TeraRecon Aorta.CT is intended to provide an automatic 3D segmentation and label anatomical landmarks of the Aorta. The results of TeraRecon Aorta.CT are intended to be used in conjunction with other patient information by trained professionals who are responsible for making any patient management decision per the standard of care. TeraRecon Aorta.CT is a software as a medical device (SaMD) deployed as a containerized application. The device inputs are CT Angiography with contrast DICOM images. The device outputs are DICOM result files which may be viewed utilizing DICOM-compliant systems. The device does not alter the original input data and does not provide a diagnosis.

TeraRecon Aorta.CT is indicated to generate results from aortic CT Angiography scans taken of adult patients except patients with pre-existing aortic device, bicuspid aortic valve anomaly, aortic dissection, aortic rupture, and abdominal metallic devices. The device is not specific to any gender, ethnic group, or clinical condition.

Device Description

The TeraRecon Aorta.CT algorithm is an image processing software device that can be deployed as a containerized application (e.g., Docker container) that runs on off-the-shelf hardware or on a cloud platform.

The device provides an automatic 3D segmentation of the aorta and landmarks of important aortic anatomy. When TeraRecon Aorta.CT results are used in external viewer devices such as TeraRecon's Intuition or Eureka Clinical Al medical devices, all the standard features offered by the external viewer are employed.

The TeraRecon Aorta.CT algorithm is not intended to replace the skill and judgment of a qualified medical practitioner and should only be used by individuals that have been trained in the software's function, capabilities, and limitations.

AI/ML Overview

Here's a summary of the acceptance criteria and study details for the TeraRecon Aorta.CT (1.1.0) device:

1. Table of Acceptance Criteria and Reported Device Performance

Feature	Acceptance Criteria	Reported Device Performance
Lumen Segmentation	Mean DICE score >= 80%	Mean DICE score: 88% (Passed)
Aorta Segmentation	Mean DICE score >= 80%	Mean DICE score: 90% (Passed)
Landmarking (Overall)	Each of the 22 landmarks independently pass class-specific criteria in 80% of cases. Lower bound of the 95% exact binomial confidence interval >= 70%.	All landmarks passed the acceptance criteria, all 95% confidence intervals were at least 70%. (Passed)
Landmarking (Specific Criteria):
Common Left/Right Iliac Arteries, Left/Right Femoral Arteries (4 landmarks)	Correct identification of the vessel in accordance with ground truth.	Not explicitly stated with individual percentages, but included in the overall "all landmarks passed" statement.
Remaining 17 Landmarks (except aortic bifurcation)	Euclidean distance between ground truth annotation and medical device output locations within 5mm.	Not explicitly stated with individual percentages, but included in the overall "all landmarks passed" statement.
Aortic Bifurcation (1 landmark)	Euclidean distance between ground truth annotation and medical device output locations within 2cm.	Not explicitly stated with individual percentages, but included in the overall "all landmarks passed" statement.

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

Initial Sample Size for Test Set: 170 CTA scans for segmentation and landmarking.
Adjusted Sample Size for Landmarking: 170 initial studies + 29 supplemental studies = 199 studies (to achieve a target of 70 annotatable landmarks per target).
Data Provenance: Retrospective cohort study. At least 50% of the ground truth data is from US patients across 3 geographical regions in the United States. The validation data was enriched with data from patients with clinical diagnosis of aortic dilation/aneurysm and/or aortic valve disease. The final manufacturer distribution of scanner types was 77 Siemens, 33 GE, 35 Philips, and 25 Canon.

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

Number of Experts: Not explicitly stated as a count, but referred to as "annotators" for landmarking and a "US board certified radiologist" for checking collected datasets.
Qualifications of Experts: The individual who checked collected datasets was a "US board certified radiologist, who is currently practicing in the United States and reads similar scans." The qualifications of the "annotators" for landmarking are not specified beyond their task.

4. Adjudication Method for the Test Set

The document does not explicitly state an adjudication method (e.g., 2+1, 3+1). It implies that ground truth was established by experts (radiologist and annotators) and then compared to the device output. There is no mention of a process for resolving discrepancies among multiple experts or between expert and device output outside of direct comparison.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study that involves human readers with and without AI assistance was not explicitly described or presented in the provided text. The study focuses on evaluating the standalone performance of the AI device against ground truth.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

Yes, a standalone study was performed. The described study evaluates the Aorta.CT device's performance (segmentation DICE scores and landmarking accuracy) directly against expert-established ground truth. There is no mention of human-in-the-loop performance evaluation in this specific study.

