation tools
  • Measurement and treatment planning tools
  • Production of physical 3D printed replicas for diagnostic purposes
  • Alignment of CT/MRI data to standing X-rays for weight-bearing 3D models
  • Hundreds of 3D spinal analytic measurements

Use Cases

  • Spinal deformity correction planning
  • Pre-surgical planning for complex spinal surgeries
  • Diagnostic purposes using 3D printed anatomical models
  • Measurement and treatment planning for musculoskeletal and craniomaxillofacial applications
  • Planning pedicle screw placement in thoracic and lumbar regions of the spine
  • Surgical preparation and implant inventory planning

What Physicians Need to Know

DICOM Support & Standards
Acorn 3D Software imports medical images in DICOM format, allows viewing of DICOM data, and supports the transfer of CT or CTA medical images to an output file. Mighty Oak Medical provides a secure and HIPAA-compliant DICOM upload page.
PACS Integration Method
While the software imports DICOM images, specific details about direct PACS integration methods (e.g., API, DICOM send/receive) are not explicitly provided in the search results. It is designed to be a software interface and image segmentation system, suggesting it can receive image data from various sources, including potentially PACS, via DICOM.
Reading Room Workflow Impact
Acorn 3D Software is primarily an AI-driven pre-surgical planning platform, not a direct reading room diagnostic tool. It aims to enhance surgical planning and patient care by providing detailed 3D digital models for measurement and treatment planning, which can lead to more efficient and safer complex spinal surgeries. This could indirectly impact the reading room by providing comprehensive pre-surgical insights to surgeons.
AI Model Architecture (deep learning approach)
The software utilizes machine learning-based automatic segmentation for certain vertebrae (thoracic and lumbar) and AI-driven segmentation for spinal alignment metrics. It employs proprietary machine learning algorithms to convert 2D X-ray images to 3D anatomical models.
FDA Clearance Pathway (510k/De Novo)
Acorn 3D Software (AC-SEG-4009) received FDA clearance via the 510(k) pathway (K234009) on July 12, 2024. It is classified as a Class II medical device.
Supported Modalities (CT/MRI/X-ray/US)
The software processes CT and CTA scans to create 3D digital models. It also leverages CT and MRI data and analytics by aligning scans to a standing X-ray to generate weight-bearing 3D models.
Sensitivity & Specificity Data
The geometric accuracy of digital models was evaluated with Dice-Sorenson coefficients exceeding 0.93 for automatic, semi-automatic, and manual segmentation methods. Physical 3D printed replicas had less than 1mm mean deviation compared to digital models. Bench testing confirmed the accuracy of pedicle screw geometry and trajectories planned with Acorn 3D Trajectory Automation. In a study on spinal alignment, a statistical shape model showed a sensitivity of 0.74 and specificity of 0.87 in differentiating surgical and non-surgical cases.
RSNA/ACR Validation
No specific mentions of RSNA or ACR validation were found in the provided search results.
Physician Tip

Acorn 3D Software is particularly beneficial for neurosurgeons and orthopedic surgeons involved in complex spinal surgeries. Utilize its AI-driven segmentation to generate detailed patient-specific 3D models from CT and CTA scans, and integrate with standing X-rays for weight-bearing analysis. The platform's ability to plan implant inventory and screw trajectories can significantly enhance pre-surgical preparation, potentially leading to improved surgical safety and efficiency. Consider using the 3D printed replicas for diagnostic purposes, surgical planning, and patient education. The software's measurement tools and Hounsfield Unit analytics can provide advanced analysis of CT data for comprehensive surgical planning.

Acorn 3D Software is designed to import DICOM medical images, making it compatible with standard imaging archives. While direct PACS integration specifics are not detailed, its DICOM support suggests it can be incorporated into existing imaging workflows. The software's ability to export 3D models to third-party packages allows for further integration into other surgical planning or navigation systems, and for the fabrication of 3D printed models. Mighty Oak Medical offers a secure, HIPAA-compliant DICOM upload portal for convenient data transfer.

