AI-CVD

K252029 · HeartLung Corporation · QIH · Dec 19, 2025 · Radiology

Device Facts

• Record ID: K252029
• Device Name: AI-CVD
• Applicant: HeartLung Corporation
• Product Code: QIH · Radiology
• Decision Date: Dec 19, 2025
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2
• Attributes: AI/ML, Software as a Medical Device

Intended Use

AI-CVD® is an opportunistic AI-powered quantitative imaging tool that provides automated CT-derived anatomical and density-based measurements for clinician review. The device does not provide diagnostic interpretation or risk prediction. It is solely intended to aid physicians and other healthcare providers in determining whether additional diagnostic tests are appropriate for implementing preventive healthcare plans. AI-CVD® has a modular structure where each module is intended to report quantitative imaging measurements for each specific component of the CT scan. AI-CVD® quantitative imaging measurement modules include coronary artery calcium (CAC) score, aortic wall calcium score, aortic valve calcium score, mitral valve calcium score, cardiac chambers volumetry, epicardial fat volumetry, aorta and pulmonary artery sizing, lung density, liver density, bone mineral density, and muscle & fat composition. Using AI-CVD® quantitative imaging measurements and their clinical evaluation, healthcare providers can investigate patients who are unaware of their risk of coronary heart disease, heart failure, atrial fibrillation, stroke, osteoporosis, liver steatosis, diabetes, and other adverse health conditions that may warrant additional risk assessment, monitoring or follow-up. AI-CVD® quantitative imaging measurements are to be reviewed by radiologists or other medical professionals and should only be used by healthcare providers in conjunction with clinical evaluation. AI-CVD® is not intended to rule out the risk of cardiovascular diseases. AI-CVD® opportunistic screening software can be applied to non-contrast thoracic CT scans such as those obtained for CAC scans, lung cancer screening scans, and other chest diagnostic CT scans. Similarly, AI-CVD® opportunistic screening software can be applied to contrast-enhanced CT scans such as coronary CT angiography (CCTA) and CT pulmonary angiography (CTPA) scans. AI-CVD® opportunistic bone density module and liver density module can be applied to CT scans of the abdomen and pelvis. All volumetric quantitative imaging measurements from the AI-CVD® opportunistic screening software are adjusted by body surface area (BSA) and reported both in cubic centimeter volume (cc) and percentiles by gender reference data from people who participated in the Multi-Ethnic Study of Atherosclerosis (MESA) and Framingham Heart Study (FHS). Except for coronary artery calcium scoring, other AI-CVD® modules should not be ordered as a standalone CT scan but instead should be used as an opportunistic add-on to existing and new CT scans.

Device Story

AI-CVD® is an opportunistic, AI-powered post-processing software tool for clinical use. It ingests DICOM-formatted CT scans (non-contrast or contrast-enhanced) of the chest, abdomen, or pelvis. The device uses deep learning models to automatically segment anatomical structures and quantify biomarkers, including calcium scores (coronary, aortic, mitral), cardiac chamber volumes, epicardial fat, aorta/pulmonary artery dimensions, lung/liver density, bone mineral density, and muscle/fat composition. Results are exported to parent software for human expert review. The clinician must approve or reject the AI-generated segmentations; the device fails if segmentations are misaligned or image quality is poor. The output provides quantitative data adjusted by body surface area and compared against MESA/FHS reference percentiles. It assists physicians in identifying patients who may benefit from further diagnostic testing or preventive care. It does not provide diagnostic interpretation or risk prediction.

Clinical Evidence

No prospective clinical studies performed. Clinical validation based on retrospective analysis of large cohorts (MESA, FHS). Performance evaluated by comparing AI-derived measurements against manual expert segmentations or gold-standard reference tests. Specific modules (CAC, aortic/mitral valve calcification, cardiac chambers, epicardial fat, aorta/pulmonary artery, liver/lung density, muscle/fat, bone density) demonstrated acceptable bias, reproducibility, and agreement across various imaging protocols (gated/non-gated, contrast/non-contrast).

Technological Characteristics

Software-only device; Linux-based. Utilizes deep learning (nnU-Net architecture) for automated ROI segmentation. Inputs: DICOM CT scans. Outputs: Quantitative volumetric and density measurements. No hardware components; no sterilization/biocompatibility requirements.

