Acorn 3D Software is a modular image processing software intended for use as an interface for visualization of medical images, segmentation, treatment planning, and production of an output file.

The Acorn 3D Segmentation module 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 3D Segmentation is also intended for measuring and treatment planning. The Acorn 3D Segmentation output can also be used for the fabrication of physical replicas of the output file using additive manufacturing methods, Acorn 3DP Models. The physical replica can be used for diagnostic purposes in the field of musculoskeletal and craniomaxillofacial applications.

The Acorn 3D Trajectory Automation module may be used to plan pedicle screw placement in the thoracic and lumbar regions of the spine in pediatric and adult patients.

Acorn 3D Software and 3DP Models should be used in conjunction with expert clinical judgment.

Device Description

Acorn 3D Software is an image processing software that allows the user to import, visualize and segment medical images, check and correct the segmentations, and create digital 3D models. The models can be used in Acorn 3D Software for measuring, treatment planning and producing an output file to be used for additive manufacturing (3D printing). Acorn 3D Software is structured as a modular package.

This includes the following functionality:

Importing medical images in DICOM format
Viewing images and DICOM data
Selecting a region of interest using generic segmentation tools
Segmenting specific anatomy using dedicated semi-automatic tools or fully automatic algorithms
Verifying and editing a region of interest
Calculating a digital 3D model and editing the model
Measuring on images and 3D models
Exporting 3D models to third-party packages
Planning pedicle screw placement

The Acorn 3D Segmentation module 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) and the pelvis (sacrum). Semi-automatic and manual segmentation tools are intended to be used for all musculoskeletal anatomy.

	Automatic	Semi-Automatic	Manual
Definition	Algorithmic with little or no direct human control	A combination of algorithmic and direct human control	Directly controlled by a human
Tool Type	Machine Learning algorithm used to automatically segment individual vertebrae and the pelvis	Algorithmic based tools that do not incorporate machine learning.	Manual tools requiring user input.
Anatomical Location(s)	Spinal anatomy:• Thoracic (T1-T12)• Lumbar (L1-L5)• Sacrum	Musculoskeletal & craniomaxillofacial bone:• Short• Long• Flat• Sesamoid• Irregular	Musculoskeletal & craniomaxillofacial bone:• Short• Long• Flat• Sesamoid• Irregular

Acorn 3DP Model is an additively manufactured physical replica of the virtual 3D model generated in Acorn 3D Segmentation. The output file from Acorn 3D Segmentation is used to additively manufacture the Acorn 3DP Model.

The Acorn 3D Trajectory Automation module contains dedicated fully automatic algorithms for planning pedicle screw trajectories. The algorithms are only intended to be used for the thoracic and lumbar regions of the spine (T1-T12 and L1-L5). The output file from Acorn 3D Trajectory Automation contains information relevant to pedicle screw placement surgery, including entry points, end points, and screw sizes of planned screws.

AI/ML Overview

The provided FDA 510(k) clearance letter describes the Acorn 3D Software, specifically focusing on the new Acorn 3D Trajectory Automation module. However, the document is quite sparse on detailed descriptions of the acceptance criteria and the specifics of the study proving the device meets these criteria. The information below is extracted from the provided text, and where details are missing, it's explicitly stated.

1. Table of Acceptance Criteria and Reported Device Performance

The document mentions "deviations were within the acceptance criteria" without specifying the numerical acceptance criteria themselves. It also doesn't provide specific numerical results of the device's performance, only a qualitative statement of accuracy.

Acceptance Criteria (Not explicitly stated in numerical terms)	Reported Device Performance
Accuracy of pedicle screw geometry: Deviations within acceptance criteria	Deviations were within the acceptance criteria.
Accuracy of pedicle screw trajectories: Deviations within acceptance criteria	Deviations were within the acceptance criteria.
Substantial equivalence to predicate device for planning pedicle screws and trajectories	Performance testing demonstrated substantial equivalence to the predicate device.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size for Test Set: Not specified. The document only mentions "clinical data" was used.
Data Provenance: Not specified. It's unclear if the clinical data was retrospective or prospective, or the country of origin.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications

The document does not specify the number of experts used or their qualifications for establishing ground truth for the test set.

