Who is the manufacturer of Axial3D Insight?

Axial Medical Printing Limited filed the 510(k) submission for Axial3D Insight (K222745).

What is the FDA product code for Axial3D Insight?

QIH. It is classified under 21 CFR 892.2050 as a Class 2 device in the Radiology panel.

What is the regulatory pathway for Axial3D Insight?

510(k) clearance (submission type: Traditional).

Does Axial3D Insight use AI or machine learning?

Yes. Axial3D Insight (K222745) is flagged as an AI/ML-enabled medical device in the FDA's AI/ML device list.

What are the predicate devices for Axial3D Insight?

Axial3D Cloud Segmentation Service (K221511).

Who can help prepare an FDA 510(k) submission like Axial3D Insight?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Can an AI/ML device like Axial3D Insight get a guaranteed FDA 510(k) clearance?

Yes. Innolitics offers a guaranteed FDA 510(k) clearance engagement for AI/ML Software as a Medical Device — combining engineering and regulatory execution under one agreement with a guaranteed clearance outcome. Eligibility: the device must be an AI/ML Software as a Medical Device (SaMD), and its performance must meet the criteria Innolitics determines during an initial regulatory strategy engagement to be necessary for FDA clearance. See https://innolitics.com/services/end-to-end-samd/ or contact https://innolitics.com/contact.

Axial3D Insight

K222745 · Axial Medical Printing Limited · QIH · Jul 3, 2023 · Radiology

Device Facts

Record ID	K222745
Device Name	Axial3D Insight
Applicant	Axial Medical Printing Limited
Product Code	QIH · Radiology
Decision Date	Jul 3, 2023
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 892.2050
Device Class	Class 2
Attributes	AI/ML, Software as a Medical Device

Intended Use

Axial3DInsight is intended for use as a cloud-based service and image segmentation framework for the transfer of DICOM imaging information from a medical scanner to an output file. The Axial3DInsight output file can be used for the fabrication of the output file using additive manufacturing methods. The output file or physical replica can be used for treatment planning. The output file or physical replica can be used for diagnostic purposes in the field of orthopedic trauma, orthopedic, maxillofacial, and cardiovascular applications. Axial3DInsight should be used with other diagnostic tools and expert clinical judgment.

Device Story

Axial3D Insight is a cloud-based software platform that processes DICOM imaging data (CT/CTA) to generate 3D models. The device utilizes machine learning models to perform initial image segmentation, which is then reviewed and finalized by trained staff to ensure quality. The output is a digital file or a 3D-printed physical replica. Used in hospital settings by clinicians, the device serves as a tool for pre-operative planning, surgical instrument design, implant selection, and patient communication. By providing patient-specific 1:1 scale anatomical models, the device aids in surgical decision-making and treatment planning, potentially improving surgical outcomes through enhanced visualization of complex anatomy.

Clinical Evidence

Clinical validation included two studies. A Clinical Segmentation Performance study with 3 radiologists reviewing 12 cases across orthopedics, trauma, maxillofacial, and cardiovascular fields used a RADPEER framework; all cases met acceptance criteria. An Intended Use validation study with 9 physicians reviewing 12 cases confirmed that the 3D models satisfied end-user needs and indications for use. Machine learning models were independently verified and validated using large datasets (totaling >39,000 images across cardiac, neuro, ortho, and trauma categories) from various scanner manufacturers.

Technological Characteristics

Cloud-based software interface; supports CT and CTA modalities. Features automated segmentation tools combined with smart editing tools, volume rendering, and quantification. Operates via web browsers (Edge, Safari, Chrome). Software is classified as Moderate Level of Concern. Validation performed per FDA guidance for software in medical devices.

