K Number
K242647
Device Name
MySegmenter (v2.0.0)
Date Cleared
2025-04-16

(225 days)

Product Code
Regulation Number
892.2050
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
MySegmenter (v2.0.0) is a medical images segmentation tool that converts CT and MRI scans into 3D anatomical models. The models are intended for surgical planning or educational purposes but are not to be used in the operating room. The software must be used under the supervision of qualified medical professionals. The 3D models and replicas are to be utilized solely for pre-operational planning in orthopedic and craniomaxillofacial cases, and for educational purposes; they must not be used in the operating room. The MR images have not been tested for craniomaxillofacial applications.
Device Description
MySegmenter (v2.0.0) is a software platform for visualizing medical images in 3D mesh format. processes images by analyzing the luminance of individual pixels to segment and highlight the regions of interest (specific anatomical areas). MySegmenter supports editing, modification and manipulation of segmented areas using various segmentation tools. The software features include: - Importing medical images in DICOM and other formats. - Viewing and navigating through DICOM images. - Segmenting selected regions using generic tools (segments, island effects, Boolean operations, etc.) - Editing segments with multiple slice edits, fast marching, watershed effects, etc. - Generating editable 3D STL files for different applications. - Converting the segment to mesh models. - Exporting the segmented models in STL format suitable for further manipulation and manufacturing.
More Information

Not Found

No.
The device description explicitly states that MySegmenter processes images by analyzing the luminance of individual pixels and segments regions using generic tools, which are traditional image processing techniques rather than AI models. There is also no mention of AI, DNN, or ML in the documentation.

No

Explanation: The device is described as a medical image segmentation tool intended for surgical planning and educational purposes, but explicitly states it is "not to be used in the operating room" and not for "therapeutic" use. Therapeutic devices are typically those that treat or alleviate a disease or condition.

No

MySegmenter is described as a medical image segmentation tool used to convert scans into 3D anatomical models for surgical planning or educational purposes. It processes images and generates editable 3D STL files and mesh models based on analyzing pixel luminance to highlight regions of interest. Its function is to create models from existing data, not to diagnose conditions or identify diseases.

Yes

The device is described purely as a "software platform" that processes medical images. All its described functionalities and outputs are related to software operations (importing, viewing, segmenting, editing, generating STL files, converting to mesh models, exporting). There is no mention of any hardware components or hardware-specific operations within the device description or intended use.

No.
The device is for surgical planning and educational purposes, processing medical images into 3D models for anatomical understanding, not for testing samples derived from the human body to provide information for diagnosis or treatment.

N/A

Intended Use / Indications for Use

MySegmenter (v2.0.0) is a medical images segmentation tool that converts CT and MRI scans into 3D anatomical models. The models are intended for surgical planning or educational purposes but are not to be used in the operating room.

The software must be used under the supervision of qualified medical professionals. The 3D models and replicas are to be utilized solely for pre-operational planning in orthopedic and craniomaxillofacial cases, and for educational purposes; they must not be used in the operating room. The MR images have not been tested for craniomaxillofacial applications.

Product codes

LLZ

Device Description

MySegmenter (v2.0.0) is a software platform for visualizing medical images in 3D mesh format. processes images by analyzing the luminance of individual pixels to segment and highlight the regions of interest (specific anatomical areas). MySegmenter supports editing, modification and manipulation of segmented areas using various segmentation tools. The software features include:

  • Importing medical images in DICOM and other formats.
  • Viewing and navigating through DICOM images.
  • Segmenting selected regions using generic tools (segments, island effects, Boolean operations, etc.)
  • Editing segments with multiple slice edits, fast marching, watershed effects, etc.
  • Generating editable 3D STL files for different applications.
  • Converting the segment to mesh models.
  • Exporting the segmented models in STL format suitable for further manipulation and manufacturing.

Mentions image processing

Yes

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

CT and MRI scans

Anatomical Site

Orthopedic and craniomaxillofacial regions.

Indicated Patient Age Range

Adult population (+18)

Intended User / Care Setting

Qualified medical professionals. Solely for pre-operational planning in orthopedic and craniomaxillofacial cases, and for educational purposes; they must not be used in the operating room.

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

CT and MRI Accuracy Studies:

  • Sample Size: 30 dataset samples (15 CT and 15 MRI)
  • Data Source: Indian origin, evenly distributed between adult male and female subjects. Acquired from 11 different scanners.
  • Annotation Protocol: Collection protocols ensured a slice thickness less than or equal to 1 mm for CT images, 2 mm for MRI images, and a minimum resolution for both of at least 512x512 for all orthopedic and craniomaxillofacial cases. For the truthing process, reference models were created using the predicate device by experts in the field of medical imaging. Inter-expert agreement was evaluated using Intraclass Correlation Coefficient (ICC) scores to ensure absolute agreement.