4. Adjudication Method for the Test Set

The document does not specify any adjudication method (e.g., 2+1, 3+1, none) used for the test set.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

The document does not mention that a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done. Therefore, no effect size of human readers improving with AI vs. without AI assistance is provided.

6. Standalone Performance Study

Yes, a standalone performance study was done for the Acorn 3D Trajectory Automation module. The document states:
- "The accuracy of pedicle screw geometry as well as pedicle screw trajectories created in the subject device, Acorn 3D Trajectory Automation, was assessed via bench testing."
- This implies the algorithm's performance was evaluated independently without human intervention during the trajectory planning process itself, as it's a "fully automatic algorithm."

7. Type of Ground Truth Used

The ground truth for the "accuracy of pedicle screw geometry" and "pedicle screw trajectories" was established by comparing the device's output to "clinical data." While the nature of this "clinical data" is not explicitly defined (e.g., expert consensus on images, surgical outcomes, or pathology reports), it serves as the reference standard.

8. Sample Size for the Training Set

The document does not specify the sample size used for the training set of the machine learning algorithms. It mentions "Using a collection of images and masks as a training dataset for machine-learning segmentation algorithm" but no numbers.

9. How the Ground Truth for the Training Set Was Established

The document states that the machine learning segmentation algorithm uses "a collection of images and masks as a training dataset." It doesn't explicitly describe how these "masks" (which represent the ground truth segmentations) were created. It can be inferred that these masks would have been generated by human experts, likely through manual or semi-automatic segmentation, but this is not confirmed in the text.

Summary

FDA 510(k) Clearance Letter - Acorn 3D Software

Page 1

U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov

Doc ID # 04017.08.00

November 3, 2025

Mighty Oak Medical
Mark Wylie
VP Quality and Regulatory
750 W. Hampden Ave
Suite 120
Englewood, CO 80110

Re: K251532
Trade/Device Name: Acorn 3D Software (AC-SEG-4009); Acorn 3DP Model (AC-101-XX)
Regulation Number: 21 CFR 892.2050
Regulation Name: Medical Image Management and Processing System
Regulatory Class: Class II
Product Code: LLZ, QIH
Dated: October 6, 2025
Received: October 6, 2025

Dear Mark Wylie:

We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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November 3, 2025

Mighty Oak Medical
Mark Wylie
VP Quality and Regulatory
750 W. Hampden Ave
Suite 120
Englewood, CO 80110

Dear Mark Wylie:

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See

Page 3

the DICE website (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Jessica Lamb, PhD
Assistant Director
Imaging Software Team
DHT8B: Division of Radiological Imaging
Devices and Electronic Products
OHT8: Office of Radiological Health
Office of Product Evaluation and Quality
Center for Devices and Radiological Health

Enclosure

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Indications for Use

Please type in the marketing application/submission number, if it is known. This textbox will be left blank for original applications/submissions. K251532

Please provide the device trade name(s).

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

Please provide your Indications for Use below.

Acorn 3D Software is a modular image processing software intended for use as an interface for visualization of medical images, segmentation, treatment planning, and production of an output file.

The Acorn 3D Trajectory Automation module may be used to plan pedicle screw placement in the thoracic and lumbar regions of the spine in pediatric and adult patients.

Acorn 3D Software and 3DP Models should be used in conjunction with expert clinical judgment.