Indications for Use

Indicated for use as a cloud-based image segmentation framework for processing DICOM data from medical scanners to create output files or physical replicas for treatment planning and diagnostic purposes in orthopedic trauma, orthopedics, maxillofacial, and cardiovascular applications. Intended for prescription use by clinicians in conjunction with other diagnostic tools and expert 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

Axial3D Cloud Segmentation Service (K221511)

Related Devices

K250369 — Axial3D Insight · Axial Medical Printing Limited · Sep 18, 2025
K232841 — Axial3D Insight · Axial Medical Printing Limited · Nov 15, 2023
K221511 — Axial3D Cloud Segmentation Service · Axial Medical Printing Limited · Jun 23, 2022
K231607 — Axial3D Cloud Segmentation Service · Axial Medical Printing Limited · Jan 24, 2024
K250237 — InferOperate Suite · Beijing Infervision Healthcare Medical Technology Co., Ltd. · Sep 15, 2025

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains two logos. On the left is the Department of Health & Human Services logo. On the right is the FDA logo, which includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text. Axial Medical Printing Limited % Sujith Shetty Executive Vice President Maxis Medical LLC 7052 Hollow Lake Way SAN JOSE, CALIFORNIA 95120 Re: K222745 Trade/Device Name: Axial3D Insight Regulation Number: 21 CFR 892.2050 Regulation Name: Medical Image Management And Processing System Regulatory Class: Class II Product Code: OIH Dated: June 2, 2023 Received: June 2, 2023 Dear Sujith Shetty: 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 (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 located 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. 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 {1}------------------------------------------------ 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 803) for devices or postmarketing safety reporting (21 CFR 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 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 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 mediation-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-regulatoryassistance/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, Wenbo Li for Jessica Lamb Jessica Lamb, 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 {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K222745 Device Name Axial3DInsight ### Indications for Use (Describe) Axial3DInsight is intended for use as a cloud-based service and image segmentation framework for the transfer of DICOM imaging information from a medical scanner to an output file. The Axial3DInsight output file can be used for the fabrication of the output file using additive manufacturing methods. The output file or physical replica can be used for treatment planning. The output file or physical replica can be used for diagnostic purposes in the field of orthopedic trauma, orthopedic, maxillofacial, and cardiovascular applications. Axial3DInsight should be used with other diagnostic tools and expert clinical judgment. Type of Use (Select one or both, as applicable) | <div> ☑ Prescription Use (Part 21 CFR 801 Subpart D) </div> | |---------------------------------------------------------------------------------------------------------------------| | <div> □ Over-The-Counter Use (21 CFR 801 Subpart C) </div> | ### 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." {3}------------------------------------------------ Image /page/3/Picture/1 description: The image shows the logo for Axial3D. The logo consists of the word "axial" in a dark gray sans-serif font, with a small teal diamond above the "i". To the right of "axial" is the superscript "3D". Below the word "axial" is the tagline "Patient data made real" in a teal sans-serif font. ## 5 510(k) Summary {4}------------------------------------------------ Image /page/4/Picture/0 description: The image shows the logo for Axial3D. The logo consists of the word "axial" in a dark blue sans-serif font, with a small teal diamond above the "i". To the right of "axial" is the superscript "3D". Below the word "axial" is the tagline "Patient data made real" in a teal sans-serif font. #### 5.1 510(k) Summary This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CRF 807.92. 