(116 days)
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 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.
VEA Align is a software indicated for assisting healthcare professionals with global alignment assessment through clinical parameters computation. The product uses biplanar 2D X-ray images, exclusively generated by EOS imaging's EOS (K152788) and EOSedge (K202394) systems and generates an initial placement of the patient anatomic landmarks on the images using a machine learning-based algorithm. The user may adjust the landmarks to align with the patient's anatomy. Landmark locations require user validation. The clinical parameters communicated to the user are inferred from the landmarks and are recalculated as the user adjusts the landmarks. 3D datasets may be exported for use in spineEOS for surgical planning. The product is hosted on a cloud infrastructure and relies on VEA Portal for support capabilities, such as user access control and data access. 2D X-ray image transmissions from healthcare institutions to the cloud are managed by VEA Portal is a Class | 510(k)-exempt device (LMD).
spineEOS 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.
The provided text describes the performance data for the VEA Align device, focusing on the standalone performance of its AI algorithm.
Here's the breakdown of the acceptance criteria and the study proving the device meets them:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Spinal Landmark Accuracy: | |
| Median error ≤ 3 mm (Euclidean distance) | Met acceptance criteria for algorithm performance (Direct comparison between skeletal landmark locations between the subject device and predicate VEA Align (K231917)). Also met for additional spinal landmarks when compared to predicate sterEOS Workstation (K172346). |
| 3rd Quartile ≤ 5 mm (Euclidean distance) | Met acceptance criteria for algorithm performance (Direct comparison between skeletal landmark locations between the subject device and predicate VEA Align (K231917)). Also met for additional spinal landmarks when compared to predicate sterEOS Workstation (K172346). |
| Spinal Mesh Accuracy: | |
| Median error ≤ 3 mm (Point to surface distance) | Met acceptance criteria (Direct comparison between the 3D thoraco-lumbar mesh from the subject device and the 3D thoraco-lumbar mesh from the predicate sterEOS Workstation (K172346)). |
| 3rd Quartile ≤ 5 mm (Point to surface distance) | Met acceptance criteria (Direct comparison between the 3D thoraco-lumbar mesh from the subject device and the 3D thoraco-lumbar mesh from the predicate sterEOS Workstation (K172346)). |
2. Sample size used for the test set and the data provenance
- Test set sample size: 538 patients.
- Data provenance: Not explicitly stated as country of origin, but the images were collected from EOS (K152788) and EOSedge (K202394) systems at a variety of sites. The subgroup analysis includes "US vs. OUS" (Outside US), implying international data. The data collection period was from 2007-2023. The study seems to be retrospective as it uses previously collected images.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
The document states that the ground truth for the test set was an "EOS 3DServices reconstruction (model) from sterEOS Workstation (K172346)". It does not explicitly state the number or qualifications of experts used to establish this ground truth for the test set. However, the nature of the sterEOS Workstation suggests that these 3D reconstructions are typically performed or validated by trained specialists.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
The document does not specify an adjudication method for the test set ground truth. It relies on the "ground truth EOS 3DServices reconstruction (model) from sterEOS Workstation (K172346)."
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
No MRMC comparative effectiveness study was described where human readers' improvement with AI vs. without AI assistance was evaluated. The performance testing focused on the standalone performance of the AI algorithm. The VEA Align device involves a machine learning-based algorithm for initial landmark placement, but then explicitly states, "The user may adjust the landmarks to align with the patient's anatomy. Landmark locations require user validation." This implies a human-in-the-loop system, but the described performance study is primarily on the algorithm's initial accuracy, not human improvement.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Yes, a standalone performance test of the AI algorithm was done. The document explicitly states: "To assess the standalone performance of the Al algorithm of the VEA Align, the test was performed with..."
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The ground truth used for the standalone algorithm performance was "a ground truth EOS 3DServices reconstruction (model) from sterEOS Workstation (K172346)". This suggests a reconstructed anatomical model derived from clinically used software, likely validated by trained operators or experts who generated that model previously.
8. The sample size for the training set
The AI algorithm was trained using 10,376 X-ray images and a total of 5,188 corresponding 3D reconstructions.
