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.

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).

AI/ML Overview

The provided text describes the VEA Align device and its performance testing to support its substantial equivalence to a predicate device. However, it does not contain a detailed table of acceptance criteria with reported device performance metrics that would typically be found in a comprehensive study report. It states that "Direct comparison between skeletal landmark locations between the subject VEA Align device and predicate sterEOS Workstation (K172346) met acceptance criteria for algorithm performance," but it does not quantify these criteria or the specific performance results.

Therefore, some of the requested information cannot be directly extracted from the provided text. I will provide what is available and note what is missing.

Here's the breakdown of the information:

1. Table of Acceptance Criteria and Reported Device Performance

The document states: "Direct comparison between skeletal landmark locations between the subject VEA Align device and predicate sterEOS Workstation (K172346) met acceptance criteria for algorithm performance." However, the specific quantitative acceptance criteria (e.g., maximum allowable error for landmark placement) and the actual numerical performance results (e.g., mean absolute error) are not provided in this text.

Acceptance Criteria	Reported Device Performance
Not specified quantified acceptance criteria for landmark location comparison.	Met acceptance criteria for algorithm performance for direct comparison between skeletal landmark locations and the predicate device. Specific metrics (e.g., mean error, standard deviation) are not provided.

2. Sample Size Used for the Test Set and Data Provenance

Test Set Sample Size: 555 patients.
Data Provenance: The images were acquired from "EOS (K152788) and EOSedge (K202394) systems." The country of origin and whether the data was retrospective or prospective are not explicitly stated.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts

This information is not provided in the text. The document refers to the predicate device manually deforming a 3D model through control points to match X-ray contours, which implies expert interaction in the past, but it does not describe how ground truth was established for the 555-patient test set for the VEA Align device.

4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set

This information is not provided in the text.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the effect size of how much human readers improve with AI vs. without AI assistance.

A MRMC comparative effectiveness study involving human readers with and without AI assistance is not mentioned in the provided text. The performance testing focuses on the standalone algorithm's comparison to the predicate device.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:

Yes, a standalone performance assessment was done. The text states:
"Standalone performance assessment of the machine learning algorithm. The testing dataset consisted of 555 patients... Direct comparison between skeletal landmark locations between the subject VEA Align device and predicate sterEOS Workstation (K172346) met acceptance criteria for algorithm performance."

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The ground truth for the standalone performance assessment appears to be based on the "skeletal landmark locations" derived from the predicate sterEOS Workstation (K172346). This implies that the predicate's output, which involved manual deformation by users ("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."), served as the reference for the VEA Align's automated landmark placement. It is not explicitly stated that an independent expert consensus or pathology was used directly for the 555-patient test set for the standalone evaluation of VEA Align, but rather conformance to the predicate's output.

8. The Sample Size for the Training Set

The sample size for the training set is not explicitly stated in the provided text. It mentions that the machine learning algorithm was "trained from data generated by EOS Imaging's imaging systems", but it doesn't quantify the size of this training dataset.

9. How the Ground Truth for the Training Set Was Established

The text states that the machine learning algorithm learns to generate "an initial placement of the patient anatomic landmarks on the images" and that "The user may adjust the landmarks to align with the patient's anatomy." For the predicate device, it mentions "identification of anatomical landmarks" or "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."

While it implies that human interaction and potentially pre-existing models established the ground truth used for training, the specific methodology and who established the ground truth labels for the VEA Align training set are not detailed. It implies the machine learning was "trained from data generated by EOS Imaging's imaging systems," which suggests leveraging existing data from their systems and prior approaches (potentially like the predicate).

Summary

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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

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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

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Indications for Use

510(k) Number (if known) K231917

Device Name VEA Align

Indications for Use (Describe)

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)

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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

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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.

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.

