(190 days)
Yes
The device description explicitly states that it uses a "machine learning-based algorithm" for the initial placement of anatomical landmarks.
No.
This device is a software tool for analysis and assessment of orthopedic conditions, not for direct therapeutic intervention.
Yes
The device is described 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," and it "assisting healthcare professionals with global alignment assessment through clinical parameters computation." This indicates its role in identifying and evaluating medical conditions, which falls under the definition of a diagnostic device.
Yes
The device is explicitly described as "cloud-based software" and "software indicated for assisting healthcare professionals". While it relies on images from specific hardware systems (EOS and EOSedge), the device itself is the software that processes and analyzes these images.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- Device Function: This device analyzes medical images (2D X-ray images) acquired from a patient's body. It does not process or analyze biological specimens.
- Intended Use: The intended use is for orthopedic applications, specifically aiding in the analysis of spinal deformities, degenerative diseases, lower limb alignment disorders, and deformities through measurements on images. This is a diagnostic aid based on imaging, not on the analysis of biological samples.
Therefore, while it is a medical device used for diagnostic purposes, it falls under the category of medical imaging software rather than an In Vitro Diagnostic device.
No
The provided text does not explicitly state that the FDA has reviewed and approved or cleared a PCCP for this specific device. The 'Control Plan Authorized (PCCP) and relevant text' section is marked 'Not Found'.
Intended Use / Indications 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. Clinical judgment and experience are required to properly use the software.
Product codes
QIH
Device Description
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. 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 I 510(k)-exempt device (LMD).
Mentions image processing
Yes
Mentions AI, DNN, or ML
Yes
Input Imaging Modality
2D X-ray images
Anatomical Site
Not Found
Indicated Patient Age Range
pediatric and adult patients aged 7 years and older.
Intended User / Care Setting
Surgeons and clinical staff (physician assistants) that have been trained to use the application
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
The testing dataset consisted of 555 patients which demographic characteristics covering the intended use population, including images from EOS (K152788) and EOSedge (K202394) systems.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Nonclinical performance testing performed on the subject device, VEA Align, supports substantial equivalence to the predicate device. The following V&V testing was performed:
A. Verifications activities cover the following:
- Design input review
- Unit testing
- Software integration
- System integration
B. Validation activities cover the following:
Validation of the multifunctional requirements in terms of design.
Usability testing was performed to demonstrate that VEA Align can be used safely by assessing and mitigating usability risks.
Validation of the reproducibility and accuracy of clinical parameter outputs.
Standalone performance assessment of the machine learning algorithm. The testing dataset consisted of 555 patients which demographic characteristics covering the intended use population, including images from EOS (K152788) and EOSedge (K202394) systems. Direct comparison between skeletal landmark locations between the subject VEA Align device and predicate sterEOS Workstation (K172346) met acceptance criteria for algorithm performance.
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 shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which 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 Engineer 10 rue Mercoeur Paris, France 75011
Re: K231917 Trade/Device Name: VEA Align Regulation Number: 21 CFR 892.2050 Regulation Name: Medical Image Management And Processing System Regulatory Class: Class II Product Code: QIH Dated: December 4, 2023 Received: December 4, 2023
January 5, 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).
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
1
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 (OS) 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.
Jessica Lamb
Jessica Lamb Assistant Director DHT8B: Division of Radiologic Imaging Devices and Electronic Products OHT8: Office of Radiological Health Office of Product Evaluation and Ouality Center for Devices and Radiological Health
2
Indications for Use
510(k) Number (if known) K231917
Device Name VEA Align
Indications for Use (Describe)
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.
Clinical judgment and experience are required to properly use the software.
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
Image /page/3/Picture/0 description: The image shows the logo for EOS imaging, an adec company. The logo is primarily orange. The letters "EOS" are 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" are the words "AN adec COMPANY" in a smaller, sans-serif font.
This 510(k) summary of safety and effectiveness is being submitted in accordance with the requirements of 21 CFR 807.92.
SUBMITTER 1 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: January 5, 2024 2 DEVICE VEA Align Trade Name: Common or Usual Name: Cloud-based software Classification Name: Automated Radiological Image Processing Software (21 C.F.R. § 892.2050) Class II Regulatory Class: Product Code: QIH
3 LEGALLY MARKETED PREDICATE DEVICES
| 510(k) | Product Name | Clearance Date |
|---|---|---|
| K172346 | sterEOS Workstation | June 2018 |
प DEVICE DESCRIPTION
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.
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
4
Image /page/4/Picture/0 description: The image shows the logo for EOS imaging. The logo consists of the letters "EOS" stacked on top of the word "imaging". The letters "EOS" are in a bold, sans-serif font and are orange in color. The word "imaging" is in a smaller, sans-serif font and is also orange in color. Below the word "imaging" is the text "AN atec COMPANY" in a smaller font.
institutions to the cloud are managed by VEA Portal is a Class I 510(k)-exempt device (LMD).
5 INDICATIONS 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.
Clinical judgment and experience are required to properly use the software.
TECHNOLOGICAL COMPARISON TO PREDICATES 6
The subject device was compared to the predicate device in intended use, indications for use, design, function and technology and it was demonstrated that they are substantially equivalent. Any technological differences within this 510(k), between the subject device and the predicate device, does not impact substantial equivalence, or safety and effectiveness.
5
Image /page/5/Picture/0 description: The image contains 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 size. The logo is simple and modern, with a focus on the company's name.
| Characteristic | Predicate Device
sterEOS Workstation
510(k): K172346 | Subject Device
VEA Align | Substantially Equivalent? |
|---------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indication for
Use | 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 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. | 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.
