(116 days)
Yes
The device description explicitly states that VEA Align "generates an initial placement of the patient anatomic landmarks on the images using a machine learning-based algorithm." The document also includes detailed descriptions of the training and test sets used for this algorithm.
No.
The device is described as a software tool for analysis and planning, not for direct treatment or therapy.
Yes
VEA Align is described as a "tool to aid in the analysis of spinal deformities and degenerative diseases, and lower limb alignment disorders and deformities through precise and length measurements," which indicates its use in the diagnostic process. spineEOS is for "preoperative planning of spine surgeries," which also requires an understanding of the patient's condition, hence fitting a diagnostic role.
Yes
The device is described as "cloud-based software" and "software indicated for assisting healthcare professionals". While it uses inputs from specific hardware (EOS imaging systems), the device itself is the software that processes these inputs and provides analysis and planning tools. There is no indication that the device includes any hardware components beyond the computing infrastructure required to run the software.
Based on the provided information, no, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information about a person's health.
- Device Function: The description clearly states that VEA Align and spineEOS are software intended for analyzing medical images (2D X-ray images) and assisting with surgical planning. They do not analyze biological specimens.
- Intended Use: The intended use is focused on orthopedic applications, assessing global alignment, analyzing spinal deformities and lower limb disorders, and assisting with preoperative spine surgery planning. This is entirely based on image analysis and clinical assessment, not laboratory testing of biological samples.
Therefore, while these devices are medical devices used in healthcare, they fall under a different regulatory category than In Vitro Diagnostics.
No
The letter does not state that the FDA has reviewed and approved or cleared a Predetermined Change Control Plan (PCCP) for this specific device.
Intended Use / Indications for Use
VEA Align: This cloud-based software is intended for orthopedic applications in both pediatric and adult populations. 2D X-ray images acquired in EOS imaging's imaging systems is the foundation and resource to display the interactive landmarks overlayed on the frontal and lateral images. These landmarks are available for users to assess patient-specific global alignment. For additional assessment, alignment parameters compared to published normative values may be available. This product serves as a tool to aid in the analysis of spinal deformities and degenerative diseases, and lower limb alignment disorders and deformities through precise and length measurements. It is suitable for use with adult and pediatric patients aged 7 years and older. Clinical judgment and experience are required to properly use the software.
spineEOS: spineEOS is indicated for assisting healthcare professionals with preoperative planning of spine surgeries. The product provides access to EOS images with associated 3D datasets and measurements. spineEOS includes surgical planning tools that enable users to define a patient specific surgical strategy.
Product codes
QIH, LLZ
Device Description
VEA Align: VEA Align is a software indicated for assisting healthcare professionals with global alignment assessment through clinical parameters computation. The product uses biplanar 2D X-ray images, exclusively generated by EOS imaging's EOS (K152788) and EOSedge (K202394) systems and generates an initial placement of the patient anatomic landmarks on the images using a machine learning-based algorithm. The user may adjust the landmarks to align with the patient's anatomy. Landmark locations require user validation. The clinical parameters communicated to the user are inferred from the landmarks and are recalculated as the user adjusts the landmarks. 3D datasets may be exported for use in spineEOS for surgical planning. The product is hosted on a cloud infrastructure and relies on VEA Portal for support capabilities, such as user access control and data access. 2D X-ray image transmissions from healthcare institutions to the cloud are managed by VEA Portal is a Class | 510(k)-exempt device (LMD).
spineEOS: spineEOS is a software indicated for assisting healthcare professionals with preoperative planning of spine surgeries. EOS images (generated from EOS imaging's acquisition system) and associated 3D datasets are used as inputs of the software. The product manages clinical measurements and allows user to access surgical planning tools to define a patient specific surgical strategy. The product is indicated for adolescent and adult patients.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Yes
Input Imaging Modality
2D X-ray images
Anatomical Site
Spine, Lower Limbs
Indicated Patient Age Range
VEA Align: pediatric and adult patients aged 7 years and older.
spineEOS: adolescent and adult patients.
Intended User / Care Setting
VEA Align: VEA Align Alignment Assessment mode is designed for surgeons and clinical staff, such as physician assistants, who have been trained to use the application. VEA Align 3D mode is designed for 3D Services team members.
spineEOS: The surgical planning application can only be used by a trained user including: Spine surgeons to define and validate the surgical plan. EOS staff and implant distributors to define and save the optional pre-planning.
Description of the training set, sample size, data source, and annotation protocol
The AI algorithm was trained using 10,376 X-ray images and a total of 5,188 corresponding 3D reconstructions. This training data set contained images which were collected from EOS (K152788) and EOSedge (K202394) systems at a variety of sites from 2007-2023. This population characteristics cover the intended use population. The data set ensures a variety of data for the different clinical metrics: scoliosis, postural balance, degenerative disease and spine surgery implant (preoperative and postoperative). The images were also acquired using different radiation exposure parameters and with different fields of view.
Description of the test set, sample size, data source, and annotation protocol
The testing data set consisted of 538 patients and the demographic characteristics cover the intended use population. The data set includes images from EOS (K152788) and EOSedge (K202394) systems.