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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 DevicesterEOS Workstation510(k): K172346	Subject DeviceVEA Align	Substantially Equivalent?
Indication forUse	The sterEOS Workstation is intended for use in thefields of musculoskeletal radiology and orthopedics inboth pediatric and adult populations as a generaldevice for acceptance, transfer, display, storage, anddigital processing of 2D X-ray images of themusculoskeletal system including interactive 2Dmeasurement tools.When using 2D X-ray images obtained with the EOSimaging EOS system, sterEOS Workstation providesinteractive 3D measurement tools:• To aid in the analysis of scoliosis and relateddisorders and deformities of the spine in adultpatients as well as pediatric patients. The 3Dmeasurement tools include interactive analysisbased either on identification of anatomicallandmarks for postural assessment, or on a model ofbone structures derived from an a priori image dataset from 175 patients (91 normal patients, 47patients with moderate idiopathic scoliosis and 37patients with severe idiopathic scoliosis), and dryisolated vertebrae data for spine modeling. Themodel of bone structures is not intended for use toassess individual vertebral abnormalities and isindicated only for patients 7 years and older. Forpostural assessment, a set of comparative tools isprovided allowing the comparison of performedmeasurements to reference values for patients over18 years old.	This cloud-based software is intended fororthopedic applications in both pediatric and adultpopulations.2D X-ray images acquired in EOS imaging'simaging systems is the foundation and resourceto display the interactive landmarks overlayed onthe frontal and lateral images. These landmarksare available for users to assess patient-specificglobal alignment.For additional assessment, alignment parameterscompared to published normative values may beavailable.This product serves as a tool to aid in the analysisof spinal deformities, degenerative diseases,lower limb alignment disorders, and deformitiesthrough precise angle and length measurements.It is suitable for use with adult and pediatricpatients aged 7 years and older.Clinical judgment and experience are required toproperly use the software.	Yes, both devices are indicated forthe display and digital processing of2D X-ray images. Both devices areindicated for the same type ofdisease, i.e., in the case of diseasesthat have an impact on the patient'sglobal alignment.The information provided by bothproducts is to be used as adiagnostic aid for the user.
Characteristic	Predicate DevicesterEOS Workstation510(k): K172346	Subject DeviceVEA Align	Substantially Equivalent?
	• To aid in the analysis of lower limbs alignment andrelated disorders and deformities based on angleand length measurements. The 3D measurementtools include interactive analysis based either onidentification of lower limb alignment landmarks oras for the spine, on a model of bone structuresderived from an a priori image data set. The modelof bone structures is not intended for use to assessindividual bone abnormalities. The 3D packageincluding model-based measurements and torsionangles is indicated only for patients 15 years orolder.Only the 2D/3D ruler is indicated formeasurements in patients younger than 15 yearsold.
RegulatoryClass/Code	Class IILLZ(21 CFR 892.2050)	Class IIQIH(21 CFR 892.2050)	The product code for the predicatedevice is LLZ. The QIH productcode was created after clearance ofthe predicate device and appears tobe a better match for VEA Alignthan LLZ. VEA Align employsmachine learning based algorithmsthat were trained from datagenerated by EOS Imaging'simaging systems to automate theradiological image processing andanalysis.
DeviceClassificationName	System, Image Processing, Radiological	Automated Radiological Image ProcessingSoftware	Yes, both devices are classifiedunder 21 CFR 892.2050.
OperatingSystem	Windows	Windows + MAC	Yes, the subject device iscompatible with windows like thepredicate device. It is also
Characteristic	Predicate DevicesterEOS Workstation510(k): K172346	Subject DeviceVEA Align	Substantially Equivalent?
User Population	Clinicians (radiologists, orthopedists, radiographers),3DServices persons, which have been trained to usethe application	Surgeons and clinical staff (physician assistants)that have been trained to use the application	Yes, while the user population isslightly different, the inclusion ofsurgeons and clinical staff do notaffect device safety oreffectiveness.
TargetPopulation	3D measurement tools are used on adult andpediatric patients over 7 years of age who suffer fromscoliosis and deformed spine pathology and forpatients over 15 years of age with deformed lowerlimb pathology.	The device is indicated only for patients 7 yearsand older.	Similar. The subject device isdedicated to understanding theglobal alignment of patients, spineand lower limb included. The 15-year-old limitation of the predicatedevice was attached to workflowdedicated specifically to lower limbsonly. This workflow is not presentin the subject device. Thisdifference does not affect devicesafety or effectiveness.
SoftwareFunctionalities /Modalities	Global alignment assessments	Global alignment assessments	Yes
ImageManipulationFunctions	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 doesnot have the possibility to makeadditional measurements afterreviewing the alignment providedby the software. The removal ofthis function does not prevent VEAAlign from achieving its intendedpurpose and does not create a newrisk in VEA Align. The computationof the specific clinical parametersclaimed in the VEA Align UserManual is not impacted by theremoval of this function. Thisfunction is not linked to the
Characteristic	Predicate DevicesterEOS Workstation510(k): K172346	Subject DeviceVEA Align	Substantially Equivalent?
			performance of VEA Align.Consequently, there is no impacton the effectiveness of VEA Align.
MeasurementFunctions	Distances and Angles	Distances and Angles	Yes
3D Model	The 3D model is deformed manually by the userthrough control points up to matching accurately theX-ray contours. This deformation is performed byusing the common linear least squares estimationalgorithm.	The 3D model supports the initial placement ofthe patient anatomic landmarks on the imagesusing a machine learning-based algorithm. It isnot displayed to the user and as such it is notpart of the device outputs.	In VEA Align, the 3D model is notvisible to the user and the lattercannot interact with it. The 3Dmodel is not part of the deviceoutputs contrary to the predicatedevice. This difference does notprevent VEA Align from achievingits intended purpose and does notcreate a new risk in VEA Align.Therefore, this difference does notaffect device safety oreffectiveness.
User Interface	Computer	Computer	Yes
SoftwareEnvironment	Standalone	Cloud-based software	Yes, the difference regarding thesoftware environment does notintroduce new risks, or impactexisting risks. Therefore, thisdifference does not affect devicesafety or effectiveness.

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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.

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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.

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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.

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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.

Regulation Number and Section

§ 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).