The HealthCCS Device is intended for use as a non-invasive post-processing software that can be used to evaluate calcified plaques in the coronary arteries, which may be a risk factor for coronary artery disease. The software can be used to generate reports of the total risk category of coronary calcium. This information can then be used by a physician for further analysis and treatment. The HealthCCS Device analyses pre-existing heart or chest ECG-Gated Triggered CT scans. The Device is indicated for use only on patients whose age at the CT scan was taken, was above 20 years old. This device generates a 4-category Agatston-equivalent risk score, and the patient management, especially for the patient with the score from 0-10, will depend on the physician's own judgment. It may require further testing to evaluate the appropriate clinical management.

Device Description

The HealthCCS Device is an automatic non-invasive post processing tool that uses cardiac CT images to identify and quantify calcification in the coronary arteries, known to be a risk factor for coronary disease. HealthCCS Device quantifies calcification on non-contrast cardiac computed tomography (CT) scans. HealthCCS Device calculates the amount of identified calcification and reports the risk category of coronary calcium. This information can then be used by a physician for further analysis and treatment.

AI/ML Overview

The provided document describes the HealthCCS device, a non-invasive post-processing software for evaluating calcified plaques in coronary arteries. Here's a breakdown of the acceptance criteria and the study that proves the device meets those criteria:

1. Table of Acceptance Criteria and Reported Device Performance

The document explicitly states the overall acceptance criterion as "adequate overall agreement" and "adequate agreement per category." It then reports the achieved performance against these criteria.

Acceptance Criteria	Reported Device Performance	Comments
Overall Agreement	0.89 (95% CI: [0.85, 0.92])	Achieved an "adequate overall agreement."
Agreement per Category	Adequate agreement per category	Implied to be met, but no specific values for each category are provided.
Reproducibility (Agatston equivalent scores)	Identical over all three readings	Assessed on 150 studies read three times.

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

Sample Size for Test Set: 249 studies.
Data Provenance: The document states a "retrospective performance study." No specific country of origin is mentioned for the data, but the applicant's address is Israel.

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

Number of Experts: 3 radiologists.
Qualifications of Experts: Not specified in the document beyond "radiologists." No information on their years of experience or subspecialty focus is provided.

4. Adjudication Method for the Test Set

The ground truth was established by "3 radiologists using the Kodak Carestream PACS device (K053347)." This implies a consensus or majority rule approach, but the specific adjudication method (e.g., 2+1, 3+1) is not explicitly stated. It seems to be a form of expert consensus derived from their use of a reference device.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

A formal MRMC comparative effectiveness study comparing human readers with and without AI assistance was not described. The study described focused on the agreement between the HealthCCS device's categorization and the ground truth established by radiologists using a reference PACS device. It was a comparison of the AI's output against human-derived ground truth, not an assessment of human performance improvement with AI assistance.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Yes, the performance study described is essentially a standalone (algorithm only) performance study. The HealthCCS device's output (4-level risk categorization) was directly compared to the ground truth established by the radiologists. There was no human-in-the-loop component described for this performance evaluation.

7. The Type of Ground Truth Used

Expert Consensus (using a reference device): The ground truth was established by "3 radiologists using the Kodak Carestream PACS device (K053347)." This indicates that the radiologists performed the calcification scoring using a legally marketed device, and their determinations served as the "ground truth" for comparison.

8. The Sample Size for the Training Set

The document does not specify the sample size used for the training set. It only details the performance validation study (test set).

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

The document does not provide information on how the ground truth for the training set was established. The focus is solely on the validation of the device's performance using a test set. However, a CNN-based probability threshold is mentioned, implying that the model was trained on data with ground truth about what constitutes coronary arterial calcification.

Summary

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Zebra Medical Vision Ltd. % Matan Neeman Director, Quality and Regulatory Shefayim Commercial Center PO Box 25 Shefayim, 6099000 ISRAEL

June 13, 2018

Re: K172983

Trade/Device Name: HealthCCS Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: II Product Code: JAK Dated: May 19, 2018 Received: May 22, 2018

Dear Matan Neeman:

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 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);

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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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

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/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

Michael D. O'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) K172983

Device Name HealthCCS

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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5. 510 (k) Summary

510(K) Summary - HealthCCS Zebra Medical Vision Ltd.

