Syngo Carbon Clinicals is intended to provide advanced visualization tools to prepare and process the medical image for evaluation, manipulation and communication of clinical data that was acquired by the medical imaging modalities (for example, CT, MR, etc.)

OrthoMatic Spine provides the means to perform musculoskeletal measurements of the whole spine, in particular spine curve angle measurements.

The TimeLens provides the means to compare a region of interest between multiple time points.

The software package is designed to support technicians and physicians in qualitative and quantitative measurements and in the analysis of clinical data that was acquired by medical imaging modalities.

An interface shall enable the connection between the Syngo Carbon Clinicals software package and the interconnected software solution for viewing, manipulation, communication, and storage of medical images.

Device Description

Syngo Carbon Clinicals is a software only Medical Device, which provides dedicated advanced imaging tools for diagnostic reading. These tools can be called up using standard interfaces any native/syngo based viewing applications (hosting applications) that is part of the SYNGO medical device portfolio. These tools help prepare and process the medical image for evaluation, manipulation and communication of clinical data that was acquired by medical imaging modalities (e.g., MR, CT etc.)

Deployment Scenario: Syngo Carbon Clinicals is a plug-in that can be added to any SYNGO based hosting applications (for example: Syngo Carbon Space, syngo.via etc…). The hosting application (native/syngo Platform-based software) is not described within this 510k submission. The hosting device decides which tools are used from Syngo Carbon Clinicals. The hosting device does not need to host all tools from the Syngo Carbon Clinicals, a desired subset of the provided tools can be used. The same can be enabled or disabled thru licenses.

When preparing the radiologist's reading workflow on a dedicated workplace or workstation, Syngo Carbon Clinicals can be called to generate additional results or renderings according to the user needs using the tools available.

AI/ML Overview

This document describes performance evaluation for two specific tools within Syngo Carbon Clinicals (VA41): OrthoMatic Spine and TimeLens.

1. Table of Acceptance Criteria and Reported Device Performance

Feature/Tool	Acceptance Criteria	Reported Device Performance
OrthoMatic Spine	Algorithm's measurement deviations for major spinal measurements (Cobb angles, thoracic kyphosis angle, lumbar lordosis angle, coronal balance, and sagittal vertical alignment) must fall within the range of inter-reader variability.	Cumulative Distribution Functions (CDFs) demonstrated that the algorithm's measurement deviations fell within the range of inter-reader variability for the major Cobb angle, thoracic kyphosis angle, lumbar lordosis angle, coronal balance, and sagittal vertical alignment. This indicates the algorithm replicates average rater performance and meets clinical reliability acceptance criteria.
TimeLens	Not specified as a reader study/bench test was not required due to its nature as a simple workflow enhancement algorithm.	No specific quantitative performance metrics are provided, as clinical performance evaluation methods (reader studies) were deemed unnecessary. The tool is described as a "simple workflow enhancement algorithm".

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

OrthoMatic Spine:
- Test Set Sample Size: 150 spine X-ray images (75 frontal views, 75 lateral views) were used in a reader study.
- Data Provenance: The document states that the main dataset for training includes data from USA, Germany, Ukraine, Austria, and Canada. While this specifies the training data provenance, the provenance of the specific 150 images used for the reader study (test set) is not explicitly segregated or stated here. The study involved US board-certified radiologists, implying the test set images are relevant to US clinical practice.
- Retrospective/Prospective: Not explicitly stated, but the description of "collected" images and patients with various spinal conditions suggests a retrospective collection of existing exams.
TimeLens: No specific test set details are provided as a reader study/bench test was not required.

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

OrthoMatic Spine:
- Number of Experts: Five US board-certified radiologists.
- Qualifications: US board-certified radiologists. No specific years of experience are mentioned.
- Ground Truth for Reader Study: The "mean values obtained from the radiologists' assessments" for the 150 spine X-ray images served as the reference for comparison against the algorithm's output.
TimeLens: Not applicable, as no reader study was conducted.

4. Adjudication Method for the Test Set

OrthoMatic Spine: The algorithm's output was assessed against the mean values obtained from the five radiologists' assessments. This implies a form of consensus or average from multiple readers rather than a strict 2+1 or 3+1 adjudication.
TimeLens: Not applicable.