510 (k) number: K222745 #### 5.2 Applicant Information Axial Medical Printing Limited 17A Ormeau Avenue Belfast BT2 8HD United Kingdom Tel: +44 (0)28 90183590 #### Contact Person 5.2.1 Dr. Sujith Shetty, Executive Vice President, Maxis Medical, Consultant Email: sjshetty@maxismedical.com Phone: 1-408-887-3211 #### 5.3 Device Information | Trade Name | Axial3D Insight | |-------------------|--------------------------------------------------| | Common Name | Automated Radiological Image Processing Software | | Regulation number | 892.2050 | | Regulation Name | Medical Image Management and Processing System | | Regulatory Class | II | | Product Code | QIH | {5}------------------------------------------------ #### 5.4 Predicate Device | Table 5-1 – Predicate Device | | | |------------------------------|--|--| |------------------------------|--|--| | Name | Manufacturer | 510(k)# | |------------------------------------|--------------------------------|---------| | Axial3D Cloud Segmentation Service | Axial Medical Printing Limited | K221511 | This predicate has not been subject to a design-related recall. No reference devices were used in this submission. #### Device Description 5.5 Axial3D Insight is a secure, highly available cloud-based image processing, segmentation and 3D modelling framework for the transfer of imaging information either as a 3D printed physical model. #### 5.5.1 Indications for Use Axial3D Insight is intended for use as a cloud-based service and image segmentation framework for the transfer of DICOM imaging information from a medical scanner to an output file. The Axial3D Insight output file can be used for the fabrication of physical replicas of the output file using additive manufacturing methods. The output file or physical replica can be used for treatment planning. The output file or the physical replica can be used for diagnostic purposes in the field of orthopedic trauma, orthopedic, maxillofacial, and cardiovascular applications. Axial3D Insight should be used with other diagnostic tools and expert clinical judgment. {6}------------------------------------------------ Image /page/6/Picture/1 description: The image shows the logo for Axial3D. The word "axial" is written in a dark blue color, with a small teal diamond above the "i". The "3D" is written in a smaller font and is located to the upper right of the word "axial". Below the word "axial", the phrase "Patient data made real" is written in a teal color. #### Comparison of Intended Use to Predicate and Reference Devices 5.6 | Attribute | Axial3D Insight (Proposed Device) | Axial3D Cloud Segmentation Service (Predicate Device) | Mimics InPrint (Reference Device) | Comparison | |----------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------| | Device Manufacturer | Axial Medical Printing Limited | Axial Medical Printing Limited | Materialise N.V. | N/A | | Device Name | Axial3D Insight | Axial3D Insight | Mimics inPrint | N/A | | Device Trade or Proprietary Name | Axial3D Insight | Axial3D Insight | Mimics inPrint | N/A | | 510(k) Number | TBD | K221511 | K173619 | N/A | | Device Regulation Name: | Automated Radiological Image Processing Software | Medical image management and processing system | Picture archiving and communications system | Different - Updated based on additional processing | | Device Regulation Number: | 21 CFR 892.2050 | 21 CFR 892.2050 | 21 CFR 892.2050 | Equivalent | | Device Product Code: | QIH | LLZ | LLZ | Different - Updated based on additional processing | | Device Classification FDA: | Class II | Class II | Class II | Equivalent | | Indication for Use | Axial3D Insight is intended for use as a cloud-based service and image segmentation framework for the transfer of DICOM imaging information from a medical scanner to an output file. | Axial3D Cloud Segmentation Service is intended for use as a cloud based service and image segmentation system for the transfer of DICOM imaging | Mimics inPrint is intended for use as a software interface and image segmentation system for the transfer of DICOM imaging information from a medical | Equivalent | | Attribute | Axial3D Insight (Proposed Device) | Axial3D Cloud Segmentation Service (Predicate Device) | Mimics InPrint (Reference Device) | Comparison | | | The Axial3D Insight output file can be used for the fabrication of physical replicas of the output file using additive manufacturing methods. The output file or physical replica can be used for treatment planning. The output file or physical replica can be used for diagnostic purposes in the field of trauma, orthopedic, maxillofacial, and cardiovascular applications. Axial3D Insight should be used with other diagnostic tools and expert clinical judgment. | information from a medical scanner to an output file. The Axial3D Cloud Segmentation Service output file can be used for the fabrication of physical replicas of the output file using additive manufacturing methods. The output file or physical replica can be used for treatment planning. The physical replica can be used for diagnostic purposes in the field of orthopedic, maxillofacial and cardiovascular applications. Axial3D Cloud Segmentation Service should be used in conjunction with other diagnostic tools