syngo.CT CaScoring is an image analysis software package for evaluating CT data sets. The software is designed to support the physician in evaluating and documenting calcified coronary lesions, using standard or low-dose spiral or sequential CT scanning data sets. After loading noncontrasted cardiac CT images, syngo.CT CaScoring can be used to mark calcified coronary lesions and to allocate each lesion to one of several coronary arteries, that is, the right coronary artery (RCA), the left main coronary artery (LM), the left anterior descending artery (LAD), and the left circumflex artery (CX). syngo.CT CaScoring calculates the Agatston equivalent score, the mass score and the volume score of each coronary artery as well as the corresponding total scores all coronary arteries. syngo.CT CaScoring allows the user to create a paper report including the calcium scoring data, any userdocumented images, cited literature and additional relevant information.

Device Description

The post-processing application syngo.CT CaScoring SOMARIS/8 VB70 is designed to support the physician in evaluating and documenting calcified coronary lesions. After loading non-contrasted cardiac CT images, syngo.CT CaScoring can be used to interactively mark calcified coronary lessions and to allocate each lesion to one of several coronary arteries, that is, the right coronary artery (RCA), the left main coronary artery (LM), the left anterior descending artery (LAD), and the left circumflex artery (CX). syngo.CT CaScoring calculates the Agatston-equivalent score, the mass score and the volume score of each coronary artery as well as the corresponding total scores across all coronary arteries. syngo.CT CaScoring allows the user to create a paper report including the calcium scoring data, any user-documented images, cited literature and additional relevant information.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the syngo.CT CaScoring device, as extracted from the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document states that "All pre-specified acceptability criteria were passed" for the performance evaluation of the algorithm, particularly for the Agatston-equivalent score and its classification into categories. However, the specific numerical targets for these criteria are not explicitly detailed in the provided text. The performance is described qualitatively as "adequate and acceptable."

Acceptance Criteria Category	Reported Device Performance
Total Agatston-equivalent score	Adequate and acceptable performance (all pre-specified acceptability criteria passed)
Classification into Agatston score categories	Adequate and acceptable performance (all pre-specified acceptability criteria passed)
Algorithm execution on testing datasets	Successfully executed on all testing datasets
Software specifications	All met the acceptance criteria
Risk control	Implemented to mitigate identified hazards
Functional and Integration Tests	Device performs as intended

2. Sample Size Used for the Test Set and Data Provenance

The document mentions that the algorithm was "re-trained on a larger database" and a "complete performance evaluation (bench test) of the algorithm has been conducted additionally" using "all testing datasets."

Test Set Sample Size: Not explicitly stated as a number of cases or images. It refers to "all testing datasets," implying all available data used for the bench test.
Data Provenance: Not specified (e.g., country of origin, retrospective or prospective). It only mentions "re-annotated data" as the basis for retraining.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

This information is not provided in the given text.

4. Adjudication Method for the Test Set

This information is not provided in the given text.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

A multi-reader multi-case (MRMC) comparative effectiveness study was not explicitly mentioned as being performed. The document focuses on the automated algorithm's performance (standalone bench test) without human-in-the-loop comparison.

6. Standalone (Algorithm Only) Performance Study

Yes, a standalone performance study was done. The document states:

"The algorithm was successfully executed on all testing datasets."
"A complete performance evaluation (bench test) of the algorithm has been conducted additionally."
"The summary of the bench test is that an adequate and acceptable performance of the automatic scoring algorithm was found for the total Agatston-equivalent score and the classification into the corresponding Agatston score categories..."

7. Type of Ground Truth Used

The ground truth for the testing set was based on "re-annotated data." The specific nature of this re-annotation (e.g., whether it involved expert consensus, pathology, or other methods) is not explicitly detailed.

8. Sample Size for the Training Set

The document mentions that "the algorithm was retrained on a larger database." The specific sample size (number of cases or images) for this training set is not explicitly stated.

9. How the Ground Truth for the Training Set Was Established

The training set ground truth was established through "re-annotated data." The exact method or source of this re-annotation (e.g., expert review, a specific validated method) is not explicitly detailed.

Summary

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

Re: K221219

Trade/Device Name: syngo.CT CaScoring Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: Class II Product Code: JAK Dated: April 25, 2022 Received: April 27, 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/cfpmp/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 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

May 17, 2022

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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 medical devices and radiation-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,

For

Laurel Burk, Ph.D. Assistant Director Diagnostic X-Rav Systems Team DHT 8B: Division of Radiological Imaging Devices and Electronic Products OHT8: Office of Radiological Health Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K221219

Device Name syngo.CT CaScoring

Indications for Use (Describe)

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

I. Identification of the 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

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 CaScoring
Propriety Trade Name:	syngo.CT CaScoring
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

Trade Name:	syngo.CT CaScoring
510(k) Number:	K201034
Clearance Date:	05/14/2020
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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IV. Device Description

For the current software version SOMARIS/8 VB70 one major and one minor change have been implemented:

. Since the last 510(k) clearance of the predicate device (syngo.CT Calcium Scoring SOMARIS/8 VB50, K201034, clearance date 05/14/2020) the algorithm to precompute the calcium score has been enhanced. In the subject device, the CaScoring algorithm was retrained on a larger database.
This version contains UI (user-interface) modifications. .

