syngo.CT Single Source Dual Energy is designed to operate with CT images which have been acquired with Siemens Dual Spiral Single Source scanners. 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 Single Source 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 functionality of the syngo.CT Single Source Dual Energy applications is as follows:

· Monoenergetic
· Monoenergetic Plus
· Brain Hemorrhage
· Liver VNC
· Gout Evaluation
Bone Marrow
Rho/Z
· Kidney Stones*)

*) Kidney Stones is designed to support 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 Single Source Dual Energy Software Package is a post processing application package consisting of several post processing application classes that can be used to improve visualization of various energy dependent materials in the human body. Different body regions require specific tools that allow for the correct evaluation of data sets. syngo.CT Single Source 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. A listing of device modifications is as follows:

1. New software version syngo.via VB10 (SOMARIS/8 VB10A) for the syngo.CT Single Source Dual Energy post processing application package to support the following features:
- Addition of new application class Rho/Z .
- Visualization of fat content (fat map) for application class Liver . VNC
- 1. Modified Indication for Use to include features Rho/Z
- 1. Modified Indication for Use to include reference to Dual Spiral Single Source Scanners

The subject device syngo.CT Single Source Dual Energy also supports the following unmodified post-processing application classes:

. Monoenergetic
Brain Hemorrhage ●
o Gout Evaluation
. Monoenergetic Plus
o Bone Marrow
o Kidney Stones

syngo.CT Single Source Dual Energy 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.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the "syngo.CT Single Source Dual Energy" device. The document focuses on establishing substantial equivalence to previously cleared predicate devices, rather than detailing a specific clinical study with acceptance criteria for device performance. As such, much of the requested information about acceptance criteria, detailed study design, and performance metrics is not explicitly present in the provided text.

However, based on the non-clinical testing summary, here's what can be extracted and inferred:

1. Table of Acceptance Criteria and Reported Device Performance

The document states:

"The testing results support that all the software specifications have met the acceptance criteria."
"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."

While these statements confirm that acceptance criteria were met, the specific quantitative criteria and detailed performance metrics are not provided in the given text. The tests were aimed at verifying the functionality of new features (Rho/Z, visualization of fat content for Liver VNC).

Acceptance Criteria (Inferred)	Reported Device Performance
All software specifications met	All software specifications met, device performs as intended.
Functionality of Rho/Z application class confirmed	Functionality demonstrated and supported by articles.
Functionality of Fat Map for Liver VNC confirmed	Functionality demonstrated and supported by articles.
Performance to support claims of substantial equivalence	Acceptable for substantial equivalence.

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

The text states:

"Phantom bench testing and retrospective analysis of available patient data was conducted for application classes Rho/Z and feature Fat Map."
Sample Size for Test Set: Not specified.
Data Provenance: Retrospective analysis of available patient data. No specific country of origin is mentioned, but the manufacturer is Siemens Medical Solutions USA, Inc. with a manufacturing facility in Germany, suggesting a likely European or US data source.

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

The document mentions for Kidney Stones evaluation: "Only a well-trained radiologist can make the final diagnosis under consideration of all available information." This suggests that clinical interpretation by radiologists is part of the diagnostic process, but it doesn't specify the number or specific qualifications of experts used to establish ground truth for the test set of this particular device functionality study.

4. Adjudication Method for the Test Set

Not specified in the provided text.

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

The provided text does not indicate that a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done. The focus is on non-clinical testing and verification/validation, not human reader performance improvement with or without AI assistance.

6. Standalone Performance Study

The testing conducted was for "algorithm only without human-in-the loop performance" in the sense that the software's functionality was evaluated on phantoms and retrospective data. However, it's a post-processing application, meaning its output is intended for human interpretation. The study primarily confirmed the technical functionality of the new features (e.g., ability to calculate Rho/Z or visualize fat content), rather than a clinical outcome or diagnostic accuracy in isolation.

7. Type of Ground Truth Used

For phantom bench testing: The ground truth would typically be known physical properties of the phantom materials.
For retrospective analysis of available patient data: The ground truth would likely be established from existing clinical records, potentially including patient history, other imaging modalities, or pathology reports for conditions like kidney stones or liver fat. The exact method for establishing ground truth for the retrospective data is not explicitly stated.

8. Sample Size for the Training Set

The document does not mention a training set or its sample size. This suggests the nature of the evaluation was more focused on verifying the implementation and performance of the software's algorithms for specific analyses (like Rho/Z or fat mapping) rather than training a machine learning model.