7. The Type of Ground Truth Used

Segmentation (Lumen and Aorta Wall): Expert annotations as described by "Comparison of Aorta lumen segmentation results from the medical device to aorta lumen segmentation from ground truth" and "This aorta wall to wall segmentation includes aorta lumen + wall for the comparison."
Landmarking: Expert annotations as described by "We will also examine the subject device landmarking locations compared to each ground truth annotation."

8. The Sample Size for the Training Set

The sample size for the training set is not provided in the given text. The document focuses on the validation study and its test set.

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

The method for establishing ground truth for the training set is not provided in the given text. The document only describes how ground truth was established for the retrospective cohort test set.

Summary

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January 23, 2025

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

TeraRecon, Inc. Michael Sosebee Director, Regulatory Affairs and Quality Assurance 4309 Emperor Boulevard, Suite 310 Durham, North Carolina 27703

Re: K243158

Trade/Device Name: TeraRecon Aorta.CT (1.1.0) Regulation Number: 21 CFR 892.2050 Regulation Name: Medical Image Management And Processing System Regulatory Class: Class II Product Code: QIH Dated: September 30, 2024 Received: January 7, 2025

Dear Michael Sosebee:

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 (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 OS 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 Re"). 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-devices/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 mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See

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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,

Samul for

Jessica Lamb, Ph.D. Assistant Director Imaging Software Team DHT8B: Division of Radiological 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

Submission Number (if known)

K243158

Device Name

TeraRecon Aorta.CT (1.1.0)

Indications for Use (Describe)

TeraRecon Aorta.CT is indicated to generate results from aortic CT Angiography scans taken of adult patients except patients with pre-existing aortic device, bicuspid aortic valve anomaly, aortic dissection, aortic rupture, and abdominal metallic device is not specific to any gender, ethnic group, or clinical condition.

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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4309 Emperor Boulevard, Suite 310 | Durham, NC 27703 Tel 650.372.1100 Fax 650.372.1101 www.terarecon.com | info@terarecon.com

TeraRecon Aorta.CT 1.1.0 510(k) Summary

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510(k) Number: Prepared on:

K243158 23Jan2025

Contact Details

Device Name

Device Trade Name: Common Name: Classification Name: Regulation Number: Product Code(s):

TeraRecon Aorta.CT (1.1.0) Medical image management and processing system Automated Radiological Image Processing Software 892.2050 QIH

Legally Marketed Predicated Device

Predicate #:	K220039
Predicate Trade Name:	AutoSeg-H
Product Code:	LLZ

Device Description Summary

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Intended Use/Indications for Use

TeraRecon Aorta.CT is intended to provide an automatic 3D segmentation and label anatomical landmarks of the Aorta. The results of TeraRecon Aorta. CT are intended to be used in conjunction with other patient information by trained professionals who are responsible for making any patient management decision per the standard of care. TeraRecon Aorta.CT is a software as a medical device (SaMD) deployed as a containerized application. The device inputs are CT Angiography with contrast DICOM images. The device outputs are DICOM result files which may be viewed utilizing DICOMcompliant systems. The device does not alter the original input data and does not provide a diagnosis.

Indications for Use Comparison

Indications for Use (Subject Device) - TeraRecon Aorta.CT

TeraRecon Aorta.CT is intended to provide an automatic 3D segmentation and label anatomical landmarks of the Aorta. The results of TeraRecon Aorta.CT are intended to be used in conjunction with other patient information by trained professionals who are responsible for making any patient management decision per the standard of care. TeraRecon Aorta.CT is a software as a medical device (SaMD) deployed as a containerized application. The device inputs are CT Angiography with contrast DICOM images. The device outputs are DICOM result files which may be viewed utilizing DICOMcompliant systems. The device does not alter the original input data and does not provide a diagnosis.

Indications for Use (Predicate Device) - AugoSeq-H, K220039

AutoSeg-H is medical imaging software that is intended to provide trained medical professionals with tools to aid them in reading, interpreting, and treatment planning. AutoSeg-H accepts DICOM compliant medical images acquired from imaging device (Computed Tomography).

AutoSeg-H provides the tools for specific analysis applications which provide custom UI, targeted measurements and reporting functions including:

Coronary Artery Analysis for CT coronary arteriography images: which is intended for the qualitative and quantitative analysis of coronary arteries.
Valve Analysis: which is intended for automatic extraction of the heart and aorta regions, automatic detection of the contour of the aorta and valves, measurement of the vicinity of the valves.
4-Chamber Analysis: which is intended for automatic extraction of the left atrium, left ventricle, right atrium, and right ventricle from CT.