Details

Category Radiology & Imaging AI, Surgical AI
Pricing Unknown — Request a quote.
Compliance
BAA AvailableUnknown AI-estimated
HIPAA CompliantUnknown AI-estimated
FDA Status Unknown AI-estimated

Acorn 3D Software (AC-SEG-4009) received FDA clearance as a Class II medical device (K234009) on January 26, 2026. [2, 9, 10] It 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, including measuring and treatment planning. [2, 3, 10]
Integrations
EHR Not specified
Specialties Neurosurgery, Orthopedics, Radiology

What the Web Says

Acorn 3D Software (AC-SEG-4009) is an advanced medical imaging software designed for processing CT and CTA scans to create detailed 3D digital models of musculoskeletal and craniomaxillofacial anatomy, including spine regions. It utilizes machine learning for automatic segmentation of certain vertebrae and offers semi-automatic/manual tools for other bones. The software is intended for use in measurement, treatment planning, and the creation of physical 3D printed replicas for diagnostic purposes, enhancing surgical planning and patient care. Mighty Oak Medical's Acorn 3D pre-surgical planning platform, which uses AI-driven segmentation, recently received FDA clearance for spinal deformity correction planning.

Overall: Mixed

Strengths

  • Advanced medical imaging for 3D digital models from CT/CTA scans.
  • Machine learning-based automatic segmentation for vertebrae.
  • Tools for measurement and treatment planning.
  • Ability to create physical 3D printed replicas for diagnostic and surgical planning.
  • FDA clearance for spinal deformity correction planning.
  • Users appreciate its ease of use and intuitive interface.

Limitations

  • Some users report lagging and frequent updates.
  • Limited to MacOS, requiring Apple products for use.
  • Lack of free credits limits accessibility and usability for various tasks.
  • Limited language support.
  • Can experience slow performance and occasional glitches.
  • Upgrade process can be frustrating, requiring manual re-entry of all settings.

Based on reviews from: Acorn 3D Software (AC-SEG-4009); Acorn 3DP Model (AC-101-XX) - X-ray Interpreter, Acorn Software Pricing, Alternatives & More 2026 - Capterra, Acorn 3D Software (AC-SEG-4009); Acorn 3DP Model (AC-101-XX) - HaRi, Acorn 3D - Mighty Oak Medical, Mighty Oak Medical earns FDA clearance for spine surgery planning software, Acorn Products | Read 84 Reviews on G2, Acorn Pros and Cons | User Likes & Dislikes - G2, Mighty Oak Medical Receives FDA Clearance for Acorn 3Du2122 Pre-Surgical Planning Platform - SPINEMarketGroup, Just a rant about Acorn : r/hobbycnc - Reddit

Last updated: 2026-07-28

Ratings & Reviews

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Press & Coverage

FDA
Acorn 3D Software (AC-SEG-4009); Acorn 3DP Model (AC-101-XX) - FDA 510(k) Premarket Notification
Mighty Oak Medical received FDA 510(k) clearance (K234009) for Acorn 3D Software (AC-SEG-4009) and Acorn 3DP Model (AC-101-XX) on January 26, 2026. The software 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, and for measuring and treatment planning.
2026-01
RegWatch
RegWatch - Regulatory Intelligence Dashboard: Acorn 3D Software (AC-SEG-4009)
Mighty Oak Medical's Acorn 3D Software (AC-SEG-4009) and Acorn 3DP Model (AC-101-XX) received FDA 510(k) clearance (K260322) for radiology applications. This regulatory update was noted in March 2026.
2026-03
PMC (MDPI)
Machine Learning-Enabled Medical Devices Authorized by the US Food and Drug Administration in 2024: Regulatory Characteristics, Predicate Lineage, and Transparency Reporting
Acorn 3D Software (AC-SEG-4009) and Acorn 3DP Model (AC-101-XX) are listed as a machine learning-enabled medical device cleared by the FDA in 2024 (K234009), intended for 3D modeling for orthopedic surgical planning. This peer-reviewed article discusses the regulatory characteristics and transparency reporting of such devices.
2025-12
X-ray Interpreter
Acorn 3D Software (AC-SEG-4009); Acorn 3DP Model (AC-101-XX) - X-ray Interpreter
This entry confirms Acorn 3D Software (AC-SEG-4009) and Acorn 3DP Model (AC-101-XX) as an FDA-cleared radiology AI listing for CT/CTA. It provides links to FDA source documents and workflow fields.
2026-06
Independent Regulatory Consultant Blog
Finding FDA authorized devices with Predetermined Change Control Plans
Acorn 3D Software (AC-SEG-4009); Acorn 3DP Model (AC-101-XX) by Mighty Oak Medical (K234009) is listed among devices authorized with a Predetermined Change Control Plan (PCCP), with a decision date of July 12, 2024. This indicates the FDA's approval of a plan for future modifications to the device.
2024-08
FDA
Mighty Oak Medical Mark Wylie VP Quality and Regulatory 750 W. Hampden Ave Suite 120 Englewood, Colorado 80110 Re: K234009 Trad
This FDA document details the 510(k) clearance for Acorn 3D Software (AC-SEG-4009) and Acorn 3DP Model (AC-101-XX), classifying it as a Class II device for medical image management and processing. It also outlines the software's intended use for importing, visualizing, segmenting medical images, and creating digital 3D models for measuring and treatment planning.
2024-07

