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

· 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 unc 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 (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
Monoenergetic Plus ●
Virtual Unenhanced ●
. Rho/Z
Hard Plaques
Kidnev 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.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the "syngo.CT Single Source Dual Energy (twin beam)" device, which is a post-processing application for CT images. The document focuses on demonstrating substantial equivalence to predicate devices rather than directly providing acceptance criteria and performance data in a detailed format typical for a clinical study with specific endpoints.

Here's an attempt to extract the requested information based on the provided text, recognizing that significant details are not present:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly list specific numerical acceptance criteria or quantitative performance metrics for the device's accuracy in a table. Instead, it relies on demonstrating that the subject device performs "as well as" the predicate device applications. The "performance" is implicitly tied to fulfilling the intended functionality and being "as safe and effective" as the predicates.

Acceptance Criteria (Implied)	Reported Device Performance (Implied)
Functionality of applications (Monoenergetic, Bone Removal, Liver VNC, Monoenergetic Plus, Virtual Unenhanced, Rho/Z, Hard Plaques, Kidney Stones)	* General: "The results of these tests demonstrate that the subject device performs as intended." and "The subject device using twin beam datasets performs as well as the predicate device applications that were tested using the same methods."* Rho/Z and Kidney Stones: Functionality was tested via "Phantom bench testing and clinical validation in a retrospective study."* Monoenergetic Plus, Bone Removal, Liver VNC, and Hard Plaques: Performance was tested via "Retrospective clinically validated studies."* Kidney Stones (Specific Caveat): "The accuracy of identification is decreased in obese patients." and "Only a well-trained radiologist can make the final diagnosis under consideration of all available information."
Conformance to safety and performance standards	The device "is designed to fulfill the requirements of" ISO 14971, IEC 62304, IEC 60601 series, and DICOM standards. "Testing for verification and validation of the device was found acceptable to support the claims of substantial equivalence."
Software specifications met	"The testing results support that all the software specifications have met the acceptance criteria."
Substantial Equivalence to 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."

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: The document does not specify the sample size for the test set used in either the phantom bench testing or the clinical validation studies.
Data Provenance: The studies were described as "retrospective clinically validated studies." The country of origin of the data is not mentioned.

3. 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)

The document does not specify the number or qualifications of experts used to establish ground truth for the test set. It only states for "Kidney Stones" that "Only a well-trained radiologist can make the final diagnosis under consideration of all available information." This implies radiologists were involved in diagnosis but doesn't detail their role in ground truth establishment for the studies.

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

The adjudication method used for the test set is not mentioned.

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

The document mentions "retrospective clinically validated studies" and notes that "The subject device using twin beam datasets performs as well as the predicate device applications that were tested using the same methods." However, it does not describe a multi-reader multi-case (MRMC) comparative effectiveness study evaluating human reader improvement with AI assistance vs. without AI. The focus is on the software's performance itself and its equivalence to predicates.

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

Yes, the testing described appears to be primarily focused on the standalone performance of the software applications compared to predicate devices. Phrases like "Phantom bench testing" and "retrospective clinically validated studies... to test the performance for applications" suggest algorithm-only assessment of its outputs. The statement regarding the "Kidney Stones" application, "Only a well-trained radiologist can make the final diagnosis," clarifies the role of the algorithm as a support tool, implying a standalone assessment of its output, which a human then interprets.

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

The document does not explicitly state the type of ground truth used for any of the studies. Given the context of "clinically validated studies," it's reasonable to infer that clinical diagnosis, potentially supported by pathology or follow-up outcomes, would be part of establishing ground truth, especially for conditions like kidney stones. However, this is not explicitly detailed.

8. The sample size for the training set

The document does not mention any training set or its sample size. This is a post-processing application, and the document focuses on validation/verification testing of its functionality rather than development or training of a new AI model in the submission text.

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

As no training set is mentioned, information on how its ground truth was established is not 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" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other, with flowing lines connecting them.

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

February 19, 2016

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

Re: K153220

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: January 19, 2016 Received: January 22, 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/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. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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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)

K153220

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

Indications for Use (Describe)

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 aremation 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

· 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@fda.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

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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 03, 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: Siemens Medical Solutions USA, Inc. 40 Liberty Boulevard Malvern, PA 19355 Establishment Registration Number 2240869

Manufacturing Facility: Siemens AG Medical Solutions Siemensstraße 1 D-91301 Forchheim, Germany Establishment Registration Number: 3004977335

2. Contact Person

Kimberlv Mangum Regulatory Affairs Specialist Siemens Medical Solutions, Inc. USA 40 Liberty Boulevard Mail Code 65-1A Malvern, PA 19355 Phone: (610) 448-6477 Fax: (610) 640-4481 Email: kimberly.mangum@siemens.com