Indications for Use V.

syngo.CT CaScoring is an image analysis software package for evaluating CT data sets.

The software is designed to support the physician in evaluating and documenting calcified coronary lesions, using standard or low-dose spiral or sequential CT scanning data sets. After loading noncontrasted cardiac CT images, syngo.CT CaScoring can be used to mark calcified coronary lessions and to allocate each lesion to one of several coronary arteries, that is, the right coronary artery (RCA), the left main coronary artery (LM), the left anterior descending artery (LAD), and the left circumflex artery (CX).

syngo.CT CaScoring calculates the Agatston equivalent score, the mass score and the volume score of each coronary artery as well as the corresponding total scores across all coronary arteries. syngo. CT CaScoring allows the user to create a paper report including the calcium scoring data, any userdocumented images, cited literature and additional relevant information.

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VI. Comparison of Technological Characteristics with the Predicate Device

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

Feature	Subject Device	Predicate Devices
	syngo.CT CaScoring(SOMARIS/8 VB70)	syngo.CT CaScoring(SOMARIS/8 VB50)
Modality	CT	CT
Loading of a series ofappropriate CT from the patientdatabase	Yes	Yes
Body Part	Heart / Chest	Heart / Chest
Acquisition Part	ECG-gated / ECG-triggered	ECG-gated / ECG-triggered
Automated Calcium ScoringEvaluation	Assignment of a probability of acandidate being a coronarycalcification based on locationwithin the heart, density, shape andsimilar properties: if the probabilityof a candidate is higher than apredefined threshold, the candidateis labelled as a calcification.Each calcification is labeledaccording to one of four coronaryarteries it most probably belongs to.In addition, results of the evaluationcan be sent via Rapid ResultsTechnology to any generic DICOMviewer.Comparison to the predicatedevice:The algorithm was re-trained on alarger database.A configuration option was added sothe user can disable the automatedcalcium scoring evaluation.	Assignment of a probability of a candidatebeing a coronary calcification based onlocation within the heart, density, shape andsimilar properties: if the probability of acandidate is higher than a predefinedthreshold, the candidate is labelled as acalcification.Each calcification is labeled according to oneof four coronary arteries it most probablybelongs to.In addition, results of the evaluation can besent via Rapid Results Technology to anygeneric DICOM viewer.
Browsing, selecting, anddisplaying images for searchingcalcium regions/lesions	Yes	Yes
Interactive definition of ROIs andassignment of the four majorcoronary arteries (LM, LAD,CRCand RCA) to the lesions	Yes	Yes
Automatic definition of ROIs andassignment of a generic calciumlabel to the lesions	Yes	Yes
Calculation and display of the2D-Agatston score/factor orother metric on the defined ROIs	Agatston, volume and mass scores	Agatston, volume and mass scores
Interactive definition of ROIs (forexample noise) to disqualify theregion from participation in thescore	Yes	Yes
Displaying the score in form ofresult tables/reports on paperand/or film	Yes	Yes
Feature	Subject Device	Predicate Devices
syngo.CT CaScoring(SOMARIS/8 VB70)		syngo.CT CaScoring(SOMARIS/8 VB50)
Pan and Zoomfunctionality/windowing	Yes	Yes
Reformatting	Yes	Yes
Comparison of Score to CitedLiterature (including calculationof coronary age)	Yes	Yes
User Interface	syngo.via GUI	syngo.via GUI
Archiving/Storing	CD-R, film, DVD, USB, Network	CD-R, film, DVD, USB, Network
Hardware	As specified by syngo.via	As specified by syngo.via
Communication	DICOM compatible	DICOM compatible

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Image /page/6/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 arranged in a circular pattern.

The subject device syngo.CT CaScoring does not have changes in fundamental scientific technology compared to the predicate device. The post-processing software functionality remains unchanged from the subject device and the predicate device. The operating principle and the scientific technology are the same; therefore, Siemens believes that syngo.CT CaScoring application is substantially equivalent to the predicate device. The major change in this software version is that the Automated Calcium Scoring Evaluation algorithm has been re-trained on a larger database.

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-clincal 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 CaScoring 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.

Performance Evaluation of the Algorithm

Since the automatic scoring algorithm was retrained on re-annotated data, a complete performance evaluation (bench test) of the algorithm has been conducted additionally. The algorithm was successfully executed on all testing datasets. No data has been excluded from the analysis. The summary of the bench test is that an adequate and acceptable performance of the automatic scoring algorithm was found for the total Agatston-equivalent score and the classification into the corresponding Agatston score categories, which are the aspects of calcium scoring that have a wellestablished impact on management recommendations. All pre-specified acceptability criteria were passed.

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.

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Siemens hereby certifies that syngo.CT CaScoring 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; 62304:2015-06 (Edition 1.1)	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 62366-1:2015 +AMD1:2020	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

VIII. Conclusion

syngo.CT CaScoring has the same intended use and same indication for use as the predicate device. The technological characteristics such as evaluation and documentation of calcified coronary lesions are the same as the predicate device. The result of all testing conducted was found acceptable to support the claim of substantial equivalence. The comparison of technological characteristics, nonclinical 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 CaScoring, Siemens used the same testing with the same workflows as used to clear the predicate device. Siemens considers syngo.CT CaScoring to be as safe, as effective and with performance substantially equivalent to the commercially available predicate device.

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.