The various materials of an anatomical region of interest have different attenuation coefficients, which depend on the used energy. These differences provide information on the chemical composition of the scanned body materials. syngo.CT Dual Energy combines images acquired with low and high energy spectra to visualize this information. Depending on the region of interest, contrast agents may be used.

The general functionality of the syngo.CT Dual Energy application is as follows:

· Monoenergetic 1)
· Brain Hemorrhage
· Gout Evaluation
· Lung Vessels
· Heart PBV
· Bone Removal
· Lung Perfusion
· Liver VNC
· Monoenergetic Plus 1)
· Virtual Unenhanced 1)
Bone Marrow
· Hard Plaques
Rho/Z
· Kidney Stones 2)
· SPR (Stopping Power Ratio)
· SPP (Spectral Post-Processing Format) 1)
· Optimum Contrast 1)

The availability of each feature depends on the Dual Energy scan mode.

This functionality supports data from Photon-Counting CT scanners.
Kidney Stones is designed to support the visualization of the chemical composition of kidney stones and especially the differentiation between uric acid stones. For full identification of the kidney stone, additional clinical information should be considered such as patient history and urine testing. Only a well-trained radiologist can make the final diagnosis upon consideration of all available information. The accuracy of identification is decreased in obese patients.

Device Description

Dual energy offers functions for qualitative and quantitative post-processing evaluations. syngo.CT Dual Energy is a post-processing application consisting of several post-processing application classes that can be used to improve the visualization of the chemical composition of various energy dependent materials in the human body when compared to single energy CT. Depending on the organ of interest, the user can select and modify different application classes or parameters and algorithms.

Different body regions require specific tools that allow the correct evaluation of data sets. syngo.CT Dual Energy provides a range of application classes that meet the requirements of each evaluation type. The different application classes for the subject device can be combined into one workflow.

AI/ML Overview

Based on the provided text, the acceptance criteria and the study proving the device meets these criteria can be summarized as follows:

The document describes software verification and validation, non-clinical testing, and an evaluation of specific application classes for Photon Counting Data. However, it does not provide a quantitative table of acceptance criteria for specific performance metrics (e.g., sensitivity, specificity, accuracy) or detailed clinical study results with human readers (MRMC study). The testing described focuses on technical performance and consistency with expected phantom values and visual comparison with clinical data, rather than diagnostic accuracy or clinical effectiveness in a human-in-the-loop setting.

Here's a breakdown of the available information:

1. Acceptance Criteria and Reported Device Performance

The document states that "all software specifications have met the acceptance criteria" and "The testing results support that all the software specifications have met the acceptance criteria." However, the document does not explicitly list the specific acceptance criteria in a table format with corresponding reported device performance values for metrics like accuracy, sensitivity, or specificity.

Instead, the performance data provided focuses on:

Software Verification and Validation: Conformance with "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices," risk analysis completion, and mitigation of identified hazards.
Non-Clinical Testing: Integration and functional tests were conducted to demonstrate the ability of included features. "The results of these tests demonstrate that the subject device performs as intended."
Evaluation of application classes for Photon Counting Data:
- Monoenergetic Plus application class: "calculated values from phantom scans agreed well with the expected ones. Clinical data showed no artifacts. The iodine contrast clearly increased with lower keV settings and decreased with higher ones."
- Virtual Unenhanced application class: "demonstrated that virtual non-contrast images and iodine concentration can be calculated from spectral data acquired at the NAEOTOM Alpha." In phantom scans, "the measured iodine concentration agrees well with the known iodine concentration. The VNC values are good approximations of the expected water value for all tested iodine concentrations." In clinical data, "the image impression of the virtual non-contrast images was compared with true non-contrast images. Measurements showed good agreement of CT values in the VNCs with the values in the TNCs."

No quantitative performance metrics (e.g., sensitivity, specificity, AUC) or a direct comparison to specific numerical acceptance criteria are provided in the document.

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

The document mentions "phantom scans" and "clinical data" for the evaluation of the Monoenergetic Plus and Virtual Unenhanced application classes.