and expert clinical judgment. | scanner to an output file. It is also used as pre- operative software for treatment planning. For this purpose, the Mimics inPrint output file can be used for the fabrication of physical replicas of the output file using traditional or additive manufacturing methods. The physical replica can be used for diagnostic purposes in the field of orthopedic, maxillofacial, and cardiovascular applications. Mimics inPrint can be used for diagnostic purposes in the field of orthopedic, maxillofacial, and cardiovascular applications. Mimics inPrint should be used in conjunction with | | | Attribute | Axial3D Insight (Proposed Device) | Axial3D Cloud Segmentation Service (Predicate Device) | Mimics InPrint (Reference Device) | Comparison | | Intended Use | Axial Medical Printing Limiteds, Axial3D Insight provides patient- specific 1:1 scale replica models, either as a digital file or as a 3D printed physical model. The digital file or 3D printed physical model is intended to be used in conjunction with the DICOM images and expert clinical judgement. The applications for using the physical 3D printed physical model as a presurgical planning tool are as follows: Preoperative planning of surgical treatment options including planning for surgical instruments, aiding decisions on implants, and aiding the surgical treatment plan., All planning using the 3D replica model should be carried out | Axial3D Cloud Segmentation Service is intended for use as a cloud based service and image segmentation system for the transfer of DICOM imaging information from a medical scanner to an output file. The Axial3D Cloud Segmentation Service output file can be used for the fabrication of physical replicas of the output file using additive manufacturing methods. The output file or physical replica can be used for treatment planning. The physical replica can be used for | other diagnostic tools and expert clinical judgement. Mimics InPrint is intended for use as a software interface and image segmentation system for the transfer of DICOM imaging information from a medical scanner to an output file. It is also used as pre- operative software for treatment planning. For this purpose, the Mimics InPrint output file can be used for the fabrication of physical replicas of the output file using traditional or additive manufacturing methods. The physical replica can be used for diagnostic purposes in the field of orthopedic, maxillofacial and | Similar | | Attribute | Axial3D Insight (Proposed Device) | Axial3D Cloud Segmentation Service (Predicate Device) | Mimics InPrint (Reference Device) | Comparison | | | with the assistance of the DICOM images Communication with the surgical team to discuss the surgical treatment plan in conjunction with DICOM images Communication with the patient to discuss the surgical treatment plan in conjunction with DICOM images Education tool for surgical planning. The 3D printed physical model can be used for surgical planning in the following applications: orthopedics and trauma, maxillofacial, and cardiovascular surgery. | diagnostic purposes in the field of orthopedic, maxillofacial and cardiovascular applications. Axial3D Cloud Segmentation Service should be used in conjunction with other diagnostic tools and expert clinical judgment. | cardiovascular applications. Mimics inPrint should be used in conjunction with other diagnostic tools and expert clinical judgement. | | | Method of Use | Used in conjunction with other diagnostic tools and expert clinical judgement. | Used in conjunction with other diagnostic tools and expert clinical judgement. | Used in conjunction with other diagnostic tools and expert clinical judgement. | Equivalent | | Environment | Hospital | Hospital | Hospital | Equivalent | | OTC or Prescription Device | Prescription Use | Prescription Use | Prescription Use | Equivalent | | Attribute | Axial3D Insight (Proposed Device) | Axial3D Cloud Segmentation Service (Predicate Device) | Mimics InPrint (Reference Device) | Comparison | | Level of Concern | Moderate | Moderate | Moderate | Equivalent | | V&V | Complies with FDA Guidance Requirement | Complies with FDA Guidance Requirement | Complies with FDA Guidance Requirement | Equivalent | Table 5-2 – Predicate Device Comparison: Intended Use {7}------------------------------------------------ Image /page/7/Picture/1 description: The image shows the logo for Axial3D. The logo consists of the word "axial" in a dark blue sans-serif font, with a small teal diamond above the "i". To the right of "axial" is the number "3D" in a smaller, lighter font. Below the logo is the tagline "Patient data made real" in a teal sans-serif font. {8}------------------------------------------------ Image /page/8/Picture/0 description: The