ClearRead CT CAC is image processing software designed to aid physicians in assessing coronary artery calcification on non-gated, non-contrast, standard, or low-dose chest CT scans of adult patients 30 years of age or older. The primary output of ClearRead CT CAC is the Agatston score. ClearRead CT CAC locates calcified coronary lesions and assigns them to one of several coronary arteries: the right coronary artery (RCA), the left main artery (LM), the left anterior descending artery (LAD), and the left circumflex artery (LCX). The software calculates the Agatston score as the sum for each artery while also providing the total across all coronary arteries. The total Agatston score is calibrated to 3.0mm slice thickness and is used to derive a CAC category and the arterial age. The provided segmentations are for illustrative purposes only and are not intended for diagnostic use.

ClearRead CT CAC provides adjunctive information and is not intended to be used without clinical expert review.

Device Description

ClearRead CT CAC is a computer aided quantification system intended to aid in the assessment of coronary artery calcification. The system receives chest Computed Tomography (CT) studies as input, in DICOM® format, and generates output in DICOM (or other) format.

AI/ML Overview

Here's a detailed breakdown of the acceptance criteria and the study proving the device meets them, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

Metric / Endpoint	Acceptance Criteria (Internal Investigation/Literature)	Reported Device Performance (Clinical Study)
Agatston Score Category Agreement	Weighted Kappa > 0.85 (considered excellent)	0.959 (95% CI: 0.943-0.975)
CAC Negative Agreement (NPA)	Not explicitly stated as acceptance criteria, but reported.	99.1% (95% CI: 98.0%, 100.0%) for Category 0 vs. Not Category 0
CAC Positive Agreement (PPA)	Not explicitly stated as acceptance criteria, but reported.	PPA for Category 0: 88.1% (95% CI: 82.5%, 93.2%)PPA for Category 1-99: 92.8% (95% CI: 87.7%, 96.9%)PPA for Category 100-399: 88.1% (95% CI: 80.5%, 94.4%)PPA for Category ≥ 400: 98.6%
Overall Continuous Agatston Score Agreement	Bland-Altman analysis showing strong agreement (qualitative, based on Figure 2 from non-clinical). No specific numerical acceptance criteria provided for LoA.	Limits of Agreement (LoA) of -12.20 ± 437.84
Coronary Artery Calcification Segmentation Accuracy	Not explicitly stated as a separate acceptance criterion with a specific numerical threshold.	Average Dice score: 0.892 (0.871, 0.911) (Device vs. GT)

2. Sample Size for Test Set and Data Provenance

Non-clinical testing: Approximately 400 cases. Data provenance is not specified, but it's referred to as "internal investigation."
Clinical testing: 491 cases (143 cases with no CAC, 348 with CAC). The data included samples from four CT manufacturers across five clinical sites. The specific country of origin is not mentioned, nor is it explicitly stated whether the data was retrospective or prospective, though the mention of "cases collected and held out from development" suggests retrospective.

3. Number of Experts and Qualifications for Ground Truth

Clinical testing: Three radiologists established the consensus ground truth review. Their specific qualifications (e.g., years of experience, subspecialty) are not detailed in the provided text.

4. Adjudication Method for the Test Set

Clinical testing: A "consensus ground truth review by three radiologists" was used. This implies that the three radiologists collectively determined the ground truth for each case. The specific mechanism (e.g., majority vote, discussion until agreement) is not specified, but it suggests a form of 3-reader consensus.

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

No MRMC comparative effectiveness study was done. The study performed was a standalone model performance assessment comparing the algorithm's output to ground truth measurements. The document does not describe human readers improving with AI vs. without AI assistance.

6. Standalone Performance Assessment

Yes, a standalone (algorithm only without human-in-the-loop performance) study was done. The document explicitly states: "This study was a standalone model performance assessment of ClearRead CT CAC."

7. Type of Ground Truth Used

Clinical testing: "Consensus ground truth review by three radiologists." This is a form of expert consensus.