Please select the types of uses (select one or both, as applicable).
☑ Prescription Use (Part 21 CFR 801 Subpart D)
☐ Over-The-Counter Use (21 CFR 801 Subpart C)

Acorn 3D Software Page 9 of 43

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510(K) SUMMARY

Acorn 3D Trajectory Automation

Submitter:
Mighty Oak Medical
750 W. Hampden Ave., Suite 120
Englewood, CO 80110
(720) 398-9703

Contact: Mark A. Wylie, VP of Quality and Regulatory
Date Prepared: 03OCT2025

Device
Trade Name: Acorn 3D Software
Common Name: Image processing system
Device Classification: Class II
Regulation, Name: 21 CFR 892.2050, Medical image management and processing system
Device Product Code: LLZ, QIH

Type of 510(k)
Original Submission: Traditional.

Predicate Device(s):
Acorn Segmentation & 3DP Model

510(k)	Product Code	Trade Name	Manufacturer
Primary Predicate Device
K234009	LLZ, QIH	Acorn 3D Software	Mighty Oak Medical
Subsequent Predicate Device
K141669	LLZ	Surgimap	Nemaris Inc.

Introduction

This 510(k) filing seeks to expand the indications for use of the previously cleared Acorn 3D Software (K234009) to plan pedicle screw placement in the spine. This submission includes the Acorn 3D Trajectory Automation module as a new extension of the Acorn 3D Software.

Acorn 3D Software is a modular and multi-functional software suite. The subject device, Acorn 3D Trajectory Automation module, builds on the functions and capabilities of the Acorn 3D Software (predicate), specifically image segmentation and the transfer of imaging information from a medical scanner to an output file. Acorn 3D Trajectory Automation module contains dedicated fully automatic algorithms for planning pedicle screw trajectories.

Description

K251532

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This includes the following functionality:

Importing medical images in DICOM format
Viewing images and DICOM data
Selecting a region of interest using generic segmentation tools
Segmenting specific anatomy using dedicated semi-automatic tools or fully automatic algorithms
Verifying and editing a region of interest
Calculating a digital 3D model and editing the model
Measuring on images and 3D models
Exporting 3D models to third-party packages
Planning pedicle screw placement

	Automatic	Semi-Automatic	Manual
Definition	Algorithmic with little or no direct human control	A combination of algorithmic and direct human control	Directly controlled by a human
Tool Type	Machine Learning algorithm used to automatically segment individual vertebrae and the pelvis	Algorithmic based tools that do not incorporate machine learning.	Manual tools requiring user input.
Anatomical Location(s)	Spinal anatomy:• Thoracic (T1-T12)• Lumbar (L1-L5)• Sacrum	Musculoskeletal & craniomaxillofacial bone:• Short• Long• Flat• Sesamoid• Irregular	Musculoskeletal & craniomaxillofacial bone:• Short• Long• Flat• Sesamoid• Irregular

Indications for Use

Acorn 3D Software is a modular image processing software intended for use as an interface for visualization of medical images, segmentation, treatment planning, and production of an output file.

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The Acorn 3D Trajectory Automation module may be used to plan pedicle screw placement in the thoracic and lumbar regions of the spine in pediatric and adult patients.

Acorn 3D Software and 3DP Models should be used in conjunction with expert clinical judgment.

Materials

The manufactured components of the Acorn 3DP Model are manufactured from a polymer powder for use in additive manufacturing (HP 3D High Reusability PA12).

Predicate Device Comparison Table

The table below provides a descriptive comparison of the similarities and differences for the subject and predicate devices. The items marked bold in the table highlight the differences between the Acorn 3D Trajectory Automation module and the predicate device Acorn 3D Software (K234009).

