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, and possibly other medical imaging modalities (e.g. MR scanners). An interface shall enable the connection between the syngo. CT Extended Functionality software package and the interconnected CT Scanner system.

Resulting 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 that offers tools to support special clinical evaluations. The "tools" are represented by the so-called Extensions. 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 or other medical imaging modalities (e.g. MR scanners) by using the Extensions. Advanced visualizations and measurements are listed as follows. The subject device in the current software version SOMARIS/8 VB70 has been extended/modified as follows:

Support of the extension "Average"
Modifications to the extension "Vessel"
Modifications to the extension "Interactive Spectral Imaging"
Modifications to the extension "Oncology"
"Trauma" Extension – No changes
"Osteo" Extension - No changes
"Neuro DSA" Extension – No changes
"ROI HU Threshold" Extension – No changes
. "Dual Energy" Extension – No changes
"Endoscopic Viewing" Extension - No changes
. "Pulmonary Density" Extension – No changes
. "General" (Extension Independent Features) – No changes

AI/ML Overview

The provided text is a 510(k) Summary for a medical device called "syngo.CT Extended Functionality." It extensively describes the device, its intended use, comparison to a predicate device, and the non-clinical testing performed.

However, the document does not contain the specific information requested regarding acceptance criteria and a study proving the device meets those criteria. The provided text states:

"This submission contains performance tests (Non-clinical test reports) 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. 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." (Page 6)
"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." (Page 6)

While it mentions that tests were conducted and acceptance criteria were met, it does not detail what those acceptance criteria are in a tabular format, nor does it describe a specific study with sample sizes, expert involvement, ground truth methods, or MRMC comparative effectiveness. The tests mentioned are high-level "integration and functional" tests, and "verification and validation" tests, common for software development, but not a detailed clinical performance study as might be expected for an AI/ML-driven device with specific performance claims.

The key modifications to the device, as noted in the document, are:

Support of the extension "Average" (new functionality)
Modifications to the extension "Vessel" (improved bone removal using a deep learning algorithm)
Modifications to the extension "Interactive Spectral Imaging" (support of circular and elliptic ROIs)
Modifications to the extension "Oncology" (spectral information for arbitrarily shaped ROIs)

Given that the "Vessel" extension now incorporates a deep learning algorithm for bone removal, one might expect a study to validate the performance of this AI-driven component. However, the provided document only states that "Non-clinical tests (integration and functional) were conducted" and that "The testing results support that all the software specifications have met the acceptance criteria." No specific study details are given for this, or any other, AI/ML component.

Therefore, for your specific questions:

A table of acceptance criteria and the reported device performance: Not provided in the document.
Sample sizes used for the test set and the data provenance: Not provided in the document.
Number of experts used to establish the ground truth for the test set and the qualifications: Not provided in the document.
Adjudication method for the test set: Not provided in the document.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and its effect size: Not provided in the document. The document primarily focuses on non-clinical software testing for substantial equivalence to a predicate device.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not explicitly detailed. The document mentions "non-clinical tests" and "verification and validation," but these are general software testing terms, not specific performance evaluations for an AI component.
The type of ground truth used: Not provided in the document.
The sample size for the training set: Not provided in the document. (Only mentions a deep learning algorithm in the "Vessel" extension, but no training details).
How the ground truth for the training set was established: Not provided in the document.

In summary, the provided FDA 510(k) summary focuses on demonstrating substantial equivalence through non-clinical software testing and quality system compliance, rather than detailing a specific clinical performance study with defined acceptance criteria for AI components. The document indicates that the device's software specifications met acceptance criteria through general testing (integration, functional, verification, validation), but the specifics of those criteria and the studies proving they were met are not disclosed in this summary.

Summary

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July 13, 2022

Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Siemens Medical Solutions USA, Inc. % Monsuru Bello Regulatory Affairs Specialist 810 Innovation Drive KNOXVILLE TN 37932

Re: K221727

Trade/Device Name: syngo.CT Extended Functionality Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: Class II Product Code: JAK Dated: June 13, 2022 Received: June 14, 2022

Dear Monsuru Bello:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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

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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Laurel Burk, Ph.D. Assistant Director Diagnostic X-Ray Systems Team OHT 8B: Division of Radiological Imaging Devices and Electronic Products Office of Radiological Health Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K221727

Device Name syngo.CT Extended Functionality

Indications for Use (Describe)

Resulting 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)

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510(k) Summary

K221727

Identification of the Submitter l.

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

Submitter Contact Person:

Submitter Contact Person: Monsuru K Bello Regulatory Affairs Specialist Siemens Medical Solutions, Inc. USA 810 Innovation Drive Knoxville, TN 37932 Phone: +1 (202) 856-6099 Email: Monsuru.bello@siemens-healthineers.com

Alternate Contact:

Alaine Medio Regulatory Affairs Manager Siemens Medical Solutions, Inc. USA (MI) 810 Innovation Drive Knoxville, TN 37932 Phone: +1 (865) 206-0337 Email: alaine.medio@siemens-healthineers.com

II. Device Name and Classification

Product Name:	syngo.CT Extended Functionality
Propriety Trade Name:	syngo.CT Extended Functionality
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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Image /page/4/Picture/1 description: The image shows the Siemens Healthineers logo. The word "SIEMENS" is in teal, and the word "Healthineers" is in orange. To the right of the words is a graphic of orange dots in a pattern.

Predicate Devices III.

Predicate Device

Trade Name:	syngo.CT Extended Functionality
510(k) Number:	K214019
Clearance Date:	01/20/2022
Classification Name:	Computed Tomography X-ray System
Classification Panel:	Radiology
CFR Section:	21 CFR §892.1750
Device Class:	Class II
Product Code:	JAK

Device Description IV.