8. Sample Size for Training Set

The sample size for the training set is not provided in the given document. The document mentions that approximately 400 cases were "held out from development of any kind to estimate the test performance," implying these were for the test set, not training.

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, as the details focus on the "held out" test set for performance estimation. For the test set, "Regions associated with coronary artery calcification were manually outlined, including the particular artery, from which the ground truth Agatston score was obtained."

Summary

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December 3, 2024

Riverain Technologies, Inc. % Jonathan Jackson Director of RAOA 3130 South Tech Boulevard MIAMISBURG, OH 45342

Re: K242188

Trade/Device Name: ClearRead CT CAC Regulation Number: 21 CFR 892.1750 Regulation Name: Computed Tomography X-Ray System Regulatory Class: Class II Product Code: JAK Dated: November 13, 2024 Received: November 14, 2024

Dear Jonathan Jackson:

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 (the 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 available 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.

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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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-regulatory

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assistance/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,

Lu Jiang

Lu Jiang, Ph.D. Assistant Director Diagnostic X-Ray Systems Team DHT8B: Division of Radiologic Imaging Devices and Electronic Products OHT8: Office of 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) K242188

Device Name ClearRead CT CAC

Indications for Use (Describe)

ClearRead CT CAC provides adjunctive information and is not intended to be used without clinical expert review.

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

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K242188

510(k) Summary

Submitter Information:

Company Name:	Riverain Technologies, Inc.
Company Address:	3130 South Tech Blvd.Miamisburg, OH 45342-4860
Contact Person:	Jonathan Jackson
	Director of RAQA
	Riverain Technologies, Inc.937.531.5092

jjackson@riveraintech.com

Device Information:

Trade Name:	ClearRead CT CAC
Regulation Number:	21 CFR 892.1750
Regulation Name:	Computed tomography x-ray system
Regulatory Class:	Class II
Product Code:	JAK
Device Description:	ClearRead CT CAC is a computer aided quantification systemintended to aid in the assessment of coronary artery calcification.The system receives chest Computed Tomography (CT) studies asinput, in DICOM® format, and generates output in DICOM (orother) format.
Intended Purpose:	ClearRead CT CAC is intended to aid physicians in assessingCoronary Artery Calcification while reviewing non-gated, non-contrast, standard, and low-dose chest CT exams.
Indications for Use:	ClearRead CT CAC is image processing software designed to aidphysicians in assessing coronary artery calcification on non-gated,non-contrast, standard, or low-dose chest CT scans of adultpatients 30 years of age or older.The primary output of ClearRead CT CAC is the Agatston score.ClearRead CT CAC locates calcified coronary lesions andassigns them to one of several coronary arteries: the right coronaryartery (RCA), the left main artery (LM), the left anteriordescending artery (LAD), and the left circumflex artery (LCX).The software calculates the Agatston score as the sum for each

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artery while also providing the total across all coronary arteries. The total Agatston score is calibrated to 3.0mm slice thickness and is used to derive a CAC category and the arterial age. The provided segmentations are for illustrative purposes only and are not intended for diagnostic use.

ClearRead CT CAC provides adjunctive information and is not intended to be used without clinical expert review.

Bunkerhill, Inc. Predicate Device: (K230223) iCAC Device

Class II

Comparison to Predicate Device Technical Characteristics

Riverain Technologies, Inc. is of the opinion that ClearRead CT CAC is substantially equivalent, both in intended use as well as to the technical characteristics of the listed predicate device. Differences in the design and performance of the cited predicate device do not affect either the safety or the effectiveness of ClearRead CT CAC for its intended use. Table 1 shows the predicate devices listed along with the subject device, including the Product Code as well as the Indications for Use for each device.

