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

K234009 · Mighty Oak Medical · QIH · Jul 12, 2024 · Radiology

Device Facts

• Record ID: K234009
• Device Name: Acorn 3D Software (AC-SEG-4009); Acorn 3DP Model (AC-101-XX)
• Applicant: Mighty Oak Medical
• Product Code: QIH · Radiology
• Decision Date: Jul 12, 2024
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2
• Attributes: AI/ML, Software as a Medical Device, PCCP

Intended Use

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 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.

Device Story

Acorn 3D Software (Acorn Segmentation) imports DICOM CT/CTA images; provides tools for visualization, segmentation, and 3D model creation. Segmentation methods include manual, semi-automatic, and machine learning-based auto-segmentation (thoracic/lumbar spine). Users verify/edit segmentations; perform measurements; plan treatments; and export digital models for additive manufacturing (Acorn 3DP Model). Physical replicas are fabricated using PA-12 polymer powder via HP multi-jet fusion. Device used in clinical settings by healthcare professionals for diagnostic support in musculoskeletal and craniomaxillofacial fields. Output aids clinical decision-making by providing anatomical replicas for pre-operative planning and diagnostic visualization.

Clinical Evidence

Bench testing only. No clinical data. Geometric accuracy of digital models assessed via Dice-Sorenson coefficient (average > 0.93) for automatic, semi-automatic, and manual methods. Physical model accuracy validated against digital models with <1mm mean deviation. Biocompatibility of 3D printed materials confirmed per ISO 10993-1.

Technological Characteristics

Standalone modular software for DICOM image processing. Features: image import, noise reduction, visualization, segmentation (manual, semi-automatic, ML-based auto-segmentation), measurement, and 3D model export. Physical models manufactured using PA-12 polymer powder via HP multi-jet fusion. Biocompatibility per ISO 10993-1. Software verification/validation per FDA guidance.

Indications for Use

Indicated for use as a software interface and image segmentation system for CT/CTA images to create digital 3D models and physical replicas via additive manufacturing. Intended for measuring and treatment planning in musculoskeletal and craniomaxillofacial applications. Auto-segmentation is limited to thoracic (T1-T12) and lumbar (L1-L5) spinal anatomy. Must be used with expert clinical judgment.

Regulatory Classification

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.

Special Controls

*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).

Predicate Devices

• Mimics Medical (K183105)
• D2P (K183489)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" underneath. The logo is simple and professional, and it is easily recognizable.

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

July 12, 2024

Re: K234009

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: QIH, LLZ Dated: June 12, 2024 Received: June 12, 2024

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.

FDA's substantial equivalence determination also included the review and clearance of your Predetermined Change Control Plan (PCCP). Under section 515C(b)(1) of the Act, a new premarket notification is not required for a change to a device cleared under section 510(k) of the Act, if such change is consistent with an

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established PCCP granted pursuant to section 515C(b)(2) of the Act. Under 21 CFR 807.81(a)(3), a new premarket notification is required if there is a major change or modification in the intended use of a device, or if there is a change or modification in a device that could significantly affect the safety or effectiveness of the device, e.g., a significant change or modification in design, material, chemical composition, energy source, or manufacturing process. Accordingly, if deviations from the established PCCP result in a major change or modification in the intended use of the device, or result in a change or modification in the device that could significantly affect the safety or effectiveness of the a new premarket notification would be required consistent with section 515C(b)(1) of the Act and 21 CFR 807.81(a)(3). Failure to submit such a premarket submission would constitute adulteration and misbranding under sections 501(f)(1)(B) and 502(o) of the Act, respectively.

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 (OS) 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 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-reportingcombination-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.

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-device-safety/medical-device-reportingmdr-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/medicaldevices/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 the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatory

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assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Jessica Lamb

Jessica Lamb Assistant Director DHT8B: Division of Radiologic 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

510(k) Number (if known) K234009

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

#### Indications for Use (Describe)

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 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.

| Type of Use (Select one or both, as applicable) |
|---------------------------------------------------------------------------------------------------------|
| <span> <span style="font-size:16px">☒</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> |
| <span> <span style="font-size:16px">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> |

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Image /page/4/Picture/2 description: The image shows the logo for Mighty Oak. The logo features three green curved lines above the words "MIGHTY OAK" in blue. The curved lines are arranged in a way that suggests movement or growth.