For each patient of this data set, a ground truth EOS 3D Services reconstruction (model) from sterEOS Workstation (K172346) that was available for comparison with the VEA Align reconstruction generated by the AI algorithm.
Test data was divided according to the subgroups listed below. The subgroups are intended to demonstrate the generalizability of the algorithm.
- Demographics: Age, Gender
- Clinical Metrics: Without spinal conditions, Spinal Deformity (Scoliosis severity, Postural balance severity), Degenerative Disease, Spine Surgery Implant (preoperative and postoperative)
- Image Acquisition: Equipment model, Radiation exposure parameters, Field of view
- Data Site Location: US vs. OUS, Different US states
A randomized sampling was used for each category to include an equal number of cases within each subgroup.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Nonclinical performance testing was performed. Activities covered design input review, unit testing, software integration, and system integration. Verification performance testing was conducted to assess the standalone performance of the AI algorithm of VEA Align. The test used a dedicated test data set different from the training data set, with no leakage. Ground truth EOS 3D Services reconstructions from sterEOS Workstation (K172346) were used for comparison. A global acceptance criterion was used to assess the performance, and subgroup analyses were performed for bias and generalizability.
Key results:
- For spinal landmark accuracy, the metric computed was the Euclidean distance.
- For spinal mesh accuracy, the metric computed was point to surface distance.
- Acceptance criteria for both landmark and mesh accuracy errors were: Median error ≤ 3 mm and 3rd Quartile ≤ 5 mm.
- Direct comparison between skeletal landmark locations between the subject device and predicate VEA Align (K231917) met acceptance criteria for algorithm performance.
- Direct comparison between additional spinal landmarks location between the subject device and predicate sterEOS Workstation (K172346) met acceptance criteria for algorithm performance.
- Direct comparison between the 3D thoraco-lumbar mesh from subject device and the 3D thoraco-lumbar mesh from the predicate sterEOS Workstation (K172346) met the acceptance criteria demonstrating substantial equivalence of the subject device.
- All tests were performed over the whole population and for each sub-group mentioned to prove generalizability.
- All studies performed indicate acceptable performances of the algorithm for its intended population.
- Validation activities covered multifunctional requirements, usability testing, and reproducibility and accuracy of clinical parameter outputs.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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).
0
June 25, 2024
Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
EOS imaging Moran Celestin Design Quality and Regulatory Affairs Specialist 10 rue Mercoeur Paris, 75011 France
Re: K240582
Trade/Device Name: VEA Align; spineEOS Regulation Number: 21 CFR 892.2050 Regulation Name: Medical Image Management And Processing System Regulatory Class: Class II Product Code: QIH, LLZ Dated: May 17, 2024 Received: May 17, 2024
Dear Moran Celestin:
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" (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).
1
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 of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-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,
Samul for
Jessica Lamb, Ph.D. 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
2
Indications for Use
510(k) Number (if known) K240582
Device Name VEA Align spineEOS
Indications for Use (Describe) VEA Align:
This cloud-based software is intended for orthopedic applications in both pediative and adult populations.
2D X-ray images acquired in EOS imaging's imaging systems is the foundation and resource to display the interactive landmarks overlayed on the frontal and lateral mages. These landmarks are available for users to assess patient-specific global alignment.
For additional assessment, alignment parameters compared to published normative values may be available.
This product serves as a tool to aid in the analysis of spinal deformities and degenerative diseases, and lower limb alignment disorders and deformities through precise and length measurements. It is suitable for use with adult and pediatric patients aged 7 years and older.
Clinical judgment and experience are required to properly use the software.
spineEOS:
spineEOS is indicated for assisting healthcare professionals with preoperative planning of spine surgeries. The product provides access to EOS images with associated 3D datasets and measurements. spineEOS includes surgical planning tools that enable users to define a patient specific surgical strategy.
| 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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3
Image /page/3/Picture/0 description: The image shows the logo for EOS imaging, an adec company. The logo is orange and features the letters "EOS" stacked on top of the word "imaging". Below "imaging" is the text "AN adec COMPANY" in a smaller font size. The logo is simple and modern, with a focus on the company's name.
510(k) Summary / K240582
4
Image /page/4/Picture/0 description: The image shows the logo for EOS imaging, an aTec company. The logo is orange and features the letters "EOS" stacked on top of the word "imaging". Below "imaging" is the phrase "AN aTec COMPANY" in a smaller font. The "O" in "EOS" is shaped like a diamond.
This 510(k) summary of safety and effectiveness is being submitted in accordance with the requirements of 21 CFR 807.92.
