syngo.CT Dual Energy by SIEMENS MEDICAL SOLUTIONS USA, INC.

syngo.CT Dual Energy is designed to operate with CT images which have been acquired with Siemens Dual Source scanners. The various materials of an anatomical region of interest have different attenuation coefficients, which depend on the used energy. Depending on the region of interest, contrast agents may be used. 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.

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

Monoenergetic ●
Brain Hemorrhage ●
Gout Evaluation ●
Lung Vessels ●
Heart PBV ●
Bone Removal
o Lung Perfusion
Liver VNC ●
Monoenergetic Plus ●
Virtual Unenhanced ●
Bone Marrow ●
Hard Plaques ●
o 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 consideration of all available information. The accuracy of identification is decreased in obese patients.

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 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 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

The provided text describes syngo.CT Dual Energy, a software package for post-processing CT images. While it mentions non-clinical testing and verification/validation, it does not provide specific acceptance criteria or details of a study that directly proves the device meets such criteria in terms of performance metrics like accuracy, sensitivity, or specificity for its various applications.

The document focuses on substantiating equivalence to predicate devices, primarily through software updates and new application classes (Rho/Z, Hard Plaques, Fat Map for Liver VNC). The testing described is more about demonstrating that the software functions as intended and meets safety standards, rather than providing performance metrics against specific acceptance thresholds for clinical utility.

Therefore, many of the requested details cannot be extracted directly from this document.

Here's an attempt to answer based on the provided text, highlighting where information is absent:

1. Table of acceptance criteria and the reported device performance

Acceptance Criteria	Reported Device Performance
Not explicitly stated in terms of quantitative performance metrics (e.g., accuracy, sensitivity, specificity). The document focuses on functional and safety requirements.	"The testing results support that all the software specifications have met the acceptance criteria." (General statement, no specific metrics provided.)
(Implicit) Compliance with recognized safety and performance standards (DICOM, IEC 62304, ISO 14971, IEC 60601-1-6, IEC 60601-1-4).	"syngo.CT Dual Energy is designed to fulfill the requirements of the following safety and performance standards listed in Table 5..." (Compliance indicated).
(Implicit) Functionality of new features (Rho/Z, Hard Plaques, Fat Map for Liver VNC).	"Performance tests were conducted to test the functionality of the syngo.CT Dual Energy. Phantom bench testing and retrospective analysis of available patient data was conducted for application classes Rho/Z, Hardplaques, and feature Fat Map." "The results of these tests demonstrate that the subject device performs as intended."
(Implicit) Substantial Equivalence to predicate devices.	"The result of all conducted testing was found acceptable to support the claim of substantial equivalence."

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample size for test set: Not specified. The document mentions "retrospective analysis of available patient data" but does not give a number of cases or patients.
Data provenance: "retrospective analysis of available patient data". No country of origin is mentioned. Whether it was prospective or retrospective is stated as retrospective.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Number of experts: Not specified.
Qualifications of experts: Not specified. However, for "Kidney Stones" application, it states, "Only a well-trained radiologist can make the final diagnosis under consideration of all available information," implying radiologists would be involved in ground truth establishment for that specific application.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Adjudication method: Not specified.

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

MRMC comparative effectiveness study: No, an MRMC comparative effectiveness study is not mentioned. The document describes a "verification/validation testing" and states that "supportive articles that demonstrate the usability" of certain application classes were provided, but it does not detail a study evaluating human reader improvement with AI assistance.

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

Standalone performance study: The non-clinical testing included "phantom bench testing," which would be a form of standalone testing on controlled data. However, quantitative performance metrics for the algorithm's standalone performance (e.g., accuracy of material decomposition in phantoms) are not provided. The overall conclusion is that the device "performs as intended," but specific performance values are absent.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Type of ground truth: Not explicitly stated. For "retrospective analysis of available patient data," the ground truth would likely be based on existing clinical reports or expert interpretation. For "phantom bench testing," the ground truth would be the known composition of the phantom materials.

8. The sample size for the training set

Sample size for training set: Not applicable/Not specified. The document describes a software package with new and modified application classes, rather than a deep learning AI model that would typically have a distinct training set. The focus is on verifying improvements and new functionalities over existing predicate devices.