3D Printing accuracy:

  • Sample Size: 20 dataset samples (15 CT and 5 MRI)
  • Data Source: Indian origin, evenly distributed between adult male and female subjects. Samples were obtained from at least 10 different scanners.
  • Annotation Protocol: Collection protocols ensured a slice thickness less than or equal to 1 mm for CT images, 2 mm for MRI images, and a minimum resolution for both of at least 512x512 for all orthopedic and craniomaxillofacial cases. Clinical models generated by MySegmenter (v2.0.0) were 3D printed, scanned, and compared against digital models produced by the predicate device to validate their precision.

Summary of Performance Studies

Performance Data:

  • Software verification and validation testing: Verification and validation were conducted according to the "Guidance for the Content of Premarket submission for software contained in Medical Devices". The analysis concluded that the software has a moderate level of concern. The following tests were performed: Unit testing, Functional testing, Integration testing, System testing, User acceptance testing, Software performance testing, and API testing. These tests were conducted by developers and testers to ensure the proper compliance with all software requirements.

  • CT and MRI Accuracy Studies:

    • Study Type: Comparative study of virtual outputs against predicate device outputs.
    • Sample Size: 30 dataset samples (15 CT and 15 MRI)
    • Key Metrics / Results: Performance was assessed using DICE and Jaccard similarity coefficients for volume, with results ranging from 90% to 98% depending on the use of manual editing. The surface accuracy was evaluated using Hausdorff distance, with all models showing deviations below 0.6 mm which falls within the acceptance criteria of 1 mm established. These results indicate that MySegmenter (v2.0.0) provides digital models with a precision substantially equivalent to the predicate device.
  • 3D Printing accuracy:

    • Study Type: Comparative study of 3D printed models against digital models produced by the predicate device.
    • Sample Size: 20 dataset samples (15 CT and 5 MRI)
    • Key Metrics / Results: Geometric accuracy was assessed using surface-to-surface comparisons via Hausdorff distance. The differences between models were consistently below 1 mm, even in the most critical scenarios. These results confirm that the printed models were within acceptable accuracy limits for the intended applications established for this device.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

  • DICE similarity coefficients (90% to 98%)
  • Jaccard similarity coefficients (90% to 98%)
  • Hausdorff distance (deviations below 0.6 mm for virtual models, consistently below 1 mm for printed models)
  • Intraclass Correlation Coefficient (ICC) scores for inter-expert agreement.

Predicate Device(s)

Materialise Mimics Medical 21.0, K183105

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

§ 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).

FDA 510(k) Clearance Letter - MySegmenter (v2.0.0)

Page 1

U.S. Food & Drug Administration
10903 New Hampshire Avenue Doc ID # 04017.07.05
Silver Spring, MD 20993
www.fda.gov

MySegmenter Technologies Inc.
Ketan Jajal
Chief Executive Officer
8th The Green
Suite #10588
DOVER, DELAWARE 19901

Re: K242647
Trade/Device Name: MySegmenter (v2.0.0)
Regulation Number: 21 CFR 892.2050
Regulation Name: Medical Image Management And Processing System
Regulatory Class: Class II
Product Code: LLZ
Dated: March 14, 2025
Received: March 14, 2025

Dear Ketan Jajal:

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.

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"

April 16, 2025

Page 2

MySegmenter Technologies Inc.
Ketan Jajal
Chief Executive Officer
8th The Green
Suite #10588
DOVER, DELAWARE 19901

April 16, 2025

Re: K242647
Trade/Device Name: MySegmenter (v2.0.0)
Regulation Number: 21 CFR 892.2050
Regulation Name: Medical Image Management And Processing System
Regulatory Class: Class II
Product Code: LLZ
Dated: March 14, 2025
Received: March 14, 2025

Dear Ketan Jajal:

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.

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"

K242647 - Ketan Jajal Page 2

(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 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).

Page 3

K242647 - Ketan Jajal Page 3

Sincerely,

Jessica Lamb
Assistant Director
Imaging Software Team
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

Page 4

FORM FDA 3881 (8/23) Page 1 of 1 PSC Publishing Services (301) 443-6740 EF

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120
Expiration Date: 07/31/2026
See PRA Statement below.

510(k) Number (if known)
K242647

Device Name
MySegmenter (v2.0.0)

Indications for Use (Describe)
MySegmenter (v2.0.0) is a medical images segmentation tool that converts CT and MRI scans into 3D anatomical models. The models are intended for surgical planning or educational purposes but are not to be used in the operating room.