1 SUBMITTER
EOS imaging 10 rue Mercoeur Paris, France 75011 Phone: +33 1 55 25 60 60 Fax: +33 1 55 25 60 61
| Contact Person: | Moran CELESTIN
Design Quality and Regulatory Affairs Specialist
EOS imaging |
|-----------------|-----------------------------------------------------------------------------------|
| Contact Phone: | +33 1 55 25 60 60 |
Date Summary Prepared: June 24, 2024
DEVICES 2
2.1 VEA Align
| Trade Name: | VEA Align |
|---|---|
| Common or Usual Name: | Cloud-based software |
| Classification Name: | Automated Radiological Image Processing Software |
| (21 C.F.R. § 892.2050) | |
| Regulatory Class: | Class II |
| Product Code: | QIH |
2.2 spineEOS
| Trade Name: | spineEOS |
|---|---|
| Common or Usual Name: | Cloud-based software |
| Classification Name: | System, image processing, radiological |
| (21 C.F.R. § 892.2050) | |
| Regulatory Class: | Class II |
| Product Code: | LLZ |
LEGALLY MARKETED PREDICATE DEVICES 3
3.1 VEA Align
| 510(k) | Product Name | Clearance Date |
|---|---|---|
| K231917 | VEA Align (primary predicate) | January 2024 |
| K172346 | sterEOS (secondary predicate) | June 2018 |
5
Image /page/5/Picture/0 description: The image shows the logo for EOS imaging. The logo is orange and consists of the letters "EOS" stacked on top of the word "imaging". Below "imaging" is the phrase "AN atec COMPANY" in a smaller font. The logo is simple and modern.
3.2 spineEOS
| 510(k) | Product Name | Clearance Date |
|---|---|---|
| K232086 | spineEOS | October 2023 |
4 DEVICE DESCRIPTION
4.1 VEA Align
VEA Align is a software indicated for assisting healthcare professionals with global alignment assessment through clinical parameters computation.
The product uses biplanar 2D X-ray images, exclusively generated by EOS imaging's EOS (K152788) and EOSedge (K202394) systems and generates an initial placement of the patient anatomic landmarks on the images using a machine learning-based algorithm. The user may adjust the landmarks to align with the patient's anatomy. Landmark locations require user validation. The clinical parameters communicated to the user are inferred from the landmarks and are recalculated as the user adjusts the landmarks. 3D datasets may be exported for use in spineEOS for surgical planning.
The product is hosted on a cloud infrastructure and relies on VEA Portal for support capabilities, such as user access control and data access. 2D X-ray image transmissions from healthcare institutions to the cloud are managed by VEA Portal is a Class | 510(k)-exempt device (LMD).
4.2 spineEOS
spineEOS is a software indicated for assisting healthcare professionals with preoperative planning of spine surgeries. EOS images (generated from EOS imaging's acquisition system) and associated 3D datasets are used as inputs of the software. The product manages clinical measurements and allows user to access surgical planning tools to define a patient specific surgical strategy. The product is indicated for adolescent and adult patients.
5 INDICATIONS FOR USE
5.1 VEA Align
This cloud-based software is intended for orthopedic applications in both pediatric and adult populations.
2D X-ray images acquired in EOS imaging's imaging systems is the foundation and resource to display the interactive landmarks overlayed on the frontal and lateral images. These landmarks are available for users to assess patient-specific global alignment.
For additional assessment, alignment parameters compared to published normative values may be available.
6
Image /page/6/Picture/0 description: The image shows the logo for EOS imaging, an adec company. The logo is orange and features the letters "EOS" stacked on top of the word "imaging". Below "imaging" is the text "AN adec COMPANY" in a smaller font. The logo is simple and modern, with a focus on the company's name.
This product serves as a tool to aid in the analysis of spinal deformities, degenerative diseases, and lower limb alignment disorders and deformities through precise angle and length measurements. It is suitable for use with adult and pediatric patients aged 7 years and older.
Clinical judgment and experience are required to properly use the software.
5.2 spineEOS
spineEOS is indicated for assisting healthcare professionals with preoperative planning of spine surgeries. The product provides access to EOS images with associated 3D datasets and measurements. spineEOS includes surgical planning tools that enable users to define a patient specific surgical strategy.
6 TECHNOLOGICAL COMPARISON TO PREDICATES
The subject devices were compared to their respective predicate devices in intended use, indications for use, design, function and technology and it was demonstrated that they are substantially equivalent. Any technological differences within this bundled 510(k), between the subject devices and the predicate devices, do not impact substantial equivalence, or safety and effectiveness.
7
Image /page/7/Picture/0 description: The image shows the logo for EOS imaging, an adtec company. The logo is orange and features the word "EOS" in a stylized font, with the "O" shaped like a diamond. Below "EOS" is the word "imaging" in a smaller, sans-serif font. Underneath "imaging" is the text "AN adtec COMPANY" in an even smaller font.
| Characteristic | Primary Predicate
VEA Align (K231917) | Secondary Predicate
sterEOS (K172346) | Subject VEA Align | Substantially
Equivalent? |
|---------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indication for Use | This cloud-based software is
intended for orthopedic
applications in both pediatric
and adult populations.
2D X-ray images acquired in
EOS imaging's imaging systems
is the foundation and resource
to display the interactive
landmarks overlayed on the
frontal and lateral images.
These landmarks are available
for users to assess patient-
specific global alignment.
For additional assessment,
alignment parameters compared
to published normative values
may be available.
This product serves as a tool to
aid in the analysis of spinal
deformities, degenerative
diseases, lower limb alignment
disorders, and deformities
through precise angle and
length measurements. It is
suitable for use with adult and
pediatric patients aged 7 years
and older. | The sterEOS Workstation is
intended for use in the fields of
musculoskeletal radiology and
orthopedics in both pediatric and
adult populations as a general
device for acceptance, transfer,
display, storage, and digital
processing of 2D X-ray images
of the musculoskeletal system
including interactive 2D
measurement tools.
