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

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

*) 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 under consideration of all available information. The accuracy of identification is decreased in obese patients.

Device Description

syngo.CT Dual Energy is a post-processing application consisting of several postprocessing application classes that can be used to improve visualization of various energy dependent materials in the human body. This software application is designed to operate on the most recent version syngo.via client/server platform, which supports preprocessing and loading of datasets by syngo.via depending on configurable rules.

These application classes are designed for specific clinical tasks, so that algorithms, additional tool buttons, the use of colored overlay images and image representation (for example MPR or maximum intensity projection) is optimized correspondingly.

AI/ML Overview

The provided text describes the syngo.CT Dual Energy device and its substantial equivalence to predicate devices, but it does not contain a specific table of acceptance criteria with reported device performance for a multi-reader multi-case (MRMC) study or standalone AI performance.

The document primarily focuses on establishing substantial equivalence based on the device's technological characteristics, adherence to standards, and functionality being similar to existing cleared devices. It states that "the post-processing software functionality remains unchanged from the subject device and the predicate devices."

However, based on the information provided, I can infer some aspects and highlight what is missing.

Here's an analysis of the acceptance criteria and study information, addressing each of your points based only on the provided text:

Acceptance Criteria and Device Performance (Inferred/Missing)

The document does not explicitly present a table of quantitative acceptance criteria for clinical performance (e.g., sensitivity, specificity, accuracy for a specific disease detection task) or corresponding reported device performance values. The clearance is based on the device having "the same intended use and similar indication for use" and "technological characteristics such as image visualization, operating platform, and image manipulation are the same as the predicate devices."

The closest the document comes to performance assessment is for the new features (SPR and SPP) and the revalidation of existing features for the combined application:

For SPR (Stopping Power Ratio): "the report shows that the SPR feature can reproduce the theoretical SPR values of the phantom inserts used from Dual Energy CT scans."
For SPP (Spectral Post-Processing Format): "the combination of the SPP-generation process produces equivalent results to the reference method based on functionality available in the predicate device(s). This means also that the information in the SPP-format (including all hidden data) was correctly calculated."
For other application classes (Rho/Z, Kidney Stones, Monoenergetic Plus, Bone Removal, Liver VNC, Hard Plaques): "These studies demonstrate that the subject device performs as well as the predicate device applications that were tested using the same methods."

Since no specific quantitative metrics or a defined Acceptance Criteria table with Reported Performance are present in the provided text, that section cannot be filled out as requested. The basis for acceptance is stated as "The result of all conducted testing was found acceptable to support the claim of substantial equivalence," implying that the performance matched the predicate devices or theoretical expectations for new features.

Detailed Study Information from the Text:

A table of acceptance criteria and the reported device performance:
- Not provided in the document. The document describes functional equivalence and performance "as well as" predicate devices or theoretical values for new features, but no specific quantitative acceptance criteria or reported values are presented in a table.
Sample sizes used for the test set and the data provenance:
- Test Set Sample Size: The document mentions "phantom-based validation" for SPR and SPP, and "phantom bench testing and clinical validation in a retrospective study" for Rho/Z and Kidney Stones. "Retrospective clinically validated studies" were also conducted for Monoenergetic Plus, Bone Removal, Liver VNC, and Hard Plaques.
  - Specific numbers for phantom or clinical cases are NOT provided.
- Data Provenance: "clinical validation in a retrospective study was conducted." The geographic origin of the data (country of origin) is NOT specified. The studies are explicitly stated as retrospective.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of Experts: The document states for Kidney Stones: "Only a well-trained radiologist can make the final diagnosis under consideration of all available information." This implies expert involvement for ground truth, but the specific number of experts used for ground truth establishment for any of the test sets is NOT provided.
- Qualifications of Experts: For Kidney Stones, "a well-trained radiologist" is mentioned. Specific experience (e.g., 10 years) is NOT provided.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- NOT specified.
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 is explicitly mentioned or described. The device is a "post-processing application" that "improves visualization" and helps in "differentiation." The focus is on the device's performance per se and its equivalence to predicate devices, not on human reader improvement with or without AI assistance. The term "AI" is not used; it's described as software providing "visualization" and "evaluation tools."
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- The evaluations for SPR and SPP ("reproduce the theoretical SPR values," "produces equivalent results to the reference method") appear to be standalone algorithm performance tests using phantoms.
- For the other clinical application classes, the description "demonstrate that the subject device performs as well as the predicate device applications" suggests an assessment of the algorithm's output, which would be standalone, but this is not explicitly delineated from a human-in-the-loop study. Given it's a post-processing application, the algorithm's output is what's being evaluated.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Theoretical values/Reference methods: For SPR (theoretical values) and SPP (reference method based on predicate device functionality).
- Clinical validation: For Rho/Z, Kidney Stones, Monoenergetic Plus, Bone Removal, Liver VNC, and Hard Plaques, it states "clinical validation" and "clinically validated studies." For Kidney Stones, "Only a well-trained radiologist can make the final diagnosis," suggesting the ground truth is expert diagnosis/interpretation, potentially combined with "patient history and urine testing." It does not explicitly mention pathology or long-term outcomes data.
The sample size for the training set:
- NOT provided. The document describes testing and validation (test set), but there is no information about a dedicated training set or its size, consistent with this being a 510(k) submission for a post-processing software update/combination, rather than a novel AI/machine learning device. The existing functionalities are described as unchanged.
How the ground truth for the training set was established:
- NOT applicable/provided. As no training set information is present, the method for establishing its ground truth is also not mentioned.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Siemens Medical Solutions, USA, Inc. % Ms. Cynthia Busch Regulatory Affairs Specialist 2501 N. Barrington Road HOFFMAN ESTATES, IL 60192

Re: K191468

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: May 29, 2019 Received: June 3, 2019

Dear Ms. Busch:

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/cfpmp/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 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

July 3, 2019

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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 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,

For

Thalia T. Mills, Ph.D. Division Director 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) K191468

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 various materials of an anatomical region of interent 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
· Brain Hemorrhage
Gout Evaluation
Lung Vessels
· Heart PBV
· Bone Removal
· Lung Perfusion
· Liver VNC
· Monenergetic Plus
Virtual Unenhanced
· Bone Marrow
· Hard Plaques
Rho/Z
· Kidney Stones*
· SPR (Stopping Power Ratio)
· SPP (Spectral Post-Processing Format)

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

*)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 information should be considered such as patient history and urine testing. Only a well-trained radiologist can make the final diagnosis under 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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Image /page/4/Picture/0 description: The image shows the Siemens Healthineers logo. The word "SIEMENS" is written in teal, and the word "Healthineers" is written in orange below it. To the right of the text is a graphic of orange dots arranged in a circular pattern.

510(K) SUMMARY FOR SYNGO.CT DUAL ENERGY

as required by 21 CFR Part 807.87(h)

K191468

I. Identification of the Submitter

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:

Cynthia Busch Regulatory Affairs Specialist 2501 North Barrington Road Hoffman Estates, IL 60192-2061 Phone: (847) 643-6818 Email: cynthia.busch(@siemens-healthineers.com

Alternate Contact Person:

Alaine Medio Regulatory Project Manager 810 Innovation Drive Knoxville, TN 37932 Phone: (865) 206-0337 Email: alaine.medio@siemens-healthineers.com

Date of Submission : May 29, 2019

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 21 CFR §892.1750 CFR Section: Device Class: Class II Product Code: 90 JAK

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III. Predicate Device

Primary Predicate Device:

Trade Name:	syngo.CT Dual Energy
510(k) Number:	K150757
Clearance Date:	08/11/2015
Classification Name:	Computed Tomography X-ray System
Classification Panel:	Radiology
CFR Section:	21 CFR § 892.1750
Device Class:	Class II
Product Code:	90 JAK
Recall:	There have been no recalls for this device

Reference Predicate Device:

Trade Name:	syngo.CT Single Source Dual Energy
510(k) Number:	K150745
Clearance Date:	08/11/2015
Classification Name:	Computed Tomography X-ray System
Classification Panel:	Radiology
CFR Section:	21 CFR §892.1750
Device Class:	Class II
Product Code:	90 JAK
Recall:	There have been no recalls for this device

Reference Predicate Device:

Trade Name:	syngo.CT Single Source Dual Energy (twin beam
510(k) Number:	K163289
Clearance Date:	02/09/2017
Classification Name:	Computed Tomography X-ray System
Classification Panel:	Radiology
CFR Section:	21 CFR § 892.1750
Device Class:	Class II
Product Code:	90 JAK
Recall:	There have been no recalls for this device

IV. Device Description

Dual energy offers functions for qualitative and quantitative post-processing evaluations. Dual energy CT can be used to improve the visualization of the chemical composition of various 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.

