The SOMATOM Emotion and SOMATOM Sensation family CT systems are intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from either the same axial plane taken at different angles or spiral planes* taken at different angles.

(*spiral planes: the axial planes resulted from the continuous rotation of detectors and x-ray tube, and the simultaneous translation of the patient.)

Device Description

syngo® CT 2014A (SOMARIS/5 VB42) is a new scanning software version for the following, already commercially available, systems:

SOMATOM Emotion 6 CT System
SOMATOM Emotion 16
SOMATOM Project P30F/Sensation 64
SOMATOM Project P30L/Sensation Open
SOMATOM P30 CT/Sensation .

The system software is a command-based program used for patient management, data management, X-ray scan control, image reconstruction, and image archive/evaluation. This new software version, syngo® CT 2014A (SOMATOM Emotion & SOMARIS/5 VB42), supports bug fixing and an upgrade for the existing commercially available SOMATOM Sensation family CT systems for better maintenance.

The SOMATOM Emotion and SOMATOM Sensation family CT systems are whole body X-ray Computed Tomography Systems. They produce CT images in DICOM format, which can be used by post-processing applications commercially distributed by Siemens and other vendors.

AI/ML Overview

The document provided does not contain a study comparing the device performance against acceptance criteria in the way described in your request (e.g., specific metrics like sensitivity, specificity, or AUC, with corresponding acceptance thresholds).

Instead, the document is a 510(k) premarket notification for a software update to existing CT systems. It primarily focuses on demonstrating substantial equivalence to previously cleared devices and adherence to relevant industry standards for safety and performance.

Here's a breakdown of the information that is present or can be inferred:

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

This specific table is not provided in the document. The document states:

"The testing results support the conclusion that all of the software specifications have met the acceptance criteria." (Page 6)
However, it does not detail what those specific acceptance criteria were or present a table of results against them. The non-clinical testing section lists adherence to various standards (ISO 14971, IEC 62304, IEC 60601 series, NEMA DICOM, NEMA XR-25). These standards themselves contain performance requirements that would serve as acceptance criteria, but no specific performance metrics like sensitivity or specificity are discussed in the context of disease detection.

2. Sample size used for the test set and the data provenance:

Sample Size for Test Set: Not explicitly mentioned. The document refers to "verification/validation as well as phantom testing" (Page 6) but does not provide details on the number of cases or phantoms used for these tests.
Data Provenance: Not applicable in the context of clinical image data for evaluation. The testing involved "phantom testing" (Page 6).

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

Not applicable, as no clinical study involving human expert ground truth for specific pathologies or conditions is described. The testing focused on technical performance and adherence to engineering standards.

4. Adjudication method for the test set:

Not applicable, as no clinical study requiring adjudication of expert readings is described.

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:

No MRMC study was done. This document describes a software update for CT systems, not an AI-assisted diagnostic tool. Therefore, there's no discussion of human reader improvement with AI.

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

Yes, in a way, standalone (algorithm only) testing was done for the software components. The non-clinical testing described involves "verification/validation as well as phantom testing" (Page 6). This would assess the software's performance (e.g., image reconstruction quality, dose management features) independently, but it's not a standalone diagnostic algorithm in the sense of detecting or classifying disease.

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

The ground truth for the technical tests would be the expected or reference values from the phantoms used and the specifications derived from the relevant engineering standards (e.g., image quality metrics, dose accuracy measurements). Not expert consensus or pathology.

8. The sample size for the training set:

Not applicable. This is a software update for existing CT systems, not a machine learning model that requires a "training set" in the conventional sense of AI.

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

Not applicable, as there is no training set mentioned for an AI model.

In summary:

This document is a regulatory submission for a software update to a Computed Tomography (CT) system. It addresses the technical performance and safety of the CT system's software, rather than the diagnostic performance of an AI algorithm in detecting specific conditions. The acceptance criteria and "study" are focused on demonstrating that the software update maintains the safety and effectiveness of the device and conforms to established medical device standards and regulations. The "performance" therefore refers to the system's ability to produce images and manage data according to its specifications and relevant standards, not its ability to detect clinical findings.

Summary

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Image /page/0/Picture/1 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract symbol that resembles a stylized caduceus, with three human profiles facing to the right.