When using 2D X-ray images
obtained with the EOS imaging
EOS system, sterEOS
Workstation provides interactive
3D measurement tools:
• To aid in the analysis of
scoliosis and related disorders
and deformities of the spine in
adult patients as well as
pediatric patients. The 3D
measurement tools include
interactive analysis based
either on identification of
anatomical landmarks for
postural assessment, or on a
model of bone structures
derived from an a priori image
data set from 175 patients (91
normal patients, 47 patients | This cloud-based software is
intended for orthopedic
applications in both pediatric
and adult populations.
2D X-ray images acquired in
EOS imaging's imaging systems
is the foundation and resource
to display the interactive
landmarks overlayed on the
frontal and lateral images.
These landmarks are available
for users to assess patient-
specific global alignment.
For additional assessment,
alignment parameters compared
to published normative values
may be available.
This product serves as a tool to
aid in the analysis of spinal
deformities and degenerative
diseases, and lower limb
alignment disorders and
deformities through precise
angle and length
measurements. It is suitable for
use with adult and pediatric
patients aged 7 years and older. | YES
Same as VEA Align. |
| Characteristic | Primary Predicate
VEA Align (K231917) | Secondary Predicate
sterEOS (K172346) | Subject VEA Align | Substantially
Equivalent? |
| | Clinical judgment and
experience are required to
properly use the software. | with moderate idiopathic
scoliosis and 37 patients with
severe idiopathic scoliosis),
and dry isolated vertebrae
data for spine modeling. The
model of bone structures is
not intended for use to assess
individual vertebral
abnormalities and is indicated
only for patients 7 years and
older. For postural
assessment, a set of
comparative tools is provided
allowing the comparison of
performed measurements to
reference values for patients
over 18 years old. | Clinical judgment and
experience are required to
properly use the software. | |
| | | • To aid in the analysis of lower
limbs alignment and related
disorders and deformities
based on angle and length
measurements. The 3D
measurement tools include
interactive analysis based
either on identification of lower
limb alignment landmarks or
as for the spine, on a model of
bone structures derived from
an a priori image data set.
The model of bone structures
is not intended for use to
assess individual bone | | |
| Characteristic | Primary Predicate
VEA Align (K231917) | Secondary Predicate
sterEOS (K172346) | Subject VEA Align | Substantially
Equivalent? |
| | | abnormalities. The 3D package including model-based measurements and torsion angles is indicated only for patients 15 years or older. Only the 2D/3D ruler is indicated for measurements in patients younger than 15 years old. | | |
| Contraindications | VEA Align is contraindicated for cases with vertebrae with severe congenital deformities (e.g., hemivertebrae, spina bifida, etc.) and supernumerary/missing vertebrae. | The 3D spine modeling software does not allow modeling of vertebrae with severe congenital deformities (e.g. hemivertebrae, spina bifida, etc.). The modeling of a spine that has a vertebrae with a congenital deformity may be generated leaving out the vertebrae with the congenital deformity.
The 3D models delivered by the sterEOS software can only be used for diagnostic purposes with the corresponding 2D images. They are designed to display the spatial relationship between anatomical structures and are unable to highlight local bone alterations such as:
• bones with significant changes in geometry following surgical intervention. | VEA Align is contraindicated for cases with vertebrae with severe congenital deformities (e.g., hemivertebrae, spina bifida, etc.) and supernumerary/missing vertebrae. | YES
Same as VEA Align. |
| Characteristic | Primary Predicate
VEA Align (K231917) | Secondary Predicate
sterEOS (K172346) | Subject VEA Align | Substantially
Equivalent? |
| | | fractures, osteophytes, fibrocartilage calluses. The lower limb 3D model is
based on an adult type and, as a
result, is not suited to pediatric
lower limb 3D reconstruction.
3D modeling can become
inaccurate and even impossible
when anatomical structures
cannot be identified as such in
the following cases: prostheses or instruments
masking or replacing
anatomical markers, certain pathological conditions
that alter the bone
composition, such as
osteoporosis, impossibility to differentiate
the internal condyle from the
external condyle or the
internal tibial plate from the
external tibial plate. | | |
| Regulatory
Class/Code | Class II
QIH
(21 CFR 892.2050) | Class II
LLZ
(21 CFR 892.2050) | Class II
QIH
(21 CFR 892.2050) | YES |
| Characteristic | Primary Predicate
VEA Align (K231917) | Secondary Predicate
sterEOS (K172346) | Subject VEA Align | Substantially
Equivalent? |
| Device Classification
Name | Automated Radiological Image
Processing Software | System, Image Processing,
Radiological | Automated Radiological Image
Processing Software | YES,
Same as VEA Align. |
| Operating System | Windows + MAC | Windows | Windows + MAC | YES |
| User Population | VEA Align is designed for
surgeons and clinical staff, such
as physician assistants, who
have been trained to use the
application. | Clinicians (radiologists,
orthopedists, radiographers), 3D
Services persons, which have
been trained to use the
application. | VEA Align Alignment
Assessment mode is designed
for surgeons and clinical staff,
such as physician assistants,
who have been trained to use
the application.