510(k) Number K172983

Applicant's Name:	Zebra Medical Vision Ltd.
	Shefayim Commercial Center
	PO Box 25
	Shefayim, 6099000
	ISRAEL
	Telephone: +972-9-8827795
	Fax: +972-9-8827795

Date Prepared: 06 June 2018
Trade Name: HealthCCS

Classification Name:

JAK - Computed tomography x-ray system

Classification:

Class II, Radiology

Predicate Device:

The HealthCCS device is substantially equivalent to the following device:

Proprietary Name	CSCS-001A Calcium Scoring Package
Premarket Notification	K072737 (5 Oct. 2007)
Classification Name	Computed tomography x-ray system
Regulation Number	21 CFR 892.1750
Product Code	JAK
Regulatory Class	II

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Image /page/4/Picture/0 description: The image shows the Zebra Medical Vision logo. The logo consists of a stylized "Z" made of black and white stripes, followed by the word "zebra" in black lowercase letters. Below the word "zebra" is the text "MEDICAL.VISION" in smaller black letters.

Reference Device:

Proprietary Name	Kodak Carestream PACS
Premarket Notification	K053347
Classification Name	Picture archiving and communications system
Regulation Number	892.2050
Product Code	LLZ
Regulatory Class	II

Performance Standards:

No performance standards have been established for such device under Section 514 of the Federal Food, Drug, and Cosmetic Act.

Indication for Use:

The HealthCCS Device is intended for use as a non-invasive post-processing software that can be used to evaluate calcified plaques in the coronary arteries, which may be a risk factor for coronary artery disease. The software can be used to generate reports of the total risk category of coronary calcium. This information can then be used by a physician for further analysis and treatment. The HealthCCS Device analyses pre-existing heart or chest ECG-Gated/Triggered CT scans. The Device is indicated for use only on patients whose age at the time, when the CT scan was taken, was above 20 years old. This device generates a 4-category Agatston-equivalent risk score, and the patient management, especially for the patient with the score from 0-10, will depend on the physician's own judgment. It may require further testing to evaluate the appropriate clinical management.

Device Description:

HealthCCS Device quantifies calcification on non-contrast cardiac computed tomography (CT) scans. HealthCCS Device calculates the amount of identified calcification and

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reports the risk category of coronary calcium. This information can then be used by a physician for further analysis and treatment.

The following quantification and data-reporting functionalities are provided by the HealthCCS Device:

Quantification:

Calcification is automatically identified based on voxel density above a predefined threshold (130HU)
। A CNN-based probability threshold is then applied to the identified calcification to determine the likelihood that the calcium is associated within the coronary arterial distribution.
Coronary Artery Calcium score is calculated for each study series using the । Agatston method
। If a single study contains more than one series for which Coronary Artery Calcium score is calculated, the results from these series are averaged to give a Agatston equivalent score for the study

Data reporting:

Generate patients' reports with their respective calcium score category

Performance Data:

Safety and performance of HealthCCS device has been evaluated and verified in accordance with software specifications and applicable performance standards. Software Development and Validation & Verification Processes have been implemented to ensure performance according to specifications, User Requirements and Federal Regulations and Guidance document: "General Principles of Software Validation".

The performance of the HealthCCS device has been validated in a retrospective performance study (n=249 studies), where the agreement between the 4-level risk categorization of the Health CCS device has been compared to the ground truth (GT) categorization by 3 radiologists using the Kodak Carestream PACS device (K053347). Adequate overall agreement of 0.89 (95% CI: [0.85, 0.92]) as well as adequate agreement per category were reported. The reproducibility was assessed on 150 studies that were

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Image /page/6/Picture/0 description: The image shows the Zebra Medical Vision logo. The logo consists of a yellow horizontal line on the left, followed by a stylized black and white zebra head, and the word "zebra" in black, with the words "MEDICAL.VISION" in smaller black letters below it. The logo is simple and modern, and it is likely used to represent a company that specializes in medical imaging or related technologies.

read three times. All Agatston equivalent scores per study ID were found identical over all three readings.