MEDICA

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

#### Submitter:

Mighty Oak Medical 750 W. Hampden Ave., Suite 120 Englewood, CO 80110 [phone]

| Contact: | Mark A. Wylie, VP of Quality and Regulatory |
|----------------|---------------------------------------------|
| Date Prepared: | 12JUL2024 |

# Device

| Trade Name: | Acorn 3D Software (AC-SEG-4009); Acorn 3DP Model (AC-101-XX) |
|------------------------|-----------------------------------------------------------------|
| Common Name: | Image processing system |
| Device Classification: | Class II |
| Regulation, Name: | 21 CFR 892.2050, Medical image management and processing system |
| Device Product Code: | QIH, LLZ |

## Type of 510(k)

Original Submission: Traditional

## Predicate Device(s):

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

| 510(k) | Product Code | Trade Name | Manufacturer |
|-----------------------------|--------------|----------------|-----------------|
| Primary Predicate Device | | | |
| K183105 | LLZ | Mimics Medical | Materialise NV |
| Subsequent Predicate Device | | | |
| K183489 | LLZ | D2P | 3D Systems, Inc |

## Description

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 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

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Acorn Seamentation contains both machine learning based auto-seamentation as well as semiautomatic 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). Semi-automatic and manual seamentation tools are intended to be used for all musculoskeletal and craniomaxillofacial anatomy. The following table provides a definition and the anatomical location(s) for each tool's intended use.

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

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

# Indications for Use

Acorn Seamentation 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 Seamentation 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.

## Materials

Acorn 3DP materials used have been tested and shown to be biocompatible in accordance with ISO 10993-1. The material used to manufacture Acorn 3DP Models is a PA-12 polymer powder for use in HP multi-jet fusion systems.

## Performance Data

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

The geometric accuracy of digital models created in the subject device, Acorn Segmentation, was assessed via bench testing of automatic, semi-automatic, and manual segmentation methods. Accuracy of automatic segmentation was evaluated for its intended use on Thoracic (T1-T12) and Lumbar (L1-L5) anatomy. Accuracy of semi-automatic and manual segmentation methods was evaluated for their intended for use on musculoskeletal and craniomaxillofacial anatomy. All segmentations were evaluated against predicate device segmentations using Dice-Sorenson coefficient. Testing of automatic, semi-automatic, and manual segmentation methods each exceeded an average Dice-Sorenson coefficient of 0.93. All deviations were within the acceptance criteria. This shows that for creating digital models, Acorn Segmentation is substantially equivalent to the predicate device.

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The geometric accuracy of physical replicas (produced by 3D printing digital models) was also assessed. This was conducted for various representative musculoskeletal and craniomaxillofacial models. Testing showed that the physical models can be printed accurately at less than 1mm mean deviation when compared to the digital models.

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

## Technological Characteristics

The following technological characteristics of the subject Acorn Seamentation & 3DP Model are equivalent to the predicate devices. These include:

- . 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

Technological characteristics which are different have been supported with descriptive information and/or performance data. Therefore the fundamental scientific technology of Acorn Segmentation & 3DP Model is the same as the previously cleared device.

# Substantial Equivalence 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 Segmentation & 3DP Model and the predicate (Materialise's Mimics Medical, K183105).