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

OrthoMatic Spine: A reader study was performed, which is a type of MRMC study. However, this was a standalone performance evaluation of the algorithm against human reader consensus, not a comparative effectiveness study with and without AI assistance for human readers. Therefore, there is no reported "effect size of how much human readers improve with AI vs without AI assistance." The study aimed to show the algorithm replicates average human rater performance.
TimeLens: Not applicable.

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

OrthoMatic Spine: Yes, a standalone performance evaluation of the OrthoMatic Spine algorithm (without human-in-the-loop assistance) was conducted. The algorithm's measurements were compared against the mean values derived from five human radiologists.
TimeLens: The description suggests the TimeLens tool itself is a "simple workflow enhancement algorithm" and its performance was evaluated through non-clinical verification and validation activities rather than a specific standalone clinical study with an AI algorithm providing measurements.

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

OrthoMatic Spine:
- For the reader study (test set performance evaluation): Expert consensus (mean of five US board-certified radiologists' measurements) was used to assess the algorithm's performance.
- For the training set: The initial annotations were performed by trained non-radiologists and then reviewed by board-certified radiologists. This can be considered a form of expert-verified annotation.
TimeLens: Not specified, as no clinical ground truth assessment was required.

8. The Sample Size for the Training Set

OrthoMatic Spine:
- Number of Individual Patients (Training Data): 6,135 unique patients.
- Number of Images (Training Data): A total of 23,464 images were collected within the entire dataset, which was split 60% for training, 20% for validation, and 20% for model selection. Therefore, the training set would comprise approximately 60% of both the patient count and image count. So, roughly 3,681 patients and 14,078 images.
TimeLens: Not specified.

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

OrthoMatic Spine: Most images in the dataset (used for training, validation, and model selection) were annotated using a dedicated annotation tool (Darwin, V7 Labs) by a US-based medical data labeling company (Cogito Tech LLC). Initial annotations were performed by trained non-radiologists and subsequently reviewed by board-certified radiologists. This process was guided by written guidelines and automated workflows to ensure quality and consistency, with annotations including vertebral landmarks and key vertebrae (C7, L1, S1).
TimeLens: Not specified.

Summary

FDA 510(k) Clearance Letter - Syngo Carbon Clinicals (VA41)

Page 1

U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov

Doc ID # 04017.08.00

October 24, 2025

Siemens Healthineers AG
Vijay Ramadas
Regulatory Affairs Manager
Siemensstraße 3
Forchheim, Bayern 91301
Germany

Re: K251059
Trade/Device Name: Syngo Carbon Clinicals (VA41)
Regulation Number: 21 CFR 892.2050
Regulation Name: Medical Image Management And Processing System
Regulatory Class: Class II
Product Code: QIH
Dated: September 18, 2025
Received: September 18, 2025

Dear Vijay Ramadas:

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.

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K251059 - Vijay Ramadas Page 2

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 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 (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-reporting-combination-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.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

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-devices/medical-device-safety/medical-device-reporting-mdr-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/medical-devices/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-devices/device-advice-comprehensive-regulatory-

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K251059 - Vijay Ramadas Page 3

assistance/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
Assistant Director
Imaging Software Team
DHT8B: Division of Radiologic Imaging
Devices and Electronic Products
OHT8: Office of Radiological Health
Office of Product Evaluation and Quality
Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120
Expiration Date: 06/30/2023
See PRA Statement below.

510(k) Number (if known)
K251059

Device Name
Syngo Carbon Clinicals (VA41)

Indications for Use (Describe)

OrthoMatic Spine provides the means to perform musculoskeletal measurements of the whole spine, in particular spine curve angle measurements.

The TimeLens provides the means to compare a region of interest between multiple time points.

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services
Food and Drug Administration
Office of Chief Information Officer
Paperwork Reduction Act (PRA) Staff
PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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K251059
510(k) for Syngo Carbon Clinicals Page -1
18-September-2025

510(k) Summary

This summary of 510(k) substantial equivalence information is being submitted in accordance with the requirements of 21 CFR §807.92.

