syngo.CT Extended Functionality is intended to provide advanced visualization tools to prepare and process medical images for diagnostic purpose. The software package is designed to support technicians and physicians in qualitative and quantitative measurements and in the analysis of clinical data that was acquired and reconstructed by Computed Tomography (CT) scanners.

An interface shall enable the connection between the syngo.CT Extended Functionality software package and the interconnected CT Scanner system.

Result images created with the syngo.CT Extended Functionality software package can be used to assist trained technicians or physicians in diagnosis.

Device Description

syngo.CT Extended Functionality is a software bundle consisting of previously cleared unmodified and modified post-processing applications that offer tools to support special clinical evaluations. syngo.CT Extended Functionality can be used to create advanced visualizations and measurements on clinical data that was acquired and reconstructed by Computed Tomography (CT) scanners.

Depending on the clinical question, the user can select functionality which supports the explicit clinical fields as listed below. The syngo.CT Extended Functionality software package is designed to operate on the most recent version syngo-compatible postprocessing platform, which currently supports the following four tools:

1. Preparation of Vascular Case for Reading Physician
1. Preparation of Oncology Case for Reading Physician
1. Preparation of Osteo Case for Reading Physician
1. Preparation of Neuro DSA Bone Subtraction for Reading Physician

The supported functionality can be used on any CT data if basic requirements are met (e.g. spiral or sequence scan, reconstruction kernel). The supported functionality will check to ensure the basic requirements are met and will not allow its execution or will provide a warning or info message to the user if appropriate. This check also allows combination of functionality of different clinical fields, (e.q. a vascular case can be prepared also on Neuro DSA bone subtracted data or on the same case as Lung CAD computation, etc.). Afterwards, any tool can be accessed as long as the data and viewing type allows it. For example, an evaluation of a ROI defined by a contour and two HU thresholds can be used to measure a certain area. No specific sequential workflow is required.

The original clinical data that was acquired and reconstructed by Computed Tomography (CT) scanners will not be modified in any form. The results of the syngo.CT Extended Functionality can be stored as additional DICOM images if needed as kev images or range or images. The subject device syngo.CT Extended Functionality is designed to operate on a syngo compatible host system (e. g. syngo.via VB20 software platform or higher).

AI/ML Overview

The provided text describes the 510(k) premarket notification for "syngo.CT Extended Functionality." However, it does not contain the specific details required to fully address all parts of your request regarding acceptance criteria and a detailed study proving device performance. The information provided is high-level and focuses on regulatory compliance and substantial equivalence to predicate devices, rather than a specific clinical performance study.

Here's a breakdown of the available information and what's missing:

1. A table of acceptance criteria and the reported device performance

The provided document does not include a specific table of acceptance criteria with corresponding performance metrics for the syngo.CT Extended Functionality as a whole, or for its individual modified components. It generally states:

"All verification and validation testing has been completed and meets Siemens acceptance criteria." (Page 7)
"The testing results support that all the software specifications have met the acceptance criteria." (Page 7)
"The results of these tests demonstrate that the subject device performs as intended." (Page 7)
"The results of all conducted testing was found acceptable to support the claim of substantial equivalence." (Page 7)

This is a general statement of compliance, not a detailed report of specific performance metrics against defined acceptance criteria.

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

The document does not specify the sample size used for any test sets, nor does it provide information about the provenance of the data (country of origin, retrospective or prospective).

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 mention the use of experts to establish ground truth for any test set or their qualifications.

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

The document does not describe any adjudication methods used for a test set.

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 does not mention an MRMC comparative effectiveness study, nor does it discuss improvements in human reader performance with or without AI assistance. The device is described as providing "advanced visualization tools to prepare and process medical images for diagnostic purpose" and assisting "trained technicians or physicians in diagnosis," but not as an AI-powered diagnostic tool in the sense of comparing human performance with and without its specific assistance.

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

The document does not describe any standalone algorithm performance studies. The device is explicitly intended to "assist trained technicians or physicians in diagnosis," implying human-in-the-loop usage.

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

The document does not specify the type of ground truth used for any testing.

8. The sample size for the training set

The document does not mention a training set or its sample size. This is consistent with the device being a "software bundle consisting of previously cleared unmodified and modified post-processing applications," rather than a novel AI/ML algorithm that requires a dedicated training phase reported in this context.