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

August 14, 2014

Siemens Medical Solutions, USA, Inc. % Ms. Eve Davis Regulatory Affairs Specialist 51 Valley Stream Parkway D02 MALVERN PA 19355

Re: K140232

Trade/Device Name: syngo® CT 2014A (SOMARIS/5 VB42) for SOMATOM Emotion & SOMATOM Sensation family CT systems Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: II Product Code: JAK Dated: August 15, 2014 Received: July 6, 2014

Dear Ms. Davis:

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.

Sm. 7)

for

Janine M. Morris 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) K140232

Device Name

syngo® CT 2014A (SOMARIS/5 VB42) for SOMATOM Emotion & SOMATOM Sensation family CT systems

Indications for Use (Describe)

(*spiral planes: the axial planes resulted from the continuous rotation of detectors and x-ray tube, and the simultaneous translation of the patient.)

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)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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 Druq 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."

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Image /page/3/Picture/0 description: The image shows the word "SIEMENS" in a sans-serif font. The letters are a light blue color, and there is a black line underneath the word. The word is in all capital letters and is centered in the image.

(SOMARIS/5 VB42) for SOMATOM Emotion & Sensation family CT systems

510(k) Summary

Submitted by: Siemens Medical Solutions USA, Inc. 51 Valley Stream Parkway Malvern, PA 19355

Date Prepared: July 15, 2014

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. 51 Valley Stream Parkway Malvern, PA 19355
  Establishment Reqistration Number: 2240869

Manufacturing Site: SIEMENS SHANGHAI, MEDICAL EQUIPMENT LTD. 278 Zhou Zhu Rd Shanghai, CHINA 201318

Establishment Registration Number: 3003202425

1. Contact Person:
  Eve Davis Regulatory Affairs Specialist, Regulatory Affairs Submissions Siemens Medical Solutions, Inc. USA 51 Valley Stream Parkway D02 Malvern, PA 19355-1406 Phone: (610) 219-7133 Fax: (610) 448-1778 Email: eve.davis@siemens.com

3. Device Name and Classification

Product Name:	syngo® CT 2014A (SOMARIS/5 VB42) for SOMATOM Emotion & SOMATOM Sensation family CT systems
Propriety Trade Name:	syngo® CT 2014A (SOMARIS/5 VB42) for SOMATOM Emotion & SOMATOM Sensation family CT systems
Classification Name:	Computed Tomography X-ray System
Classification Panel:	Radiology
CFR Section:	21 CFR §892.1750
Device Class:	Class II
Product Code:	JAK

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Substantial Equivalence: 4.

Siemens syngo® CT 2014A (SOMARIS/5 VB42) for SOMATOM Emotion & SOMATOM Sensation family CT systems is substantially equivalent to the following medical devices in commercial distribution:

Predicate Devices	FDA ClearanceNumber	FDA ClearanceDate
syngo® CT 2013A (SOMARIS/5 VC20B)	K133424	January 17, 2014
SOMATOM Project P30F/ Sensation 64	K040655	April 2, 2004
SOMATOM Project P30L/ Sensation Open	K040577	March 22, 2004
SOMATOM P30 CT Systems/ Sensation	K013522	November 07, 2001

5. Device Description:

syngo® CT 2014A (SOMARIS/5 VB42) is a new scanning software version for the following, already commercially available, systems:

SOMATOM Emotion 6 CT System ●
SOMATOM Emotion 16 ●
SOMATOM Project P30F/Sensation 64 ●
SOMATOM Project P30L/Sensation Open ●
SOMATOM P30 CT/Sensation .

6. Summary of Technical Characteristics of the Subject Device as Compared with the Predicate Device:

There are no significant changes in the materials, energy source, or technological characteristics when compared to the predicate devices for syngo® CT 2014A (SOMARIS/5 VB42) for SOMATOM Emotion & SOMATOM Sensation family CT systems. The imaging components (tube, collimator, detector, and DAS) are the same as the predicate devices.

In addition to the bug fixing and upgrade, the new software version syngo® CT 2014A (SOMARIS/5 VB42) supports features which already exist on other commercially available SOMATOM Emotion and SOMATOM Sensation Family CT

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Image /page/5/Picture/0 description: The image shows the word "SIEMENS" in a sans-serif font. The letters are a light blue color. There is a black line underneath the word.