1. Submitter:

Siemens Healthineers AG
Siemensstrasse 1
91301 Forchheim
Germany

2. Contact Person:

Mr. Vijay Ramadas
Regulatory Affairs Manager
Siemens Healthineers AG
Siemensstr. 3
91301 Forchheim
Germany

E-mail: vijay.ramadas@siemens-healthineers.com
Telephone: +49 (172) 4324369
Fax: +49 (9191) 18-4404

3. Device Name and Classification

Device/Trade Name: Syngo Carbon Clinicals
Classification Panel: Radiology Devices
Classification Number: 21 CFR 892.2050
Classification Name: Medical Image Management and Processing System
Device Class: Class II
Product Code: QIH

4. Predicate Device(s):

Main Predicate Device

Device/Trade Name: Syngo Carbon Clinicals
510(k) Clearance: K232856
Classification Panel: Radiology Devices
Classification Number: 21 CFR 892.2050
Classification Name: Medical Image Management and Processing System
Device Class: Class II
Product Code: QIH

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©Siemens Healthineers AG, 2025
Page -2 510(k) for Syngo Carbon Clinicals

5. Device Description:

6. Intended/Indications for use:

OrthoMatic Spine provides the means to perform musculoskeletal measurements of the whole spine, in particular spine curve angle measurements.

The TimeLens provides the means to compare a region of interest between multiple time points.

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©Siemens Healthineers AG, 2025
510(k) for Syngo Carbon Clinicals Page -3

7. Technological Characteristics:

The Syngo Carbon Clinicals plug-in provides the below listed tools.

Cinematic insight – An advanced visualization tool for cinematic rendering of anatomical structures using presets
Manual Calibration – The Calibration tool is used manually calibrate non-calibrated images to enable measurement on such images
Basic Onco Tools
- Assisted Perpendicular – Tool to draw perpendicular distance lines to perform diameter measurements and thus to evaluate lesions
- Lesion Quantification – Tool to perform diameter measurements (longest diameter, perpendicular diameter) and to create segmentation objects of suspect lesions in lung parenchyma with one click (semi automatically)
- Lung Nodule Marker – Tool used to evaluate lung parenchyma for suspect lesions. This tool can also be used to evaluate lesions across different time points
OrthoMatic Spine – An interactive tool that provides automated calculation of spine measurements in CR and DX images of the entire spine in Frontal and Lateral acquisition
Time Lens – A tool that compares a region of interest between multiple timepoints

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©Siemens Healthineers AG, 2025
Page -4 510(k) for Syngo Carbon Clinicals

8. Summary of Differences between the Subject Device and the Predicate Device:

The differences between the subject device described in this premarket notification and the predicate device are summarized in the following comparison table:

Specification	Subject Device	Predicate Device	Comparison
Device name and version	Syngo Carbon Clinicals (VA41) K251059	Syngo Carbon Clinicals (VA30) K232856	New version of the predicate device with added features
Indications for use	Syngo Carbon Clinicals is intended to provide advanced visualization tools to prepare and process the medical image for evaluation, manipulation and communication of clinical data that was acquired by the medical imaging modalities (for example, CT, MR, etc.)OrthoMatic Spine provides the means to perform musculoskeletal measurements of the whole spine, in particular spine curve angle measurements.The TimeLens provides the means to compare a region of interest between multiple time points.The software package is designed to support technicians and physicians in qualitative and quantitative measurements and in the analysis of clinical data that was acquired by medical imaging modalities.An interface shall enable the connection between the Syngo Carbon Clinicals software package and the interconnected software solution for viewing, manipulation, communication, and storage of medical images.	Syngo Carbon Clinicals is intended to provide advanced visualization tools to prepare and process the medical image for evaluation, manipulation and communication of clinical data that was acquired by the medical imaging modalities (for example, CT, MR, etc.)The software package is designed to support technicians and physicians in qualitative and quantitative measurements and in the analysis of clinical data that was acquired by medical imaging modalities.An interface shall enable the connection between the Syngo Carbon Clinicals software package and the interconnected software solution for viewing, manipulation, communication, and storage of medical images.	Indications adapted to include the new features
Contraindications	Syngo Carbon Clinicals is not indicated for mammography images for diagnosis in the U.S.Syngo Carbon Clinicals is not to be used as a sole basis for clinical decisions	Syngo Carbon Clinicals is not indicated for mammography images for diagnosis in the U.S.Syngo Carbon Clinicals is not to be used as a sole basis for clinical decisions	Same

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©Siemens Healthineers AG, 2025