Indications for Use

Indicated for patients undergoing chest or abdominal CT scans. Used by healthcare providers to obtain quantitative imaging measurements (calcium scores, volumetry, density, composition) to aid in identifying patients requiring further risk assessment for cardiovascular disease, heart failure, atrial fibrillation, stroke, osteoporosis, liver steatosis, or diabetes.

Regulatory Classification

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.

Special Controls

*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).

Predicate Devices

• AutoChamber (K240786)
• ABMD Software (K213760)

Reference Devices

• AI-Rad (K183268)
• Imbio (K230112)
• Imbio (K141069)

Submission Summary (Full Text)

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FDA U.S. FOOD & DRUG ADMINISTRATION

December 19, 2025

HeartLung Corporation
Mark Scott
Official Applicant
2450 Holcombe Blvd
Houston, Texas 77021

Re: K252029
Trade/Device Name: AI-CVD®
Regulation Number: 21 CFR 892.2050
Regulation Name: Medical Image Management And Processing System
Regulatory Class: Class II
Product Code: QIH, KGI
Dated: November 24, 2025
Received: November 24, 2025

Dear Mark Scott:

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.

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"

U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov

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K252029 - Mark Scott
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(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 (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-reporting-combination-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-devices/device-advice-comprehensive-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-devices/medical-device-safety/medical-device-reporting-mdr-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/medical-devices/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-devices/device-advice-comprehensive-regulatory-

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K252029 - Mark Scott
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assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,


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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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120
Expiration Date: 07/31/2026
See PRA Statement below.

510(k) Number (if known)
K252029

Device Name
AI-CVD®

Indications for Use (Describe)
AI-CVD® is an opportunistic AI-powered quantitative imaging tool that provides automated CT-derived anatomical and density-based measurements for clinician review. The device does not provide diagnostic interpretation or risk prediction. It is solely intended to aid physicians and other healthcare providers in determining whether additional diagnostic tests are appropriate for implementing preventive healthcare plans. AI-CVD® has a modular structure where each module is intended to report quantitative imaging measurements for each specific component of the CT scan. AI-CVD® quantitative imaging measurement modules include coronary artery calcium (CAC) score, aortic wall calcium score, aortic valve calcium score, mitral valve calcium score, cardiac chambers volumetry, epicardial fat volumetry, aorta and pulmonary artery sizing, lung density, liver density, bone mineral density, and muscle & fat composition.

Using AI-CVD® quantitative imaging measurements and their clinical evaluation, healthcare providers can investigate patients who are unaware of their risk of coronary heart disease, heart failure, atrial fibrillation, stroke, osteoporosis, liver steatosis, diabetes, and other adverse health conditions that may warrant additional risk assessment, monitoring or follow-up. AI-CVD® quantitative imaging measurements are to be reviewed by radiologists or other medical professionals and should only be used by healthcare providers in conjunction with clinical evaluation.

AI-CVD® is not intended to rule out the risk of cardiovascular diseases. AI-CVD® opportunistic screening software can be applied to non-contrast thoracic CT scans such as those obtained for CAC scans, lung cancer screening scans, and other chest diagnostic CT scans. Similarly, AI-CVD® opportunistic screening software can be applied to contrast-enhanced CT scans such as coronary CT angiography (CCTA) and CT pulmonary angiography (CTPA) scans. AI-CVD® opportunistic bone density module and liver density module can be applied to CT scans of the abdomen and pelvis. All volumetric quantitative imaging measurements from the AI-CVD® opportunistic screening software are adjusted by body surface area (BSA) and reported both in cubic centimeter volume (cc) and percentiles by gender reference data from people who participated in the Multi-Ethnic Study of Atherosclerosis (MESA) and Framingham Heart Study (FHS). Except for coronary artery calcium scoring, other AI-CVD® modules should not be ordered as a standalone CT scan but instead should be used as an opportunistic add-on to existing and new CT scans.

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

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PSC Publishing Services [phone]

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HeartLung

HeartLung Corporation
2450 Holcombe Blvd
Houston, TX 77021

# K252029

# 510(K) Summary

This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of 21 CFR 807.92:

1. Submitter
HeartLung Corporation
2450 Holcombe Blvd, Houston, TX 77021
Tel: [phone]
Contact: Dr. Morteza Naghavi
Date Prepared: Monday, June 9, 2025

2. Device
Subject Device: AI-CVD®
Trade Name: AI-CVD®
Common Name: AI-CVD®
Classification: Class II, 21 CFR 892.2050
Product Code: QIH, KGI

