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 user-documented images, cited literature and additional relevant information.

Device Description

The post-processing application syngo.CT CaScoring SOMARIS/8 VB50 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.

For the current software version SOMARIS/8 VB50 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 VB40, K192763, clearance date 12/17/2019) the algorithm to precompute the calcium score has been enhanced and extended. In the subject device, the CaScoring algorithm was extended to label coronary calcifications as belonging to either the left main, left anterior descending, left circumflex or right coronary artery.
. This version contains UI (user-interface) modifications.

AI/ML Overview

The provided text outlines the performance evaluation of the syngo.CT CaScoring algorithm. Although it mentions a "bench test" and a "reader study," the details regarding the acceptance criteria and the studies are somewhat general. Based on the information available, here's a structured description:

Acceptance Criteria and Device Performance Study

The syngo.CT CaScoring device aims to automatically score and assign coronary calcifications to specific coronary arteries. The enhanced algorithm's performance was evaluated through a "bench test" and a "reader study."

1. Table of Acceptance Criteria and Device Performance

Acceptance Criteria Category	Specific Criteria	Reported Device Performance/Conclusion
Bench Test Performance	Overall "adequate and acceptable performance" for total Agatston-equivalent score and classification into corresponding Agatston score categories.	"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 well-established impact on management recommendations. All pre-specified acceptability criteria were passed."
Reader Study Performance	Meeting "all prespecified acceptability thresholds." Comparison of performance for vessel-specific calcium scores.	"The conclusion of the ready study is that all prespecified acceptability thresholds were met by the results of this study." The study found "no statistically relevant difference between the performance of the three individual readers compared to their consensus, and the algorithm compared to the consensus" regarding vessel-specific assignments. It notes "less but still significant deviation of the automatic LM scores from the consensus annotations compared to the bench test." The overall pattern between the bench test and reader study populations is described as "very comparable." The performance of assigning calcifications to individual vessels is deemed "adequate and acceptable," especially considering the limited clinical relevance of vessel-specific calcium scores and the similar difficulty for human readers.
Algorithm Execution	Successful execution on all testing datasets.	"The algorithm was successfully executed on all testing datasets. No data has been excluded from the analysis."
Data Diversity (Bench Test)	Not explicitly stated as a criterion, but mentioned as a characteristic aiding representativeness.	The bench test population is described as "considerably more diverse" than the reader study population.
Representativeness (Reader Study)	Not explicitly stated as a criterion, but a conclusion made about the study's generalizability.	"The reader study population is from a single, modern scanner. The overall statistics on the performance of the automatic scoring algorithm demonstrate a good comparability with the bench test population, which is considerably more diverse. ... Thus, Siemens concludes that the results of the reader study are representative for the general performance of the algorithm."

2. Sample Size and Data Provenance

Test Set Sample Size:
- Bench Test: Not explicitly stated, but described as "considerably more diverse" than the reader study population, implying a larger and/or more varied dataset.
- Reader Study: Not explicitly stated, but mentioned to be "from a single, modern scanner."
Data Provenance: The document does not specify the country of origin of the data. It also does not explicitly state whether the data was retrospective or prospective. However, for a bench test and reader study evaluating an enhanced algorithm, it is common to use retrospective data.

3. Number of Experts and Qualifications for Ground Truth

Number of Experts: The reader study involved "three individual readers."
Qualifications of Experts: Not explicitly stated within the provided text. It is generally assumed that "readers" in a medical imaging context are qualified medical professionals like radiologists or cardiologists.

4. Adjudication Method for the Test Set

The reader study mentions comparing the performance of "the three individual readers compared to their consensus." This strongly implies a consensus-based adjudication method for establishing the ground truth. A common consensus method is a (N-1) rule or a majority vote among multiple experts (e.g., 2 out of 3, 3 out of 4). The text doesn't specify the exact method (e.g., 2+1 or 3+1), but the use of "their consensus" indicates that the three readers arrived at an agreed-upon ground truth.

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

Yes, a multi-reader multi-case (MRMC) study was implicitly part of the "reader study." The study involved "three individual readers" and compared their performance (as part of a consensus group) against the algorithm.
Effect Size: The text states: "No statistically relevant difference between the performance of the three individual readers compared to their consensus, and the algorithm compared to the consensus was found." This suggests that the AI assistance (or the algorithm's standalone performance compared to human consensus) did not statistically significantly improve or worsen the performance for the specific metrics evaluated, particularly for vessel-specific assignments where the task was similarly difficult for humans and the algorithm. It does not provide a specific quantitative effect size (e.g., AUC increase, accuracy percentage point change) for human reader improvement with versus without AI assistance. The focus seems to be on whether the algorithm performs comparably to expert consensus.

6. Standalone (Algorithm Only) Performance

Yes, a standalone performance evaluation was done. The "bench test" assessed the "adequate and acceptable performance of the automatic scoring algorithm" independently. The "reader study" also compared the algorithm's performance directly against the human consensus, indicating an assessment of its standalone capabilities.