With respect to the specified requirements of accuracy, precision, and reproducibility, the obtained results have been found to be acceptable. The performance validation study demonstrated that HealthCCS device, provides accurate calcium scoring as compared to a reference device that shares the same intended use and technological characteristics as the predicate device that is currently marketed.

Technological Characteristics Compared to Predicate Device:

The technological characteristics, e.g., overall design, mechanism of action, mode of operation, performance characteristics, etc., and the intended use of the HealthCCS device are substantially equivalent to the predicate device cited above.

A comparison of the technological characteristics with the predicate and reference devices is summarized below.

TechnologicalCharacteristics	ProposedDevice:HealthCCSsoftware tool	Predicate Device:CSCS-001A,Calcium ScoringPackage (K072737)	Reference DeviceKodak CarestreamPACS (K053347)	Summary
General
Modality	CT	CT	CT	Same
Image format	DICOM	DICOM	DICOM	Same
SupportedComputedTomography(CT) scan - bodypart	Heart/Chest	Heart/Chest	Heart/Chest	Same
SupportedComputedTomography(CT) scan - dose	Typically NormalDose	Typically NormalDose	Typically NormalDose	Same
SupportedComputedTomography(CT) scan - Useof IV contrast	No	No	No	Same
SupportedComputedTomography(CT) scan – ECGGating/Triggering	ECG-Gated	ECG-Gated	ECG-Gated	Same
Quantification
Calcificationlocation marking	Automatic	Semi-automatic,Manual	Semi-automatic,Manual	Substantiallyequivalent
Selection of acalcified plaquesbased on voxelidentificationabove a knownthreshold	Yes	Yes	Yes	Same
Default thresholdof Calcium	130 HU(HounsfieldUnits)	130 HU (HounsfieldUnits)	130 HU (HounsfieldUnits)	Same
Spatial threshold	1.5 mm²	1 mm²	1 mm²	Substantiallyequivalent
CoronaryCalcificationcalculationmethod	Agatstonequivalent scorebased on theAgatston method	– Agatston score– Mass score– Volume score	– Agatston score– Mass score– Volume score	Substantiallyequivalent
Computedcalcium scoring	Total calciumscore	Total calcium score,and per-arterycalcium score	Total calcium score,and per-arterycalcium score	Substantiallyequivalent
Data reporting
Generate patientreport	Yes	Yes	Yes	Same
Printable hardcopy reports	No	Yes	Yes	Substantiallyequivalent
Maintain apatient databasefor futurereference	No	Yes	Yes	Substantiallyequivalent
Report of thecalcium scorecategory	Yes	Yes	Yes	Substantiallyequivalent

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Image /page/7/Picture/0 description: The image shows the Zebra Medical Vision logo. The logo consists of a stylized "Z" symbol on the left and the word "zebra" in lowercase letters on the right. Below the word "zebra" is the text "MEDICAL.VISION" in smaller letters. The logo is black and white.

Substantial Equivalence:

Based on the information submitted in this premarket notification, and based on the indications for use, technological characteristics and performance testing, HealthCCS

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Image /page/8/Picture/0 description: The image shows the Zebra Medical Vision logo. The logo consists of a yellow horizontal line, a stylized black and white "Z" symbol, and the word "zebra" in black, with the words "MEDICAL.VISION" in smaller font below it. The logo is simple and modern, and it is likely used to represent a company that specializes in medical imaging or related technologies.

device raises no new questions of safety and effectiveness and is substantially equivalent to the predicate device in terms of safety, efficacy and performance.

The results of the performance comparison study demonstrated that the HealthCCS device performs as intended, in the specified use conditions, similarly to the reference device. The HealthCCS device is therefore substantially equivalent to the predicate device as the reference device and the predicate device share the same intended use and equivalent technological characteristics.

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.