VEA Align; spineEOS

K240582 · Eos Imaging · QIH · Jun 25, 2024 · Radiology

Device Facts

• Record ID: K240582
• Device Name: VEA Align; spineEOS
• Applicant: Eos Imaging
• Product Code: QIH · Radiology
• Decision Date: Jun 25, 2024
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2
• Attributes: AI/ML, Software as a Medical Device, Pediatric

Intended 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, 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. 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.

Device Story

VEA Align and spineEOS are cloud-based software tools for orthopedic assessment and surgical planning. VEA Align takes biplanar 2D X-ray images from EOS/EOSedge systems as input; uses a machine learning algorithm to place initial anatomic landmarks; allows user validation/adjustment of landmarks; computes clinical parameters; and outputs alignment data. spineEOS uses EOS images and 3D datasets to provide surgical planning tools for spine surgery. Both are used by surgeons and clinical staff in clinical settings. Output allows providers to assess global alignment, analyze deformities, and define patient-specific surgical strategies, aiding in preoperative planning and potentially improving surgical outcomes.

Clinical Evidence

Bench testing only. Performance of the AI algorithm was validated using a dataset of 538 patients (distinct from the 10,376-image training set). Primary endpoints were landmark accuracy (Euclidean distance) and mesh accuracy (point-to-surface distance). Acceptance criteria were median error ≤ 3 mm and 3rd quartile ≤ 5 mm. Results demonstrated equivalence to predicate devices (sterEOS and VEA Align) across all subgroups, including demographics, clinical metrics, and image acquisition parameters.

Technological Characteristics

Cloud-based software; utilizes machine learning-based algorithm for landmark placement and 3D model initialization; requires user validation. Connectivity via web browser (Windows/Mac). Inputs: biplanar 2D X-ray images. Outputs: clinical parameters, 3D datasets, surgical planning tools. No hardware components.

Indications for Use

Indicated for orthopedic applications in pediatric and adult patients aged 7 years and older. Used for analysis of spinal deformities, degenerative diseases, and lower limb alignment disorders. spineEOS is indicated for preoperative planning of spine surgeries in adolescent and adult patients.

Regulatory Classification

Identification

A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.

Special Controls

*Classification.* Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).

Predicate Devices

• VEA Align (K231917)
• sterEOS (K172346)
• spineEOS (K232086)

Reference Devices

• EOS (K152788)
• EOSedge (K202394)

Submission Summary (Full Text)

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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).

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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 ([e-mail]) or phone [phone] 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

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# 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) |
|-------------------------------------------------------------------------------------------------|
| <span style="text-decoration: underline;">☑</span> 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/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

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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: [phone] Fax: [phone]

| Contact Person: | Moran CELESTIN<br>Design Quality and Regulatory Affairs Specialist<br>EOS imaging |
|-----------------|-----------------------------------------------------------------------------------|
| Contact Phone: | [phone] |

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<br>(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<br>(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 |

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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.

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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.

