(294 days)
Yes
The document explicitly mentions "AxialM- machine learning model training data" and "AxialM- machine learning models" multiple times in the "Description of the training set" and "Description of the test set" sections, as well as in the "Summary of Performance Studies".
No.
The device is used for treatment planning and diagnostic purposes, not for providing therapeutic treatment itself.
Yes
The "Intended Use / Indications for Use" section explicitly states that "The output file or physical replica can be used for diagnostic purposes in the field of orthopedic trauma, orthopedic, maxillofacial, and cardiovascular applications."
Yes
The device is described as a "cloud-based image processing, segmentation and 3D modelling framework" and a "cloud-based service and image segmentation framework". While it facilitates the creation of physical models, the device itself is the software framework and service, not the physical model or the manufacturing equipment.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body (like blood, urine, or tissue) to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Axial3DInsight's Function: Axial3DInsight processes medical images (DICOM files from CT/CTA scans) to create 3D models or output files for purposes like treatment planning, diagnostic purposes (in specific fields), and fabrication of physical replicas. It does not analyze biological samples from the body.
- Intended Use: The intended use clearly states it's for processing imaging information and creating outputs for downstream uses like treatment planning and diagnostic purposes in conjunction with other tools and clinical judgment. It's a tool that aids in the interpretation and utilization of existing imaging data, not a diagnostic test performed on a biological sample.
While the device is used for "diagnostic purposes" in certain fields, this refers to its role in assisting clinicians in making diagnoses based on the processed imaging data, not as a standalone in vitro diagnostic test.
No
The letter makes no mention of a Predetermined Change Control Plan (PCCP), let alone explicit language stating that the FDA has reviewed and approved or cleared such a plan for this device.
Intended Use / Indications for 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.
Product codes
OIH
Device Description
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.
Mentions image processing
Yes
Mentions AI, DNN, or ML
AxialTM- 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 AxialTM machine learning models are used by Axial3D trained staff who complete the final segmentation and validation of the quality of each 3D patient specific model produced.
AxialTM- machine learning models were independently verified and validated before inclusion in the Axial3D Insight device.
Input Imaging Modality
CT and CTA
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Hospital
Description of the training set, sample size, data source, and annotation protocol
The AxialTM- machine learning model training data used during the algorithm development was explicitly kept separate and independent from the validation data used.
Description of the test set, sample size, data source, and annotation protocol
AxialTM- 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 |
*NeuroCT/CTa model is used for cardiology cases.
The imaging scanner manufacturers and models used within the validation dataset are listed below.
| 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, 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 |
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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).
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)
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| □ Over-The-Counter Use (21 CFR 801 Subpart C) |
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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
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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.
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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
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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.
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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
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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
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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 |
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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.