7. Type of Ground Truth Used

The ground truth for the test sets (both bench test and reader study) was established by expert consensus annotations. The text explicitly mentions "consensus annotations" for comparing automatically assigned LM scores and for comparing reader performance.

8. Sample Size for the Training Set

The sample size for the training set is not specified in the provided text. It only mentions that the "automatic scoring algorithm was retrained on re-annotated data as part of the vessel assignment extension."

9. How Ground Truth for Training Set was Established

The ground truth for the training set was established through re-annotation. The text states, "the automatic scoring algorithm was retrained on re-annotated data." While the specifics of who performed the re-annotation (e.g., experts, number of experts, adjudication) are not detailed, it implies data that underwent a human review and labeling process to serve as the training truth.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA acronym with the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a square and the full name written out to the right of the square. The full name of the agency is "U.S. Food & Drug Administration".

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

Re: K201034

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 17, 2020 Received: April 20, 2020

Dear Tabitha Estes:

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 14, 2020

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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

Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known)

K201034

Device Name syngo.CT CaScoring

Indications for Use (Describe)

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

Type of Use (Select one or both, as applicable)
区 Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)

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Section 5 510(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:

Tabitha Estes Regulatory Affairs Specialist Siemens Medical Solutions, Inc. USA 810 Innovation Drive Knoxville, TN 37932 Phone: (865) 804-4553 Email: tabitha.estes(@siemens-healthineers.com

Alternate Contact:

Alaine Medio

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:	90 JAK

III. Predicate Device

Trade Name:	syngo.CT CaScoring
510(k) Number:	K192763
Clearance Date:	12/17/2019
Classification Name:	Computed Tomography X-ray System
Classification Panel:	Radiology
CFR Section:	21 CFR §892.1750

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Device Class:	Class II
Product Code:	90 JAK

Device Description IV.

For the current software version SOMARIS/8 VB50 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 VB40, K192763, clearance date 12/17/2019) the algorithm to precompute the calcium score has been enhanced and extended. In the subject device, the CaScoring algorithm was extended to label coronary calcifications as belonging to either the left main, left anterior descending, left circumflex or right coronary artery.
. This version contains UI (user-interface) modifications.

V. Indications for Use

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 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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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 Devices
	syngo.CT CaScoring(SOMARIS/8 VB50)	syngo.CT CaScoring(SOMARIS/8 VB40)
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 first part of the automaticCalcium Scoring algorithm works inthe same manner as cleared with thepredicate device. From functionalperspective there are no differences.The second part (labeling ofcalcifications according to coronaryartery) is new in the subject device.	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.In addition, results of the evaluation can besent via Rapid Results Technology 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
Feature	Subject Device	Predicate Devices
Displaying the score in form ofresult tables/reports on paperand/or film	syngo.CT CaScoring(SOMARIS/8 VB50)	syngo.CT CaScoring(SOMARIS/8 VB40)
Pan and Zoomfunctionality/windowing	Yes	Yes
Reformatting	Yes	Yes
Comparison of Score to CitedLiterature (including calculationof coronary age)	Yes	Yes
User Interface	syngo.via GUIAs part of a platform-wide change in thissoftware version, the user interface ofsyngo.CT CaScoring was adapted tofollow the new user interface styleintroduced in SOMARIS/8 VB50.	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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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 extended to label calcifications according to coronary artery.

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 as part of the vessel assignment extension, a complete performance evaluation (bench test and reader study) 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 well-established impact on management recommendations. All pre-specified acceptability criteria were passed.

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The conclusion of the ready study is that all prespecified acceptability thresholds were met by the results of this study. The reader study population is from a single, modern scanner. The overall statistics on the performance of the automatic scoring algorithm demonstrate a good comparability with the bench test population, which is considerably more diverse. There is less but still significant deviation of the automatic LM scores from the consensus annotations compared to the bench test. The overall pattern is very comparable between both populations. Thus, Siemens concludes that the results of the reader study are representative for the general performance of the algorithm. No statistically relevant difference between the performance of the three individual readers compared to their consensus, and the algorithm compared to the consensus was found. We conclude that the precise assignment of calcifications in the bifurcation region between left main, left anterior descending and left circumflex artery is a task that is similarly difficult for both human readers as well as the automatic scoring algorithm. Combined with the limited clinical relevance of the vessel-specific calcium scores, we therefore deem the performance of the automatic scoring algorithm in assigning calcifications to individual vessels adequate and acceptable.

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.

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)	01/14/2019	AAMI, ANSI,IEC
5-40	Software/Informatics	Medical devices – Application of riskmanagement to medical devices; 14971 SecondEdition 2007-03-01	06/27/2016	ISO
5-114	General I(QS/RM)	Medical devices - Part 1: Application ofusability engineering to medical devicesIEC 62366-1:2015	12/23/2016	IEC

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:

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.