This computed tomography system is intended to generate and process cross-sectional images of patients by computer reconstruction of x-ray transmission data. The images delivered by the system can be used by a trained physician as an aid in diagnosis.

The images delivered by the system can be used by trained staff as an aid in diagnosis, treatment preparation and radiation therapy planning.

This CT system can be used for low dose lung cancer screening in high risk populations.*

*As defined by professional medical societies. Please refer to clinical literature, including the results of the National Lung Screening Trial (N Engl J Med 2011: 365:395-409) and subsequent literature, for further information.

Device Description

The Siemens SOMATOM Confidence is a Computed Tomography X- ray System which features one continuously rotating tube-detector system and functions according to the fan beam principle. The SOMATOM Confidence produces CT images in DICOM format, which can be used by trained staff for post-processing applications commercially distributed by Siemens and other vendors as an aid in diagnosis, treatment preparation and therapy planning support (including, but not limited to, Brachytherapy, Particle including Proton Therapy, External Beam Radiation Therapy, Surgery). The computer system delivered with the CT scanner is able to run the post processing applications optionally.

The platform software for the SOMATOM Confidence, syngo CT VA62A (SOMARIS/7 VA62A), is a command-based program used for patient management, data management, X-ray scan control, image reconstruction, and image archive/evaluation. The SOMATOM Confidence will support the following modifications in comparison to the predicate devices:

1. New Marketing Name: SOMATOM Confidence (SOMATOM Confidence® RT Pro)
1. Modified Indication for Use Statement
1. New/Modified Hardware
- Touch Panels ●
- New Gantry and Patient Table Covers .
- Stellar RT Detector .
1. Software version SOMARIS/7 VA62A
- Data Exchange with external SW Client (Teamplay) ●
- IT Hardening .
- DirectDensity™ .
1. Update 510(k) Information

The SOMATOM Confidence will be offered in 20 and 64 slice configurations.

AI/ML Overview

The provided text does not contain detailed acceptance criteria and the comprehensive study results to populate all the requested fields for a specific AI device. The document is a 510(k) summary for a CT scanner (SOMATOM Confidence® RT Pro), which is a general imaging device, not an AI-powered diagnostic tool with specific performance metrics like sensitivity, specificity, or AUC related to an AI algorithm.

However, I can extract the information related to the device itself and its general performance verification, as well as the reference to a clinical trial relevant to one of its indications for use (low-dose lung cancer screening).

Here's a breakdown of what can and cannot be answered from the provided text:

Information directly available or inferable about the SOMATOM Confidence® RT Pro (CT System):

1. A table of acceptance criteria and the reported device performance: The document states that "all of the software specifications have met the acceptance criteria" and that "the testing results support that the requirement specifications have met the acceptance criteria" for the DirectDensity™ feature. However, the specific acceptance criteria values (e.g., specific signal-to-noise ratios, spatial resolution, CT number accuracy) and their corresponding reported performance values for the device itself (the CT scanner) are not presented in a table format within this summary. It generally assures conformity to performance standards like ISO 14791, NEMA XR-29, IEC 61223-2-6, IEC 61223-3-5, IEC 62304, NEMA XR-25, and DICOM 3.1-3.20. For DirectDensity™, it mentions "image values proportional to relative electron density and perform as expected," but no quantitative criteria or performance figures are given.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: The document describes the CT system's performance, including features like DirectDensity™. This is essentially a "standalone" evaluation of the imaging device's capabilities. There is no mention of an AI diagnostic algorithm being tested in a standalone capacity within this text.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): For the testing of the CT system and its features such as DirectDensity™, phantom tests (using a Gammex 467 Tissue Characterization Phantom) and simulations were used.
8. The sample size for the training set: Not applicable for the CT scanner hardware/software itself. If this were an AI algorithm submission, this would be crucial.
9. How the ground truth for the training set was established: Not applicable for the CT scanner hardware/software itself.

Information related to the referenced "National Lung Screening Trial (NLST)" for the low-dose lung cancer screening indication:

2. Sample size used for the test set and the data provenance:
- Sample Size: The NLST was "a randomized trial of screening with the use of low-dose CT compared to chest radiography." While the exact number of participants is not given in this document, the referenced paper (N Engl J Med 2011; 365:395-409) is the primary source for this information. It is a prospective trial.
- Data Provenance: The trial was sponsored by the National Cancer Institute, implying multi-center US-based data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not specified in this document, but would be detailed in the NLST publication. The interpretation task for CT in NLST was "to detect lung nodules of 4mm diameter or greater."
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not specified in this document for the NLST.
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 NLST was a comparative effectiveness study comparing low-dose CT to chest radiography for lung cancer screening outcomes (mortality reduction). It was not specifically an MRMC study with AI assistance. It evaluated human readers interpreting images from two different modalities. The effect size reported by NLST was that screening with low-dose CT reduced lung cancer mortality compared to chest radiography. This document does not quantify that effect size but refers to the publication.