3. Predicate Device
Manufacturer: HeartLung Corporation
Trade Name: AutoChamber®
Reference 510(k): K240786

4. Reference Device
Manufacturer: HeartLung Corporation
Trade Name: ABMD Software
Predicate 510(k): K213760

5. Device Description

General Description
AI-CVD® is an opportunistic AI-powered modular tool that provides automated quantitative imaging reports on CT scans and outputs the following measurements:
- Coronary Artery Calcium Score
- Aortic Wall and Valves Calcium Scores
- Mitral Valve Calcium Score
- Cardiac Chambers Volume
- Epicardial Fat Volume
- Aorta and Main Pulmonary Artery Volume and Diameters
- Liver Attenuation Index

AI-CVD® is a registered trademark of the HeartLung Corporation. THIS DOCUMENT IS THE PROPERTY OF HEARTLUNG CORPORATION.
© HEARTLUNG CORPORATION. ALL RIGHTS RESERVED.
Pg. 1 of 11

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HeartLung

HeartLung Corporation
2450 Holcombe Blvd
Houston, TX 77021

- Lung Attenuation Index
- Muscle and Visceral Fat
- Bone Mineral Density

The above quantitative imaging measurements enable care providers to take necessary actions to prevent adverse health outcomes.

## Intended Patient Population

Patients who underwent a CT scan of chest or abdomen.

## Principles of Ops

AI-CVD® modules are installed by trained personnel only. AI-CVD® is executed via parent software which provides the necessary inputs and receives the outputs. The software itself does not offer user controls or access.

AI-CVD® reads a CT scan (in DICOM format) and extracts scan specific information like acquisition time, pixel size, scanner type, etc. AI-CVD® uses trained AI models that automatically segment and report quantitative imaging measurements specific to each AI-CVD® module. The output of each AI-CVD® module is inputted into the parent software which exports the results for review and confirmation by a human expert.

AI-CVD® is a post-processing tool that works on existing and new CT scans.

AI-CVD® passes if the human expert approves the segmentation highlighted by the AI-CVD® module is correctly placed on the target anatomical region. For example, Software passes if the human expert sees the AI-CVD® cardiac chamber volumetry module highlighted the heart anatomy.

AI-CVD® fails if the human expert sees the segmentation highlighted by the AI-CVD® module is not correctly placed on the target anatomical region. For example, Software fails if the human expert sees the AI-CVD® cardiac chamber volumetry module highlighted the lungs anatomy or a portion of the sternum or any adjacent organs. Furthermore, Software fails if the human expert sees that the quality of the CT scan is compromised by image artifacts, severe motion, or excessive noise.

The user cannot change or edit the segmentation or results of the device. The user must accept or reject the segmentation where the AI-CVD® quantitative imaging measurements are performed.

## Conditions of Use:

| AI-CVD® is a registered trademark of the HeartLung Corporation. THIS DOCUMENT IS THE PROPERTY OF HEARTLUNG CORPORATION. © HEARTLUNG CORPORATION. ALL RIGHTS RESERVED. | Pg. 2 of 11 |
| --- | --- |

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HeartLung

HeartLung Corporation
2450 Holcombe Blvd
Houston, TX 77021

AI-CVD® is an AI-powered post-processing tool that works on non-contrast and contrast-enhanced CT scans of chest and abdomen.

# Software and Model Detailed Description

AI-CVD® is a multi-module deep learning-based software platform developed to automatically segment and quantify a broad range of cardiovascular, pulmonary, musculoskeletal, and metabolic biomarkers from standard chest or whole-body CT scans. AI-CVD® system builds upon the open-source TotalSegmentator as its foundational segmentation framework, incorporating additional supervised learning and model training layers specific to each module's clinical task.

The original TotalSegmentator architecture utilizes a self-configuring neural network known as nnU-Net³, which was trained on 1,139 total body CT cases for general anatomical segmentation and 447 coronary CT angiography (CCTA) scans for high-resolution cardiac structure segmentation. Input data included both contrast-enhanced and non-contrast ECG-gated CT scans with 1.0 mm slice thickness, enabling robust cross-modality performance. Where available, matched contrast and non-contrast scans from the same subjects were registered and aligned to optimize anatomical consistency during training. Each module within AI-CVD® was further refined based on human expert knowledge for each particular measurement. Custom datasets were constructed for coronary artery calcium scoring, aortic and valvular calcifications, cardiac chamber volumetry, epicardial and visceral fat quantification, bone mineral density assessment, liver fat estimation, muscle mass and quality, and lung attenuation analysis. For each module, iterative model enhancement was applied: human reviewers evaluated model-generated segmentations and corrected any inaccuracies, and these corrections were looped back into the training process to improve performance and generalizability.