Specification	Subject Device	Predicate Device	Comparison
Software architecture	Syngo Carbon Clinicals has architecture that is based on a layered pattern where the various clinical tools/functionality are decomposed into modules/common tools which provide their individual functionalities.	Syngo Carbon Clinicals has architecture that is based on a layered pattern where the various clinical tools/functionality are decomposed into modules/common tools which provide their individual functionalities.	Same
Image communication	Syngo Carbon Clinicals relies on the interfacing application for Image communication.	Syngo Carbon Clinicals relies on the interfacing application for Image communication.	Same
Image display algorithms	• Rendering Tools: Cinematic Insight	• Rendering Tools: Cinematic Insight	Same
Measurement, Evaluation/Interpretation Tools	• Oncological evaluation: - Lesion Quantification - Assisted Perpendicular Tool - Lung Nodule Marker - Time Lens• Orthopaedic measurements: - Manual calibration - OrthoMatic Spine	• Oncological evaluation: - Lesion Quantification - Assisted Perpendicular Tool - Lung Nodule Marker• Orthopaedic measurements: - Manual calibration	Time Lens tool enables comparison of a region of interest between multiple timepoints.OrthoMatic Spine tool provides automated calculation of spine measurements in CR and DX images.
Supported objects for display	DICOM image object display• CT Image• DX Image• CR Image	DICOM image object display• CT Image• DX Image• CR Image	Same

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Specification	Subject Device	Predicate Device	Comparison
Operating system	NoneSyngo Carbon Clinicals relies on the interfacing application for operating system.	NoneSyngo Carbon Clinicals relies on the interfacing application for operating system.	Same
Impact on Image Acquisition Devices	NoneSyngo Carbon Clinicals provides advanced visualization tools to prepare and process the medical images and it has no influence on the image acquisition devices	NoneSyngo Carbon Clinicals provides advanced visualization tools to prepare and process the medical images and it has no influence on the image acquisition devices	Same
CAD Functionalities	NoneNo automated diagnostic interpretation capabilities like CAD are included. All image data are to be interpreted by trained personnel.	NoneNo automated diagnostic interpretation capabilities like CAD are included. All image data are to be interpreted by trained personnel.	Same
Clinical condition the device is intended to diagnose, treat, or manage	No limitation on the clinical condition of the patient	No limitation on the clinical condition of the patient	Same
Intended patient population	No limitation concerning the patient population (e.g., age, weight, health, condition)	No limitation concerning the patient population (e.g., age, weight, health, condition)	Same
Site of the body the device is intended to be used	No limitation concerning region of body or tissue type	No limitation concerning region of body or tissue type	Same
Intended use environment	Syngo Carbon Clinicals offers a wide range of tools from the major clinical fields, i.e. general radiology, oncology environments.	Syngo Carbon Clinicals offers a wide range of tools from the major clinical fields, i.e. general radiology, oncology environments.	Same
Intended user(s)	Trained healthcare professionals	Trained healthcare professionals	Same
Device Type	Software application	Software application	Same

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Specification	Subject Device	Predicate Device	Comparison
Cyber Security	The cybersecurity aspects for Syngo Carbon Clinicals is handled by the interfacing/hosting system.	The cybersecurity aspects for Syngo Carbon Clinicals is handled by the interfacing/hosting system.	Same
Graphical user interface	Not offered by Syngo Carbon Clinicals, it relies on the hosting applications	Not offered by Syngo Carbon Clinicals, it relies on the hosting applications	Same
Image Archiving	Not offered by Syngo Carbon Clinicals	Not offered by Syngo Carbon Clinicals	Same
Annotation Tool	Not offered by Syngo Carbon Clinicals	Not offered by Syngo Carbon Clinicals	Same
Printing	Not offered by Syngo Carbon Clinicals	Not offered by Syngo Carbon Clinicals	Same
Online help system	Yes, with search, indexing, filtering, library function and document collections	Yes, with search, indexing, filtering, library function and document collections	Same

Page -4 510(k) for Syngo Carbon Clinicals

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9. Clinical Testing

No clinical studies were carried out for the product, all performance testing was conducted in a non-clinical fashion as part of verification and validation activities of the medical device

10. Performance Evaluation Summary

Orthomatic Spine:

A. Summary Test Statistics and Acceptance Criteria

A reader study was performed utilizing 150 spine X-ray images (comprising 75 frontal and 75 lateral views) and included five US board-certified radiologists. The OrthoMatic Spine core algorithm's outputs for six primary spinal measurements—Cobb angles, coronal balance, kyphosis angle, lordosis angle, and sagittal vertical alignment—were assessed against the mean values obtained from the radiologists' assessments.

