syngo. CT Single Source Dual Energy is designed to operate with CT images which have been acquired with Siemens Twin Beam 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 are as follows:

· Monoenergetic
· Bone Removal
· Liver VNC
· Lung Analysis
· Gout Evaluation
· Monoenergetic Plus
· Virtual Unenhanced
· Rho/Z
· Hard Plaques
· 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 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 (twin beam) 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. 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.

After loading the two reconstructed image datasets acquired with two different X-ray spectra into syngo.CT Single Source Dual Energy (twin beam), a correction algorithm is used in order to minimize motion effects. They are then displayed using linear blending with selectable mixing ratio and color scale. Multiplanar reformations (MPR) of the volume are shown in 3 image segments, which are initialized as sagittal, coronal and axial view. After arriving at an initial diagnosis on the basis of the CT-images, the user can choose one of the following application classes:

. Monoenergetic
Bone Removal ●
Liver VNC
Lung Analysis
Gout Evaluation ●
Monoenergetic Plus ●
Virtual Unenhanced .
Rho/Z ●
Hard Plaques .
Kidney Stones .

AI/ML Overview

The provided document is a 510(k) premarket notification for a medical device called "syngo.CT Single Source Dual Energy (twin beam)". It describes the device, its intended use, and a comparison with predicate devices. While it mentions "clinical validation" and "performance tests", it does not detail specific acceptance criteria or provide quantitative results in the format of a clinical study or performance study with the level of detail requested in the prompt.

The document states:

"A clinical validation has been conducted to show that both application classes "Gout" and "Lung Analysis" operate as intended."
"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 using twin beam datasets performs as well as the predicate device applications that were tested using the same methods."
"The result of all conducted testing was found acceptable to support the claim of substantial equivalence."

However, it does not provide the specific "acceptance criteria" (e.g., minimum sensitivity, specificity, accuracy) nor the "reported device performance" (e.g., actual sensitivity, specificity, accuracy values) in a table format. It also does not explicitly state the details requested about sample size, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, or training set details.

Therefore, I cannot fully answer the prompt based on the provided text. The document acts as a summary for a 510(k) submission, confirming that studies were performed and found acceptable for substantial equivalence, but it does not present the detailed results expected from an clinical study report.

No information is provided in the document for the following points, so I cannot answer them:

A table of acceptance criteria and the reported device performance: The document states that "clinical validation" and "performance tests" were conducted and found "acceptable," and that the device "performs as well as the predicate device applications." However, it does not specify the quantitative acceptance criteria (e.g., specific thresholds for sensitivity, specificity, or accuracy) or the actual reported device performance metrics in a table.
Sample sized used for the test set and the data provenance: No specific sample sizes for test sets are mentioned. The provenance is implied to be "clinical validation" and "retrospective studies," but the country of origin is not specified.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience): Not specified.
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: Not mentioned. The studies described are for the device's performance, not comparative effectiveness with human readers.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: The document describes "clinical validation" and "performance tests" for the application, implying standalone performance of the software, but does not explicitly label it as "standalone" or provide specific metrics to differentiate it from assisted performance.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not specified.
The sample size for the training set: The document discusses performance and clinical validation, but does not describe the training set or its size, or the use of deep learning/AI models that would require a distinct training set.
How the ground truth for the training set was established: Not applicable, as training set details are not provided.

The only specific information related to "proof" of meeting criteria is:

"Performance tests were conducted to test the functionality of the syngo.CT Single Source Dual Energy (twin beam) post-processing application."
"A clinical validation has been conducted to show that both application classes "Gout" and "Lung Analysis" operate as intended."
"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 using twin beam datasets performs as well as the predicate device applications that were tested using the same methods."
"The result of all conducted testing was found acceptable to support the claim of substantial equivalence."

This indicates that internal studies were performed and deemed sufficient by the manufacturer for the 510(k) submission, confirming the device operates as intended and is comparable to predicate devices. However, the specific quantitative details of these studies are not disclosed in this summary.

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 circle with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the top half of the circle. Inside the circle is a stylized image of three human profiles.