9. How the ground truth for the training set was established
The document states that the training data included "corresponding 3D reconstructions" presumably generated by sterEOS Workstation (K172346), similar to the test set ground truth. These 3D reconstructions would have been based on images from EOS systems and likely performed by trained personnel using the sterEOS Workstation. It's implied that these served as the ground truth for training the AI algorithm to generate its initial placements.
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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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Samul for
Jessica Lamb, Ph.D. Assistant Director Imaging Software Team DHT8B: Division of Radiological Imaging Devices and Electronic Products OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
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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) |
|---|
| ☑ 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: +33 1 55 25 60 60 Fax: +33 1 55 25 60 61
| Contact Person: | Moran CELESTINDesign Quality and Regulatory Affairs SpecialistEOS imaging |
|---|---|
| Contact Phone: | +33 1 55 25 60 60 |
Date Summary Prepared: June 24, 2024
DEVICES 2
2.1 VEA Align
| Trade Name: | VEA Align |
|---|---|
| Common or Usual Name: | Cloud-based software |
| Classification Name: | Automated Radiological Image Processing Software(21 C.F.R. § 892.2050) |
| Regulatory Class: | Class II |
| Product Code: | QIH |
2.2 spineEOS
| Trade Name: | spineEOS |
|---|---|
| Common or Usual Name: | Cloud-based software |
| Classification Name: | System, image processing, radiological(21 C.F.R. § 892.2050) |
| Regulatory Class: | Class II |
| Product Code: | LLZ |
LEGALLY MARKETED PREDICATE DEVICES 3
3.1 VEA Align
| 510(k) | Product Name | Clearance Date |
|---|---|---|
| K231917 | VEA Align (primary predicate) | January 2024 |
| K172346 | sterEOS (secondary predicate) | June 2018 |
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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 PredicateVEA Align (K231917) | Secondary PredicatesterEOS (K172346) | Subject VEA Align | SubstantiallyEquivalent? |
|---|---|---|---|---|
| Indication for Use | This cloud-based software isintended for orthopedicapplications in both pediatricand adult populations.2D X-ray images acquired inEOS imaging's imaging systemsis the foundation and resourceto display the interactivelandmarks overlayed on thefrontal and lateral images.These landmarks are availablefor users to assess patient-specific global alignment.For additional assessment,alignment parameters comparedto published normative valuesmay be available.This product serves as a tool toaid in the analysis of spinaldeformities, degenerativediseases, lower limb alignmentdisorders, and deformitiesthrough precise angle andlength measurements. It issuitable for use with adult andpediatric patients aged 7 yearsand older. | The sterEOS Workstation isintended for use in the fields ofmusculoskeletal radiology andorthopedics in both pediatric andadult populations as a generaldevice for acceptance, transfer,display, storage, and digitalprocessing of 2D X-ray imagesof the musculoskeletal systemincluding interactive 2Dmeasurement tools.When using 2D X-ray imagesobtained with the EOS imagingEOS system, sterEOSWorkstation provides interactive3D measurement tools:• To aid in the analysis ofscoliosis and related disordersand deformities of the spine inadult patients as well aspediatric patients. The 3Dmeasurement tools includeinteractive analysis basedeither on identification ofanatomical landmarks forpostural assessment, or on amodel of bone structuresderived from an a priori imagedata set from 175 patients (91normal patients, 47 patients | This cloud-based software isintended for orthopedicapplications in both pediatricand adult populations.2D X-ray images acquired inEOS imaging's imaging systemsis the foundation and resourceto display the interactivelandmarks overlayed on thefrontal and lateral images.These landmarks are availablefor users to assess patient-specific global alignment.For additional assessment,alignment parameters comparedto published normative valuesmay be available.This product serves as a tool toaid in the analysis of spinaldeformities and degenerativediseases, and lower limbalignment disorders anddeformities through preciseangle and lengthmeasurements. It is suitable foruse with adult and pediatricpatients aged 7 years and older. | YESSame as VEA Align. |
| Characteristic | Primary PredicateVEA Align (K231917) | Secondary PredicatesterEOS (K172346) | Subject VEA Align | SubstantiallyEquivalent? |