Support of the extension "Average"
Modifications to the extension "Vessel"
Modifications to the extension "Interactive Spectral Imaging"
Modifications to the extension "Oncology"
"Trauma" Extension – No changes
"Osteo" Extension - No changes
"Neuro DSA" Extension – No changes
"ROI HU Threshold" Extension – No changes
. "Dual Energy" Extension – No changes
"Endoscopic Viewing" Extension - No changes
. "Pulmonary Density" Extension – No changes
. "General" (Extension Independent Features) – No changes

Indications for Use V.

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

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

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Image /page/5/Picture/1 description: The image shows the logo for Siemens Healthineers. The word "SIEMENS" is in teal, and the word "Healthineers" is in orange. To the right of the words is a graphic of orange dots arranged in a circular pattern.

Comparison of Technological Characteristics with the Predicate Device VI.

The differences and similarities between the above referenced predicate device are listed at a highlevel in the following table:

Feature	Subject Device	Predicate Device
	syngo.CT Extended Functionality(SOMARIS/8 VB70)	syngo.CT Extended Functionality(SOMARIS/8 VB60)
1. Average	The extension offers the possibility toaverage on a pixel-by-pixel basis of twodifferent DICOM images. The "Average"functionality can be used on individualframes of the same series, or for framesbelonging to different series. The toolsaves a DICOM image as result series. Thisextension does not introduce any newclinical algorithms or features.	N/A
2. Vessel Extension	The user can perform a vascularevaluation supporting the following mainfunctionalities:• Measuring vessels• Creating DICOM snapshots or resultseries for documenting findings• Working on images that are acquiredwith CT or MR scanner systemsconstituting one or more volumes ofvascular structuresModification:Improved quality of the bone removalalgorithm for the head & neck region.Segmentation of the bones use a deeplearning algorithm instead of atraditional image processing.	The user can perform a vascularevaluation supporting the following mainfunctionalities:• Measuring vessels• Creating DICOM snapshots or resultseries for documenting findings• Working on images that are acquiredwith CT or MR scanner systemsconstituting one or more volumes ofvascular structures
3. Interactive SpectralImaging	Display different representations of DualEnergy data.Modifications:Support of circular and elliptic ROIs. InVB70 version the measurement toolsupports all others ROIs (ROI Circle (incl.elliptic) / ROI Freehand / ROI AutoContour / ROI Polygonal).	Display different representations of DualEnergy data.
4. Oncology	The oncology extension offers tools forlocalization and evaluation of nodules.Modifications:With SOMARIS/8 VB70, the spectralinformation displayed for circular ROIswas extended to arbitrarily shaped ROIs.	The oncology extension offers tools forlocalization and evaluation of nodules.

The remaining functions in syngo.CT Extended Functionality remain unchanged compared to the predicate version.

Trauma- displays of sorted large number of reconstruction series into body region specific layouts.
Osteo Extension - Evaluation of Bone Mineral Density (BMD) values (mg CA-HA/ml).
Neuro DSA Extension - Selective bone removal from a CT angiography dataset

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Healthinee

ROI HU Threshold Extension Evaluation of HU Value distributions
Dual Energy Extension – Simultaneous evaluation for low and high kV dual energy images
Endoscopic Viewing Extension – Interactive fly through tubular structures that are filled by either low-intensity or high-intensity material
. Pulmonary Density – Segmentation of opacity regions inside the lung using an Al algorithm.

The core modification of the subject device as compared to its predicate device (syngo.CT Extended Functionality (SOMARIS/8 VB60)) are the modifications shown in the table above.

VII. Performance Data

The following performance data were provided in support of the substantial equivalence determination.

Non-Clinical Testing

This submission contains performance tests (Non-clinical test reports) 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. 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.

Risk Analysis

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.

Siemens hereby certifies that syngo.CT Extended Functionality will meet the following voluntary standards covering electrical and mechanical safety listed below, prior to introduction into interstate commerce:

RecognitionNumber	ProductArea	Title of Standard	Date ofRecognition	StandardsDevelopmentOrganization
12-300	Radiology	Digital Imaging and Communications inMedicine (DICOM) Set; PS 3.1 - 3.20	06/27/2016	NEMA
13-79	Software	Medical Device Software –Software Life CycleProcesses; 62304:2006 (1st Edition)/A1:2016	01/14/2019	AAMI, ANSI, IEC
5-125	Software/Informatics	Medical devices – Application of riskmanagement to medical devices; 14971 ThirdEdition 2019-12	12/23/2019	ISO
5-129	General I(QS/RM)	Medical devices - Part 1: Application ofusability engineering to medical devicesIEC 62366-1:2016	07/06/2020	ANSI, AAMI, IEC
5-117	General I(QS/RM)	Medical devices - Symbols to be used withmedical device labels, labelling, andinformation to be supplied - Part 1: Generalrequirements 15223-1:2016	8/21/2017	ISO

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Image /page/7/Picture/2 description: The image shows the logo for Siemens Healthineers. The word "SIEMENS" is in teal, and the word "Healthineers" is in orange. To the right of the words is a graphic of orange dots arranged in a circular pattern.

VIII. Conclusion

syngo.CT Extended Functionality has the same intended use and same indications for use as the predicate device. The technological characteristics such as image visualization, operating platform, and image measurement are the same as the predicate device.

For the subject device, syngo.CT Extended Functionality, Siemens used the same testing with the same workflows as used to clear the primary predicate device. Siemens considers syngo.CT Extended Functionality to be as safe, as effective, and with performance substantially equivalent to the commercially available predicate devices.

Regulation Number and Section

N/A