Table 1: Comparison of devices

Device→Features↓	Acorn 3D Software & 3DP Models(K251532)	Acorn 3D Software & 3DP Models(K234009)	Surgimap(K141669)
Trade Name	Acorn 3D Software(AC-SEG-4009);Acorn 3DP Model (AC-101-XX)	Acorn 3D Software (AC-SEG-4009); Acorn 3DP Model (AC-101-XX)	Surgimap
Common Name	Image processing system	Image processing system	Picture Archiving and Communication System (PACS)
Premarket notification	K251532	K234009	K141669
Manufacturer	Mighty Oak Medical	Mighty Oak Medical	Nemaris Inc.
Indications for Use Statement	Acorn 3D Software is a modular image processing software intended for use as an interface for visualization of medical images, segmentation, treatment planning, and production of an output file.The Acorn 3D Segmentation module 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. The physical replica can be used for diagnostic purposes in the field of musculoskeletal and craniomaxillofacial applications.The Acorn 3D Trajectory Automation module may be used to plan pedicle screw placement in the spine in pediatric and adult patients.Acorn 3D Software and 3DP Models should be used in conjunction with expert clinical judgment.	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. The physical replica can be used for diagnostic purposes in the field of musculoskeletal and craniomaxillofacial applications.Acorn Segmentation and 3DP Models should be used in conjunction with expert clinical judgment.	The Surgimap software assists healthcare professionals in viewing, storing, and measuring images as well as planning orthopedic surgeries. The device allows service providers to perform generic as well as specialty measurements of the images, and to plan surgical procedures. The device also includes tools for measuring anatomical components for placement of surgical implants, and offer online synchronization of the database with the possibility to share data among Surgimap users. Clinical judgment and experience are required to properly use the software.

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Device→Features↓	Acorn 3D Software & 3DP Models(this submission)	Acorn 3D Software & 3DP Models(K234009)	Surgimap(K141669)
General intended use	Acorn 3D Software is an image processing software that allows the user to import, visualize and segment medical images, check and correct the segmentations, and create digital 3D models.	Acorn Segmentation is an image processing software that allows the user to import, visualize and segment medical images, check and correct the segmentations, and create digital 3D models.	Surgimap is image analysis and surgical planning software intended for use by medical professionals to view, measure, and annotate medical images (including DICOM images) for diagnostic and preoperative planning purposes.
Product Classification	Automated radiological image processing software	Automated radiological image processing software	Medical image management and processing system.
Regulatory Class	Class II	Class II	Class II
Classification	892.2050	892.2050	892.2050
Product Code	QIH, LLZ	QIH, LLZ	LLZ
Device Description	Acorn 3D Software is an image processing software that allows the user to import, visualize and segment medical images, check and correct the segmentations, and create digital 3D models. The models can be used in Acorn 3D Software for measuring, treatment planning and producing an output file to be used for additive manufacturing (3D printing). Acorn 3D Software is structured as a modular package.This includes the following functionality:• Importing medical images in DICOM format• Viewing images and DICOM data• Selecting a region of interest using generic segmentation tools• Segmenting specific anatomy using dedicated semi-automatic tools or fully automatic algorithms• Verifying and editing a region of interest• Calculating a digital 3D model and editing the model• Measuring on images and 3D models• Exporting 3D models to third-party packages• Planning pedicle screw placementThe Acorn 3D Segmentation module 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) and the pelvis (sacrum). Semi-automatic and manual segmentation tools are intended to be used for all musculoskeletal anatomy.\|Automatic\|Semi-Automatic\|Manual\|\|Definition\|Algorithmic with little or no direct human control\|A combination of algorithmic and direct human control\|Directly controlled by a human\|	Acorn Segmentation is an image processing software that allows the user to import, visualize and segment medical images, check and correct the segmentations, and create digital 3D models. The models can be used in Acorn Segmentation for measuring, treatment planning and producing an output file to be used for additive manufacturing (3D printing). Acorn Segmentation is structured as a modular package.This includes the following functionality:• Importing medical images in DICOM format• Viewing images and DICOM data• Selecting a region of interest using generic segmentation tools• Segmenting specific anatomy using dedicated semi-automatic tools or fully automatic algorithms• Verifying and editing a region of interest• Calculating a digital 3D model and editing the model• Measuring on images and 3D models• Exporting 3D models to third-party packagesThe Acorn Segmentation module 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) and the pelvis (sacrum). Semi-automatic and manual segmentation tools are intended to be used for all musculoskeletal anatomy.\|Automatic\|Semi-Automatic\|Manual\|\|Definition\|Algorithmic with little or no direct human control\|A combination of algorithmic and direct human control\|Directly controlled by a human\|	Surgimap is a software application intended for use by trained medical professionals, including physicians, to view, measure, and annotate medical images (including DICOM images) for diagnostic and planning purposes.Surgimap provides tools for orthopedic surgical planning such as templating and measuring angles, lengths, and other relevant anatomical data. The software may also be used to create preoperative plans that can be shared among healthcare professionals.It is intended as a planning and imaging tool and not for primary image interpretation or as a sole diagnostic device.