| Clinical judgment andexperience are required toproperly use the software. | with moderate idiopathicscoliosis and 37 patients withsevere idiopathic scoliosis),and dry isolated vertebraedata for spine modeling. Themodel of bone structures isnot intended for use to assessindividual vertebralabnormalities and is indicatedonly for patients 7 years andolder. For posturalassessment, a set ofcomparative tools is providedallowing the comparison ofperformed measurements toreference values for patientsover 18 years old. | Clinical judgment andexperience are required toproperly use the software. | ||
| • To aid in the analysis of lowerlimbs alignment and relateddisorders and deformitiesbased on angle and lengthmeasurements. The 3Dmeasurement tools includeinteractive analysis basedeither on identification of lowerlimb alignment landmarks oras for the spine, on a model ofbone structures derived froman a priori image data set.The model of bone structuresis not intended for use toassess individual bone | ||||
| Characteristic | Primary PredicateVEA Align (K231917) | Secondary PredicatesterEOS (K172346) | Subject VEA Align | SubstantiallyEquivalent? |
| abnormalities. The 3D package including model-based measurements and torsion angles is indicated only for patients 15 years or older. Only the 2D/3D ruler is indicated for measurements in patients younger than 15 years old. | ||||
| Contraindications | VEA Align is contraindicated for cases with vertebrae with severe congenital deformities (e.g., hemivertebrae, spina bifida, etc.) and supernumerary/missing vertebrae. | The 3D spine modeling software does not allow modeling of vertebrae with severe congenital deformities (e.g. hemivertebrae, spina bifida, etc.). The modeling of a spine that has a vertebrae with a congenital deformity may be generated leaving out the vertebrae with the congenital deformity.The 3D models delivered by the sterEOS software can only be used for diagnostic purposes with the corresponding 2D images. They are designed to display the spatial relationship between anatomical structures and are unable to highlight local bone alterations such as:• bones with significant changes in geometry following surgical intervention. | VEA Align is contraindicated for cases with vertebrae with severe congenital deformities (e.g., hemivertebrae, spina bifida, etc.) and supernumerary/missing vertebrae. | YESSame as VEA Align. |
| Characteristic | Primary PredicateVEA Align (K231917) | Secondary PredicatesterEOS (K172346) | Subject VEA Align | SubstantiallyEquivalent? |
| fractures, osteophytes, fibrocartilage calluses. The lower limb 3D model isbased on an adult type and, as aresult, is not suited to pediatriclower limb 3D reconstruction.3D modeling can becomeinaccurate and even impossiblewhen anatomical structurescannot be identified as such inthe following cases: prostheses or instrumentsmasking or replacinganatomical markers, certain pathological conditionsthat alter the bonecomposition, such asosteoporosis, impossibility to differentiatethe internal condyle from theexternal condyle or theinternal tibial plate from theexternal tibial plate. | ||||
| RegulatoryClass/Code | Class IIQIH(21 CFR 892.2050) | Class IILLZ(21 CFR 892.2050) | Class IIQIH(21 CFR 892.2050) | YES |
| Characteristic | Primary PredicateVEA Align (K231917) | Secondary PredicatesterEOS (K172346) | Subject VEA Align | SubstantiallyEquivalent? |
| Device ClassificationName | Automated Radiological ImageProcessing Software | System, Image Processing,Radiological | Automated Radiological ImageProcessing Software | YES,Same as VEA Align. |
| Operating System | Windows + MAC | Windows | Windows + MAC | YES |
| User Population | VEA Align is designed forsurgeons and clinical staff, suchas physician assistants, whohave been trained to use theapplication. | Clinicians (radiologists,orthopedists, radiographers), 3DServices persons, which havebeen trained to use theapplication. | VEA Align AlignmentAssessment mode is designedfor surgeons and clinical staff,such as physician assistants,who have been trained to usethe application.VEA Align 3D mode is designedfor 3D Services team members. | YESAlignment Assessmentmode is equivalent topredicate VEA Align and3D Mode is equivalent topredicate sterEOS (3DServices users). |
| Target Population | The device is indicated only forpatients 7 years and older. | 3D measurement tools are usedon adult and pediatric patientsover 7 years of age who sufferfrom scoliosis and deformedspine pathology and for patientsover 15 years of age withdeformed lower limb pathology. | The device is indicated only forpatients 7 years and older. | YESSame as VEA Align. |