	Predicate:	Subject Device:
	iCAC Device(Bunkerhill, Inc.)	ClearRead CT CAC(Riverain Technologies, Inc.)
	K230223
ProductCode	JAK	JAK
Indications forUse	iCAC is a software deviceintended for use in estimatingpresence and quantity ofcoronary artery calcium forpatients aged 30 years and aboveduring routine care. The deviceautomatically analyzes non-gated, non-contrast chestcomputed tomography (CT)images collected during routinecare and outputs a visualrepresentation of estimatedcoronary artery calcium	ClearRead CT CAC is imageprocessing software designed toaid physicians in assessingcoronary artery calcification onnon-gated, non-contrast, standard,or low-dose chest CT scans ofadult patients 30 years of age orolder.The primary output of ClearReadCT CAC is the Agatston score.ClearRead CT CAC locatescalcified coronary lesions andassigns them to one of several
	informational purposes only) andboth exact and four-categoryquantitative estimates of thepatient's coronary artery calciumburden in Agatston units.The output of the subject deviceis made available to thephysician on-demand as part ofhis or her standard workflow.The device generated calciumscore or score group can beviewed in the patient report atthe discretion of the physician,and the physician also has theoption of viewing the device-generated calcium segmentationin a diagnostic image viewer.The subject device output in noway replaces the original patientreport or the original chest CTscan; both are still available to beviewed and used at the discretionof the physician.The device is intended to provideinformation to the physician toprovide assistance during reviewof the patient's case. Results ofthe subject device are notintended to be used on a stand-alone basis and are solelyintended to aid and provideinformation to the physician. Inall cases, further action taken ona patient should only come at therecommendation of the physicianafter further reviewing thepatient's results.	coronary arteries: the rightcoronary artery (RCA), the leftmain artery (LM), the left anteriordescending artery (LAD), and theleft circumflex artery (LCX). Thesoftware calculates the Agatstonscore as the sum for each arterywhile also providing the totalacross all coronary arteries. Thetotal Agatston score is calibratedto 3.0mm slice thickness and isused to derive a CAC category andthe arterial age. The providedsegmentations are for illustrativepurposes only and are not intendedfor diagnostic use.ClearRead CT CAC providesadjunctive information and is notintended to be used withoutclinical expert review.

Intended User	Radiologists	Radiologists
Modality	Routine, non-contrast, non-gatedchest CT Series	Non-contrast, non-gated, standard,or low-dose chest CT scans
AnatomicalRegion	Chest	Chest
ClinicalCondition	Coronary Artery Calcification	Coronary Artery Calcification
Quantificationof CalciumBurden	Yes	Yes
Segmentationof Calcium	Yes	Yes
Number ofDetectionCategories	4	4
Calculation ofExact CalciumScore	Yes	Yes
Type ofInformation	Adjunctive	Adjunctive
Intendedlocation	Medical Facility	Medical Facility
PrescriptiveUse	Yes	Yes
MeasurementScale	Agatston Units	Agatston Units
Image Format	DICOM	DICOM
SliceThickness	Up to 5mm	Up to 3mm
CalcificationDetection	Automatic	Automatic
DefaultThreshold ofCalcium	130 HU (Hounsfield Units)	130 HU (Hounsfield Units)
CoronaryArteryCalcificationQuantificationMethod	CAC detection category (basedon Agatston score), exactAgatston score.	CAC detection category andarterial age based on the measuredAgatston score.
Annotation ofDetectedCalcium	Yes	Yes
GeneratePatient Report	Optional to copy result toclipboard, insert in report,DICOM Secondary Capture	Optional to copy result toclipboard, insert in report, DICOMSecondary Capture
Report of theCalcium Score	Yes, Coronary CalciumDetection Category and exactAgatston score 4 categories (fordetection category):• 0• 1-99• 100-399• 400 +	Yes, Coronary Calcium DetectionCategory and measured Agatstonscore 4 categories (for detectioncategory):• 0• 1-99• 100-399• 400 +

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Traditional 510(k) Premarket Notification ClearRead™ CT CAC

Table 1: Predicate Devices vs. Subject Device

Key features identified that differ from the predicate are discussed below.