VEA Align 3D mode is designed
for 3D Services team members. | YES
Alignment Assessment
mode is equivalent to
predicate VEA Align and
3D Mode is equivalent to
predicate sterEOS (3D
Services users). |
| Target Population | The device is indicated only for
patients 7 years and older. | 3D measurement tools are used
on adult and pediatric patients
over 7 years of age who suffer
from scoliosis and deformed
spine pathology and for patients
over 15 years of age with
deformed lower limb pathology. | The device is indicated only for
patients 7 years and older. | YES
Same as VEA Align. |
| Software
Functionalities /
Modalities | Global alignment assessments
Includes landmarks associated
with vertebral endplates needed
to calculate coronal and sagittal
clinical parameters. These
landmarks are adjustable by the
user.
Includes landmarks associated
with the pelvis and lower limbs
needed to calculate coronal and
sagittal clinical parameters. | Global alignment assessments
Includes landmarks associated
with vertebral endplates needed
to calculate coronal and sagittal
clinical parameters. These
landmarks are adjustable by the
user.
Includes landmarks associated
with the pelvis and lower limbs
needed to calculate coronal and
sagittal clinical parameters. | Global alignment assessments
Includes landmarks associated
with vertebral endplates needed
to calculate coronal and sagittal
clinical parameters. These
landmarks are adjustable by the
user.
Includes landmarks associated
with the pelvis and lower limbs
needed to calculate coronal and
sagittal clinical parameters. | YES
YES
YES |
| Characteristic | Primary Predicate
VEA Align (K231917) | Secondary Predicate
sterEOS (K172346) | Subject VEA Align | Substantially
Equivalent? |
| | These landmarks are adjustable
by the user. | These landmarks are adjustable
by the user. | These landmarks are adjustable
by the user. | |
| | Provides normative values used
to assess patients' global
alignment | Provides normative values used
to assess patients' global
alignment | Provides normative values used
to assess patients' global
alignment | YES |
| | Provides color-coded clinical
parameters to display variance
from the defined normative
values | Provides color-coded clinical
parameters to display variance
from the defined normative
values | Provides color-coded clinical
parameters to display variance
from the defined normative
values | YES |
| Image Manipulation
Functions | 2D images display and basic
manipulation (zoom, panning) | 2D images display and basic
manipulation (zoom, panning,
distance, and angles
measurements) | 2D images display and basic
manipulation (zoom, panning) | YES
Same as VEA Align. |
| Measurement
Functions | Distances and Angles | Distances and Angles | Distances and Angles | YES |
| Algorithms | Patient-specific clinical
parameters and calculations
based on published literature. | Patient-specific clinical
parameters and calculations
based on published literature. | Patient-specific clinical
parameters and calculations
based on published literature. | YES |
| 3D Reconstruction
Model | Alignment mode: The 3D model
supports the initial placement of
the patient anatomic landmarks
on the images using a machine
learning-based algorithm. It is
not displayed to the user and as
such it is not part of the device
outputs. | The 3D model is deformed
manually by the user through
control points up to matching
accurately the X-ray contours. | Alignment mode: The 3D model
supports the initial placement of
the patient anatomic landmarks
on the images using a machine
learning-based algorithm. It is
not displayed to the user and as
such it is not part of the mode
outputs.
3D mode: The 3D reconstruction
model is initialized by an Al
algorithm and then deformed
manually by the user through
control points up to matching | YES
Alignment Assessment
mode is equivalent to
predicate VEA Align. In
the 3D mode, the 3D
reconstruction model is
an output of the device
as for the secondary
predicate, sterEOS. The
difference between the
secondary predicate
sterEOS and the subject |
| Characteristic | Primary Predicate
VEA Align (K231917) | Secondary Predicate
sterEOS (K172346) | Subject VEA Align | Substantially
Equivalent? |
| | | | accurately the X-ray contours.
The 3D reconstruction model is
an output of the 3D mode. | VEA Align is the
automatic initialization
using an AI algorithm for
VEA Align 3D model
reconstruction
generation. This
difference allows the user
to gain time
duringmanual
adjustment. This
difference does not
prevent VEA Align from
achieving its intended
purpose and does not
create a new risk in VEA
Align. Therefore, this
difference does not affect
device safety or
effectiveness. |
| User Interface | Computer | Computer | Computer | YES |
| Obtaining an image | Transferred from other devices | Transferred from other devices | Transferred from other devices | YES |
| Software
Environment | Cloud-based software | Standalone | Cloud-based software | YES Same as VEA Align. |
| Human Intervention
for interpretation and
manipulation of
images | Required | Required | Required | YES |
| Control of life-saving
devices | None | None | None | YES |
Table 1: Summary of Predicate and Subject VEA Align Device Characteristics to Demonstrate Substantial Equivalence
8
Image /page/8/Picture/0 description: The image shows the logo for EOS imaging, an adtec company. The logo is orange and features the letters "EOS" stacked on top of the word "imaging". Below "imaging" is the text "AN adtec COMPANY" in a smaller font. The logo is simple and modern, with rounded corners and a clean design.