| SoftwareFunctionalities /Modalities | Global alignment assessmentsIncludes landmarks associatedwith vertebral endplates neededto calculate coronal and sagittalclinical parameters. Theselandmarks are adjustable by theuser.Includes landmarks associatedwith the pelvis and lower limbsneeded to calculate coronal andsagittal clinical parameters. | Global alignment assessmentsIncludes landmarks associatedwith vertebral endplates neededto calculate coronal and sagittalclinical parameters. Theselandmarks are adjustable by theuser.Includes landmarks associatedwith the pelvis and lower limbsneeded to calculate coronal andsagittal clinical parameters. | Global alignment assessmentsIncludes landmarks associatedwith vertebral endplates neededto calculate coronal and sagittalclinical parameters. Theselandmarks are adjustable by theuser.Includes landmarks associatedwith the pelvis and lower limbsneeded to calculate coronal andsagittal clinical parameters. | YESYESYES |
| Characteristic | Primary PredicateVEA Align (K231917) | Secondary PredicatesterEOS (K172346) | Subject VEA Align | SubstantiallyEquivalent? |
| These landmarks are adjustableby the user. | These landmarks are adjustableby the user. | These landmarks are adjustableby the user. | ||
| Provides normative values usedto assess patients' globalalignment | Provides normative values usedto assess patients' globalalignment | Provides normative values usedto assess patients' globalalignment | YES | |
| Provides color-coded clinicalparameters to display variancefrom the defined normativevalues | Provides color-coded clinicalparameters to display variancefrom the defined normativevalues | Provides color-coded clinicalparameters to display variancefrom the defined normativevalues | YES | |
| Image ManipulationFunctions | 2D images display and basicmanipulation (zoom, panning) | 2D images display and basicmanipulation (zoom, panning,distance, and anglesmeasurements) | 2D images display and basicmanipulation (zoom, panning) | YESSame as VEA Align. |
| MeasurementFunctions | Distances and Angles | Distances and Angles | Distances and Angles | YES |
| Algorithms | Patient-specific clinicalparameters and calculationsbased on published literature. | Patient-specific clinicalparameters and calculationsbased on published literature. | Patient-specific clinicalparameters and calculationsbased on published literature. | YES |
| 3D ReconstructionModel | Alignment mode: The 3D modelsupports the initial placement ofthe patient anatomic landmarkson the images using a machinelearning-based algorithm. It isnot displayed to the user and assuch it is not part of the deviceoutputs. | The 3D model is deformedmanually by the user throughcontrol points up to matchingaccurately the X-ray contours. | Alignment mode: The 3D modelsupports the initial placement ofthe patient anatomic landmarkson the images using a machinelearning-based algorithm. It isnot displayed to the user and assuch it is not part of the modeoutputs.3D mode: The 3D reconstructionmodel is initialized by an Alalgorithm and then deformedmanually by the user throughcontrol points up to matching | YESAlignment Assessmentmode is equivalent topredicate VEA Align. Inthe 3D mode, the 3Dreconstruction model isan output of the deviceas for the secondarypredicate, sterEOS. Thedifference between thesecondary predicatesterEOS and the subject |
| Characteristic | Primary PredicateVEA Align (K231917) | Secondary PredicatesterEOS (K172346) | Subject VEA Align | SubstantiallyEquivalent? |
| accurately the X-ray contours.The 3D reconstruction model isan output of the 3D mode. | VEA Align is theautomatic initializationusing an AI algorithm forVEA Align 3D modelreconstructiongeneration. Thisdifference allows the userto gain timeduringmanualadjustment. Thisdifference does notprevent VEA Align fromachieving its intendedpurpose and does notcreate a new risk in VEAAlign. Therefore, thisdifference does not affectdevice safety oreffectiveness. | |||
| User Interface | Computer | Computer | Computer | YES |
| Obtaining an image | Transferred from other devices | Transferred from other devices | Transferred from other devices | YES |
| SoftwareEnvironment | Cloud-based software | Standalone | Cloud-based software | YES Same as VEA Align. |
| Human Interventionfor interpretation andmanipulation ofimages | Required | Required | Required | YES |
| Control of life-savingdevices | None | None | None | YES |
Table 1: Summary of Predicate and Subject VEA Align Device Characteristics to Demonstrate Substantial Equivalence
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Image /page/8/Picture/0 description: The image shows the logo for EOS imaging, an adtec company. The logo is orange and features the letters "EOS" stacked on top of the word "imaging". Below "imaging" is the text "AN adtec COMPANY" in a smaller font. The logo is simple and modern, with rounded corners and a clean design.