Slice Thickness

ClearRead CT CAC operates slice thickness up to 3mm, whereas the predicate device indicates use up to 5mm slice thickness. A limit of 3mm is in keeping with the current standards used for gated protocols, to which the Agatston score is calibrated to. For values exceeding 3mm, it is unclear how the performance of the measurement or detection of CAC scores degrades and, therefore, is excluded from consideration.

Testing Summary

Non-clinical Testing

Non-clinical tests were conducted during the development process in accordance with the Riverain Technologies Design Control Process, which is compliant with the FDA Quality System Regulations, ISO 13485:2016 with MDSAP, and the following standards.

IEC 62304:2006/AMD1:2016, Medical devices - Software life cycle processes
. IEC62366-1:2015, Medical device - Part1: Application of usability engineering to medical devices
ISO14971:2019, Medical devices Application of Risk Assessment to Medical Devices ●
NEMA PS 3.1-3-20, Digital Imaging and Communications in Medicine (DICOM) Set ● 2016
Guidance for Industry and Food and Drug Administration Staff - Cybersecurity in Medical Devices: Ouality System Considerations and Content of Premarket Submissions. Issues September 27, 2023

Testing verified the requirements according to the ClearRead CT CAC device specifications.

The ClearRead CT CAC Risk Assessment was created for this device, with risk control measures implemented to mitigate identified hazards. Documentation required for software with

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Traditional 510(k) Premarket Notification ClearRead™ CT CAC

a Moderate Level of Concern is included as part of this submission. Device labeling, together with the results from verification and validation testing, demonstrate that the device is safe and effective.

Approximately 400 cases were collected and held out from development of any kind to estimate the test performance of the CAC scoring system. Regions associated with coronary artery calcification were manually outlined, including the particular artery, from which the ground truth Agatston score was obtained.

To assess the measurement of the Agatston score, we used weighted kappa scores (weighted, owing to the ordinal nature of the categories) and Bland-Altman analysis. Pre-test acceptance criteria were defined based on existing literature and internal investigation from visually inspected validation performance. If kappa scores were greater than 0.85, these would be considered excellent. Actual CAC scores are those derived from the use of the ground truth mask, while predicted scores come from the ClearRead CT CAC system. Figure 1 below shows a plot of the predicted versus true CAC categories. A weighted kappa score of 0.958 was achieved, demonstrating good agreement between the automatic method and manual processing.

5	0	0
115	2	0
18	91	1
0	10	95

Ground Truth

Figure 1: Confusion table of predicted versus ground truth CAC categories

A Bland-Altman plot, as shown in Figure 2, demonstrates strong agreement with the true score compared to the estimated score.

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Image /page/10/Figure/2 description: This image is a scatter plot with the x-axis ranging from 0 to 4000 and the y-axis ranging from -1000 to 200. The plot includes a horizontal line indicating the mean at -19.64, with a confidence interval (CI) of -31.54 to -7.734. Additionally, there are two dashed lines representing the limits of agreement (LoA) at 163.1 (CI: 142.4-183.7) and -202.3 (CI: -223--181.7).

Figure 2: Bland-Altman analysis plot for the Agatston scores within the internal test set

Clinical Performance Testing

A clinical study was performed to validate the clinical efficacy of ClearRead CT CAC.

This study was a standalone model performance assessment of ClearRead CT CAC. This software, as a medical device product, was developed using machine learning to measure the amount of arterial calcification in non-contrast chest CT cases. This assessment involved comparing the algorithm outputs to ground-truth measurements on non-contrast, non-gated chest CT cases to determine the algorithm accuracy in automated measurements of the Agatston score (scaled to 3mm slice thickness). The Agatston score was measured overall and for the four component arteries of the right coronary artery, left anterior descending artery, left circumflex artery, and left main coronary artery.

In total, 491 cases were used in the clinical assessment of the device: 143 cases with no sign of coronary artery calcification and 348 with evidence of CAC, as determined by a consensus ground truth review by three radiologists. These nearly 500 cases included samples from four CT manufacturers across five clinical sites. In the CAC positive cases, selection was performed to ensure the entire range of scores was spanned.