# 6. Indications for Use

AI-CVD® is an opportunistic AI-powered quantitative imaging tool that provides automated CT-derived anatomical and density-based measurements for clinician review. The device does not provide diagnostic interpretation or risk prediction. It is solely intended to aid physicians and other healthcare providers in determining whether additional diagnostic tests are appropriate for implementing preventive healthcare plans. AI-CVD® has a modular structure where each module is intended to report quantitative imaging measurements for each specific component of the CT scan. AI-CVD® quantitative imaging measurement modules include coronary artery calcium (CAC) score, aortic wall calcium score, aortic valve calcium score, mitral valve calcium score, cardiac chambers volumetry, epicardial fat volumetry, aorta and pulmonary artery sizing, lung density, liver density, bone mineral density, and muscle & fat composition.

Using AI-CVD® quantitative imaging measurements and their clinical evaluation, healthcare providers can investigate patients who are unaware of their risk of coronary heart disease, heart failure, atrial fibrillation, stroke, osteoporosis, liver steatosis, diabetes, and other adverse health

AI-CVD® is a registered trademark of the HeartLung Corporation. THIS DOCUMENT IS THE PROPERTY OF HEARTLUNG CORPORATION. © HEARTLUNG CORPORATION. ALL RIGHTS RESERVED.

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HeartLung Corporation
2450 Holcombe Blvd
Houston, TX 77021

conditions that may warrant additional risk assessment, monitoring or follow-up. AI-CVD® quantitative imaging measurements are to be reviewed by radiologists or other medical professionals and should only be used by healthcare providers in conjunction with clinical evaluation.

AI-CVD® is not intended to rule out the risk of cardiovascular diseases. AI-CVD® opportunistic screening software can be applied to non-contrast thoracic CT scans such as those obtained for CAC scans, lung cancer screening scans, and other chest diagnostic CT scans. Similarly, AI-CVD® opportunistic screening software can be applied to contrast-enhanced CT scans such as coronary CT angiography (CCTA) and CT pulmonary angiography (CTPA) scans. AI-CVD® opportunistic bone density module and liver density module can be applied to CT scans of the abdomen and pelvis. All volumetric quantitative imaging measurements from the AI-CVD® opportunistic screening software are adjusted by body surface area (BSA) and reported both in cubic centimeter volume (cc) and percentiles by gender reference data from people who participated in the Multi-Ethnic Study of Atherosclerosis (MESA) and Framingham Heart Study (FHS). Except for coronary artery calcium scoring, other AI-CVD® modules should not be ordered as a standalone CT scan but instead should be used as an opportunistic add-on to existing and new CT scans.

AI-CVD® is a registered trademark of the HeartLung Corporation. THIS DOCUMENT IS THE PROPERTY OF HEARTLUNG CORPORATION.
© HEARTLUNG CORPORATION. ALL RIGHTS RESERVED.
Pg. 4 of 11

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HeartLung Corporation
2450 Holcombe Blvd
Houston, TX 77021

# Comparison of Technological Characteristics & Intended Use to Predicate Device

The table below provides a summary of the technological characteristics of AI-CVD® in comparison to the predicate device. The indications for use for the predicate device are similar to the indications for the use of AI-CVD®. There are no major technological differences between the two systems that raise new issues of safety and/or effectiveness. Thus, AI-CVD® is substantially equivalent to the predicate and reference devices.

| Feature | Subject Device
AI-CVD® | Predicate 1
AutoChamber
K240786 | Predicate 2
Auto-BMD
K213760 | Reference 1
AI-Rad
K183268 | Reference 2
Imbio
K230112 | Reference 3
Imbio
K141069 |
| --- | --- | --- | --- | --- | --- | --- |
| Indication for Use
/Intended Use | Estimate the volume of cardiac chambers, epicardial fat, aortic valves, ascending aorta, and pulmonary artery in non-contrast and contrast-enhanced CT scan images

Estimate the percentage of liver voxels below 40HU in non-contrast CT scan images

Estimate the percentage of lung voxels below -950 and above -250 in non-contrast CT scan images | Estimate the volume of cardiac chambers in non-contrast and contrast-enhanced CT scan images | Estimate bone mineral density within the spine | Estimate the volume of the heart