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Image /page/9/Picture/0 description: The image contains the logo for EOS imaging, which is an orange color. The logo consists of the letters "EOS" in a stylized font, with the "O" shaped like a diamond. Below the word "EOS" is the word "imaging" in a smaller font. Underneath "imaging" is the text "AN aztec COMPANY" in a very small font.
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Image /page/10/Picture/0 description: The image shows the logo for EOS imaging, an adec company. The logo features the letters "EOS" in a stylized, sans-serif font, stacked on top of the word "imaging" in a smaller, lowercase font. Below "imaging" is the text "AN adec COMPANY" in an even smaller font. The color of the logo is a muted orange.
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Image /page/11/Picture/0 description: The image contains the logo for EOS imaging, which is an orange color. The logo consists of the letters "EOS" in a stylized font, with the "O" shaped like a diamond. Below the word "EOS" is the word "imaging" in a smaller font. Underneath "imaging" is the text "AN aztec COMPANY" in a very small font.
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Image /page/12/Picture/0 description: The image shows the logo for EOS imaging, which is an "atec COMPANY". The logo is orange and features the letters "EOS" stacked on top of the word "imaging". Below the word "imaging" is the text "AN atec COMPANY" in a smaller font size. The logo is simple and modern, and the orange color is eye-catching.
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Image /page/13/Picture/0 description: The image contains the logo for EOS imaging. The logo consists of the letters "EOS" in a stylized, sans-serif font, with the "O" resembling a diamond shape. Below the letters, the word "imaging" is written in a smaller, sans-serif font. Underneath "imaging" is the text "AN atec COMPANY" in a smaller font size. The logo is orange.
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Image /page/14/Picture/0 description: The image shows the logo for EOS imaging, an adtec company. The logo is in orange and features the letters "EOS" in a stylized font, with the "O" shaped like a diamond. Below the letters, the word "imaging" is written in a smaller, sans-serif font. Underneath "imaging", the text "AN adtec COMPANY" is written in an even smaller font.