Summary Table:

Feature/Criterion	Acceptance Criteria (from text)	Reported Device Performance (from text)	Notes
CT System (SOMATOM Confidence® RT Pro)
General Performance	Conformance to ISO 14791, NEMA XR-29, IEC 61223-2-6, IEC 61223-3-5, IEC 62304, NEMA XR-25, and DICOM 3.1-3.20. (Implicit: All software specifications meet acceptance criteria).	"All of the software specifications have met the acceptance criteria." "The test results show that all of the software specifications have met the acceptance criteria." "The data included in this submission demonstrates that the SOMATOM Confidence performs comparably to the predicate device that is currently marketed for the same intended use."	Specific quantitative criteria and performance values for the CT scanner (e.g., resolution, noise) are not explicitly detailed in this summary. General conformance to standards is stated.
DirectDensity™ Reconstruction	(Implicit: Requirement specifications for) "image values proportional to relative electron density and perform as expected."	"The results of verification and validation testing demonstrate that the subject device modifications for DirectDensity™ - image values proportional to relative electron density and perform as expected. The testing results support that the requirement specifications have met the acceptance criteria."	No quantitative metrics are provided for "proportional" or "as expected."
Electrical Safety & EMC	Conformance to IEC 60601-1, 60601-2-44, and 60601-1-2.	"Electrical Safety and Electromagnetic Compatibility (EMC) testing were conducted on the SOMATOM Confidence in accordance with the following standards." (Implicit: Conformed to these standards).	"Completed Form FDA 3654 are provided within this submission" indicates successful completion.
Cybersecurity	(Implicit: Implementation of) "process of preventing unauthorized access, modifications, misuse or denial of use, or the unauthorized use of information that is stored, accessed, or transferred from a medical device to an external recipient."	"Siemens conforms to the Cybersecurity requirements by implementing a process..."	Conformance to guidance document "Content of Premarket Submissions for Management of Cybersecurity Medical Devices issues on October 2, 2014" is stated.
Study for Low Dose Lung Cancer Screening Indication (Referenced NLST)	(Implicit: Demonstrate benefit of low-dose CT screening for lung cancer in high-risk populations).	NLST "was a randomized trial of screening with the use of low-dose CT compared to chest radiography to determine whether screening with low-dose CT could reduce mortality from lung cancer." "screening with low-dose CT could reduce mortality from lung cancer."	The specific effect size of mortality reduction is not quantified in this document, but the benefit is stated and refers to the NLST publication.

Additional Requested Information:

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- For CT System Testing: Not explicitly specified (phantom tests, simulations).
- For NLST: Not explicitly stated in this document, but implied to be a large, prospective, multi-center US trial (National Cancer Institute sponsorship).
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)
- For CT System Testing: Not applicable (phantom/simulations).
- For NLST: Not specified in this document.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- For CT System Testing: Not applicable.
- For NLST: Not specified in this document.
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
- Not done with AI assistance. The NLST was a comparative effectiveness trial of two screening modalities (low-dose CT vs. chest radiography) interpreted by human readers. It did not involve AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Yes, for the CT system itself. The performance of the SOMATOM Confidence CT system and its features (like DirectDensity™) were evaluated. This is not an AI diagnostic algorithm, but the imaging device's performance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- For CT System Testing: Phantom tests (Gammex 467 Tissue Characterization Phantom) and simulations.
- For NLST: Lung cancer mortality (outcomes data) was the primary endpoint. The "interpretation task with CT for this study was to detect lung nodules of 4mm diameter or greater" which would have likely been verified by pathology/follow-up.
8. The sample size for the training set
- Not applicable; this is for a CT system, not an AI algorithm requiring a training set in the typical sense.
9. How the ground truth for the training set was established
- Not applicable.

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" 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 beneath them.

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

December 16, 2016

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

Re: K162302

Trade/Device Name: SOMATOM Confidence ® RT Pro Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: II Product Code: JAK Dated: November 10, 2016 Received: November 14, 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) K162302

Device Name

SOMATOM Confidence ® RT Pro

Indications for Use (Describe)

The images delivered by the system can be used by trained staff as an aid in diagnosis, treatment preparation and radiation therapy planning.