Estimate the total volume of calcium in coronary arteries

Estimate the maximum diameter of the aorta at typical landmarks | Estimate coronary artery calcium score | Estimate pulmonary tissue density within the lungs |

AI-CVD® is a registered trademark of the HeartLung Corporation. THIS DOCUMENT IS THE PROPERTY OF HEARTLUNG CORPORATION. © HEARTLUNG CORPORATION. ALL RIGHTS RESERVED.
Pg. 5 of 11

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HeartLung Corporation
2450 Holcombe Blvd
Houston, TX 77021

| | Estimate the volume of skeletal muscle, subcutaneous fat, and visceral fat in non-contrast CT scan images

Estimate coronary artery calcium score, aortic wall and valve calcium scores, and mitral valve calcium score in non-contrast ECG-gate and non-gated chest CT scan images | | | | | |
| --- | --- | --- | --- | --- | --- | --- |
| Modality | CT scan images (DICOM) | CT scan images (DICOM) | CT scan images (DICOM) | CT scan images (DICOM) | CT scan images (DICOM) | CT scan images (DICOM) |
| Body Part | Chest / Abdomen | Chest | Chest / Abdomen | Chest | Chest | Chest |

AI-CVD® is a registered trademark of the HeartLung Corporation. THIS DOCUMENT IS THE PROPERTY OF HEARTLUNG CORPORATION.
© HEARTLUNG CORPORATION. ALL RIGHTS RESERVED.
Pg. 6 of 11

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HeartLung Corporation
2450 Holcombe Blvd
Houston, TX 77021

| Automatic definition of ROIs | Yes, Deep Learning | Yes, Deep Learning | Yes, Deep Learning | Yes, Deep Learning | Yes, Deep Learning | Yes, Deep Learning |
| --- | --- | --- | --- | --- | --- | --- |
| Device measures volume within the Region of Interest (ROI). | Yes | Yes | Yes | Yes | Yes | Yes |
| Device measures densities within the Region of Interest (ROI). | Yes | Yes | Yes | Yes | Yes | Yes |
| User | Healthcare Provider | Healthcare Provider | Healthcare Provider | Healthcare Provider | Healthcare Provider | Healthcare Provider |
| Operating System | Linux | Linux | Linux | Windows | Windows | Windows |

AI-CVD® is a registered trademark of the HeartLung Corporation. THIS DOCUMENT IS THE PROPERTY OF HEARTLUNG CORPORATION.
© HEARTLUNG CORPORATION. ALL RIGHTS RESERVED.
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HeartLung

HeartLung Corporation
2450 Holcombe Blvd
Houston, TX 77021

| | | | | | | |
| --- | --- | --- | --- | --- | --- | --- |
| Retrospective measurements from CT scans. | Yes | Yes | Yes | Yes | Yes | Yes |

## 7. Performance Data

The following performance data were provided in support of the substantial equivalence determination.

### Sterilization & Shelf-Life Testing

Not applicable for this software as a medical device.

### Biocompatibility Testing

Not applicable for this software as a medical device.

### Electrical Safety and Electromagnetic Compatibility (EMC)

Not applicable for this software as a medical device.

### Software Verification and Validation Testing

Software Verification and Validation testing was completed to demonstrate the safety and effectiveness of the device. Testing demonstrates AI-CVD® meets all its functional requirements and performance specifications.

### Mechanical and Acoustic Testing

Not applicable for this software as a medical device.

AI-CVD® is a registered trademark of the HeartLung Corporation. THIS DOCUMENT IS THE PROPERTY OF HEARTLUNG CORPORATION.
© HEARTLUNG CORPORATION. ALL RIGHTS RESERVED.
Pg. 8 of 11

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HeartLung

HeartLung Corporation
2450 Holcombe Blvd
Houston, TX 77021

# Animal Study

Animal performance testing was not required to demonstrate safety and effectiveness of the device.

# Clinical Studies

Prospective clinical studies were not required to demonstrate the safety and effectiveness of the device. Instead, clinical validation studies were performed based upon retrospective analyses of AI-CVD® measurements performed on large population cohorts such as the Multi-Ethnic Study of Atherosclerosis (MESA) and Framingham Heart Study (FHS). All AI-CVD® quantitative imaging measurements were compared with measurements made manually by human experts or by gold standard reference tests to demonstrate the comparative safety and effectiveness of the device.