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

February 9, 2017

Siemens Medical Solutions USA, Inc., % Ms. Kimberly Mangum Regulatory Affairs Specialist 40 Liberty Blvd., Mail Code 65-1A MALVERN PA 19355

Re: K163289

Trade/Device Name: syngo.CT Single Source Dual Energy (twin beam) Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: II Product Code: JAK Dated: November 22, 2016 Received: November 23, 2016

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/ResourcesforYou/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. O'Hara

For

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

Enclosure

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Image /page/2/Picture/0 description: The image shows the word "SIEMENS" in a sans-serif font. The word is displayed in a light blue color. The letters are evenly spaced and appear to be bolded.

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

Indications for Use

510(k) Number (if known)

K163289

Device Name syngo. CT Single Source Dual Energy (twin beam)

Indications for Use (Describe)

The functionality of the syngo. CT Single Source Dual Energy applications are as follows:

· Monoenergetic
· Bone Removal
· Liver VNC
· Lung Analysis
· Gout Evaluation
· Monoenergetic Plus
· Virtual Unenhanced
· Rho/Z
· Hard Plaques
· 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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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

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

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

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(0fda.hhs.gov

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

FORM FDA 3881 (8/14)

Page 1 of 1

PSC Pablabling Services (101) 443-5740 EFF

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510(K) SUMMARY FOR SYNGO.CT SINGLE SOURCE DUAL ENERGY (TWIN BEAM)

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

Date Prepared: November 09, 2016

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.

I. 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

Contact Person

Kimberly Mangum Regulatory Affairs Specialist Siemens Medical Solutions USA, Inc. 40 Liberty Boulevard Malvern, PA 19355 Phone: (610) 448 - 6477 Fax: (610) 640 - 4481 Email: kimberly.mangum@siemens.com

II. Device Name and Classification

Product Name: Propriety Trade Name: Classification Name: Classification Panel: CFR Section: Device Class: Product Code:

syngo.CT Single Source Dual Energy (twin beam) syngo.CT Single Source Dual Energy (twin beam) Computed Tomography X-ray System Radiology 21 CFR §892.1750 Class II 90JAK

III. Predicate Device

Primary Predicate Device:

Trade Name:
510(k) Number:
Clearance Date:

syngo.CT Single Source Dual Energy (twin beam) K153220 02/19/2016

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Classification Name:	Computed Tomography X-ray System
Classification Panel:	Radiology
CFR Section:	21 CFR §892.1750
Device Class:	Class II
Product Code:	90JAK
Recall:	There have been no recalls for this device

Secondary 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:	90JAK
Recall:	There have been no recalls for this device

IV. 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 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.

. Monoenergetic
Bone Removal ●
Liver VNC
Lung Analysis
Gout Evaluation ●
Monoenergetic Plus ●
Virtual Unenhanced .
Rho/Z ●
Hard Plaques .
Kidney Stones .

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. A listing of major device modifications within the scope of the new software version SOMARIS 8/VB20 is as follows:

. The Use of Twin Beam Images for additional Dual Energy post-processing Applications (Lung Analysis and Gout)
Modified Indications for Use Statement ●

An additional modification is the support of Offline Ranges for Dual Energy which allows the user to select the required post-processing for reconstructed Dual Energy image series at the scanner.

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V. Indications for Use

syngo.CT Single Source Dual Energy is designed to operate with CT images which have been acquired with Siemens Twin Beam 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 are as follows:

. Monoenergetic
Bone Removal ●
Liver VNC ●
Lung Analysis ●
Gout Evaluation ●
Monoenergetic Plus ●
Virtual Unenhanced ●
. Rho/Z
. Hard Plaques
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.

VI. Comparison of Technological Characteristics with the Predicate Device

syngo.CT Single Source Dual Energy (twin beam) Software Package is a post-processing application operating on the multi-user syngo.via client/server platform. The subject syngo.CT Single Source Dual Energy (twin beam) provides the same evaluation, reporting and visualization tools, and functionality as the primary predicate device. This includes image processing and visualization tools such as basic visualization of various energy dependent materials in the human body and VRT visualization. Compared to the secondary predicate device, the aforementioned evaluation reporting and visualization tools and functionality as well as the post-processing algorithms remain unchanged.