This CT system can be used for low dose lung cancer screening in high risk populations *

As defined by professional medical societies. Please refer to clinical literature, including the results of the National Lung Screening Trial (N Engl J Med 2011; 365:395-409) and subsequent literature, for further information.

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)

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510(K) SUMMARY FOR

SOMATOM Confidence

Submitted by: Siemens Medical Solutions USA, Inc. 40 Liberty Boulevard Malvern, PA 19355 Date Prepared: November 9, 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

Location of Manufacturing Site

Siemens Healthcare GmbH Siemensstr. 1 D-91301 Forchheim, Germany

Establishment Registration Number

3004977335

Contact Person:

Kimberly Mangum Requlatory 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: SOMATOM Confidence Propriety Trade Name: SOMATOM Confidence® RT Pro Classification Name: Computed Tomography X-Ray System Classification Panel: Radiology CFR Section: 21 CFR §892.1750 Device Class: Class II Product Code: JAK

III. Predicate Device Primary Predicate Device:

SOMATOM Definition AS Open Trade Name: 510(k) Number: K142955

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Clearance Date:	November 24, 2015
Classification Name:	Computed Tomography X-ray System
Classification Panel:	Radiology
CFR Section:	21 CFR §892.1750
Device Class:	Class II
Product Code:	JAK
Recall Information:	Information about design related recalls are provided in Section18.

Secondary Predicate Device:

Trade Name:	SOMATOM Definition Flash
510(k) Number:	K142955
Clearance Date:	November 24, 2015
Classification Name:	Computed Tomography X-ray System
Classification Panel:	Radiology
CFR Section:	21 CFR § 892.1750
Device Class:	Class II
Product Code:	JAK
Recall Information:	Information about design related recalls are provided in Section 18.

Reference Devices:

Trade Name:510(k) Number:Clearance Date:Classification Name:Classification Panel:CFR Section:Device Class:Product Code:Recall Information:	SOMATOM Definition AS OpenK130901January 2, 2014Computed Tomography X-ray SystemRadiology21 CFR § 892.1750Class IIJAKInformation about design related recalls are provided in Section18.
Trade Name:	SOMATOM Definition Flash
510(k) Number:	K121072
Clearance Date:	May 08, 2012
Classification Name:	Computed Tomography X-ray System

Clearance Date:	May 08, 2012
Classification Name:	Computed Tomography X-ray System
Classification Panel:	Radiology
CFR Section:	21 CFR § 892.1750
Device Class:	Class II
Product Code:	JAK
Recall Information:	Information about design related recalls are provided in Section 18.

IV. Device Description

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system delivered with the CT scanner is able to run the post processing applications optionally.

1. New Marketing Name: SOMATOM Confidence (SOMATOM Confidence® RT Pro)
1. Modified Indication for Use Statement
1. New/Modified Hardware
- Touch Panels ●
- New Gantry and Patient Table Covers .
- Stellar RT Detector .
1. Software version SOMARIS/7 VA62A
- Data Exchange with external SW Client (Teamplay) ●
- IT Hardening .
- DirectDensity™ .
1. Update 510(k) Information

A comparison of these modifications with respect to the predicate devices in provided the "Comparison of Technological Characteristics with the Predicate Device" section below. The SOMATOM Confidence will be offered in 20 and 64 slice configurations.

V. Indications for Use

The images delivered by the system can be used by trained staff as an aid in diagnosis, treatment preparation and radiation therapy planning.

This CT system can be used for low dose lung cancer screening in high risk populations.*

VI. Comparison of Technological Characteristics with the Predicate Device

The SOMATOM Confidence provides the same technological characteristics in terms of materials, energy source, and control mechanisms when compared to the predicate devices. The software and hardware components of the SOMATOM Confidence have been modified or improved in comparison to the predicate device to support enhanced device functionality compared to the predicate device. The hardware components of the subject device have been modified to include a touch panel user interface, new gantry and patient table covers, and the Stellar RT Detector.

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Software version SOMARIS/7 VA62 supports software features that are designed to enhance cybersecurity, and feature DirectDensity™ which provides CT images with an HU-like scaling that is nearly proportional to relative electron density. The intended use and fundamental scientific technology for the SOMATOM Confidence remains unchanged from the predicate devices.