# Coronary Artery Calcium Score

The AI-CVD® Coronary Artery Calcium (CAC) module provides fully automated Agatston CAC scoring, as well as an AI-derived calcium score based on relative density using an internal calibration reference. This approach enables detection of small and low-density calcified plaques that may not be captured by conventional fixed-threshold methods. Performance was evaluated outside of the MESA and FHS cohorts against manually measured Agatston scores using 913 consecutive, real-world coronary calcium screening CT scans acquired across three community imaging centers. The results demonstrated comparative safety and effectiveness between expert manual measurements and both the automated Agatston CAC scores and the AI-derived relative density-based calcium scores.

# Aortic Wall and Aortic Valve Calcium Scores

The AI-CVD® Aortic Wall and Aortic Valve Calcification module provides automated quantification of calcified plaque within the thoracic aorta and calcification of the aortic valve from chest CT scans. Technical performance was evaluated through comparison with manual reference standards, with Bland-Altman agreement analyses demonstrating acceptable bias and reproducibility across imaging protocols.

# Mitral Valve Calcium Score

The AI-CVD® Mitral Valve Calcification module provides automated quantification of calcification of the mitral valve from chest CT scans. Technical performance was evaluated through comparison with manual measurements, with agreement analyses demonstrating reproducible mitral valve calcium quantification across imaging protocols.

AI-CVD® is a registered trademark of the HeartLung Corporation. THIS DOCUMENT IS THE PROPERTY OF HEARTLUNG CORPORATION. © HEARTLUNG CORPORATION. ALL RIGHTS RESERVED.

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HeartLung

HeartLung Corporation
2450 Holcombe Blvd
Houston, TX 77021

# Cardiac Chambers Volume

The AI-CVD® Cardiac Chamber Volumetry module is based on previously FDA-cleared technology and utilizes established quantitative imaging measurement principles. The cardiac chamber volumetry module is AutoChamber™ (K240786), which has been reviewed and cleared by the FDA, and its inclusion within AI-CVD® does not raise new questions of effectiveness.

# Epicardial Fat Volume

The AI-CVD® Epicardial Fat module provides automated volumetric quantification of epicardial adipose tissue from chest CT scans. Technical performance was further evaluated through agreement studies comparing AI-derived epicardial fat volumes with manual measurements and across non-contrast and contrast-enhanced CT acquisitions, demonstrating acceptable agreement and reproducibility.

# Aorta and Main Pulmonary Artery Volume and Diameters

The AI-CVD® Aortic and Pulmonary Artery Size module provides automated measurements of thoracic aortic diameters and main pulmonary artery diameter from chest and abdominal CT scans. Agreement studies comparing AI-derived measurements of aortic and pulmonary artery measurements with manual reference measurements demonstrated low bias and comparable performance across gated and non-gated CT acquisitions. These findings support the reliability of AI-CVD® Aorta and Main Pulmonary Artery Volume and Diameter measurements.

# Liver Attenuation Index

The AI-CVD® Liver Density module provides automated quantification of hepatic attenuation from chest CT scans. Agreement analysis comparing AI-derived liver attenuation measurements across imaging protocols demonstrated acceptable reproducibility.

# Lung Attenuation Index

The AI-CVD® Lung Density module provides quantitative analysis of lung parenchymal attenuation from chest CT scans and within the field of view of cardiac CT scans. Agreement studies demonstrated reproducible lung density measurements across gated and non-gated CT acquisitions.

AI-CVD® is a registered trademark of the HeartLung Corporation. THIS DOCUMENT IS THE PROPERTY OF HEARTLUNG CORPORATION. © HEARTLUNG CORPORATION. ALL RIGHTS RESERVED.

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HeartLung Corporation
2450 Holcombe Blvd
Houston, TX 77021

# Muscle and Visceral Fat

The AI-CVD® Thoracic Muscle and Fat Composition module provides quantitative assessment of skeletal muscle attenuation and adipose tissue composition from chest CT scans. Agreement analyses between AI-derived fat and muscle measurements demonstrated acceptable reproducibility across imaging protocols.

# Bone Mineral Density

The AI-CVD® Bone Mineral Density module is based on previously FDA-cleared technology and utilizes established quantitative imaging measurement principles. The bone mineral density module is AutoBMD (K213760), which has been reviewed and cleared by the FDA, and its inclusion within AI-CVD® does not raise new questions of effectiveness.

# 8. Conclusions

The testing results demonstrate that AI-CVD® is as safe and effective as the predicate and reference devices. No new safety or effectiveness issues are raised by AI-CVD®.

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