image shows the logo for Axial3D. The logo consists of the word "axial" in a dark blue sans-serif font, with a small teal diamond above the "i". To the right of "axial" is the superscript "3D". Below the word "axial" is the tagline "Patient data made real" in a teal sans-serif font. {9}------------------------------------------------ Image /page/9/Picture/1 description: The image contains the logo for Axial3D. The logo consists of the word "axial" in a dark blue sans-serif font, with a small teal diamond shape above the "i". To the right of "axial" is the number "3D" in a smaller font size. Below the logo is the tagline "Patient data made real" in a teal sans-serif font. {10}------------------------------------------------ Image /page/10/Picture/1 description: The image shows the logo for Axial3D. The word "axial" is in bold, dark blue font, and the "3D" is in a smaller, lighter blue font. Below the logo, the words "Patient data made real" are written in a light blue font. ### 5.7 Comparison of Technological Characteristics to the Predicate Device and Reference Device | Attribute | Axial3D Insight (Proposed Device) | Axial3D Cloud Segmentation Service (Predicate Device) | Mimics InPrint (Reference Device) | Comparison | |--------------------------------------------------------------------------|-----------------------------------------------------------------------------|-----------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Method of Use | software interface | software interface | software interface | Equivalent | | Computer Platform and Operating System | Microsoft Edge (v104), Safari (v15) or Chrome (v103) or equivalent | Internet Explorer 11 or equivalent | Windows 7 — 64bit Internet Explorer 8 and compatible Intel Core 2 Duo / AMD X2 AM2 or equivalent | The proposed device only requires Microsoft Edge (v104), Safari (v15) or Chrome (v103) or equivalent to operate. Underlying hardware is irrelevant to the user as it is hosted by Axial Medical. The change does not affect establishing | | Attribute | Axial3D Insight (Proposed Device) | Axial3D Cloud Segmentation Service (Predicate Device) | Mimics InPrint (Reference Device) | Comparison | | | | | | substantial equivalence as the output of the proposed device and predicate devices is equivalent. | | Supported Modalities | CT and CTA | CT | CT, MRI, X-ray | The proposed device uses a subset of the predicate device image modalities | | Image registration | Yes | Yes | Yes | Equivalent | | Segmentation Features | A combination of automated tools with smart editing tools | A combination of automated tools with smart editing tools | Combination of automated tools with smart editing tools | Equivalent | | View Manipulation and Volume Rendering | Yes | Yes | Yes | Equivalent | | Regions and Volumes of Interest (ROI) | Orthopedics / Trauma Cardiovascular Cranio- Maxillofacial | Orthopedics / Trauma Cardiovascular Cranio- Maxillofacial | Orthopedics / Trauma Cardiovascular Cranio-Maxillofacial | Equivalent | | Region/volume of interest measurements and size measurements | Yes | Yes | Yes | Equivalent | | Attribute | Axial3D Insight (Proposed Device) | Axial3D Cloud Segmentation Service (Predicate Device) | Mimics InPrint (Reference Device) | Comparison | | Region/Volume Quantification | Yes | Yes | Yes | Equivalent | Table 5-3 – Predicate Comparison: Technology {11}------------------------------------------------ Image /page/11/Picture/1 description: The image shows the logo for Axial3D. The word "axial" is in a bold, dark blue font, with a small teal diamond above the "i". To the right of "axial" is a smaller "3D" in the same dark blue color. Below the logo is the tagline "Patient data made real" in a teal color. {12}------------------------------------------------ Image /page/12/Picture/1 description: The image shows the logo for Axial3D. The word "axial" is in a dark blue color, and the "3D" is in a smaller font and is located to the upper right of the word "axial". Above the "i" in axial is a teal diamond shape. Below the logo is the phrase "Patient data made real" in a teal color. #### 5.8 Performance Data #### 5.8.1 Axial3D Insight Device Validation Axial3D performed software design verification and validation testing on all three software components of the device and the software documentation for a Moderate Level of Concern software in accordance with the FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices May 11, 2015. Axial3D has conducted software verification and validation, in accordance with the FDA quidance, General Principles of Software Validation; Final Guidance for Industry and FDA Staff, issued on January 11, 2002. All software requirements and risk analysis have been successfully verified and traced. In addition to the human factors