Videos

Product demos, reviews, and walkthroughs for Acorn 3D Software (AC-SEG-4009).

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Frequently Asked Questions

Acorn 3D Software is an advanced medical imaging software that processes CT and CTA scans to visualize, segment, and create detailed 3D digital models of musculoskeletal and craniomaxillofacial anatomy, including spine regions. It offers machine learning-based automatic segmentation for certain vertebrae and semi-automatic/manual tools for other bones. Physicians can use these digital models for measurement, treatment planning, and to produce physical 3D printed replicas for diagnostic purposes, enhancing surgical planning and patient care.
Acorn 3D Software utilizes AI-driven segmentation to generate 3D spinal alignment metrics and plan implant inventory for deformity correction and surgical preparation. It can automatically plan screw sizes and trajectories, and its AI-driven spine segmentation allows for importing DICOM scans and offers a complete segmentation editing toolset.
Yes, Acorn 3D Software (AC-SEG-4009) has received FDA clearance. It is intended for use as a software interface and image segmentation system for transferring CT or CTA medical images to an output file, including measuring and treatment planning, and for fabricating physical replicas for diagnostic purposes in musculoskeletal and craniomaxillofacial applications.
While Acorn 3D Software offers machine learning-based automatic segmentation for thoracic and lumbar vertebrae, semi-automatic and manual segmentation tools are intended for other musculoskeletal and craniomaxillofacial anatomy. The software and its 3DP Models should always be used in conjunction with expert clinical judgment.
Yes, several other platforms offer 3D planning and segmentation capabilities. Some FDA-cleared alternatives include Formus Labs for hip planning, CustomSurg/OrthoPlanner for fracture planning, Bodycad for knee osteotomy, and ImageBiopsy Lab for knee-OA grading and leg-alignment measurement. Materialise Mimics is also a well-established reference for engineering-grade segmentation.
Acorn 3D Software and its associated 3DP Models are subject to regulatory registrations and clearances across various bodies, including the FDA. As a medical device, it must comply with requirements such as registration and listing, labeling, and medical device reporting.
Specific pricing for Acorn 3D Software (AC-SEG-4009) is not publicly available and typically requires a quote. However, general compliance platforms for medical software, which may be relevant to the operational costs of such tools, can range from approximately $2,700 for early-stage innovators to $3,600 for scaling innovators, often including features like AI Compliance Copilot and validation services.

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More from Mighty Oak Medical

Acorn 3D Software (AC-SEG-4009)
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Mighty Oak Medical's Acorn 3D Software is an AI-driven pre-surgical planning platform for complex spinal surgeries, offering automated 3D segmentation, alignment metrics, and implant planning. It is FDA cleared for medical image processing and surgical planning, supporting the creation of patient-specific 3D models.
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The Acorn 3DP Model (AC-101-XX) by Mighty Oak Medical is a 3D printed anatomical replica derived from AI-driven pre-surgical planning software, designed to enhance spinal surgery safety and efficiency through detailed visualization, measurement, and trajectory planning.
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Suggest an Edit → | Last Verified: 2026-07-28 | First Added: 2026-07-28
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