At a high level, the subject and predicate devices are based on the following same technoloqical elements:

Scanner Principle- Whole body X-Rav Computed Tomography Scanner System ● Acquisition - Continuously rotating tube detector system
X-Rav Tube Straton MX P ●
kV Steps - Adjustable kV acquisition steps
Operating System Windows based operating platform ●
Iterative Reconstruction Support of various optional iterative reconstruction ● methods
. Workplaces - Support of workplaces that include reconstruction and image evaluation software

The following technological differences exist between the subject device and predicate devices:

Support of touch panel user interface ●
Reduced width 2 cm Stellar RT Detector ●
Software version VA62A .
DirectDensity™ Reconstruction, which provides CT images with an HU-like o scaling that is nearly proportional to relative electron density
o Support of additional cvbersecurity features

Any differences in technological characteristics do not raise different questions of safety and effectiveness. Siemens believes that the subject device is substantially equivalent to the predicate devices.

Testing and validation is completed. Test results show that the subject device, the SOMATOM Confidence, is comparable to the predicate devices in terms of technological characteristics, safety and effectiveness and therefore is substantially equivalent.

VII. Performance Data

Non Clinical Testing

Non-clinical test (integration and functional) including phantom tests were conducted for the SOMATOM Confidence during product development. The modifications described in this Premarket Notification were supported with verification and validation testing. Siemens claims conformance to the following performance standards: ISO 14791, NEMA XR-29, IEC 61223-2-6, IEC 61223-3-5, IEC 62304, NEMA XR-25, and DICOM 3.1-3.20.

Electrical Safety and Electromagnetic Compatibility (EMC) testing were conducted on the SOMATOM Confidence in accordance with the following standards: IEC 60601-1, 60601-2-44, and 60601-1-2. Completed Form FDA 3654 are provided within this submission.

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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. The performance data demonstrates continued conformance with special controls for medical devices containing software. The Risk Analysis was completed and risk control implemented to mitigate identified hazards. The testing supports that all software specifications have met the acceptance criteria. Testing for verification and validation support the claims of substantial equivalence.

The performance testing data for optional reconstruction feature DirectDensity™ was acquired on a Siemens Healthineers SOMATOM Confidence with a Gammex 467 Tissue Characterization Phantom with varied arranqements of the tissue substitutes. Additional performance testing data for DirectDensity" was obtained from simulations. The results of verification and validation testing demonstrate that the subject device modifications for DirectDensity" - image values proportional to relative electron density and perform as expected. The testing results support that the requirement specifications have met the acceptance criteria. Testing for verification and validation of the device was found acceptable to support the claims for DirectDensity". Safety and performance parameters have not been affected by supporting DirectDensity™. The technical characteristics supporting DirectDensity"" do not change the indication for use, safety or efficacv.

Siemens conforms to the Cybersecurity requirements by implementing a process of preventing unauthorized access, modifications, misuse or denial of use, or the unauthorized use of information that is stored, accessed, or transferred from a medical device to an external recipient. Cybersecurity information in accordance with guidance document "Content of Premarket Submissions for Management of Cybersecurity Medical Devices issues on October 2, 2014" is included within this submission.

Additional Supportive Data

The National Lung Screening Trial (NLST), sponsored by the National Cancer Institute, is used to support the additional lung cancer screening Indications for Use. The study was a randomized trial of screening with the use of low-dose CT compared to chest radiography to determine whether screening with low-dose CT could reduce mortality from lung cancer. The study start date was August. 2002 and the completion date was October, 2010. The interpretation task with CT for this study was to detect lung nodules of 4mm diameter or greater.

Summary

Features described in this premarket notification are supported with verification and validation testing, supportive literature, dosimetry and imaging performance, and analysis of phantom images to assess device and feature performance during product development. The risk analysis was completed and risk control implemented to mitigate identified hazards. The test results show that all of the software specifications have met the acceptance criteria. Verification and validation testing of the device was found acceptable to support the claim of substantial equivalence.

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, which is used to identify potential hazards. These

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potential hazards are controlled during development, verification and validation testing. In order to minimize electrical, mechanical, and radiation hazards. Siemens adheres to recognized and established industry practice and standards.

VIII. Conclusions

The predicate devices were cleared based on the results of non-clinical testing including verification and validation, phantom tests, and supportive literature. The subject device is also tested using the same methods as used for the predicate devices. The nonclinical data supports the safety of the device and the hardware and software verification and validation demonstrates that the SOMATOM Confidence should perform as intended in the specified use conditions. The data included in this submission demonstrates that the SOMATOM Confidence performs comparably to the predicate device that is currently marketed for the same intended use. Since both devices were tested using the same methods, Siemens believes that the data generated from the SOMATOM Confidence 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.