9. How the ground truth for the training set was established

How ground truth for training set was established: Not applicable/Not specified, as a distinct "training set" for an AI model is not described. The document pertains to updates to an existing software package for image post-processing.

Summary

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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, D02 MALVERN PA 19355

Re: K150757

Trade/Device Name: syngo.CT Dual Energy Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: II Product Code: JAK Dated: July 6, 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 D'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) K150757

Device Name syngo.CT Dual Energy

Indications for Use (Describe)

Syngo. Ct dual energy is designed to operate with ct images which siemens dual source scanners. The various materials of an anatomical region of interest have different attenuation coefficients, which depend on the used energy. Depending on the region of interest, contrast agents may be used. These differences provide information on the chemical composition of the scanned body materials. Syngo.Ct dual energy combines mages acquired with low and high energy spectra to visualize this information.

The functionality of the syngo. Ct dual energy applications 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

*) 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

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 Submitted by: Siemens Medical Solutions USA, Inc. 51 Valley Stream Parkway Malvern. PA 19355 Date Prepared: June 19, 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 Registration 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 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

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4. Legally Marketed Primary 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

Legally Marketed Secondary Predicate Device

Product Name:	syngo® Dual Energy with extended functionality
Propriety Trade Name:	syngo® Dual Energy with extended functionality
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

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

Monoenergetic ●
Brain Hemorrhage ●
Gout Evaluation ●
Lung Vessels ●
Heart PBV ●
Bone Removal
o Lung Perfusion
Liver VNC ●
Monoenergetic Plus ●
Virtual Unenhanced ●
Bone Marrow ●
Hard Plaques ●
o 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

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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.

6. Substantial Equivalence:

The subject device Siemens syngo.CT 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	K133648	July 7, 2014
Siemens	Secondary Predicate Device:syngo® Dual Energy with extendedfunctionality	K083524	April 1, 2009
Siemens	Secondary Predicate Device:SOMATOM DRI X-ray Scanner	K837107	March 9, 1983

	Table 1: Predicate Devices

7. Device Description:

1. New software version syngo.via VB10 (SOMARIS/8 VB10A) for the syngo.CT Dual Energy post processing application package to support the following features:
- Addition of new application class Rho/Z .
- Support of application class Hard Plaque on synqo.via client . server platform

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Visualization of fat content (fat map) for application class Liver o VNC
1. Modified Indication for Use to include features Rho/Z and Hard Plaques

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

Monoenergetic ●
Brain Hemorrhage
Gout Evaluation ●
Lung Vessels
Heart PBV
Bone Removal
Luna Perfusion o
Monoenergetic Plus ●
Virtual Unenhanced
Bone Marrow
Kidney Stones ●

syngo.CT Dual Energy is designed to operate on the most recent version syngo.via client server platform which supports preprocessing and loading of datasets by synqo.via depending on confiqurable rules.

1. Summary of Technical Characteristics of the Subject Device as Compared with the Predicate Device:
  syngo.CT 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 Dual Energy provides similar evaluation, reporting and visualization tools, and functionality as the primary predicate device syngo.CT 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.

Property	Subject Device	Primary Predicate Device K133648	Secondary Predicate Device K083524	Secondary Predicate Device K837107
SoftwareFeatures/Functionality	Rho/Z -Measurement of electron density as well as effective atomic number	Base material decomposition into tissue and iodine	Not Applicable	Visualization - Electron Density Visualization Features
	Hard Plaques-Support on syngo.via client server platform	Not Applicable	Hard Plaques and Vessels - Support on syngo classic platform	Not Applicable

Table 2: Predicate and Subject Device Comparable Technological Characteristics

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Property	Subject Device	PrimaryPredicateDeviceK133648	SecondaryPredicateDeviceK083524	SecondaryPredicateDeviceK837107
	Liver VNC -Visualization offat content	Fat contentresult in thecalculation ofVirtual NonContrast (VNC)images	Fat contentresult in thecalculation ofVirtual NonContrast (VNC)images	Not Applicable

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

9. Nonclinical Testing:

syngo.CT 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

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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.

Non-Clinical Testing Summary

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

In addition, 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 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.

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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 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.