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

As no training set is mentioned, this information is not applicable/provided.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines connecting them.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

August 11, 2015

Siemens Medical Solutions USA, Inc. % Ms. Kimberly Mangum Regulatory Affairs Specialist 51 Valley Stream Parkway MALVERN PA 19355

Re: K150745

Trade/Device Name: syngo.CT Single Source Dual Energy Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: II Product Code: JAK Dated: June 24, 2015 Received: July 8, 2015

Dear Ms. Mangum:

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. 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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Michael O'Hara

For

Robert Ochs, Ph.D. Acting Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K150745

Device Name syngo.CT Single Source Dual Energy

Indications for Use (Describe)

Syngo.CT Single Source Dual Energy is designed to operate with CT images which have been acquired with Siemens Dual Spiral Single Source scanners. 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 Single Source 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 functionality of the syngo.CT Single Source Dual Energy applications is as follows:

· Monoenergetic
· Monoenergetic Plus
· Brain Hemorrhage
· Liver VNC
· Gout Evaluation
Bone Marrow
Rho/Z
· Kidney Stones*)

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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510(k) Summary FOR syngo.CT Single Source Dual Energy Submitted by: Siemens Medical Solutions USA, Inc. 51 Valley Stream Parkway Malvern. PA 19355 Date Prepared: June 24, 2015

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92.

1. General Information

Importer/Distributor Establishment: Registration No: 2240869 Siemens Medical Solutions USA, Inc. 51 Valley Stream Parkway Malvern, PA 19355

Manufacturing Facility:

Siemens AG Medical Solutions Siemens Str. 1 D-91301 Forchheim, Germany Establishment Reqistration Number: 3004977335

2. Contact Person:

Kimberly Manqum Regulatory Affairs Specialist Siemens Medical Solutions, Inc. USA 51 Valley Stream Parkway, Mail Code D02 Malvern, PA 19355 Phone: (610) 448-4912 Fax: (610) 448-1787 Email: kimberly.mangum@siemens.com

3. Device Name and Classification

Product Name: syngo.CT Single Source Dual Energy Propriety Trade Name: syngo.CT Single Source Dual Energy (dual spiral) Classification Name: Computed Tomography X-ray System Classification Panel: Radiology CFR Section: 21 CFR §892.1750 Device Class: Class II Product Code: 90JAK

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4. Legally Marketed Primary Predicate Device:

Product Name:	syngo.CT Single Source Dual Energy
Propriety Trade Name:	syngo.CT Single Source Dual Energy
Classification Name:	Computed Tomography X-ray System
Classification Panel:	Radiology
CFR Section:	21 CFR § 892.1750
Device Class:	Class II
Product Code:	90JAK

Legally Marketed Secondary Predicate Device

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:	90JAK

Product Name:	SOMATOM DRI X-Ray CT Scanner
Propriety Trade Name:	SOMATOM DRI X-Ray CT Scanner
Classification Name:	Computed Tomography X-ray System
Classification Panel:	Radiology
CFR Section:	21 CFR § 892.1750
Device Class:	Class II
Product Code:	90JAK

5. Indications for Use

syngo.CT Single Source Dual Energy is designed to operate with CT images which have been acquired with Siemens Dual Spiral Single Source scanners. 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 Single Source 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 functionality of the syngo.CT Dual Energy applications is as follows:

Monoenergetic ●
Monoenergetic Plus ●
Brain Hemorrhage ●
Liver VNC
Gout Evaluation .
Bone Marrow .
Rho/Z .
Kidney Stones® ●

*) 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

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

6. Substantial Equivalence:

The subject device Siemens syngo.CT Single Source Dual Energy is substantially equivalent to following medical devices in commercial distribution as listed in Table 1:

Manufacturer	Predicate Device	510(k)	Clearance Date
Siemens	Primary Predicate Device:syngo.CT Dual Energy	K133677	October 16, 2014
Siemens	Secondary Predicate Device:syngo.CT Dual Energy	K133648	July 07, 2014
Siemens	Secondary Predicate Device:SOMATOM DRI X-ray Scanner	K837107	March 9, 1983

Table 1: Predicate Devices

7. Device Description:

Dual energy offers functions for qualitative and quantitative evaluations. Dual energy CT 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. syngo.CT Single Source Dual Energy Software Package is a post processing application package consisting of several post processing application classes that can be used to improve visualization of various energy dependent materials in the human body.