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 also absent.

Summary of what is present in the document regarding testing:

The document focuses on "Non-Clinical Testing Summary" (Page 7) to demonstrate substantial equivalence, rather than detailed clinical performance studies.

Type of Study: Non-clinical tests (integration and functional) were conducted. Verification/validation testing was performed for modifications to previously cleared components.
Acceptance Criteria (General): "All verification and validation testing has been completed and meets Siemens acceptance criteria." "The testing results support that all the software specifications have met the acceptance criteria."
Risk Analysis: A risk analysis was completed, and risk control was implemented in accordance with ISO 14971.
Software Verification and Validation: Documentation for "Moderate Level of Concern" software was included, conforming to FDA's "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" (May 11, 2005).
Intended Use: The tests demonstrated the device "performs as intended."
Comparison to Predicate: "Siemens used the same testing with the same workflows as used to clear the predicate device."

Conclusion based on the provided text:

The submission confirms that the device underwent verification and validation testing as part of the regulatory approval process for software, especially for modifications made to existing functionalities (like the Osteo feature). However, it does not provide the detailed clinical performance study data (including specific acceptance criteria, sample sizes, expert involvement, and ground truth methodologies) often associated with new diagnostic algorithms or AI-driven systems. The clearance is based on demonstrating substantial equivalence to predicate devices, supported by non-clinical performance data and software validation, suggesting the device's functionality is well-understood and its safety and effectiveness are established through these engineering and software-level tests.

Summary

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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: K163341

Trade/Device Name: syngo.CT Extended Functionality Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: II Product Code: JAK Dated: November 17, 2016 Received: November 29, 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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Indications for Use

510(k) Number (if known) K163341

Device Name syngo.CT Extended Functionality

Indications for Use (Describe)

An interface shall enable the connection between the syngo.CT Extended Functionality software package and the interconnected CT Scanner system.

Result images created with the syngo.CT Extended Functionality software package can be used to assist trained technicians or physicians in diagnosis.

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 EXTENDED FUNCTIONALITY

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

Date Prepared: January 24, 2017

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.

l. 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, Inc. USA 40 Liberty Boulevard Malvern, PA 19355 Phone: (610) 448 - 6477 Fax: (610) 640 - 4481 Email: kimberly.mangum@siemens.com

II. Device Name and Classification

510(k) Number: K163341 Product Name: syngo.CT Extended Functionality Propriety Trade Name: syngo.CT Extended Functionality Classification Name: Computed Tomography X-ray System Classification Panel: Radiology 21 CFR §892.1750 CFR Section: Device Class: Class II Product Code: 90JAK

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SIEMENS

III. Predicate Device

Predicate Device:

Trade Name: syngo.CT Vascular Analysis 510(k) Number: K112020 08/18/2011 Clearance Date: Classification Name: System, X-Ray, Tomography, Computed Classification Panel: Radiology CFR Section: 21 CFR § 892.1750 Device Class: Class II Product Code: JAK

Predicate Device:

Trade Name:	syngo.CT Lung CAD
510(k) Number:	K143196
Clearance Date:	05/12/2015
Classification Name:	Lung Computed Tomography System, Computer-Aided Detection
Classification Panel:	Radiology
CFR Section:	21 CFR § 892.2050
Device Class:	Class II
Product Code:	OEB

Predicate Device:

Osteo CT Option for SOMATOM CT Systems Trade Name: 510(k) Number: K971054 Clearance Date: 06/13/1997 Classification Name: System, X-Ray, Tomography, Computed Classification Panel: Radiology CFR Section: 21 CFR § 892.1750 Device Class: Class II Product Code: JAK Subsequent Product Code: KGI

Predicate Device:

Trade Name:	syngo Neuro DSA CT
510(k) Number:	K053024
Clearance Date:	11/04/2005
Classification Name:	System, X-Ray, Tomography, Computed
Classification Panel:	Radiology
CFR Section:	21 CFR § 892.1750
Device Class:	Class II
Product Code:	JAK

IV. Device Description

Depending on the clinical question, the user can select functionality which supports the explicit clinical fields as listed below. The syngo.CT Extended Functionality software