The software must be used under the supervision of qualified medical professionals. The 3D models and replicas are to be utilized solely for pre-operational planning in orthopedic and craniomaxillofacial cases, and for educational purposes; they must not be used in the operating room. The MR images have not been tested for craniomaxillofacial applications

Type of Use (Select one or both, as applicable)
☒ Prescription Use (Part 21 CFR 801 Subpart D) ☐ Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services
Food and Drug Administration
Office of Chief Information Officer
Paperwork Reduction Act (PRA) Staff
PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

Page 5

MySegmenter Technologies Inc. 510(K) Summary

K242647

510(k) Summary Page 1 of 6

1. Submission Sponsor

MySegmenter Technologies Inc.

2. Submission Correspondent:

Name: Ketan Jajal
Phone: +1 3025492288
Email: ketan.jajal@3dsurgical.com

Name: Ravikant Kamal
Phone: +91 9971882750
Email: ravi.kamal@3dsurgical.com

Name: Nelson Barrios
Phone: +58 424 1122354
Email: nelson.barrios@3dsurgical.com

3. Submitter Address:

8 The Green Suite # 10588 Dover, DE 19901

4. Date Summary Prepared:

16 August, 2024

5. Device name & classification:

Trade/Proprietary Name: MySegmenter (v2.0.0)
Common/Usual Name: MySegmenter
Device classification Regulation: 21CFR Part 892.2050
Product Code: LLZ
Device Class: Class 2
Classification Panel: Radiology
Application number: K242647
Predicate utilized: Materialise Mimics Medical 21.0

Introduction

The MySegmenter (v2.0.0) is a post-processing tool for medical image segmentation. It is designed for use by surgeons, medical imaging technologists, and medical device designers. The selection of the appropriate anatomical region for each patient case is determined by the user. MySegmenter provides a 3D visualization environment to view a patient's anatomy, creating a 3D augmented model derived from CT and MRI scans in DICOM format. This software enables detailed visualization and planning based on patient-specific imaging data.

Page 6

MySegmenter Technologies Inc. 510(K) Summary
K242647

510(k) Summary Page 2 of 6

Device Description

MySegmenter (v2.0.0) is a software platform for visualizing medical images in 3D mesh format. processes images by analyzing the luminance of individual pixels to segment and highlight the regions of interest (specific anatomical areas). MySegmenter supports editing, modification and manipulation of segmented areas using various segmentation tools. The software features include:

  • Importing medical images in DICOM and other formats.
  • Viewing and navigating through DICOM images.
  • Segmenting selected regions using generic tools (segments, island effects, Boolean operations, etc.)
  • Editing segments with multiple slice edits, fast marching, watershed effects, etc.
  • Generating editable 3D STL files for different applications.
  • Converting the segment to mesh models.
  • Exporting the segmented models in STL format suitable for further manipulation and manufacturing.

Indications for use

MySegmenter (v2.0.0) is a medical images segmentation tool that converts CT and MRI scans into 3D anatomical models. The models are intended for surgical planning or educational purposes but are not to be used in the operating room.

The software must be used under the supervision of qualified medical professionals. The 3D models and replicas are to be utilized solely for pre-operational planning in orthopedic and craniomaxillofacial cases, and for educational purposes; they must not be used in the operating room. The MR images have not been tested for craniomaxillofacial applications.

Comparison of technological parameters

The subject and its predicate devices are platforms to transfer the medical images into workable 3D mesh models that can be used for certain medical purpose such as visualization, planning, customized solutions etc. The comparison mentioned in the table below.

SubjectPrimary Predicate
NameMySegmenter (v2.0.0)Mimics Medical 21.0
Regulation Number21 CFR Part 892.205021 CFR Part 892.2050
Product CodeLLZLLZ

Page 7

MySegmenter Technologies Inc. 510(K) Summary
K242647

510(k) Summary Page 3 of 6

SubjectPrimary Predicate
Indication for useMySegmenter (v2.0.0) is a medical images segmentation tool that converts CT and MRI scans into 3D anatomical models. The models are intended for surgical planning or educational purposes but are not to be used in the operating room.

The software must be used under the supervision of qualified medical professionals. The 3D models and replicas are to be utilized solely for pre-operational planning in orthopedic and craniomaxillofacial cases, and for educational purposes; they must not be used in the operating room. The MR images have not been tested for craniomaxillofacial applications. | Mimics Medical is intended for use as a software interface and image segmentation system for the transfer of medical imaging information to an output file. Mimics Medical is also intended for measuring and treatment planning.