Clinical judgment and experience are required to
properly use the software. | Yes, both devices are indicated for
the display and digital processing of
2D X-ray images. Both devices are
indicated for the same type of
disease, i.e., in the case of diseases
that have an impact on the patient's
global alignment.
The information provided by both
products is to be used as a
diagnostic aid for the user. |
| Characteristic | Predicate Device
sterEOS Workstation
510(k): K172346 | Subject Device
VEA Align | Substantially Equivalent? |
| | • 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 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. | | |
| Regulatory
Class/Code | Class II
LLZ
(21 CFR 892.2050) | Class II
QIH
(21 CFR 892.2050) | The product code for the predicate
device is LLZ. The QIH product
code was created after clearance of
the predicate device and appears to
be a better match for VEA Align
than LLZ. VEA Align employs
machine learning based algorithms
that were trained from data
generated by EOS Imaging's
imaging systems to automate the
radiological image processing and
analysis. |
| Device
Classification
Name | System, Image Processing, Radiological | Automated Radiological Image Processing
Software | Yes, both devices are classified
under 21 CFR 892.2050. |
| Operating
System | Windows | Windows + MAC | Yes, the subject device is
compatible with windows like the
predicate device. It is also |
| Characteristic | Predicate Device
sterEOS Workstation
510(k): K172346 | Subject Device
VEA Align | Substantially Equivalent? |
| User Population | Clinicians (radiologists, orthopedists, radiographers),
3DServices persons, which have been trained to use
the application | Surgeons and clinical staff (physician assistants)
that have been trained to use the application | Yes, while the user population is
slightly different, the inclusion of
surgeons and clinical staff do not
affect device safety or
effectiveness. |
| Target
Population | 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. | Similar. The subject device is
dedicated to understanding the
global alignment of patients, spine
and lower limb included. The 15-
year-old limitation of the predicate
device was attached to workflow
dedicated specifically to lower limbs
only. This workflow is not present
in the subject device. This
difference does not affect device
safety or effectiveness. |
| Software
Functionalities /
Modalities | Global alignment assessments | Global alignment assessments | Yes |
| Image
Manipulation
Functions | 2D images display and basic manipulation (zoom,
panning, distance, and angles measurements) | 2D images display and basic manipulation
(zoom, panning) | Similar. In VEA Align the user does
not have the possibility to make
additional measurements after
reviewing the alignment provided
by the software. The removal of
this function does not prevent VEA
Align from achieving its intended
purpose and does not create a new
risk in VEA Align. The computation
of the specific clinical parameters
claimed in the VEA Align User
Manual is not impacted by the
removal of this function. This
function is not linked to the |
| Characteristic | Predicate Device
sterEOS Workstation
510(k): K172346 | Subject Device
VEA Align | Substantially Equivalent? |
| | | | performance of VEA Align.
Consequently, there is no impact
on the effectiveness of VEA Align. |
| Measurement
Functions | Distances and Angles | Distances and Angles | Yes |
| 3D Model | The 3D model is deformed manually by the user
through control points up to matching accurately the
X-ray contours. This deformation is performed by
using the common linear least squares estimation
algorithm. | 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. | In VEA Align, the 3D model is not
visible to the user and the latter
cannot interact with it. The 3D
model is not part of the device
outputs contrary to the predicate
device. 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 | Yes |
| Software
Environment | Standalone | Cloud-based software | Yes, the difference regarding the
software environment does not
introduce new risks, or impact
existing risks. Therefore, this
difference does not affect device
safety or effectiveness. |
6
Image /page/6/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 size. The "O" in EOS is shaped like a diamond.
7
Image /page/7/Picture/0 description: The image contains the logo for EOS imaging, an adtec company. The logo is orange and features the letters "EOS" in a stylized font, with the "O" represented by a diamond shape. Below the letters, the word "imaging" is written in a smaller, sans-serif font. Underneath "imaging" the text "AN adtec COMPANY" is written in a smaller font.
8
Image /page/8/Picture/0 description: The image shows the logo for EOS imaging, an Adtec company. The word "EOS" is in a bold, sans-serif font and is colored orange. Below "EOS" is the word "imaging" in a smaller, sans-serif font, also in orange. Underneath "imaging" is the phrase "AN Adtec COMPANY" in a smaller, sans-serif font in black.
9
Image /page/9/Picture/0 description: The image contains the logo for EOS imaging, an adtec company. The logo is in 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 size. The logo is simple and modern, with a focus on the company name.
7 PERFORMANCE DATA
Nonclinical performance testing performed on the subject device, VEA Align, supports substantial equivalence to the predicate device. The following V&V testing was performed:
A. Verifications activities cover the following:
- Design input review ●
- Unit testing
- Software integration ●
- . System integration
- B. Validation activities cover the following:
- Validation of the multifunctional requirements in terms of design. ●
- Usability testing was performed to demonstrate that VEA Align can be used safely by assessing and mitigating usability risks.
- Validation of the reproducibility and accuracy of clinical parameter outputs. ●
- Standalone performance assessment of the machine learning algorithm. . The testing dataset consisted of 555 patients which demographic characteristics covering the intended use population, including images from EOS (K152788) and EOSedge (K202394) systems. Direct comparison between skeletal landmark locations between the subject VEA Align device and predicate sterEOS Workstation (K172346) met acceptance criteria for algorithm performance.
CONCLUSION 09
Based upon the information provided in this 510(k) submission, it has been determined that the subject device, VEA Align, is substantially equivalent to the legally marketed predicate device in regards to indications for use, intended use, design, technology, and performance.