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SIEMENS

package is designed to operate on the most recent version syngo-compatible postprocessing platform, which currently supports the following four tools:

1. Preparation of Vascular Case for Reading Physician
1. Preparation of Oncology Case for Reading Physician
1. Preparation of Osteo Case for Reading Physician
1. Preparation of Neuro DSA Bone Subtraction for Reading Physician

V. Indications for Use

An interface shall enable the connection between the syngo.CT Extended Functionality software package and the interconnected CT scanner system. Result images created with the syngo.CT Extended Functionality software package can be used to assist trained technicians or physicians in diagnosis.

VI. Comparison of Technological Characteristics with the Predicate Device

This subject device is a bundle software package consisting of previously cleared unmodified and modified software applications that provide advanced visualization and measurement tools. At a high-level, the subject and predicate device are based on the following same/similar technological characteristics:

Subject SupportedFunctionality	Predicate Device and SupportedFunctionality	Comparison Results
Tools and layouts for vascularassessment	predicate device:K112020 - syngo.CT Vascular AnalysisTools and layouts for vascularassessment	Supports the sameunmodified functionalityfrom the predicate device.
Display of the findings of theLung CAD algorithm	predicate device:K143416 - syngo.CT Lung CAD	Supports the sameunmodified functionality

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Subject SupportedFunctionality	Predicate Device and SupportedFunctionality	Comparison Results
	Display of the findings of the Lung CADalgorithm	from the predicate device.
Provides a set of routine toolsfor the assessment of bonemineral content	predicate device:K971054 - Osteo CT Option forSOMATOM CT SystemsProvides a set of routine tools for theassessment of bone mineral content	Modified to evaluateimages from volume scansand semi-automaticallycalculate the position andorientation of mid-vertebralslices (MVS).
Provides a set of tools forassessment of the cerebralvasculature by removinginterfering bone structures	predicate device:K971054Provides a set of tools for assessment ofthe cerebral vasculature by removinginterfering bone structures	Supports the sameunmodified functionalityfrom the predicate device.

VII. Performance Data

The following performance data were provided in support of the substantial equivalence determination. 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 Extended Functionality during product development. The modifications described in this Premarket Notification were supported with verification/validation testing. Verification testing for the Osteo feature was conducted to demonstrate successful software integration and performance in accordance to Siemens internal procedure which includes risk identification and mitigation in accordance with ISO 14971. All verification and validation testing has been completed and meets Siemens acceptance criteria. Additionally, all risks for the complete subject device have been identified and mitigated in accordingly.

Risk Analvsis

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 synqo.CT Extended 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.

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SIEMENS

syngo.CT Extended Functionality 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 (1stEdition)	08/20/2012	AAMI, ANSI, IEC
5-40	Software/Informatics	Medical devices - Application of riskmanagement to medical devices; 14971Second Edition 2007-03-01	08/20/2012	ISO
5-95	General I(QS/RM)	Medical devices - Part 1: Application ofusability engineering to medical devicesIEC 62366-1:2015	06/27/2016	IEC
19-4	General II(ES/EMC)	AAMI / ANSI ES60601-1:2005/(R)2012and A1:2012, Medical electricalequipment - part 1: generalrequirements for basic safety andessential performance (IEC 60601-1:2005, mod)	07/09/2014	AAMI, ANSI

VIII. Conclusions

This subject device combines four advanced visualization and measurement tools into one software bundle package. The fundamental software technology which is provided within the scope of the advanced tools is already cleared and remains unchanged in comparison to the predicate devices. The Indications for Use for the subject device has been adapted to provide a more specific description of the syngo.CT Extended Functionality realized as software package including a software bundle that consists of previously cleared post-processing software applications. The conducted modifications described in this Premarket Notification were supported with verification and validation testing. The Risk analysis was completed and risk control implemented to mitigate identified hazards.

The predicate devices were cleared based on non-clinical supportive information. 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 device that is currently marketed for the same intended use. For the subject device, syngo.CT Extended Functionality, Siemens used the same testing with the same workflows as used to clear the predicate device. Since both devices were tested using the same methods, Siemens believes that the data generated from the syngo.CT Extended Functionality 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.