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Image /page/6/Picture/0 description: The image shows the logo for Siemens Healthineers. The word "SIEMENS" is written in teal, and the word "Healthineers" is written in orange below it. To the right of the words is a graphic of orange dots arranged in a pattern.

1. Monoenergetic
1. Brain Hemorrhage
Gout Evaluation 3.
1. Lung Vessels
1. Heart PBV
Bone Removal 6.
1. Lung Perfusion
1. Liver VNC
1. Monoenergetic Plus
1. Virtual Unenhanced
1. Bone Marrow
1. Hard Plaques
1. Rho/Z
1. Kidney Stones
1. SPR (Stopping Power Ratio)
1. SPP (Spectral Post-Processing format)

Modifications

syngo.CT Dual Energy modifications with software version SOMARIS/8 VB40 are as follows:

1. The merge of the three already cleared post-processing Dual Energy applications into one application called syngo.CT Dual Energy:
- syngo.CT Dual Energy (e.g. K150757, clearance date 08/11/2015), o
- syngo.CT Single Source Dual Energy (e.g. K150745, clearance date o 08/11/2015)
- syngo.CT Single Source Dual Energy (twin beam) (e.g. K163289, O clearance date 02/09/2017)
1. Update of the Indications for Use statement because of the aforementioned combination
1. Enhancement to image output and alternate image format:
- SPP (Stopping Power Ratio) O
- SPR (Spectral Post-Processing Format) ೧
1. Workflow Improvements:
- Provide Dual Energy results with Rapid Results Technology for other o Workflows.
- Provide Dual Energy results as input for other rapid results technology O types.

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:

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Image /page/7/Picture/0 description: The image contains the logo for Siemens Healthineers. The word "SIEMENS" is written in teal, and the word "Healthineers" is written in orange below it. To the right of the words is a graphic of orange dots arranged in a circular pattern.

1. Monoenergetic
1. Brain Hemorrhage
Gout Evaluation 3.
Lung Vessels 4.
Heart PBV 5.
1. Bone Removal
1. Lung Perfusion
1. Liver VNC
1. Monoenergetic Plus
1. Virtual Unenhanced
1. Bone Marrow
1. Hard Plaques
1. Rho/Z
1. Kidney Stones*
1. SPR (Stopping Power Ratio)
1. SPP (Spectral Post-Processing Format)

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

VI. Comparison of Technological Characteristics with the Predicate Device

syngo.CT Dual Energy is a post-processing application operating on the multi-user syngo.via client/server platform. The subject syngo.CT Dual Energy provides the same evaluation, reporting and visualization tools, and functionality as the predicate devices. This includes image processing and visualization tools such as basic visualization of various energy dependent materials in the human body and VRT visualization.

The differences between the above referenced predicate devices are described at a high-level in the next table below:

	Subject Device	PrimaryPredicateDevice	ReferencePredicateDevice	ReferencePredicateDevice
Feature	Siemenssyngo, CT DualEnergy	Siemenssyngo.CT DualEnergy(K150757)	Siemenssyngo.CTSingle SourceDual Energy(K150745)	Siemenssyngo.CTSingle SourceDual Energy(twin beam)(K163289)	ComparisonResults
Input Data
Feature	Subject DeviceSiemenssyngo,CT DualEnergy	PrimaryPredicateDeviceSiemenssyngo.CT DualEnergy(K150757)	ReferencePredicateDeviceSiemenssyngo.CTSingle SourceDual Energy(K150745)	ReferencePredicateDeviceSiemenssyngo.CTSingle SourceDual Energy(twin beam)(K163289)	ComparisonResults
DataAcquisitionMode	The subjectdevice unifiesall three dataacquisitionmodesacquiringimages fromDual Sourcescanners, DualEnergy SingleSource, andTwin Beamscanners.	The softwareanalyzes DualSource DualEnergy imagesacquired withDual Sourcescanners.	The softwareanalyzes DualSpiral DualEnergy imagesacquired withDual SpiralSingle Sourcescanners.	The softwareanalyzes TwinBeam DualEnergy imagesacquired withTwin BeamSingle Sourcescanners.	EquivalentThe subjectdevice dataacquisitionmode supportsall acquisitionmodes of thethreepredicates:single sourceand dualsourcescanner imageacquisitions.
ImageProcessingandEvaluation	MPR, MIP,VRT, thickMPR, thin MIP,fused VRT,tinted VRT	MPR, MIP,VRT, thickMPR, thin MIP,fused VRT,tinted VRT	MPR, MIP,VRT, thickMPR, thin MIP,fused VRT,tinted VRT	MPR, MIP,VRT, thickMPR, thin MIP,fused VRT,tinted VRT	Same
ProvideDualEnergyresults alsoas input forotherRapidResultsTechnologytypes	Dual Energyresult imagesgenerated withRapid ResultsTechnology canbe used as inputfor other typesof RapidResultsTechnology(e.g. organranges).	The outputimages from allDual Energyapplicationclasses canmanually beprocessed onsyngo.via withthe availableplatform tools(e.g. organranges).	The outputimages from allDual Energyapplicationclasses canmanually beprocessed onsyngo.via withthe availableplatform tools(e.g. organranges).	The outputimages from allDual Energyapplicationclasses canmanually beprocessed onsyngo.via withthe availableplatform tools(e.g. organranges).	ExtendedThe subjectdeviceimprovesworkflow butdoes notchange theresults thatcan begenerated.
ProvideDualEnergyresults withRapidResultsTechnologyalso forotherWorkflows.	The generationof Dual Energyautomaticarchivingranges isseparated fromthe Dual Energyapplication andcan be obtainedfor anysyngo.viaworkflow.	The generationof Dual Energyautomaticarchivingranges is onlypossible withinthe Dual Energyworkflow.	The generationof Dual Energyautomaticarchivingranges is onlypossible withinthe Dual Energyworkflow.	The generationof Dual Energyautomaticarchivingranges is onlypossible withinthe Dual Energyworkflow.	ExtendedThe subjectdeviceimprovesworkflow butdoes notchange theresults thatcan begenerated.
	Subject Device	PrimaryPredicateDevice	ReferencePredicateDevice	ReferencePredicateDevice
Feature	Siemenssyngo,CT DualEnergy	Siemenssyngo.CT DualEnergy(K150757)	Siemenssyngo.CTSingle SourceDual Energy(K150745)	Siemenssyngo.CTSingle SourceDual Energy(twin beam)(K163289)	ComparisonResults
SPR(StoppingPowerRatio)	The RapidResultTechnologyoutput type SPRallows for thecalculation ofstopping powerimages, whichshow theexpected energyloss of protonsin the materialat each voxelposition.	The applicationclass Rho/Zprovides all thenecessaryinformation thatenables simplecalculation ofSPR-images.These imagescan becalculatedoffline bystarting fromRho-images andapplying a verysmall correctionbased on Z.	The applicationclass Rho/Zprovides all thenecessaryinformation thatenables simplecalculation ofSPR-images.These imagescan becalculatedoffline bystarting fromRho-images andapplying a verysmall correctionbased on Z.	N/A – notsupported by aTwinBeamscan.	ExtendedThe subjectdevice mergesthe outputimages of analreadyclearedalgorithm in asimple way.
SPP(SpectralPost-ProcessingFormat)	syngo.CT DualEnergy useslow/high energyimages for allcalculations.Together withintermediateprocessingresults theseimages can bestored in SPPimages and alsoextracted fromthem.	syngo.CT DualEnergy useslow/high energyimages for allcalculations.Intermediateprocessingresults arestored asseparate seriesin the database.	syngo.CT DualEnergy useslow/high energyimages for allcalculations.Intermediateprocessingresults arestored asseparate seriesin the database.	syngo.CT DualEnergy useslow/high energyimages for allcalculations.Intermediateprocessingresults arestored asseparate seriesin the database.	SimilarAn alternativeimage formatis introduced.whichcontains thesameinformation asimages seriesthat werepreviouslyavailable.