Algorithm performance was evaluated using cumulative distribution functions (CDFs), which demonstrated that the algorithm's measurement deviations fell within the range of inter-reader variability for the major Cobb angle, thoracic kyphosis angle, lumbar lordosis angle, coronal balance, and sagittal vertical alignment. These findings indicate that the algorithm closely replicates average rater performance and satisfies the predetermined clinical reliability acceptance criteria.

B. Number of Individual Patients

The main dataset used for training includes 6,135 unique patients, with most undergoing one or two full-spine imaging exams.

C. Number of Samples and Relationship to Patients

A total of 23,464 images were collected, including multiple image types per patient (e.g., frontal, lateral, partial spine views).

D. Demographic Distribution

i. Gender: 56% Female, 36% Male, 8% Unknown.
ii. Age: Patients span from 5 to 85 years, with at least 200 images per 5-year interval.
iii. Geographic Location: Data collected from USA, Germany, Ukraine, Austria and Canada.

Note: It is notable that young female patients are overrepresented in the study dataset

E. Clinical Subgroups and Confounders

The dataset includes patients with various spinal conditions, notably adolescent idiopathic scoliosis. Confounders include variability in imaging protocols and equipment, differences in image quality, and images with and without pathologies.

F. Equipment and Protocols Used

Images were acquired using systems from a wide range of manufacturers, including Siemens Healthineers (38%), EOS imaging (17%), Agfa (16%), KODAK (11%), KONICA MINOLTA (8%), Canon Inc. (2%), GE Healthcare (2%), and others. This diversity supports the algorithm's generalizability across imaging platforms.

G. Reference Standard Derivation (Truthing Process)

Most of the images were annotated using a dedicated annotation tool (Darwin, V7 Labs) by US-based medical data labeling company (Cogito Tech LLC). Initial annotations were performed by trained non-radiologists and reviewed by board-certified

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radiologists. Annotations included vertebral landmarks and key vertebrae (C7, L1, S1). The process was guided by written guidelines and automated workflows to ensure quality and consistency.

H. Independence of Test Data from Training Data

The dataset was split into 60% for training, 20% for validation, and 20% for model selection. Splitting was done at the patient level, ensuring no overlap between subsets. Stratification ensured balanced representation across data sources and patient positions.

TimeLens:

There is no reader study/bench test that was required for the TimeLens tool as the AI algorithm is very simple workflow enhancement algorithm and the above criteria does not affect the algorithm.

11. Non-clinical Performance Testing:

Non-clinical tests were conducted for the subject device during product development. The modifications described in this Premarket Notification were supported with verification and validation testing.

Siemens Healthcare GmbH claims conformance to the following standards:

ISO 14971 Third Edition 2019-12
IEC 62304 Edition 1.1 2015-06 CONSOLIDATED VERSION
IEC 82304-1 Edition 1.0 2016-10
IEC 62366-1 Edition 1.1 2020-06 CONSOLIDATED VERSION

12. Software Verification and Validation:

Software documentation for a Moderate Level of Concern software per FDA's Guidance Document "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" is also included as part of this submission. The performance data demonstrates continued conformance with special controls for medical devices containing software. Non-clinical tests were conducted on the device Syngo Carbon Clinicals during product development.

The Risk Analysis was completed, and risk control implemented to mitigate identified hazards. The testing results support that all the software specifications have met the acceptance criteria. Testing for verification and validation for the device was found acceptable to support the claims of substantial equivalence.

Siemens Healthcare GmbH conforms to the Cybersecurity requirements by implementing a process of preventing unauthorized access, modifications, misuse or denial of use, or the unauthorized use of information that is stored, accessed, or transferred from a medical device to an external recipient. Contained in this submission are our cybersecurity considerations as they relate to the device Syngo Carbon Clinicals.

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13. Conclusion as to Substantial Equivalence:

The predicate device was cleared based on non-clinical supportive information. The comparison of technological characteristics, device hazards, non-clinical performance data, and software validation data demonstrates that the subject device performs comparably to and is as safe and effective as the predicate device that is currently marketed for the same intended use.

In summary, we are of the opinion that the subject device Syngo Carbon Clinicals, software version VA41, does not introduce any new significant potential safety risks and is substantially equivalent to and performs as well as the predicate device Syngo Carbon Clinicals VA30.

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).