For clinical assessment, the following predefined endpoints were used:

. Primary endpoint: the accuracy of ClearRead CT CAC in calculating the Agatston score category (0, 1-99, 100-399, ≥400) as defined by the quadratic weighted Kappa coefficient when compared with ground truth radiologist Agatston score category.
. Secondary endpoint: the accuracy of ClearRead CT CAC in calculating the overall continuous Agatston score as assessed by Bland-Altman analysis.
Secondary endpoint: the accuracy of ClearRead CT CAC in segmenting the overall coronary artery calcification as assessed by Dice score comparison.

The results of the primary and secondary endpoints are as follows:

. Primary endpoint: kappa of 0.959 (95% CI: 0.943-0.975). In addition to kappa scoring, percentage agreement scores for CAC positive (PPA) and negative (NPA) cases were

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assessed. These calculations assessed the proportion of cases correctly identified in the relevant category (for PPA) or in all other categories (for NPA). Figure 3 summarizes all percentage agreement scores as stratified by CAC category.

Secondary endpoint: Bland-Altman analysis (see Figure 4 for a data plot) yielding limits ● of agreement (LoA) of -12.20 ± 437.84.
. Secondary endpoint: Dice score comparison (see Table 2) between the annotator ground truth and automatic outputs, giving average scores of 0.910 (0.893,0.927) and 0.892 (0.871,0.911), respectively.

		Ground truth radiologist category
		Category 0	Not category 0
Device category	Category 0	126	3
	Not category 0	17	345
		PPA 88.195% CI (82.5,93.2)	NPA 99.195% CI (98.0,100.0)
		Ground truth radiologist category
		Category 1-99	Not category 1-99
Device category	Category 1-99	116	17
	Not category 1-99	9	349
		PPA 92.895% CI (87.7,96.9)	NPA 95.495% CI (93.0,97.4)
		Ground truth radiologist category
		Category 100-399	Not category 100-399
Device category	Category 100-399	74	12
	Not category 100-399	10	395
		PPA 88.195% CI (80.5,94.4)	NPA 97.195% CI (95.2,98.5)
		Ground truth radiologist category
		Category ≥ 400	Not category ≥ 400
Device category	Category ≥ 400	137	6
	Not category ≥ 400	2	346
		PPA 98.6	NPA 98.3

Figure 3: Tabularized percentage agreement scores stratified by CAC category

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Traditional 510(k) Premarket Notification ClearRead™ CT CAC

Image /page/12/Figure/2 description: The image is a Bland-Altman plot for the Agatston score. The x-axis represents the average of the ground truth interpretation and ClearRead CT CAC Agatston score, while the y-axis represents the difference between the ground truth interpretation and ClearRead CT CAC Agatston score. The plot includes a mean line at -12.20, an upper limit of agreement (LoA) at 425.65, and a lower LoA at -450.04.

Figure 4: Bland-Altman plot from clinical testing

Average Dice score (95% CI)			Wilcoxon test
Device versus GT	GT versus GT	Difference	p-value
0.892 (0.871,0.911)	0.910 (0.893,0.927)	-0.008 (-0.024,0.007)	0.121

Image /page/12/Figure/5 description: The image shows the title of a table. The title is "Table 2: Dice score comparison to the consensus ground truth". The title indicates that the table will compare dice scores to a consensus ground truth.

Conclusion

In preparing this 510(k) submission, Riverain Technologies has carefully considered the relevant statutory and regulatory requirements and believes that the information contained within satisfies the requirements for demonstrating substantial equivalence in terms of design features, fundamental technology, indications for use, and the safety and effectiveness of the device. Additionally, verification and validation testing demonstrate the safety and efficacy of the device to meet its intended use and specifications when operated as intended, with no detrimental impact on the benefit/risk ratio of the 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.