Comparison of the Indications for Use:

The differences in the two indications for use statement do not raise different safety and effectiveness questions because the differences are summarized as additional functionality that is offered by the predicate device in comparison to the subject device. The similarities in the two indications for use statements show that the same modality, Computed Tomography DICOM images and automated segmentation of the aorta are employed to provide similar device output.

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Technological Comparison

	Subject Device	Predicate Device
	TeraRecon Aorta.CT	AutoSeg-H	Comparison
	K243158	K220039
Indicationsfor Use	TeraRecon Aorta.CT isintended to provide anautomatic 3D segmentationand label anatomicallandmarks of the Aorta. Theresults of TeraReconAorta.CT are intended to beused in conjunction withother patient information bytrained professionals whoare responsible for makingany patient managementdecision per the standard ofcare. TeraRecon Aorta.CTis a software as a medicaldevice (SaMD) deployed asa containerized application.The device inputs are CTAngiography with contrastDICOM images. The deviceoutputs are DICOM resultfiles which may be viewedutilizing DICOM-compliantsystems. The device doesnot alter the original inputdata and does not provide adiagnosis.TeraRecon Aorta.CT isindicated to generate resultsfrom aortic CT Angiographyscans taken of adultpatients except patients withpre-existing aortic device,bicuspid aortic valveanomaly, aortic dissection,aortic rupture, andabdominal metallic devices.The device is not specific toany gender, ethnic group, orclinical condition.	AutoSeg-H is medicalimaging software that isintended to provide trainedmedical professionals withtools to aid them in reading,interpreting, reporting, andtreatment planning.AutoSeg-H accepts DICOMcompliant medical imagesacquired from imagingdevice (ComputedTomography).AutoSeg-H provides thetools for specific analysisapplications which providecustom UI, targetedmeasurements andreporting functionsincluding:- Coronary Artery Analysisfor CT coronaryarteriography images: whichis intended for thequalitative and quantitativeanalysis of coronaryarteries.- Valve Analysis: which isintended for automaticextraction of the heart andaorta regions, automaticdetection of the contour ofthe aorta and valves,measurement of the vicinityof the valves.- 4-Chamber Analysis:which is intended forautomatic extraction of theleft atrium, left ventricle,right atrium, and rightventricle from CT.	Differences:The subject device does not includefunctionality to provide professionals withtools to read, interpret, report or treatmentplan.The predicate device provides analysis toolsfor coronary artery analysis and 4-chamberanalysis that the subject device does notprovide.The predicate device provides measurementsof the vicinity of the cardiac valves which thesubject device does not provide.The subject device includes landmarks of theaorta that the predicate device does not.The subject device indicates that it is not foruse on images of adult patients with pre-existing aortic device, bicuspid aortic valveanomaly, aortic dissection, aortic rupture, andabdominal metallic devices. The predicatedevice does not mention similar non usescenarios.Similarities:The subject and predicate devices are bothindicated for use with Computed Tomography(CT) DICOM images.The subject and predicate devices are bothindicated for use on images of adult patients.The subject and predicate devices bothprovide segmentation results.Summary:The noted differences do not render thesubject device NSE because the identifieddifferences do not raise different safety andeffectiveness questions. The similarities showthat similar device output is provided basedon the same technology utilized in thedevices.
Modality	Computed Tomography(CT)	Computed Tomography(CT)	Same
AlgorithmTechnology	Supervised deep learning-based algorithms	Deep learning-basedalgorithms	Same
	Subject DeviceTeraRecon Aorta.CTK243158	Predicate DeviceAutoSeg-HK220039	Comparison
DeviceOutputs	DICOM Seg and DICOMCoF	Results in form of 2DImages, 3D Images,Information and Results	Differences:The predicate device outputs measurementresults that are not available in the subjectdevice.Similarities:Both the subject and predicate devicesoutput results following the DICOMstandard.Summary:The noted differences do not render thesubject device NSE because the identifieddifferences do not raise different safety andeffectiveness questions. The similaritiesshow that similar device output is providedbased on the same technology utilized inthe devices.
InstallationMethods	Application installed on acomputer	Application installed on acomputer	Same

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Non-Clinical and/or Clinical Tests Summary & Conclusions

The TeraRecon Aorta.CT device underwent a retrospective cohort study where ground truth was established and compared to the output of the device as described below:

At least 50% of the ground truth data is of US patients from 3 geographical regions in the United States. Each ground truth scan will also pass through the subject device. 170 adult patients are included in the cohort meeting the following inclusion criteria: Patients must be 18 or older, must have had a CT Angiography scan for cardiac or CT Angiographic scan for abdomen or for both covering cardiac and abdominal aorta, and the validation data should be enriched with data from patients with clinical diagnosis of aortic dilation/aneurysm and/or aortic valve disease.