validation of the Axial3D Insight device. Axial3D conducted two validation studies - the Clinical Segmentation performance and the Intended Use of the device output - the 3D patient specific model. The Clinical Segmentation Performance study was conducted with 3 radiologists reviewing the segmentation of 12 cases across the fields of orthopedics, trauma, maxillofacial and cardiovascular. Axial3D adopted a peer reviewed medical imaging review framework of RADPEER to capture the assessment and feedback from the radiologists involved - all cases were scored within the acceptance criteria of 1 or 2a [1]. The Intended Use validation study of the device was conducted with 9 physicians reviewing 12 cases across the fields of Orthopedics, Trauma, Maxillofacial, and Cardiovascular, as defined in the Intended Use statement of the device. This study concluded successful validation of the 3D models produced by Axial3D demonstrating the device outputs satisfied end user needs and indications for use. #### Axial™- Machine Learning Validation 5.8.2 AxialM- machine learning models are used to generate an initial segmentation of cases, however the output of these models is not used in isolation to produce the final 3D patient specific model. The segmentations produced by the Axial™ machine learning models are used by Axial3D trained {13}------------------------------------------------ Image /page/13/Picture/1 description: The image shows the logo for Axial3D. The word "axial" is in a dark blue color, with a teal diamond above the "i". To the right of "axial" is the number "3D" in a smaller font. Below the logo is the phrase "Patient data made real" in teal. staff who complete the final segmentation and validation of the quality of each 3D patient specific model produced. Axial™- machine learning models were independently verified and validated before inclusion in the Axial3D Insight device. Details of the data used in the validation of each machine learning model is provided below. | | Cardiac CT/CTa | Neuro CT/CTa* | Ortho CT | Trauma CT | |-----------------------------------------|-------------------|------------------|-------------|-------------| | Number of Images Used for Validation | 4,838 | 4,041 | 10,857 | 19,134 | | Slice Spacing Range (Min, Max [mm]) | 0.4 - 0.8 | 0.44 - 1.0 | 0.3 - 2.0 | 0.2 - 2.0 | | Slice Spacing Average [mm] | 0.54 | 0.63 | 0.79 | 0.76 | | Pixel Size Range (Min, Max [mm]) | 0.23 - 0.78 | 0.34 - 0.70 | 0.18 - 0.98 | 0.22 - 0.98 | | Pixel Size Average [mm] | 0.46 | 0.51 | 0.44 | 0.51 | | Table 5-4 – Software Validation Data | | |--------------------------------------|--| |--------------------------------------|--| *NeuroCT/CTa model is used for cardiology cases. The imaging scanner manufacturers and models used within the validation dataset are listed below. Table 5-5 – Imaging scanner manufacturers and models used for the validation datasets | Manufacturer | Model | |--------------------|-------------------------------------------------------------------------------------------------------------------------------| | GE Medical Systems | Lightspeed Pro 16 Lightspeed Pro 32 Revolution CT Optima CT660 Discovery CT750 HD | | Siemens | SOMATOM Definition Flash SOMATOM Definition Edge SOMATOM Definition AS SOMATOM Definition AS+ SOMATOM Perspective | {14}------------------------------------------------ Image /page/14/Picture/1 description: The image shows the logo for Axial3D. The word "axial" is in a dark gray color, and the "3D" is in a smaller font and is located to the upper right of the word "axial". A teal diamond is located above the "i" in "axial". Below the logo is the phrase "Patient data made real" in a teal color. | Manufacturer | Model | |--------------|-------------------------------------------------------------------------------| | | SOMATOM Force Sensation 16 AXIOM-Artis Emotion 16 | | Phillips | IQON Spectral CT iCT 128 iCT 256 Ingenuity Core 128 Brilliance 62 | | Toshiba | Aquillon PRIME Aquillon PRIME SP | The AxialM- machine learning model training data used during the algorithm development was explicitly kept separate and independent from the validation data used. #### 5.9 Conclusions: Based on the indications for use, product performance, and clinical information provided in this notification, the Axial3D Insight is considered substantially equivalent to the marketed predicate device, Axial3D Cloud Segmentation Service. Both the predicate device and the Axial3D Insight have similar DICOM segmentation and 3D model creation. This 510(k) notification contains the technological characteristics and validation and verification to demonstrate the Axial3D Insight does not raise any different questions regarding safety and effectiveness compared to the predicate, Axial3D Cloud Segmentation Service.