9
Image /page/9/Picture/0 description: The image contains the logo for EOS imaging, which is an orange color. The logo consists of the letters "EOS" in a stylized font, with the "O" shaped like a diamond. Below the word "EOS" is the word "imaging" in a smaller font. Underneath "imaging" is the text "AN aztec COMPANY" in a very small font.
10
Image /page/10/Picture/0 description: The image shows the logo for EOS imaging, an adec company. The logo features the letters "EOS" in a stylized, sans-serif font, stacked on top of the word "imaging" in a smaller, lowercase font. Below "imaging" is the text "AN adec COMPANY" in an even smaller font. The color of the logo is a muted orange.
11
Image /page/11/Picture/0 description: The image contains the logo for EOS imaging, which is an orange color. The logo consists of the letters "EOS" in a stylized font, with the "O" shaped like a diamond. Below the word "EOS" is the word "imaging" in a smaller font. Underneath "imaging" is the text "AN aztec COMPANY" in a very small font.
12
Image /page/12/Picture/0 description: The image shows the logo for EOS imaging, which is an "atec COMPANY". The logo is orange and features the letters "EOS" stacked on top of the word "imaging". Below the word "imaging" is the text "AN atec COMPANY" in a smaller font size. The logo is simple and modern, and the orange color is eye-catching.
13
Image /page/13/Picture/0 description: The image contains the logo for EOS imaging. The logo consists of the letters "EOS" in a stylized, sans-serif font, with the "O" resembling a diamond shape. Below the letters, the word "imaging" is written in a smaller, sans-serif font. Underneath "imaging" is the text "AN atec COMPANY" in a smaller font size. The logo is orange.
14
Image /page/14/Picture/0 description: The image shows the logo for EOS imaging, an adtec company. The logo is in orange and features the letters "EOS" in a stylized font, with the "O" shaped like a diamond. Below the letters, the word "imaging" is written in a smaller, sans-serif font. Underneath "imaging", the text "AN adtec COMPANY" is written in an even smaller font.
| Characteristic | Predicate Device
spineEOS (K232086) | Subject Device
spineEOS | Substantially Equivalent? |
|---------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use | spineEOS software is indicated for assisting
healthcare professionals with preoperative
planning of spine surgeries. spineEOS provides
access to EOS images with associated 3D
datasets and measurements. spineEOS
includes surgical planning tools that enable
users to define a patient specific surgical
strategy. | spineEOS is indicated for assisting healthcare
professionals with preoperative planning of
spine surgeries. The product provides access to
EOS images with associated 3D datasets and
measurements. spineEOS includes surgical
planning tools that enable users to define a
patient specific surgical strategy. | YES
Despite different wording, the
objective and intent of both devices
are the same. |
| Contraindications | spineEOS is not intended to be used in the
following cases:
Patients under the age of 7.
Patients with vertebrae with congenital
deformities (e.g., hemivertebrae, spina bifida,
etc.).
The 3D models delivered by sterEOS can only
be used for diagnostic purposes in association
with the corresponding 2D images. They are
intended for the visualization of the spatial
relationship between anatomical structures and
do not allow the identification of local bone
alterations such as:
Bones with a significant change in geometry
following surgery,
Fractures,
Osteophytes
Fibrocartilage calluses | The surgical planning application is
contraindicated for cases with vertebrae with
severe congenital deformities (e.g.,
hemivertebrae, spina bifida, etc.) and
supernumerary/missing vertebrae. | YES
The product's contraindications
come from the device providing the
input data. |
| Regulatory
Class/Code | Class II
LLZ
(21 CFR 892.2050) | Class II
LLZ
(21 CFR 892.2050) | YES |
| Characteristic | Predicate Device
spineEOS (K232086) | Subject Device
spineEOS | Substantially Equivalent? |
| Device
Classification
Name | System, image processing, radiological | System, image processing, radiological | YES |
| User Population | spineEOS can only be used by a trained user
including:
Spine surgeons to define and validate the
surgical plan.
EOS staff and implant distributors to define and
save the optional pre-planning. | The surgical planning application can only be
used by a trained user including:
Spine surgeons to define and validate the
surgical plan.
EOS staff and implant distributors to define and
save the optional pre-planning. | YES |
| Target Population | The device is recommended in the preoperative
planning of primary and revision spine surgeries
for:
Degenerative spine and adult spinal deformity.
Adolescent Idiopathic Scoliosis (AIS) patients. | The product is recommended in the
preoperative planning of primary and revision
spine surgeries for:
Degenerative spine and adult spinal deformity.
Adolescent Idiopathic Scoliosis (AIS) patients. | YES |
| Hardware and
Software
Requirement | Web Browsers:
With Windows 10 or 11: Google Chrome in
version 111 or higher, and Edge in version
111 or higher.
With Mac OS Monterey or Ventura: Google
Chrome in version 111 or higher, and Safari
in version 16.2 or higher.
PC Configuration:
A stable high speed internet connection is
required: DSL 100Mb/s connection or higher,
Wi-Fi or Ethernet.