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The subject device syngo.CT Dual Energy does not have changes in fundamental scientific technology compared to the predicate devices. The post-processing software functionality remains unchanged from the subject device and the predicate devices. The operating principle and the scientific technology are same; therefore, Siemens believes that syngo.CT Dual Energy application is substantially equivalent to the predicate devices.

VII. Performance Data

Software Verification and Validation Testing

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.

Non-Clinical / Clinical Testing Summary

syngo.CT Dual Energy is designed to fulfill the requirements of the following safety and performance standards:

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Image /page/10/Picture/0 description: The image shows the Siemens Healthineers logo. The word "SIEMENS" is in teal, and the word "Healthineers" is in orange. To the right of the words is a graphic of orange dots arranged in a circular pattern.

RecognitionNumber	ProductArea	Title of Standard	PublicationDate	StandardsDevelopmentOrganization
12-300	Radiology	Digital Imaging and Communications inMedicine (DICOM) Set; PS 3.1 – 3.20	06/27/2016	NEMA
13-32	Software	Medical Device Software -Software LifeCycle Processes; 62304:2006 (1st Edition)	08/20/2012	AAMI, ANSI,IEC
5-40	Software/Informatics	Medical devices – Application of riskmanagement to medical devices; 14971Second Edition 2007-03-01	08/20/2012	ISO
5-95	General I(QS/RM)	Medical devices - Part 1: Application ofusability engineering to medical devicesIEC 62366-1:2015	06/27/2016	IEC

Performance tests were conducted to test the functionality of the syngo.CT Dual Energy post-processing application. A phantom-based validation has been conducted to show that both features SPR (Stopping Power Ratio) and SPP (Spectral Post-Processing Format) operate as intended.

For SPR, the report shows that the SPR feature can reproduce the theoretical SPR values of the phantom inserts used from Dual Energy CT scans. The evaluation is described and validated in the report "Detailed Description of the DE application "DirectSPR" as part of the medical product "Syngo.CT Dual Energy", Version VB40".

Regarding the SPP evaluation, the combination of the SPP-generation process produces equivalent results to the reference method based on functionality available in the predicate device(s). This means also that the information in the SPP-format (including all hidden data) was correctly calculated. Hence, two new modules introduced to support the new SPP data format, "SPP Generation Unit" and "ISI Preparation Unit", which are part of syngo.CT Dual Energy are working as specified. The evaluation is described and evaluated in the report "Detailed Description and Bench Tests for the Feature "SPP/ISI"".

Furthermore, phantom bench testing and clinical validation in a retrospective study was conducted to test the functionality of the remaining application classes Rho/Z and Kidney Stones. Retrospective clinically validated studies were conducted to test the performance for applications classes Monoenergetic Plus, Bone Removal, Liver VNC, and Hard Plaques, as well as the predicate device application classes. These studies demonstrate that the subject device performs as well as the predicate device applications that were tested using the same methods. Supportive articles that demonstrate the usability of the application classes are provided to support device performance and functionality.

Non-clinical tests and clinical validation have been conducted to establish the proficiency of the 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.

General Safety and Effectiveness Concerns

The device labeling contains instructions for use and any necessary cautions and warnings to provide for safe and effective use of the device. Risk management is ensured via a hazard analysis, which is used to identify potential hazards. These potential hazards are controlled during development, verification and validation testing. To minimize electrical, mechanical, and radiation hazards, Siemens adheres to recognized and established industry practice and standards.

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VIII. Conclusions

syngo.CT Dual Energy has the same intended use and similar indication for use as the predicate devices. The technological characteristics such as image visualization, operating platform, and image manipulation are the same as the predicate devices. The comparison of technological characteristics, non-clinical performance data, and software validation demonstrates that the subject device is as safe and effective when compared to the predicate devices that are currently marketed for the same intended use. For the subject device, syngo.CT Dual Energy, Siemens used the same testing with the same workflows as used to clear the primary predicate device. Siemens considers syngo.CT Dual Energy to be as safe, as effective, and with performance substantially equivalent to the commercially available predicate devices.

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.