Different body regions require specific tools that allow for the correct evaluation of data sets. syngo.CT Single Source 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. A listing of device modifications is as follows:

1. New software version syngo.via VB10 (SOMARIS/8 VB10A) for the syngo.CT Single Source Dual Energy post processing application package to support the following features:
- Addition of new application class Rho/Z .
- Visualization of fat content (fat map) for application class Liver . VNC
- 1. Modified Indication for Use to include features Rho/Z
- 1. Modified Indication for Use to include reference to Dual Spiral Single Source Scanners

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The subject device syngo.CT Single Source Dual Energy also supports the following unmodified post-processing application classes:

. Monoenergetic
Brain Hemorrhage ●
o Gout Evaluation
. Monoenergetic Plus
o Bone Marrow
o Kidney Stones

1. Summary of Technical Characteristics of the Subject Device as Compared with the Predicate Device:
  syngo.CT Single Source Dual Energy Software Package is a post processing application operating on the most recent version of the syngo.via client server platform. The subject device syngo.CT Single Source Dual Energy provides similar evaluation, reporting and visualization tools, and functionality as the primary predicate device synqo.CT Single Source Dual Energy, and secondary 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. Table 2 below provides a comparison of the primary features of the subject device in comparison to the predicate devices.

Table 2: Predicate and Subject Device Comparable Technological
Characteristics
Property	Subject Device	PrimaryPredicate DeviceK133677	SecondaryPredicate DeviceK133648	SecondaryPredicateDeviceK837107
SoftwareFeatures/Functionality	Rho/Z -Measurement ofelectron densityas well aseffective atomicnumber	Not Applicable	Base materialdecompositioninto tissue andiodine	Visualization -Electron DensityVisualizationFeatures
	Liver VNC -Visualization offat content	Fat content resultin the calculationof Virtual NonContrast (VNC)images	Fat content resultin the calculationof Virtual NonContrast (VNC)images	Not Applicable

syngo.CT Single Source Dual Energy does not have significant changes in technological characteristics when compared to the primary predicate device syngo.CT Single Source Dual Energy. The Indication for Use, operating principle, and the scientific technology are similar: therefore, Siemens believes that syngo.CT Single Source Dual Energy Package is substantially equivalent to the predicate devices.

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9. Nonclinical Testing:

syngo.CT Single Source Dual Energy is designed to fulfill the requirements of the following safety and performance standards listed in Table 5 below:

RecognitionNumber	ProductArea	Title of Standard	ReferenceNumber andDate	PublicationDate	StandardsDevelopmentOrganization
12-238	Radiology	Digital Imaging andCommunications inMedicine (DICOM) Set	PS 3.1 -3.20	03/16/2012	NEMA
13-8	Software	Medical device software -Software life cycleprocesses	62304 Firstedition 2006-05	08/20/2012	IEC
5-40	General	Medical devices -Application of riskmanagement to medicaldevices	14971SecondEdition 2007-03-01	08/20/2012	ISO
5-85	General	Medical electricalequipment -- Part 1-6:General requirements forbasic safety and essentialperformance -- CollateralStandard: Usability	60601-1-6Edition 3.02010-01	07/09/2014	IEC
5-41	General	Medical electricalequipment - Part 1-4:General requirements forsafety -- Collateralstandard: Programmableelectrical medicalsystems, edition 1.1	60601-1-4:2000,Consol. Ed.1.1	09/08/2009	IEC

Table 5: Conformance Standards:

This submission contains performance data to demonstrate continued conformance with special controls for medical devices containing software. Non clinical tests (integration and functional) were conducted for syngo.CT Single Source Dual Energy during product development. The modifications described in this Premarket Notification were supported with verification/validation testing.

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.

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.

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Non-Clinical Testing Summary

Performance tests were conducted to test the functionality of the syngo.CT Single Source Dual Energy. Phantom bench testing and retrospective analysis of available patient data was conducted for application classes Rho/Z and feature Fat Map. Supportive articles that demonstrate the usability of application class Rho/Z and feature Fat Map for Liver VNC were provided to support device performance and functionality.

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.

10. 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.

11. Conclusion as to Substantial Equivalence

syngo.CT Single Source Dual Energy has the same intended use and comparable indication for use as the predicate devices. The technological characteristics such as image visualization, operating platform, and image manipulation are similar to the predicate devices. Any differences in technological characteristics between the subject device and the predicate devices do not raise different questions of safety or effectiveness. The result of all conducted testing was found acceptable to support the claim of substantial equivalence.

The predicate devices were cleared based on non-clinical supportive information including phantom bench test, retrospective review of available patient data, and supportive clinical articles. The results of these tests demonstrate that the predicate devices are adequate for the intended use. The same testing and workflows were used to test the subject device modifications. 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. Since both devices were tested using the same methods, Siemens believes that the data generated from the syngo.CT Single Source Dual Energy testing supports a finding of substantial equivalence.

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.