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Device→Features↓	Acorn 3D Software & 3DP Models(this submission)	Acorn 3D Software & 3DP Models(K234009)	Surgimap(K141669)
General intended use	Acorn 3D Software is an image processing software that allows the user to import, visualize and segment medical images, check and correct the segmentations, and create digital 3D models.	Acorn Segmentation is an image processing software that allows the user to import, visualize and segment medical images, check and correct the segmentations, and create digital 3D models.	Surgimap is image analysis and surgical planning software intended for use by medical professionals to view, measure, and annotate medical images (including DICOM images) for diagnostic and preoperative planning purposes.
Product Classification	Automated radiological image processing software	Automated radiological image processing software	Medical image management and processing system.
Regulatory Class	Class II	Class II	Class II
Classification	892.2050	892.2050	892.2050
Product Code	QIH, LLZ	QIH, LLZ	LLZ
Device Description	Acorn 3D Software is an image processing software that allows the user to import, visualize and segment medical images, check and correct the segmentations, and create digital 3D models. The models can be used in Acorn 3D Software for measuring, treatment planning and producing an output file to be used for additive manufacturing (3D printing). Acorn 3D Software is structured as a modular package.This includes the following functionality:• Importing medical images in DICOM format• Viewing images and DICOM data• Selecting a region of interest using generic segmentation tools• Segmenting specific anatomy using dedicated semi-automatic tools or fully automatic algorithms• Verifying and editing a region of interest• Calculating a digital 3D model and editing the model• Measuring on images and 3D models• Exporting 3D models to third-party packages• Planning pedicle screw placementThe Acorn 3D Trajectory Automation contains dedicated fully automatic algorithms for planning pedicle screw trajectories. The algorithms are only intended to be used for the thoracic and lumbar regions of the spine (T1-T12 and L1-L5). The output file from Acorn 3D Trajectory Automation contains information relevant to pedicle screw placement surgery, including entry points, end points, and screw sizes of planned screws.	Acorn Segmentation is an image processing software that allows the user to import, visualize and segment medical images, check and correct the segmentations, and create digital 3D models. The models can be used in Acorn Segmentation for measuring, treatment planning and producing an output file to be used for additive manufacturing (3D printing). Acorn Segmentation is structured as a modular package.This includes the following functionality:• Importing medical images in DICOM format• Viewing images and DICOM data• Selecting a region of interest using generic segmentation tools• Segmenting specific anatomy using dedicated semi-automatic tools or fully automatic algorithms• Verifying and editing a region of interest• Calculating a digital 3D model and editing the model• Measuring on images and 3D models• Exporting 3D models to third-party packagesThe Acorn Segmentation module 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) and the pelvis (sacrum). Semi-automatic and manual segmentation tools are intended to be used for all musculoskeletal anatomy.	Surgimap is a software application intended for use by trained medical professionals, including physicians, to view, measure, and annotate medical images (including DICOM images) for diagnostic and planning purposes.Surgimap provides tools for orthopedic surgical planning such as templating and measuring angles, lengths, and other relevant anatomical data. The software may also be used to create preoperative plans that can be shared among healthcare professionals.It is intended as a planning and imaging tool and not for primary image interpretation or as a sole diagnostic device.