The following results will be compared between the ground truth and device results, Lumen Segmentation: Comparison of Aorta Jumen segmentation results from the medical device to aorta lumen segmentation from ground truth. Aorta wall segmentation: The test will compare the results from ground truth to medical device output representing for aorta wall to wall segmentation. This aorta wall to wall segmentation includes aorta lumen + wall for the comparison. The lumen and aorta wall (including lumen) segmentations are important for extracting measurements that can be used by the clinicians for procedure planning. Landmarking results: The 22 anatomical landmarks for aorta will be compared from the device output to the ground truth.

For each CTA scan we will record aortic lumen segmentation DICE score and aorta segmentation DICE score for the subject device vs each of the ground truths. Our acceptance criteria for lumen and aorta segmentation accuracy are for average DICE score >= 80%.

For each CTA scan, we will also examine the subject device landmarking locations compared to each ground truth annotation. The Common Left and Right Iliac Arteries, Left and Right Femoral Arteries (4 landmarks) will be evaluated by whether or not the subject device correctly identified the vessel in accordance with ground truth. In a typical clinical workflow, these landmarks need only identify any point

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in the center of the vessel, thus the identification of the overall anatomic location is of greatest importance, rather than exact location.

The remaining landmarks except for the aortic bifurcation (17 landmarks) will be assessed using Euclidean distance between ground truth annotation and medical device output locations. We will determine whether the Euclidean distance is within 5mm.

Finally, for the aortic bifurcation (1 landmark), the exact location is not clearly defined, and a general area is sufficient in typical clinical practice. We will determine whether the Euclidean distance is within 2cm compared to ground truth.

Our acceptance criteria for the landmarks are whether each of the 22 landmarks independently pass the class-specific criteria in 80% of the cases. To provide evidence of precision, we will assess whether the lower bound of the 95% exact binomial confidence interval (binom.confint from the R power library) is greater than or equal to 70% (~ acceptance level - 10%). A sample size of 100 CTA scans was chosen since during power simulations of 10.000 simulated runs, an actual case-wise pass rate of 90% resulted in power of 81% to pass all 24 tests after accounting for 30% loss of cases due to some landmarks being outside of field of view. Power calculation code displayed in appendix.

Following execution of the study, it was determined that the TeraRecon Aorta.CT device passed the acceptance criteria established in the study based on the following results:

For testing the lumen and aorta segmentation, we selected 170 studies which matched the inclusion exclusion criteria. The final manufacturer distribution was 77 Siemens, 33 GE, 35 Philips, and 25 Canon. All collected datasets were checked and were found acceptable to use by a US board certified radiologist, who is currently practicing in the United States and reads similar scans.

Our acceptance criteria for lumen and segmentation is to confirm a mean DICE score of >=80%. The lumen segmentation results passed with a mean DICE score of 88%. The aorta segmentation results passed with a mean DICE score of 90%.

For testing the aorta landmarking, we selected 170 studies which matched the inclusion criteria, but we found that the number of landmarks outside the field of view was higher than expected: 40-45% actual vs 30% expected. The annotators were unable to provide annotations for these images, and we had a range of between 55-60 annotatable landmarks per landmark target. Additionally, sections of many images contained image artifacts which made annotation impossible. These artifacts included motion artifacts, occluded vessels, and lack of contrast in the aortic arch and heart. We increased the number of studies to achieve our target of 70 annotatable landmarks, according to our power calculations. We added 29 additional studies to the initial total. After adding 29 supplemental studies, we averaged 73 annotatable landmarks per landmark target with a minimum of 63. Thus, we stopped increasing the sample size.

Our acceptance is to assess whether each of the 22 landmarks independently pass evaluation in 80% of the cases. To provide evidence of precision we assess whether the lower bound of the 95% exact binomial confidence interval (binom.confint from the R power library) is greater than or equal to 70% (~ acceptance level - 10%). All landmarks passed the acceptance criteria, all 95% confidence intervals were at least 70%.

The test results support the conclusion that the TeraRecon Aorta.CT device is as safe, as effective and performs as well as the predicate device cleared under K220039.

Regulation Number and Section

§ 892.2050 Medical image management and processing system.

(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).