| Device→ | Acorn Segmentation<br>(K234009) | Mimics Medical<br>(K183105) | D2P<br>(K183489) |
|----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Features↓ | | | |
| Premarket<br>notification | K234009 | K183105 | K183489 |
| Manufacturer | Mighty Oak Medical | Materialise N.V. | 3D Systems |
| Indications for Use<br>Statement | Acorn Segmentation is intended for use as a<br>software interface and image segmentation<br>system for the transfer of CT or CTA medical<br>imaging information to an output file. Acorn<br>Segmentation is also intended for measuring and<br>treatment planning. The Acorn Segmentation<br>output can also be used for the fabrication of<br>physical replicas of the output file using additive<br>manufacturing methods, Acorn 3DP Models. The<br>physical replica can be used for diagnostic<br>purposes in the field of musculoskeletal and<br>craniomaxillofacial applications.<br>Acorn Segmentation and 3DP Models should be<br>used in conjunction with expert clinical judgment. | Mimics is intended for<br>use as a software<br>interface and image<br>segmentation system<br>for the transfer of<br>medical imaging<br>information to an<br>output file. Mimics<br>Medical is also<br>intended for<br>measuring and<br>treatment planning.<br>The Mimics Medical<br>output can be used<br>for the fabrication of<br>physical replicas of<br>the output file using<br>traditional or additive<br>manufacturing<br>methods.<br>The physical replica<br>can be used for<br>diagnostic purposes in | The D2P software is<br>intended for use as a<br>software interface<br>and image<br>segmentation system<br>for the transfer of<br>DICOM imaging<br>information from a<br>medical scanner to<br>an output file. It is also<br>intended as pre-<br>operative software for<br>surgical planning. For<br>this purpose, the<br>output file may be<br>used to produce a<br>physical replica. The<br>physical replica is<br>intended for<br>adjunctive use along<br>with other diagnostic<br>tools and expert<br>clinical judgement for |
| Device→<br>Features↓ | Acorn Segmentation<br>(K234009) | Mimics Medical<br>(K183105) | D2P<br>(K183489) |
| | | the field of<br>orthopaedic,<br>maxillofacial and<br>cardiovascular<br>applications.<br>Mimics Medical<br>should be used in<br>conjunction with<br>expert clinical<br>judgment. | diagnosis, patient<br>management, and/or<br>treatment selection of<br>cardiovascular,<br>craniofacial,<br>gastrointestinal,<br>genitourinary,<br>neurological, and/or<br>musculoskeletal<br>applications. |
| General intended<br>use | Acorn Segmentation is image processing software<br>that allows the user to import, visualize and<br>segment medical images, check and correct the<br>segmentations, and create digital 3D models. | Mimics Medical is<br>image processing<br>software that allows<br>the user to import,<br>visualize and segment<br>medical images,<br>check and correct the<br>segmentations, and<br>create digital 3D<br>models. | D2P is image<br>processing software<br>that allows the user to<br>import, visualize and<br>segment medical<br>images, check and<br>correct the<br>segmentations, and<br>create digital 3D<br>models. |
| Product<br>Classification | System, Image processing, Radiological | System, Image<br>processing,<br>Radiological | System, Image<br>processing,<br>Radiological |
| Regulatory Class | Class II | Class II | Class II |
| Regulation<br>Number | 892.2050 | 892.2050 | 892.2050 |
| Product Code | QIH, LLZ | LLZ | LLZ |
| Device<br>Description | Acorn Segmentation is an image processing<br>software that allows the user to import, visualize<br>and segment medical images, check and<br>correct the segmentations, and create digital 3D<br>models. The models can be used in Acorn<br>Segmentation for measuring, treatment planning<br>and producing an output file to be used for<br>additive manufacturing (3D printing). Acorn<br>Segmentation is structured as a modular<br>package. This includes the following functionality:<br>Importing medical images in DICOM format Viewing images and DICOM data Selecting a region of interest using generic<br>segmentation tools Segmenting specific anatomy using<br>dedicated semi-automatic tools or fully<br>automatic algorithms Verifying and editing a region of interest Calculating a digital 3D model and editing<br>the model Measuring on images and 3D models Exporting 3D models to third-party packages Acorn Segmentation contains both machine<br>learning based auto-segmentation as well as<br>semi-automatic and manual segmentation tools.<br>The auto-segmentation tool is only intended to be<br>used for thoracic and lumbar regions of the spine<br>(T1-T12 and L1-L5). Semi-automatic and manual<br>segmentation tools are intended to be used for all<br>musculoskeletal and craniomaxillofacial<br>anatomy. The following table provides a definition | Mimics Medical is<br>image processing<br>software that allows<br>the user to import,<br>visualize and segment<br>medical images,<br>check and correct the<br>segmentations, and<br>create digital 3D<br>models. The models<br>can be used in Mimics<br>Medical for<br>measuring, treatment<br>planning and<br>producing an output<br>file to be used for<br>additive<br>manufacturing (3D<br>printing). Mimics<br>Medical also has<br>functionality for linking<br>to third party software<br>packages. Mimics<br>Medical is structured<br>as a modular<br>package. This includes<br>the following<br>functionality:<br>Importing<br>medical images<br>in DICOM format<br>and other<br>formats (such as | The D2P software is a<br>stand-alone modular<br>software package<br>that provides<br>advanced<br>visualization of DICOM<br>imaging data. This<br>modular package<br>includes, but is not<br>limited to the following<br>functions:<br>DICOM viewer<br>and analysis Automated<br>segmentation Editing and pre-<br>printing Seamless<br>integration with<br>3D Systems<br>printers Seamless<br>integration with<br>3D Systems<br>software<br>packages Seamless<br>integration with<br>Virtual Reality<br>visualization for<br>non-diagnostic<br>use. |