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Device→Features↓	Acorn 3D Software & 3DP Models(this submission)	Acorn 3D Software & 3DP Models(K234009)	Surgimap(K141669)
Technological characteristics	Acorn 3D Software is a standalone modular software package. This software package includes, but is not limited to, the following functions:Image import• Importing medical images in DICOM format (e.g. CT and CTA)Image Processing• Processing of images with common noise-reduction filters• Editing of spatial arrangement of imagesVisualization• Viewing images and DICOM dataSegmentation• Selecting a region of interest using generic segmentation tools• Segmenting specific anatomy using dedicated semi-automatic tools• Segmenting specific vertebral anatomy using machine-learning-based fully automatic algorithms• Verifying and editing a region of interestMeasurement• Measuring on images and 3D modelsData Export• Machine-readable format (e.g. JSON and STL)• Project Files (proprietary file format specific to the software)	Acorn Segmentation is a standalone modular software package. This module includes, but is not limited to the following functions:Image Import• Importing medical images in DICOM format (e.g. CT and CTA)Image Processing• Processing of images with common noise-reduction filters• Editing of spatial arrangement of imagesVisualization• Viewing images and DICOM dataSegmentation• Selecting a region of interest using generic segmentation tools• Segmenting specific anatomy using dedicated semi-automatic tools• Segmenting specific vertebral anatomy using machine-learning-based fully automatic algorithms• Verifying and editing a region of interestMeasurement• Measuring on images and 3D modelsData Export• Machine-readable format (e.g. STL)• Project Files (proprietary file format specific to the software)	Surgimap software includes the following functions:Image Import• Importing medical images in DICOM format (e.g. CT, CTA, MRI, etc.)• Standard formats (JPEG, TIFF, PNG, PPT…)Image Processing• Processing of images with common noise-reduction filters• Editing of spatial arrangement of imagesVisualization• Viewing images and DICOM dataSegmentation• NoneMeasurement• Measuring on imagesData Export• Machine-readable format (e.g. CSV and DICOM)• Project Files (proprietary file format specific to the software)

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Performance Data

Software verification and validation were performed and documentation was provided following the "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices". This includes verification against defined requirements and validation against user needs. Both end-user validation and bench testing were performed.

The accuracy of pedicle screw geometry as well as pedicle screw trajectories created in the subject device, Acorn 3D Trajectory Automation, was assessed via bench testing. This was tested using worse-case-scenario conditions. Accuracy of the pedicle screws was compared using clinical data. Deviations were within the acceptance criteria. This shows that for planning pedicle screws and pedicle screw trajectories, Acorn 3D Trajectory Automation is substantially equivalent to the predicate device.

In conclusion, all performance testing conducted demonstrated device performance and substantial equivalence to the predicate device.

Technological Characteristics

Acorn 3D Software is a standalone modular software package. This software package includes, but is not limited to, the following functions:

Image import

Importing medical images in DICOM format (e.g., CT and CTA)

Image Processing

Processing of images with common noise-reduction filters
Editing of spatial arrangement of images

Visualization

Viewing images and DICOM data

Segmentation

Selecting a region of interest using generic segmentation tools
Segmenting specific anatomy using dedicated semi-automatic tools
Segmenting specific vertebral anatomy using machine-learning-based fully automatic algorithms
Verifying and editing a region of interest

Measurement

Measuring on images and 3D models

Data Export

Output information is exported in a machine-readable format (e.g., JSON and STL)

3D Models

Calculating a digital 3D model and editing the model
Smoothing a 3D model
Importing 3D models

Treatment Planning

Importing of third-party STLs to visualize planned interactions with anatomy as represented in DICOM images
Generic Implants
- Pedicle Screw Implant

Other features

Using a collection of images and masks as a training dataset for machine-learning segmentation algorithm

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Conclusion

The Acorn 3D Software with Trajectory Automation possesses the same intended use and technological characteristics as the predicate devices. Therefore, the Acorn 3D Trajectory Automation module is substantially equivalent for its intended use.

Regulation Number and Section

§ 892.2050 Medical image management and processing system.

(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).