3. Device Name and Classification

syngo.CT Single Source Dual Energy (twin beam) Product Name: Propriety Trade Name: syngo.CT Single Source Dual Energy (twin beam) 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 Predicate Device: Primary Predicate Device: Trade Name: syngo.CT Dual Energy 510(k)#: K150757 Clearance Date: August 11, 2015 Classification Name: Computed Tomography X-ray System Classification Panel: Radiology Classification Requlation: 21 CFR § 892.1750

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Device Class:Product Code:	Class II90JAK
Secondary Predicate Device:
Trade Name:	SOMATOM Definition AS/ AS+ andSOMATOM Definition Edge
510(k)#:	K152036
Clearance Date:	October 9, 2015
Classification Name:	Computed Tomography X-ray System
Classification Panel:	Radiology
Classification Regulation:	21 CFR § 892.1750
Device Class:	Class II
Product Code:	90JAK

4. Substantial Equivalence:

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

Predicate Device	FDA ClearanceNumber	FDAClearanceDate
Primary Predicate Device:syngo.CT Dual Energy	K150757	August 11,2015
Secondary Predicate Device:SOMATOM Definition AS/ AS+ andSOMATOM Definition Edge	K152036	October 9,2015

Table 1 Predicate Device

5. 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
Monoenergetic Plus ●
Virtual Unenhanced ●
. Rho/Z

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Hard Plaques
Kidnev Stones .

1. The Use of Twin Beam Images for Dual Energy post-processing Applications
1. Modified Indications for Use Statement
1. Modified Product Name

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

6. Summary of Technical Characteristics of the Subject Device as compared 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 syngo.CT Dual Energy. 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 same type of input images is accepted and the same alqorithms as well as the same spectrum dependent parameters are used to generate the output images.

Table 2 below provides a comparison of the primary features of the subject device in comparison to the predicate devices.

Property /Feature	Subject Device	Primary Predicate DeviceK150757	Secondary PredicateDeviceK152036
Data AcquisitionMode	The subject device usesDICOM images acquiredusing Twin Beam (splitfiltration) Single Sourcescanners.	This device uses DICOMimages acquired with DualSource scanners.	This device provides aSingle Source Twin Beam(split filtration) dataacquisition mode.
Imageprocessing	The software processesTwin Beam Dual Energyimages.	The software processesDual Source Dual Energyimages.	The software processesTwin Beam (split filtration)Single Source images.
SoftwareFeatures/Functionality	Post-processing applicationsupports the use ofTwinBeam datasets withvarious post-processingapplications	Post processing applicationsupports the use of DualSource datasets with variouspost processing applications	Scanner supports the useof TwinBeam datasetswith application FAST DEResults for post-processing ApplicationsMonoenegetic Plus andVirtual Unenhanced

Table 2 Predicate and Subject Device Comparable Technological Characteristics

The subject device synao.CT Single Source Dual Energy (twin beam) does not have significant changes in technological characteristics when compared to the predicate devices. The postprocessing software functionality remains unchanged from the subject device and the predicate The Indication for Use, operating principle, and the scientific technology are similar; devices. therefore, Siemens believes that syngo.CT Single Source Dual Energy (twin beam) application is substantially equivalent to the predicate devices.

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7. Nonclinical Testing:

syngo.CT Single Source Dual Energy (twin beam) is designed to fulfill the requirements of the following safety and performance standards:

Table 3 Conformance Standards
-------------------------------

RecognitionNumber	ProductArea	Title of Standard	ReferenceNumber andDate	PublicationDate	StandardsDevelopmentOrganization
N/A	Radiology	Digital Imaging andCommunications in Medicine(DICOM) Set	PS 3.1 - 3.18	2008	NEMA
13-8	Software	Medical device software -Software life cycle processes	62304 Firstedition 2006-05	08/20/2012	IEC
5-40	General	Medical devices - Applicationof risk management to medicaldevices	14971 SecondEdition 2007-03-01	08/20/2012	ISO
5-85	General	Medical electrical equipment -Part 1-6: Generalrequirements for basic safetyand essential performance -Collateral Standard: Usability	60601-1-6Edition 3.0	07/09/2014	IEC
N/A	General	Medical electrical equipment -Part 1-4: Generalrequirements for safety -Collateral standardProgrammable electricalmedical systems, Edition 1.1	60601-1-4:2000,Consol. Ed.1.1	09/08/2009	IEC

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 (twin beam) 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 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 Single Source Dual Energy (twin beam) application package. Phantom bench testing and clinical validation in a retrospective study was conducted to test the functionality of applications Rho/Z and Kidney Stones. Retrospective clinically validated studies were conducted to test the performance for applications Monoenergetic Plus, Bone Removal, Liver VNC, and Hard Plaques, as well as the predicate device applications. 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.

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SIEMENS

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.

8. 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
· 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.

9. 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.

10. Conclusion as to Substantial Equivalence:

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 primary predicate device. 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 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

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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.