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| Device→<br>Features↓ | Acorn Segmentation<br>(K234009)<br>and the anatomical location(s) for each tool's<br>intended use. | | | Mimics Medical<br>(K183105) | D2P<br>(K183489) |
|----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Automatic | Semi-<br>Automatic | Manual | BMP, TIFF, JPG<br>and raw images) Viewing images<br>and DICOM data Selecting a<br>region of interest<br>using generic<br>segmentation<br>tools Segmenting<br>specific anatomy<br>using dedicated<br>semi-automatic<br>tools or fully<br>automatic<br>algorithms Verifying and<br>editing a region<br>of interest Calculating a<br>digital 3D model<br>and editing the<br>model Measuring on<br>images and 3D<br>models Exporting<br>images,<br>measurements<br>and 3D models<br>to third-party<br>packages Planning<br>treatments<br>(surgical cuts<br>etc.) on the 3D<br>models Interfacing with<br>packages for<br>Finite Element<br>Analysis Creating Python<br>scripts to<br>automate<br>workflows | |
| | Definition | Algorithmic<br>with little or<br>no direct<br>human<br>control | A<br>combination<br>of<br>algorithmic<br>and direct<br>human<br>control | Directly<br>controlled<br>by a<br>human | |
| | Tool<br>Type | Machine<br>Learning<br>algorithm<br>used to<br>automat-<br>ically<br>segment<br>individual<br>vertebrae | Algorithmic<br>based tools<br>that do not<br>incorporate<br>machine<br>learning. | Manual<br>tools<br>requiring<br>user input. | |
| | Anatom-<br>ical<br>Location<br>(s) | Spinal<br>anatomy:<br>• Thoracic<br>(T1-T12)<br>• Lumbar<br>(L1-L5) | Musculo-<br>skeletal &<br>cranioma-<br>xillofacial<br>bone:<br>• Short<br>• Long<br>• Flat<br>• Sesamoid<br>• Irregular | Musculo-<br>skeletal &<br>craniuma-<br>xillofacial<br>bone:<br>• Short<br>• Long<br>• Flat<br>• Sesa-<br>moid<br>• Irreg-<br>ular | |
| Technological<br>characteristics | Acorn Segmentation is a standalone modular<br>software package. This module includes, but is<br>not limited to the following functions:<br>Image Import<br>• Importing medical images in DICOM format<br>Image Processing<br>• Processing of images with common noise-<br>reduction filters<br>• Editing of spatial arrangement of images<br>Visualization<br>• Viewing images and DICOM data<br>Segmentation<br>• Selecting a region of interest using generic<br>segmentation tools<br>• Segmenting specific anatomy using | | | Mimics Medical is<br>structured as a<br>modular package.<br>This includes the<br>following functionality:<br>Image Import<br>• Importing<br>medical images<br>in DICOM format<br>and other formats<br>(such as BMP,<br>TIFF, JPG and raw<br>images)<br>Image Processing<br>• Processing of<br>images with<br>common noise- | D2P is structured as a<br>modular package.<br>This includes the<br>following functionality:<br>Image Import<br>• Importing<br>medical images<br>in DICOM format<br>and other<br>formats (such as<br>BMP, TIFF, JPG<br>and raw images)<br>Image Processing<br>• Processing of<br>images with<br>common noise-<br>reduction filters |

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| Device→<br>Features↓ | Acorn Segmentation<br>(K234009) | Mimics Medical<br>(K183105) | D2P<br>(K183489) |
|----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Segmenting specific vertebral anatomy using machine-learning-based fully automatic algorithms Verifying and editing a region of interest | Editing of spatial arrangement of images <b>Processing of imaging data for removal of common artifacts (e.g. scatter)</b> | Editing of spatial arrangement of images |
| Measurement | Measuring on images and 3D models | Visualization Viewing images and DICOM data | Visualization Viewing images and DICOM data |
| Image Export | Exporting images and 3D models to third-party packages | Segmentation 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 | Segmentation Selecting a region of interest using generic segmentation tools Segmenting specific anatomy using dedicated semi-automatic tools or fully automatic deep learning tools Verifying and editing a region of interest |
| 3D Models | Calculating a digital 3D model and editing the model Smoothing a 3D model Importing 3D models | Measurement Measuring on images and 3D models | Measurement Measuring on images and 3D models |
| | | Image Export Exporting images, <b>measurements</b> and 3D models to third-party packages | Image Export Exporting images and 3D models to third-party packages |
| | | 3D Models Calculating a digital 3D model and editing the model <b>Wrapping a 3D model</b> Smoothing a 3D model Importing 3D models | 3D Models Calculating a digital 3D model and editing the model Smoothing a model Importing 3D models |
| Treatment Planning | Importing of third-party STLs to visualize planned interactions with anatomy as represented in DICOM images | Treatment Planning Importing of third-party STLs to visualize planned interactions with anatomy as represented in DICOM images | Treatment Planning Importing of third-party STLs to visualize planned interactions with anatomy as represented in DICOM images <b>Planning treatments (surgical cuts etc.) on the 3D models</b> |
| Other features | Using a collection of images and masks as a training dataset for machine-learning segmentation algorithm | | Other features |
| Device→<br>Features↓ | Acorn Segmentation<br>(K234009) | Mimics Medical<br>(K183105) | D2P<br>(K183489) |
| | | Other features Interfacing with<br>packages for<br>Finite Element<br>Analysis Creating Python<br>scripts to<br>automate<br>workflows |…