Mimics Medical should be used in conjunction with expert clinical judgement. |
| Patient population | Adult population (+18) | Unspecified |
| Clinical use | Pre-operative planning, visualization and diagnostic aid for orthopedic, and craniomaxillofacial cases. | Visualising medical imaging information to an output file, measuring and treatment planning, diagnostic aid for orthopaedic, maxillofacial, and cardiovascular applications |
| Component | Standalone software | Standalone software |
| Connectivity | License based | License based |
| Images formats supported | DICOM images | DICOM, BMP, JPEG images |

Page 8

MySegmenter Technologies Inc. 510(K) Summary
K242647

510(k) Summary Page 4 of 6

SubjectPrimary Predicate
Key Featured functionalitiesThe following features are included in MySegmenter:
• Manual and Semiautomatic tools for segmentation.
• Measurement tools for annotations.
• 3D rendering visualization functionality.
• Anonymization functionality.
• Video recording module.The following features are included in Materialise Mimics:
• Manual, and Semiautomatic tools for segmentation.
• Measurement tools for annotation
• 3D rendering visualization functionality.
• Anonymization functionality.
• Video recording module.
• Aligning tools
• Among other features
Operating system64-bits Microsoft Windows 10 or superior (Recommended 64-bits Microsoft Windows 11)64-bit Microsoft Windows 10 or superior
Graphical user interfaceYesYes
Network requiredYesYes

Performance data:

The following performance data supports the conclusion of equivalence between MySegmenter (v2.0.0) and the predicate device:

Software verification and validation testing:

Verification and validation were conducted according to the "Guidance for the Content of Premarket submission for software contained in Medical Devices". The analysis concluded that the software has a moderate level of concern.

The following tests were performed: Unit testing, Functional testing, Integration testing, System testing, User acceptance testing, Software performance testing, and API testing. These tests were conducted by developers and testers to ensure the proper compliance with all software requirements.

Accuracy studies:

The outputs of the MySegmenter (v2.0.0) were evaluated through various accuracy studies to ensure that the final virtual and printed models accurately represent the original structures and can be utilized for their intended purposes. Detailed findings are provided below:

1. CT and MRI Accuracy Studies:

This study utilized 30 dataset samples (15 CT and 15 MRI) from Indian origin, evenly distributed between adult male and female subjects, in order to ensure diversity and

Page 9

MySegmenter Technologies Inc. 510(K) Summary
K242647

510(k) Summary Page 5 of 6

generalizability in the data. The datasets include craniomaxillofacial and orthopedic models from CT scans, and orthopedic models from MRI.

The samples were acquired from 11 different scanners, using collection protocols that ensured a slice thickness less than or equal to 1 mm for CT images, 2 mm for MRI images, and a minimum resolution for both of at least 512×512 for all orthopedic and craniomaxillofacial cases, in order to guarantee an adequate quality in all the generated models.

For the truthing process, reference models were created using the predicate device by experts in the field of medical imaging. Inter-expert agreement was evaluated using Intraclass Correlation Coefficient (ICC) scores to ensure absolute agreement.

The virtual outputs generated by MySegmenter were compared with those from the predicate device for both orthopedic and maxillofacial models. The performance was assessed using DICE and Jaccard similarity coefficients for volume, with results ranging from 90% to 98% depending on the use of manual editing. Also, the surface accuracy was evaluated using Hausdorff distance, with all models showing deviations below 0.6 mm which falls within the acceptance criteria of 1 mm established. These results indicate that MySegmenter (v2.0.0) provides digital models with a precision substantially equivalent to the predicate device.

2. 3D Printing accuracy:

This study utilized 20 dataset samples (15 CT and 5 MRI) from Indian origin, evenly distributed between adult male and female subjects, in order to ensure diversity and generalizability in the data. The datasets included craniomaxillofacial and orthopedic applications from CT scans, and orthopedic models from MRI. Samples were obtained from at least 10 different scanners, using collection protocols that ensured a slice thickness less than or equal to 1 mm for CT images, 2 mm for MRI images, and a minimum resolution for both of at least 512×512 for all orthopedic and craniomaxillofacial cases, in order to guarantee an adequate quality in all the generated models.

The applications selected for printing test represented some of the most common and critical clinical scenarios, including fracture malunions, hip dysplasia, and congenital scoliosis in orthopedic cases; and cranial and mandible complex fractures, temporomandibular joint (TMJ) disorders, and mandibular neoplasms in craniomaxillofacial cases.

In this study, clinical models generated by MySegmenter (v2.0.0) were 3D printed, scanned, and compared against digital models produced by the predicate device to validate their precision. Geometric accuracy was assessed using surface-to-surface comparisons via Hausdorff distance. The differences between models were consistently below 1 mm, even in the most critical scenarios. These results confirm that the printed models were within acceptable accuracy limits for the intended applications established for this device.

Summary:

In conclusion, the testing data indicates that MySegmenter (v2.0.0) is substantially equivalent in performance and intended use to the predicate device, Materialise Mimics 21.0 (K183105).

Page 10

MySegmenter Technologies Inc. 510(K) Summary
K242647

510(k) Summary Page 6 of 6

While there are minor differences in algorithms, features and performance, the testing results confirm that MySegmenter (v2.0.0) is as safe, and effective as the predicate device.