| Characteristic | Predicate DevicespineEOS (K232086) | Subject DevicespineEOS | Substantially Equivalent? |
|---|---|---|---|
| Indications for Use | spineEOS software is indicated for assistinghealthcare professionals with preoperativeplanning of spine surgeries. spineEOS providesaccess to EOS images with associated 3Ddatasets and measurements. spineEOSincludes surgical planning tools that enableusers to define a patient specific surgicalstrategy. | spineEOS is indicated for assisting healthcareprofessionals with preoperative planning ofspine surgeries. The product provides access toEOS images with associated 3D datasets andmeasurements. spineEOS includes surgicalplanning tools that enable users to define apatient specific surgical strategy. | YESDespite different wording, theobjective and intent of both devicesare the same. |
| Contraindications | spineEOS is not intended to be used in thefollowing cases:Patients under the age of 7.Patients with vertebrae with congenitaldeformities (e.g., hemivertebrae, spina bifida,etc.).The 3D models delivered by sterEOS can onlybe used for diagnostic purposes in associationwith the corresponding 2D images. They areintended for the visualization of the spatialrelationship between anatomical structures anddo not allow the identification of local bonealterations such as:Bones with a significant change in geometryfollowing surgery,Fractures,OsteophytesFibrocartilage calluses | The surgical planning application iscontraindicated for cases with vertebrae withsevere congenital deformities (e.g.,hemivertebrae, spina bifida, etc.) andsupernumerary/missing vertebrae. | YESThe product's contraindicationscome from the device providing theinput data. |
| RegulatoryClass/Code | Class IILLZ(21 CFR 892.2050) | Class IILLZ(21 CFR 892.2050) | YES |
| Characteristic | Predicate DevicespineEOS (K232086) | Subject DevicespineEOS | Substantially Equivalent? |
| DeviceClassificationName | System, image processing, radiological | System, image processing, radiological | YES |
| User Population | spineEOS can only be used by a trained userincluding:Spine surgeons to define and validate thesurgical plan.EOS staff and implant distributors to define andsave the optional pre-planning. | The surgical planning application can only beused by a trained user including:Spine surgeons to define and validate thesurgical plan.EOS staff and implant distributors to define andsave the optional pre-planning. | YES |
| Target Population | The device is recommended in the preoperativeplanning of primary and revision spine surgeriesfor:Degenerative spine and adult spinal deformity.Adolescent Idiopathic Scoliosis (AIS) patients. | The product is recommended in thepreoperative planning of primary and revisionspine surgeries for:Degenerative spine and adult spinal deformity.Adolescent Idiopathic Scoliosis (AIS) patients. | YES |
| Hardware andSoftwareRequirement | Web Browsers:With Windows 10 or 11: Google Chrome inversion 111 or higher, and Edge in version111 or higher.With Mac OS Monterey or Ventura: GoogleChrome in version 111 or higher, and Safariin version 16.2 or higher.PC Configuration:A stable high speed internet connection isrequired: DSL 100Mb/s connection or higher,Wi-Fi or Ethernet.Screen Resolution:The minimum screen resolution ensuring fulldisplay of the interface is 1600 x 900. | Web Browsers:With Windows 10 or 11: Google Chrome inversion 121 or higher, and Edge in version121 or higher.With Mac OS Monterey or Ventura: GoogleChrome in version 121 or higher.PC Configuration:A stable high speed internet connection isrequired: DSL 100Mb/s connection or higher,Wi-Fi or Ethernet.Screen Resolution:The minimum screen resolution ensuring fulldisplay of the interface is 1366 x 768. | YESSafari has been removed forthe subject device |
| Input Data | Patient's informationX-rays images3D landmarks of the spine generated from VEAAlign | Patient's informationX-rays images3D landmarks of the spine generated from VEAAlign | YES |
| Product Workflow | Model Validation: allow users to validate orreject the 3D landmarks. | 3D spine reconstruction confirmation: allowusers to accept the 3D spine representation andassociated landmarks, or reject the 3D spine | YES.The name of the "ModelValidation" step has beenchanged in the subject |
| Characteristic | Predicate DevicespineEOS (K232086) | Subject DevicespineEOS | Substantially Equivalent? |
| Preoperative: allow user to consult thepreoperative state of the patientPlanning: allow user to define patient specificsurgical strategyRod: allow user to define the design of rods | representation and associated landmarks andprovide feedback on corrective adjustments.Preoperative: allow user to consult thepreoperative state of the patientPlanning: allow user to define patient specificsurgical strategyRod: allow user to define the design of rods | spineEOS to conform with thetype of input data | |
| Tools Available forPlanning | Segmental AlignmentInterbody ImplantOsteotomySpondylolisthesisRod Curvature Management | Segmental AlignmentInterbody ImplantOsteotomySpondylolisthesisRod Curvature Management | YES |