Feature	Subject Device	Primary Predicate Device(K153220)	Secondary Predicate Device(K150757)
DataAcquisitionMode	The subject device usesDICOM images acquiredusing Twin Beam (splitfiltration) Single Sourcescanners.	The primary predicate deviceuses DICOM images acquiredusing Twin Beam (splitfiltration) Single Sourcescanners.	This device uses DICOMimages acquired with DualSource scanners.
ImageProcessing	The software processes TwinBeam Dual Energy images.	The software processes TwinBeam Dual Energy images.	The software processes DualSource Dual Energy images.
Functionality	Post-processing applicationsupports the use of TwinBeam datasets with variouspost-processing applications.Here, two additional (GoutEvaluation and LungAnalysis) post-processingapplications are able toprocess twin beam images.	Post-processing applicationsupports the use of TwinBeam datasets with variouspost-processing applications.	Post processing applicationsupports the use of DualSource datasets with variouspost processing applications

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Feature	Subject Device	Primary Predicate Device (K153220)	Secondary Predicate Device (K150757)
Application Class"Gout Evaluation"	The Dual Energy informationcan be used to visualize urate,calcifications and contrastagent in the case of gout. Thebasis for this approach is amaterial decomposition intotissue and uric acid deposits.The results of this calculationare shown as color overlay toanatomical, grayscaleinformation.This application classevaluates images acquiredwith Siemens Twin BeamScanners. The post-processing functionality hasnot been changed comparedto the secondary predicatedevice.	N/A	The Dual Energy informationcan be used to visualize urate,calcifications and contrastagent in the case of gout. Thebasis for this approach is amaterial decomposition intotissue and uric acid deposits.The results of this calculationare shown as color overlay toanatomical, grayscaleinformation.This application classevaluates images acquiredwith Siemens Dual SourceScanners.
Application Class"Lung Analysis	This application class isdesigned to visualize theiodine enhancement inpulmonary vessels andvisualize and quantify theiodine uptake in the lungparenchyma.This application classevaluates images acquiredwith Siemens Twin BeamScanners. The post-processing functionality hasnot been changed comparedto the secondary predicatedevice.	N/A	This application class isdesigned to visualize theiodine enhancement inpulmonary vessels andvisualize and quantify theiodine uptake in the lungparenchyma.This application classevaluates images acquiredwith Siemens Dual SourceScanners.

The subject device syngo.CT Single Source Dual Energy (twin beam) does not have changes in technological characteristics when 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 Single Source Dual Energy (twin beam) 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 Single Source Dual Energy (twin beam) is designed to fulfill the requirements of the following safety and performance standards:

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

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RecognitionNumber	ProductArea	Title of Standard	PublicationDate	StandardsDevelopmentOrganization
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
19-4	General II(ES/EMC)	AAMI / ANSI ES60601-1:2005/(R)2012 andA1:2012, Medical electrical equipment - part1: general requirements for basic safety andessential performance (IEC 60601-1:2005,mod)	07/09/2014	AAMI, ANSI

Performance tests were conducted to test the functionality of the syngo.CT Single Source Dual Energy (twin beam) post-processing application. A clinical validation has been conducted to show that both application classes "Gout" and "Lung Analysis" operate as intended. We have shown that this software application based on Twin Beam Dual Energy data successfully visualizes urate depositions as a consequence of gout. The second validation shows that the application class Lung Analysis for Twin Beam data successfully calculates Lung PBV and Lung Vessels images from contrast enhanced Dual Energy CT-scans of the lung. Both application classes do not offer additional or new application features compared to the secondary predicate device.

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 using twin beam datasets 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 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.

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, and radiation hazards, Siemens adheres to recognized and established industry practice and standards.

VIII. Conclusions

syngo.CT Single Source Dual Energy (twin beam) 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 result of all testing conducted was found acceptable to support the claim of substantial equivalence. The predicate devices were cleared based on non-clinical supportive information and clinical images. The results of these tests demonstrate that the predicate devices are adequate for the intended use. 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 Single Source Dual Energy (twin beam), Siemens used the same testing with the same workflows as used to clear the primary predicate device. Since both devices were tested using the same methods, Siemens believes that the data generated from the syngo.CT Single Source Dual Energy (twin beam) 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.