Phantom Scans: "Multi-Energy CT Phantom (Sun Nuclear Corporation, Melbourne, Florida, USA) was scanned at a NAETOM Alpha."
Clinical Data: Used for visual comparison and measurement of CT values. The text refers to "clinical data" in general without specifying the sample size (number of patients/cases).
Data Provenance: Not specified (e.g., country of origin). The data from the NAETOM Alpha appears to be prospectively acquired for testing purposes. It is not stated whether the clinical data used for comparison was retrospective or prospective.

3. Number of Experts Used to Establish Ground Truth and Qualifications

The document mentions that for the Kidney Stones feature, "Only a well-trained radiologist can make the final diagnosis upon consideration of all available information." However, it does not specify the number of experts used to establish ground truth for the test set or their specific qualifications (e.g., years of experience, subspecialty) for the evaluations described (phantom studies or clinical data comparisons).

4. Adjudication Method for the Test Set

The document does not describe any formal adjudication method (e.g., 2+1, 3+1 consensus) for establishing ground truth for the "clinical data" used. The evaluations seem to rely on technical comparisons for phantom data and general observation/measurement agreement for clinical data.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC comparative effectiveness study was conducted or reported. The submission focuses on technical validation and comparison of the device's outputs to expected values and impressions, rather than measuring human reader performance with and without AI assistance.

6. Standalone (Algorithm Only) Performance Study

The study appears to be an algorithm-only performance evaluation in terms of its ability to generate specific types of images/data (monoenergetic images, virtual non-contrast images, iodine concentrations) and the agreement of these outputs with expected or true values (for phantom data) and visual/measurement comparisons (for clinical data). However, no specific standalone diagnostic performance metrics (e.g., sensitivity, specificity for disease detection) are reported.

7. Type of Ground Truth Used

Technical/Physical Ground Truth: For phantom studies, the "known iodine concentration" and "expected" values serve as ground truth.
Reference Image Ground Truth: For the Virtual Unenhanced application, "true non-contrast images" are used as a reference for comparison.
Expert Interpretive Ground Truth: While "well-trained radiologist" is mentioned in the Indications for Use for Kidney Stones, the actual methodology for establishing ground truth for the clinical data used in the evaluation is not detailed beyond "image impression" and "measurements." It's an implicit expert consensus by a "well-trained radiologist" who would interpret the images, but the methodology for establishing this is not formalized in the provided text.

8. Sample Size for the Training Set

The document does not specify the sample size for the training set used to develop the syngo.CT Dual Energy algorithms. The focus of this submission is on verification and validation of a device modification, not initial algorithm development.

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

The document does not describe how the ground truth for the training set was established, as it pertains to the validation of a device modification rather than the initial algorithm development.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there is a symbol representing the Department of Health & Human Services. To the right of the symbol, there is the FDA logo in blue, followed by the words "U.S. FOOD & DRUG" in a larger font and "ADMINISTRATION" in a smaller font below it, also in blue.

March 28, 2022

Siemens Medical Solutions USA Inc. % Clayton Ginn Regulatory Affairs Specialist 810 Innovation Drive KNOXVILLE TN 37932

Re: K212889

Trade/Device Name: Syngo.CT Dual Energy Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: Class II Product Code: JAK Dated: February 24, 2021 Received: February 25, 2021

Dear Clayton Ginn:

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 (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 located 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.

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

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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 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 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 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 mediation-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,

Laurel Burk, Ph.D. Diagnostic X-ray Systems Team Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K212889

Device Name syngo.CT Dual Energy

Indications for Use (Describe)

syngo.CT Dual Energy is designed to operate with CT images based on two different X-ray spectra.

The general functionality of the syngo.CT Dual Energy application is as follows:

· Monoenergetic 1)
· Brain Hemorrhage
· Gout Evaluation
· Lung Vessels
· Heart PBV
· Bone Removal
· Lung Perfusion
· Liver VNC
· Monoenergetic Plus 1)
· Virtual Unenhanced 1)
Bone Marrow
· Hard Plaques
Rho/Z
· Kidney Stones 2)
· SPR (Stopping Power Ratio)
· SPP (Spectral Post-Processing Format) 1)
· Optimum Contrast 1)

The availability of each feature depends on the Dual Energy scan mode.