Screen Resolution:
The minimum screen resolution ensuring full
display of the interface is 1600 x 900. | Web Browsers:
With Windows 10 or 11: Google Chrome in
version 121 or higher, and Edge in version
121 or higher.
With Mac OS Monterey or Ventura: Google
Chrome in version 121 or higher.
PC Configuration:
A stable high speed internet connection is
required: DSL 100Mb/s connection or higher,
Wi-Fi or Ethernet.
Screen Resolution:
The minimum screen resolution ensuring full
display of the interface is 1366 x 768. | YES
Safari has been removed for
the subject device |
| Input Data | Patient's information
X-rays images
3D landmarks of the spine generated from VEA
Align | Patient's information
X-rays images
3D landmarks of the spine generated from VEA
Align | YES |
| Product Workflow | Model Validation: allow users to validate or
reject the 3D landmarks. | 3D spine reconstruction confirmation: allow
users to accept the 3D spine representation and
associated landmarks, or reject the 3D spine | YES.
The name of the "Model
Validation" step has been
changed in the subject |
| Characteristic | Predicate Device
spineEOS (K232086) | Subject Device
spineEOS | Substantially Equivalent? |
| | Preoperative: allow user to consult the
preoperative state of the patient
Planning: allow user to define patient specific
surgical strategy
Rod: allow user to define the design of rods | representation and associated landmarks and
provide feedback on corrective adjustments.
Preoperative: allow user to consult the
preoperative state of the patient
Planning: allow user to define patient specific
surgical strategy
Rod: allow user to define the design of rods | spineEOS to conform with the
type of input data |
| Tools Available for
Planning | Segmental Alignment
Interbody Implant
Osteotomy
Spondylolisthesis
Rod Curvature Management | Segmental Alignment
Interbody Implant
Osteotomy
Spondylolisthesis
Rod Curvature Management | YES |
| Software
Functionalities /
Modalities | Obtains an image and 3D model transferred
from other devices
Provides normative values used to follow the
impact of the planning on the patient
alignment
Provides color-coded clinical parameters to
display variance from the defined normative | Obtains an image and 3D model transferred
from other devices
Provides normative values used to follow the
impact of the planning on the patient
alignment
Provides color-coded clinical parameters to
display variance from the defined normative | YES
YES
YES |
| | values
Requires human intervention for
interpretation and manipulation of images | values
Requires human intervention for
interpretation and manipulation of images | YES |
| Image Manipulation
Functions | 2D images and 3D model display and basic
manipulation (zoom, panning, and angles
measurements, plumbline, and possibility to
add comments on the image) | 2D images and 3D spine display and basic
manipulation (zoom, panning, angles
measurements, plumbline, and possibility to
add comments on the image) | YES
The wording referring to the
representation of the spine in 3D
differs from the predicate to more
precisely describe the spine
representation. However, it
remains the same between the
predicate and the subject
spineEOS. |
| Measurement
Functions | Distances and Angles | Distances and Angles | YES. |
| User Interface | Computer | Computer | YES |
| Characteristic | Predicate Device
spineEOS (K232086) | Subject Device
spineEOS | Substantially Equivalent? |
| Software
Environment | Cloud-based software | Cloud-based software | YES |
| Clinical Parameters
Computation | Pelvic Tilt (PT)
Sacral Slope (SS)
Pelvic Incidence (PI)
Pelvic Obliquity (PO)
Pelvic Axial Rotation
Sagittal Vertical Axis (SVA)
C7-CSL
PI-LL
T1 Pelvic Angle (TPA)
Cobb Angle
Kyphosis/Lordosis Angle
Knee Flexion/Extension Angle
Lordosis Percentage Distributions
Spondylolisthesis grade (i.e., Slippage percentage) | Pelvic Tilt (PT)
Sacral Slope (SS)
Pelvic Incidence (PI)
Pelvic Obliquity (PO)
Sagittal Vertical Axis (SVA)
C7-CSL
PI-LL
T1 Pelvic Angle (TPA)
Cobb Angle
Kyphosis/Lordosis Angle
Knee Flexion/Extension Angle
Lordosis Percentage Distributions
Spondylolisthesis grade (i.e., Slippage percentage) | YES
Pelvic Axial Rotation has been
removed from the subject device.
Cotyle Axis allows determination of
the patient frame in which clinical
parameters are computed. Pelvic
Axial Rotation is computed based
on Cotyle Axis. So, in the patient
frame the value is always 0 for this
parameter. |
| Control of Life-
Saving Devices | None | None | YES |
Table 2: Summary of Predicate and Subject spineEOS Device Characteristics to Demonstrate Substantial Equivalence
15
Image /page/15/Picture/0 description: The image shows the logo for EOS imaging, an adtec company. The logo is orange and features the letters "EOS" stacked on top of the word "imaging". Below "imaging" is the text "AN adtec COMPANY" in a smaller font. The logo is simple and modern, with rounded corners and a clean design.
16
Image /page/16/Picture/0 description: The image shows the logo for EOS imaging, an adtec company. The logo is primarily orange. The letters "EOS" are in a stylized, sans-serif font, stacked above the word "imaging" in a smaller, sans-serif font. Below "imaging" are the words "AN adtec COMPANY" in a very small, sans-serif font.