(SOMARIS/5 VB42) for SOMATOM Emotion & Sensation family CT systems

Systems. These features are now also provided to the above mentioned systems, which have been installed or were in use prior to their introduction. These features are:

Dose MAP ●
. e-Start Functionality
. IRIS

Nonclinical Testing: 7.

The SOMATOM Emotion and SOMATOM Sensation family CT systems configured with software version syngo® CT 2014A (SOMARİS/5 VB42) are designed to fulfill the requirements of the following standards:

RecognitionNumber	ProductArea	Title of Standard	ReferenceNumber &Date	PublicationDate	StandardsDevelopmentOrganization
5-40	General	Medical devices –Application of riskmanagement to medicaldevices	14971SecondEdition 2007-03-01	08/20/2012	ISO
13-8	Software	Medical device software –Software life cycle processes	62304 Firstedition 2006-05	08/20/2012	IEC
5-41	General	Medical electrical equipment– Part 1-4: Generalrequirements for safety –Collateral standard:Programmable electricalmedical systems, edition 1.1	60601-1-4:2000Consol.Ed1.1	09/08/2009	IEC
12-218	Radiology	Digital Imaging andCommunications in Medicine(DICOM) Set	PS 3.1-3.15,2001	3/18/2011	NEMA
12-222	Radiology	Evaluation and routinetesting in medical imagingdepartments - Part 3-5:Acceptance tests - Imagingperformance of computedtomography X-ray equipment	61223-3-5First edition2004-08	03/18/2011	IEC
12-226	Radiology	Evaluation and routinetesting in medical imagingdepartments - Part 2-6:Constancy tests - Imagingperformance of computed	61223-2-6SecondEdition 2006-11	02/28/2011	IEC

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		tomography X-ray equipment
12-225	Radiology	Computed TomographyDose Check	XR-25	03/18/2011	NEMA
5-78	General	A2:2010/(R)2012(Consolidated Text) Medicalelectrical equipment-Part 1:General requirements forbasic safety and essentialperformance (IEC 60601-1:2005, MOD)	ES60601-1:2005/(R)2012 andC1:2009/(R)2012 anda2:2010/(R)2012	01/14/2014	AAMI ANSI
5-53	General	Medical electrical equipment-Part 1-2: Generalrequirements for basic safetyand essential performance-Collateral standard:Electromagneticcompatibility-Requirementsand tests	60601-1-2Edition3:2007-03	01/30/2014	IEC
5-54	General	Medical electrical equipment-Part 1-2: Generalrequirements for basic safetyand essential performance-Collateral standard:Electromagneticcompatibility-Requirementsand tests (Edition 3)	60601-1-2:2007/(R)2012	01/30/2014	AAMI ANSIIEC
12-257	Radiology	Medical electrical equipment-Part 2-44: Particularrequirements for the basicsafety and essentialperformance of X-rayequipment for X-rayequipment for computedtomography	60601-2-44Edition 3.02009-02	01/14/2014	IEC

Non-clinical tests were conducted for the SOMATOM Emotion & SOMATOM Sensation family CT systems configured with software version syngo® CT 2014A (SOMARIS/5 VB42) during product development. The modifications described in this Premarket Notification were supported with verification/validation as well as phantom testing.

The Risk analysis was completed and risk control implemented to mitigate identified hazards. The testing results support the conclusion that all of 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.

FDA's Guidance Document "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" issued on May 11, 2005, was adhered to.

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(SOMARIS/5 VB42) for SOMATOM Emotion & Sensation family CT systems

8. Indications for Use:

(*spiral planes: the axial planes resulted from the continuous rotation of detectors and x-ray tube, and the simultaneous translation of the patient.)

9. General Safety and Effectiveness Concerns:

The device labeling contains instructions for use as well as necessary cautions and warnings to provide for safe and effective use of the device.

Risk management is ensured via a hazard analysis. 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

In summary, Siemens is of the opinion that syngo® CT 2014A (SOMARIS/5 VB42) for SOMATOM Emotion & SOMATOM Sensation family CT systems does not introduce any new potential safety risk, and is substantially equivalent to and performs as well as the predicate devices.

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.