| SoftwareFunctionalities /Modalities | Obtains an image and 3D model transferredfrom other devicesProvides normative values used to follow theimpact of the planning on the patientalignmentProvides color-coded clinical parameters todisplay variance from the defined normative | Obtains an image and 3D model transferredfrom other devicesProvides normative values used to follow theimpact of the planning on the patientalignmentProvides color-coded clinical parameters todisplay variance from the defined normative | YESYESYES |
| valuesRequires human intervention forinterpretation and manipulation of images | valuesRequires human intervention forinterpretation and manipulation of images | YES | |
| Image ManipulationFunctions | 2D images and 3D model display and basicmanipulation (zoom, panning, and anglesmeasurements, plumbline, and possibility toadd comments on the image) | 2D images and 3D spine display and basicmanipulation (zoom, panning, anglesmeasurements, plumbline, and possibility toadd comments on the image) | YESThe wording referring to therepresentation of the spine in 3Ddiffers from the predicate to moreprecisely describe the spinerepresentation. However, itremains the same between thepredicate and the subjectspineEOS. |
| MeasurementFunctions | Distances and Angles | Distances and Angles | YES. |
| User Interface | Computer | Computer | YES |
| Characteristic | Predicate DevicespineEOS (K232086) | Subject DevicespineEOS | Substantially Equivalent? |
| SoftwareEnvironment | Cloud-based software | Cloud-based software | YES |
| Clinical ParametersComputation | Pelvic Tilt (PT)Sacral Slope (SS)Pelvic Incidence (PI)Pelvic Obliquity (PO)Pelvic Axial RotationSagittal Vertical Axis (SVA)C7-CSLPI-LLT1 Pelvic Angle (TPA)Cobb AngleKyphosis/Lordosis AngleKnee Flexion/Extension AngleLordosis Percentage DistributionsSpondylolisthesis grade (i.e., Slippage percentage) | Pelvic Tilt (PT)Sacral Slope (SS)Pelvic Incidence (PI)Pelvic Obliquity (PO)Sagittal Vertical Axis (SVA)C7-CSLPI-LLT1 Pelvic Angle (TPA)Cobb AngleKyphosis/Lordosis AngleKnee Flexion/Extension AngleLordosis Percentage DistributionsSpondylolisthesis grade (i.e., Slippage percentage) | YESPelvic Axial Rotation has beenremoved from the subject device.Cotyle Axis allows determination ofthe patient frame in which clinicalparameters are computed. PelvicAxial Rotation is computed basedon Cotyle Axis. So, in the patientframe the value is always 0 for thisparameter. |
| Control of Life-Saving Devices | None | None | YES |
Table 2: Summary of Predicate and Subject spineEOS Device Characteristics to Demonstrate Substantial Equivalence
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Image /page/15/Picture/0 description: The image shows the logo for EOS imaging, an adtec company. The logo is orange and features the letters "EOS" stacked on top of the word "imaging". Below "imaging" is the text "AN adtec COMPANY" in a smaller font. The logo is simple and modern, with rounded corners and a clean design.
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Image /page/16/Picture/0 description: The image shows the logo for EOS imaging, an adtec company. The logo is primarily orange. The letters "EOS" are in a stylized, sans-serif font, stacked above the word "imaging" in a smaller, sans-serif font. Below "imaging" are the words "AN adtec COMPANY" in a very small, sans-serif font.
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Image /page/17/Picture/0 description: The image shows the logo for EOS imaging, an adec company. The logo is in orange and consists of the letters "EOS" stacked on top of the word "imaging". Below "imaging" is the phrase "AN adec COMPANY" in smaller font. The logo is simple and modern, with a focus on the company's name and affiliation.
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Image /page/18/Picture/0 description: The image contains the logo for EOS imaging, an aztec company. The logo features the letters "EOS" stacked on top of the word "imaging". Below "imaging" is the text "AN aztec COMPANY". The letters "EOS" are in a bold, sans-serif font and are a bright orange color.
7 PERFORMANCE DATA
Nonclinical performance testing performed on the subject devices. VEA Align and spineEOS, supports substantial equivalence to their respective predicate devices. The following V&V testing was performed on both subject devices:
- A. Verifications activities cover the following:
- Design input review
- . Unit testing
- Software integration
- System integration ●
B. Verification performance test:
To assess the standalone performance of the Al algorithm of the VEA Align, the test was performed with:
- . A dedicated test data set containing different data from the training data set. Specifically, the test data set was not a sampling of the training data set, has never been used for the algorithm training or for tunning the algorithm and leakage between training and test data sets did not occur.