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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<br>VEA Align (K231917) | Secondary Predicate<br>sterEOS (K172346) | Subject VEA Align | Substantially<br>Equivalent? |
|---------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indication for Use | This cloud-based software is<br>intended for orthopedic<br>applications in both pediatric<br>and adult populations.<br>2D X-ray images acquired in<br>EOS imaging's imaging systems<br>is the foundation and resource<br>to display the interactive<br>landmarks overlayed on the<br>frontal and lateral images.<br>These landmarks are available<br>for users to assess patient-<br>specific global alignment.<br>For additional assessment,<br>alignment parameters compared<br>to published normative values<br>may be available.<br>This product serves as a tool to<br>aid in the analysis of spinal<br>deformities, degenerative<br>diseases, lower limb alignment<br>disorders, and deformities<br>through precise angle and<br>length measurements. It is<br>suitable for use with adult and<br>pediatric patients aged 7 years<br>and older. | The sterEOS Workstation is<br>intended for use in the fields of<br>musculoskeletal radiology and<br>orthopedics in both pediatric and<br>adult populations as a general<br>device for acceptance, transfer,<br>display, storage, and digital<br>processing of 2D X-ray images<br>of the musculoskeletal system<br>including interactive 2D<br>measurement tools.<br>When using 2D X-ray images<br>obtained with the EOS imaging<br>EOS system, sterEOS<br>Workstation provides interactive<br>3D measurement tools:<br>• To aid in the analysis of<br>scoliosis and related disorders<br>and deformities of the spine in<br>adult patients as well as<br>pediatric patients. The 3D<br>measurement tools include<br>interactive analysis based<br>either on identification of<br>anatomical landmarks for<br>postural assessment, or on a<br>model of bone structures<br>derived from an a priori image<br>data set from 175 patients (91<br>normal patients, 47 patients | This cloud-based software is<br>intended for orthopedic<br>applications in both pediatric<br>and adult populations.<br>2D X-ray images acquired in<br>EOS imaging's imaging systems<br>is the foundation and resource<br>to display the interactive<br>landmarks overlayed on the<br>frontal and lateral images.<br>These landmarks are available<br>for users to assess patient-<br>specific global alignment.<br>For additional assessment,<br>alignment parameters compared<br>to published normative values<br>may be available.<br>This product serves as a tool to<br>aid in the analysis of spinal<br>deformities and degenerative<br>diseases, and lower limb<br>alignment disorders and<br>deformities through precise<br>angle and length<br>measurements. It is suitable for<br>use with adult and pediatric<br>patients aged 7 years and older. | YES<br>Same as VEA Align. |
| Characteristic | Primary Predicate<br>VEA Align (K231917) | Secondary Predicate<br>sterEOS (K172346) | Subject VEA Align | Substantially<br>Equivalent? |
| | Clinical judgment and<br>experience are required to<br>properly use the software. | with moderate idiopathic<br>scoliosis and 37 patients with<br>severe idiopathic scoliosis),<br>and dry isolated vertebrae<br>data for spine modeling. The<br>model of bone structures is<br>not intended for use to assess<br>individual vertebral<br>abnormalities and is indicated<br>only for patients 7 years and<br>older. For postural<br>assessment, a set of<br>comparative tools is provided<br>allowing the comparison of<br>performed measurements to<br>reference values for patients<br>over 18 years old. | Clinical judgment and<br>experience are required to<br>properly use the software. | |
| | | • To aid in the analysis of lower<br>limbs alignment and related<br>disorders and deformities<br>based on angle and length<br>measurements. The 3D<br>measurement tools include<br>interactive analysis based<br>either on identification of lower<br>limb alignment landmarks or<br>as for the spine, on a model of<br>bone structures derived from<br>an a priori image data set.<br>The model of bone structures<br>is not intended for use to<br>assess individual bone | | |
| Characteristic | Primary Predicate<br>VEA Align (K231917) | Secondary Predicate<br>sterEOS (K172346) | Subject VEA Align | Substantially<br>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.<br>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:<br>• 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<br>Same as VEA Align. |
| Characteristic | Primary Predicate<br>VEA Align (K231917) | Secondary Predicate<br>sterEOS (K172346) | Subject VEA Align | Substantially<br>Equivalent? |
| | | fractures, osteophytes, fibrocartilage calluses. The lower limb 3D model is<br>based on an adult type and, as a<br>result, is not suited to pediatric<br>lower limb 3D reconstruction.<br>3D modeling can become<br>inaccurate and even impossible<br>when anatomical structures<br>cannot be identified as such in<br>the following cases: prostheses or instruments<br>masking or replacing<br>anatomical markers, certain pathological conditions<br>that alter the bone<br>composition, such as<br>osteoporosis, impossibility to differentiate<br>the internal condyle from the<br>external condyle or the<br>internal tibial plate from the<br>external tibial plate. | | |
| Regulatory<br>Class/Code | Class II<br>QIH<br>(21 CFR 892.2050) | Class II<br>LLZ<br>(21 CFR 892.2050) | Class II<br>QIH<br>(21 CFR 892.2050) | YES |
| Characteristic | Primary Predicate<br>VEA Align (K231917) | Secondary Predicate<br>sterEOS (K172346) | Subject VEA Align | Substantially<br>Equivalent? |
| Device Classification<br>Name | Automated Radiological Image<br>Processing Software | System, Image Processing,<br>Radiological | Automated Radiological Image<br>Processing Software | YES,<br>Same as VEA Align. |
| Operating System | Windows + MAC | Windows | Windows + MAC | YES |
| User Population | VEA Align is designed for<br>surgeons and clinical staff, such<br>as physician assistants, who<br>have been trained to use the<br>application. | Clinicians (radiologists,<br>orthopedists, radiographers), 3D<br>Services persons, which have<br>been trained to use the<br>application. | VEA Align Alignment<br>Assessment mode is designed<br>for surgeons and clinical staff,<br>such as physician assistants,<br>who have been trained to use<br>the application.<br>VEA Align 3D mode is designed<br>for 3D Services team members. | YES<br>Alignment Assessment<br>mode is equivalent to<br>predicate VEA Align and<br>3D Mode is equivalent to<br>predicate sterEOS (3D<br>Services users). |
| Target Population | The device is indicated only for<br>patients 7 years and older. | 3D measurement tools are used<br>on adult and pediatric patients<br>over 7 years of age who suffer<br>from scoliosis and deformed<br>spine pathology and for patients<br>over 15 years of age with<br>deformed lower limb pathology. | The device is indicated only for<br>patients 7 years and older. | YES<br>Same as VEA Align. |
| Software<br>Functionalities /<br>Modalities | Global alignment assessments<br>Includes landmarks associated<br>with vertebral endplates needed<br>to calculate coronal and sagittal<br>clinical parameters. These<br>landmarks are adjustable by the<br>user.<br>Includes landmarks associated<br>with the pelvis and lower limbs<br>needed to calculate coronal and<br>sagittal clinical parameters. | Global alignment assessments<br>Includes landmarks associated<br>with vertebral endplates needed<br>to calculate coronal and sagittal<br>clinical parameters. These<br>landmarks are adjustable by the<br>user.<br>Includes landmarks associated<br>with the pelvis and lower limbs<br>needed to calculate coronal and<br>sagittal clinical parameters. | Global alignment assessments<br>Includes landmarks associated<br>with vertebral endplates needed<br>to calculate coronal and sagittal<br>clinical parameters. These<br>landmarks are adjustable by the<br>user.<br>Includes landmarks associated<br>with the pelvis and lower limbs<br>needed to calculate coronal and<br>sagittal clinical parameters. | YES<br>YES<br>YES |
| Characteristic | Primary Predicate<br>VEA Align (K231917) | Secondary Predicate<br>sterEOS (K172346) | Subject VEA Align | Substantially<br>Equivalent? |
| | These landmarks are adjustable<br>by the user. | These landmarks are adjustable<br>by the user. | These landmarks are adjustable<br>by the user. | |
| | Provides normative values used<br>to assess patients' global<br>alignment | Provides normative values used<br>to assess patients' global<br>alignment | Provides normative values used<br>to…