17
Image /page/17/Picture/0 description: The image shows the logo for EOS imaging, an adec company. The logo is in orange and consists of the letters "EOS" stacked on top of the word "imaging". Below "imaging" is the phrase "AN adec COMPANY" in smaller font. The logo is simple and modern, with a focus on the company's name and affiliation.
18
Image /page/18/Picture/0 description: The image contains the logo for EOS imaging, an aztec company. The logo features the letters "EOS" stacked on top of the word "imaging". Below "imaging" is the text "AN aztec COMPANY". The letters "EOS" are in a bold, sans-serif font and are a bright orange color.
7 PERFORMANCE DATA
Nonclinical performance testing performed on the subject devices. VEA Align and spineEOS, supports substantial equivalence to their respective predicate devices. The following V&V testing was performed on both subject devices:
- A. Verifications activities cover the following:
- Design input review
- . Unit testing
- Software integration
- System integration ●
B. Verification performance test:
To assess the standalone performance of the Al algorithm of the VEA Align, the test was performed with:
- . A dedicated test data set containing different data from the training data set. Specifically, the test data set was not a sampling of the training data set, has never been used for the algorithm training or for tunning the algorithm and leakage between training and test data sets did not occur.
- . For each patient of this data set, a ground truth EOS 3DServices reconstruction (model) from sterEOS Workstation (K172346)that was available for comparison with the VEA Align reconstruction generated by the Al algorithm.
- A global acceptance criterion to assess the performance of the Al algorithm . predictions regarding the ground truth.
- . Subgroup analyses to assess bias and generalizability.
Training data information
The Al algorithm was trained using 10,376 X-ray images and a total of 5,188 corresponding 3D reconstructions. This training data set contained images which were collected from EOS (K152788) and EOSedge (K202394) systems at a variety of sites from 2007-2023. This population characteristics cover the intended use population. The data set ensures a variety of data for the different clinical metrics: scoliosis, postural balance, degenerative disease and spine surgery implant (preoperative and postoperative). The images were also acquired using different radiation exposure parameters and with different fields of view.
Testing data information
The testing data set consisted of 538 patients and the demographic characteristics cover the intended use population. The data set includes images from EOS (K152788) and EOSedge (K202394) systems.
19
Image /page/19/Picture/0 description: The image shows the logo for EOS imaging, an adec company. The logo features the letters "EOS" in a bold, sans-serif font, with the "O" shaped like a diamond. Below the letters, the word "imaging" is written in a smaller, lowercase font. Underneath "imaging" is the text "AN adec COMPANY" in a smaller font.
Subgroup definition (generalizability)
Test data was divided according to the subgroups listed below. The subgroups are intended to demonstrate the generalizability of the algorithm.
- Demographics .
- o Age
- o Gender
- Clinical Metrics: .
- o Without spinal conditions
- o Spinal Deformity
- . Scoliosis severity
- I Postural balance severity
- o Degenerative Disease
- o Spine Surgery Implant (preoperative and postoperative)
- . Image Acquisition
- Equipment model
- Radiation exposure parameters o
- Field of view O
- Data Site Location: .
- o US vs. OUS
- Different US states O
A randomized sampling was used for each category to include an equal number of cases within each subgroup.
Acceptance criteria
For spinal landmark accuracy the metric computed was the Euclidean distance and for spinal mesh accuracy the metric computed was point to surface distance. The acceptance criteria for both landmark and mesh accuracy errors was defined as:
- Median error ≤ 3 mm .
- 3rd Quartile ≤ 5 mm
Testing summary
Direct comparison between skeletal landmark locations between the subject device and predicate VEA aliqn ( K231917) met acceptance criteria for alqorithm performance.
Direct comparison between additional spinal landmarks location between the subject device and predicate sterEOS Workstation (K172346) met acceptance criteria for algorithm performance.
Direct comparison between the 3D thoraco-lumbar mesh from subject device and the 3D thoraco-lumbar mesh from the predicate sterEOS Workstation (K172346) met the acceptance criteria demonstrating substantial equivalence of the subject device.
20
Image /page/20/Picture/0 description: The image shows the logo for EOS imaging, an adtec company. The logo is primarily orange. The word "EOS" is in a bold, sans-serif font, with the "O" shaped like a diamond. Below "EOS" is the word "imaging" in a smaller, less bold font. Underneath "imaging" is the phrase "AN adtec COMPANY" in a very small font.
All those tests were performed over the whole population and for each sub-group mentioned before in order to prove the generalizability of the device performance across the different populations.
All the studies performed indicate acceptable performances of the algorithm for its intended population.
- C. Validation activities cover the following:
- Validation of the multifunctional requirements in terms of design. ●
- Usability testing was performed to demonstrate that the subject devices can be used safely by assessing and mitigating usability risks.
- Validation of the reproducibility and accuracy of clinical parameter outputs. .
8 CONCLUSION
Based on the information provided in this 510(k) submission, it was determined that the subject devices, VEA Align and spineEOS, are substantially equivalent to the legally marketed predicate devices with regards to indications for use, intended use, design, technology, and performance.