- . For each patient of this data set, a ground truth EOS 3DServices reconstruction (model) from sterEOS Workstation (K172346)that was available for comparison with the VEA Align reconstruction generated by the Al algorithm.
- A global acceptance criterion to assess the performance of the Al algorithm . predictions regarding the ground truth.
- . Subgroup analyses to assess bias and generalizability.
Training data information
The Al algorithm was trained using 10,376 X-ray images and a total of 5,188 corresponding 3D reconstructions. This training data set contained images which were collected from EOS (K152788) and EOSedge (K202394) systems at a variety of sites from 2007-2023. This population characteristics cover the intended use population. The data set ensures a variety of data for the different clinical metrics: scoliosis, postural balance, degenerative disease and spine surgery implant (preoperative and postoperative). The images were also acquired using different radiation exposure parameters and with different fields of view.
Testing data information
The testing data set consisted of 538 patients and the demographic characteristics cover the intended use population. The data set includes images from EOS (K152788) and EOSedge (K202394) systems.
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Image /page/19/Picture/0 description: The image shows the logo for EOS imaging, an adec company. The logo features the letters "EOS" in a bold, sans-serif font, with the "O" shaped like a diamond. Below the letters, the word "imaging" is written in a smaller, lowercase font. Underneath "imaging" is the text "AN adec COMPANY" in a smaller font.
Subgroup definition (generalizability)
Test data was divided according to the subgroups listed below. The subgroups are intended to demonstrate the generalizability of the algorithm.
- Demographics .
- o Age
- o Gender
- Clinical Metrics: .
- o Without spinal conditions
- o Spinal Deformity
- . Scoliosis severity
- I Postural balance severity
- o Degenerative Disease
- o Spine Surgery Implant (preoperative and postoperative)
- . Image Acquisition
- Equipment model
- Radiation exposure parameters o
- Field of view O
- Data Site Location: .
- o US vs. OUS
- Different US states O
A randomized sampling was used for each category to include an equal number of cases within each subgroup.
Acceptance criteria
For spinal landmark accuracy the metric computed was the Euclidean distance and for spinal mesh accuracy the metric computed was point to surface distance. The acceptance criteria for both landmark and mesh accuracy errors was defined as:
- Median error ≤ 3 mm .
- 3rd Quartile ≤ 5 mm
Testing summary
Direct comparison between skeletal landmark locations between the subject device and predicate VEA aliqn ( K231917) met acceptance criteria for alqorithm performance.
Direct comparison between additional spinal landmarks location between the subject device and predicate sterEOS Workstation (K172346) met acceptance criteria for algorithm performance.
Direct comparison between the 3D thoraco-lumbar mesh from subject device and the 3D thoraco-lumbar mesh from the predicate sterEOS Workstation (K172346) met the acceptance criteria demonstrating substantial equivalence of the subject device.
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Image /page/20/Picture/0 description: The image shows the logo for EOS imaging, an adtec company. The logo is primarily orange. The word "EOS" is in a bold, sans-serif font, with the "O" shaped like a diamond. Below "EOS" is the word "imaging" in a smaller, less bold font. Underneath "imaging" is the phrase "AN adtec COMPANY" in a very small font.
All those tests were performed over the whole population and for each sub-group mentioned before in order to prove the generalizability of the device performance across the different populations.
All the studies performed indicate acceptable performances of the algorithm for its intended population.
- C. Validation activities cover the following:
- Validation of the multifunctional requirements in terms of design. ●
- Usability testing was performed to demonstrate that the subject devices can be used safely by assessing and mitigating usability risks.
- Validation of the reproducibility and accuracy of clinical parameter outputs. .
8 CONCLUSION
Based on the information provided in this 510(k) submission, it was determined that the subject devices, VEA Align and spineEOS, are substantially equivalent to the legally marketed predicate devices with regards to indications for use, intended use, design, technology, and performance.
§ 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).