This functionality supports data from Photon-Counting CT scanners.
Kidney Stones is designed to support the visualization of the chemical composition of kidney stones and especially the differentiation between uric acid stones. For full identification of the kidney stone, additional clinical information should be considered such as patient history and urine testing. Only a well-trained radiologist can make the final diagnosis upon consideration of all available information. The accuracy of identification is decreased in obese patients.

Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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510(k) Summary

FOR

syngo.CT Dual Energy

K212889

Identification of the Submitter l.

Importer/Distributor

Siemens Medical Solutions USA, Inc. 40 Liberty Boulevard Malvern, PA 19355

Establishment Registration Number

2240869

Manufacturing Site

Siemens Healthcare GmbH Siemensstr 1 D-91301 Forchheim, Germany

Establishment Registration Number

3004977335

Submitter Contact Person:

Clayton Ginn Regulatory Affairs Specialist Siemens Medical Solutions, Inc. USA 810 Innovation Drive Knoxville, TN 37932 Phone: (865) 898-2692 Email: clayton.ginn@siemens-healthineers.com

II. Device Name and Classification

Product Name:	syngo.CT Dual Energy
Propriety Trade Name:	syngo.CT Dual Energy
Classification Name:	Computed Tomography X-ray System
Classification Panel:	Radiology
CFR Section:	21 CFR §892.1750
Device Class:	Class II
Product Code:	JAK

Predicate Device III.

Trade Name:	syngo.CT Dual Energy
510(k) Number:	K191468
Clearance Date:	07/03/2019
Classification Name:	Computed Tomography X-ray System
Classification Panel:	Radiology

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CFR Section:	21 CFR §892.1750
Device Class:	Class II
Product Code:	JAK

IV. Device Description

Modifications

A listing of device modifications for the software version SOMARIS/8 VB60 is as follows:

SPP data from Siemens Photon Counting Computed Tomography (PCCT) data can be loaded into syngo.CT Dual Energy. For PCCT data, monoenergetic images at 70keV are shown for initial reading instead of the mixed images used for the scan modes Dual Source, Twin Beam, and Twin Spiral. The application classes Virtual Unenhanced and Monoenergetic Plus are supported for PCCT data.
There are no relevant changes for the three DE scan modes Dual Source, Twin Beam, and Twin Spiral.

V. Indications for Use

syngo.CT Dual Energy is designed to operate with CT images based on two different X-ray spectra.

The general functionality of the syngo.CT Dual Energy application is as follows:

· Monoenergetic1)
. Brain Hemorrhage
. Gout Evaluation
Lung Vessels
Heart PBV
. Bone Removal
Lung Perfusion
· Liver VNC
. Monoenergetic Plus1)
Virtual Unenhanced1)
. Bone Marrow
Hard Plaques
Rho/Z

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Kidney Stones2)
· SPR (Stopping Power Ratio)
· SPP (Spectral Post-Processing Format)1)
· Optimum Contrast1)

The availability of each feature depends on the Dual Energy scan mode.

1. This functionality supports data from Photon-Counting CT scanners.
1. Kidney Stones is designed to support the visualization of the chemical composition of kidney stones and especially the differentiation between uric acid and non-uric acid stones. For full identification of the kidney stone, additional clinical information should be considered such as patient history and urine testing. Only a well-trained radiologist can make the final diagnosis upon consideration of all available information. The accuracy of identification is decreased in obese patients.

VI. Comparison of Technological Characteristics with the Predicate Device

The differences and similarities between the above referenced predicate device are listed at a highlevel in the following table:

Feature	Subject Device	Predicate Device
	syngo.CT Dual Energy(SOMARIS/8 VB60)	syngo.CT Dual Energy(SOMARIS/8 VB40, K191468)
Data Acquisition Mode	The subject device provides post-processing application classes for all fourdata acquisition modes acquiring imagesfrom Dual Source scanners, Dual EnergySingle Source, Twin Beam and PhotonCounting scanners (PCCT).Comparison:The subject device supports newly thepost-processing of DICOM image dataacquired from Photon Counting scanners.The clinical algorithms of the post-processing application classes remainunchanged.	The subject device provides post-processing application classes for all threedata acquisition modes acquiring imagesfrom Dual Source scanners, Dual EnergySingle Source, and Twin Beam scanners.

While SPP data from Photon-Counting CTs can now be viewed using the general viewing functions and the Virtual Unenhanced and Monoenergetic Plus application classes, the remaining application classes in syngo.CT Dual Energy remain unchanged compared to the predicate version.

VII. Performance Data

The following performance data were provided in support of the substantial equivalence determination.

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" issued on May 11, 2005 is also included as part of this submission. The performance data demonstrates continued conformance with special controls for medical devices containing software. The Risk Analysis was completed, and risk control implemented to mitigate identified hazards. The testing supports that all software specifications have met the acceptance criteria. Testing for verification and validation support the claim of substantial equivalence.

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Non-Clinical Testing

This submission contains performance tests (Non-clinical test reports) to demonstrate continued conformance with special controls for medical devices containing software. Non-clinical tests (integration and functional) were conducted for syngo.CT Dual Energy functionality during product development. These tests have been performed to test the ability of the included features of the subject device. The results of these tests demonstrate that the subject device performs as intended. The result of all conducted testing was found acceptable to support the claim of substantial equivalence.

Summary of the Evaluation of application classes for Photon Counting Data.

The subject device extends the application classes Monoenergetic Plus and Virtual Unenhanced for Photon Counting Data.

For a technical evaluation, the Multi-Energy CT Phantom (Sun Nuclear Corporation, Melbourne, Florida, USA) was scanned at a NAETOM Alpha (K211591)1

For the Monenergetic Plus application class, the calculated values from phantom scans agreed well with the expected ones. Clinical data showed no artifacts. The iodine contrast clearly increased with lower keV settings and decreased with higher ones.

For the Virtual Unenhanced application class it was demonstrated that virtual non-contrast images and iodine concentration can be calculated from spectral data acquired at the NAEOTOM Alpha.

In phantom scans, the measured iodine concentration agrees well with the known iodine concentration. The VNC values are good approximations of the expected water value for all tested iodine concentrations.

In clinical data, the image impression of the virtual non-contrast images was compared with true non-contrast images. Measurements showed good agreement of CT values in the VNCs with the values in the TNCs.

However, it has not been claimed that the VNC can fully substitute a true non-contrast image. In the clinical application of CT imaging, there is always a trade-off between radiation dose and accuracy. Replacing the non-contrast scan with a VNC might save dose, but if the VNC is suitable to answer a specific clinical question cannot be decided here.

Risk Analysis

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 of the device was found acceptable to support the claims of substantial equivalence.

Siemens hereby certifies that syngo.CT Dual Energy meets the following FDA Recognized Consensus standards listed on the next page:

¹ Display of data specific to new scanners are only applicable after the scanners are commercially available in their own right. This feature is not functional prior to that.

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RecognitionNumber	ProductArea	Title of Standard	Date ofRecognition	StandardsDevelopmentOrganization
12-300	Radiology	Digital Imaging and Communications inMedicine (DICOM) Set; PS 3.1 - 3.20	06/27/2016	NEMA
13-79	Software	Medical Device Software –Software Life CycleProcesses; 62304:2006 (1st Edition)/A1:2016	01/14/2019	AAMI, ANSI, IEC
5-125	Software/Informatics	Medical devices – Application of riskmanagement to medical devices; 14971 ThirdEdition 2019-12	12/23/2019	ISO
5-114	General I(QS/RM)	Medical devices - Part 1: Application ofusability engineering to medical devicesIEC 62366-1:2015	12/23/2016	IEC
5-117	General I(QS/RM)	Medical devices - Symbols to be used withmedical device labels, labelling, andinformation to be supplied - Part 1: Generalrequirements	08/21/2017	ISO

VIII. Conclusion

syngo.CT Dual Energy has the same intended use and same indication for use as the predicate device.

The subject device syngo.CT Dual Energy does not have changes in fundamental scientific technology compared to the predicate devices. The technological characteristics such as image visualization, operating platform, and image measurement are the same as the predicate device.

For the subject device, syngo.CT Dual Energy, Siemens used the same testing with the same workflows as used to clear the predicate device. Siemens considers syngo.CT Dual Energy to be as safe, as effective, and with performance substantially equivalent to the commercially available predicate device.

Regulation Number and Section

§ 892.1750 Computed tomography x-ray system.

(a)
Identification. A computed tomography x-ray system is a diagnostic x-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.