Bunkerhill MAC is a software device intended for use in detecting presence and estimating quantity of mitral annulus calcification for adult patients aged 40 years and above. The device automatically analyzes non-gated, non-contrast chest computed tomography (CT) images collected during clinical care and outputs the region of interest (intended for informational purposes only) and quantification of detected calcium.

The device-generated quantification can be viewed in the patient report at the discretion of the physician, and the physician also has the option of viewing the device-generated calcium region of interest in a diagnostic image viewer. The subject device output in no way replaces the original patient report or the original non-gated, non-contrast CT scan; both are still available to be viewed and used at the discretion of the physician.

The device is intended to provide information to the physician to provide assistance during review of the patient's case. Results of the subject device are not intended to be used on a stand-alone basis and are solely intended to aid and provide information to the physician. In all cases, further action taken on a patient should only come at the recommendation of the physician after further reviewing the patient's results.

Device Description

Bunkerhill MAC is a software as a medical device (SaMD) product that interfaces with compatible and commercially available computed tomography (CT) systems. Bunkerhill MAC detects, localizes, and quantifies mitral annulus calcification in non-gated, non-contrast chest CT studies. The core features of the product are:

Detection of mitral annulus calcification at an Agatston-equivalent score threshold of 0 AU.
Quantification of the overall mitral annulus calcification burden in the form of an estimated Agatston Score up to 5000 Agatston-equivalent units
Localization of estimated calcium burden in the form of circular region of interest applied to a copy of the original CT scan.

AI/ML Overview

Here's a detailed breakdown of the acceptance criteria and the study proving the Bunkerhill MAC device meets them, based on the provided FDA 510(k) clearance letter:

Acceptance Criteria and Reported Device Performance

Metric	Acceptance Criteria	Reported Device Performance
Positive Agreement Rate	Derived from predicate device performance and clinical literature on inter-reader agreement of manual segmentation (Specific numerical criteria not explicitly stated in the document, but is implied to be met successfully based on the conclusion).	Met successfully
Negative Agreement Rate	Derived from predicate device performance and clinical literature on inter-reader agreement of manual segmentation (Specific numerical criteria not explicitly stated in the document, but is implied to be met successfully based on the conclusion).	Met successfully
Precision (circular ROI)	Derived from predicate device performance and clinical literature on inter-reader agreement of manual segmentation (Specific numerical criteria not explicitly stated in the document, but is implied to be met successfully based on the conclusion).	0.885 (95% CI: 0.848, 0.919)
Recall (circular ROI)	Derived from predicate device performance and clinical literature on inter-reader agreement of manual segmentation (Specific numerical criteria not explicitly stated in the document, but is implied to be met successfully based on the conclusion).	0.867 (95% CI: 0.834, 0.895)
Bland-Altman Agreement Analysis (Bias)	Derived from predicate device performance and clinical literature on inter-reader agreement of manual segmentation. (Specific numerical criteria not explicitly stated in the document, but is implied to be met successfully based on the conclusion).	-6.47 AU
Bland-Altman Agreement Analysis (Lower Limit of Agreement)	Derived from predicate device performance and clinical literature on inter-reader agreement of manual segmentation. (Specific numerical criteria not explicitly stated in the document, but is implied to be met successfully based on the conclusion).	-399.57 AU
Bland-Altman Agreement Analysis (Upper Limit of Agreement)	Derived from predicate device performance and clinical literature on inter-reader agreement of manual segmentation. (Specific numerical criteria not explicitly stated in the document, but is implied to be met successfully based on the conclusion).	386.64 AU
Correlation Coefficient	Derived from predicate device performance and clinical literature on inter-reader agreement of manual segmentation. (Specific numerical criteria not explicitly stated in the document, but is implied to be met successfully based on the conclusion).	Met successfully

Study Details

Sample Size used for the test set and the data provenance:
- Test Set Sample Size: Not explicitly stated as a number of cases, but referred to as "the pivotal dataset."
- Data Provenance: "curated from multiple sites across three geographical regions in the United States." (Retrospective study).
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- The document states "agreement of the device output compared to the established reference standard." It does not explicitly state the number of experts used or their qualifications for establishing this "established reference standard." It only refers to "clinical literature in high impact journals that investigate the inter-reader agreement of manual segmentation" as informing the acceptance criteria.
Adjudication method for the test set:
- The document does not explicitly state an adjudication method (e.g., 2+1, 3+1) for establishing the ground truth of the test set. It refers to an "established reference standard."
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No, a multi-reader multi-case (MRMC) comparative effectiveness study comparing human readers with AI assistance versus human readers without AI assistance was not conducted or reported in this document. The study was a "stand-alone retrospective study for detection, localization and agreement of the device output compared to the established reference standard."
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Yes, a standalone study was performed. The document explicitly states: "The Bunkerhill MAC performance was validated in a stand-alone retrospective study for detection, localization and agreement of the device output compared to the established reference standard."
The type of ground truth used:
- The ground truth was an "established reference standard" which was used for comparison against the device's output. The document implies this reference standard is based on non-gated CT reference measurements and potentially "manual segmentation" informed by clinical literature. It does not explicitly state pathology confirmation or direct outcomes data as the primary ground truth.
The sample size for the training set:
- The sample size for the training set is not provided in the document.
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. It only refers to the performance validation on a "pivotal dataset" (test set).

Summary

FDA 510(k) Clearance Letter - Bunkerhill MAC

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

Doc ID # 04017.08.00

October 3, 2025

BunkerHill Health
℅ John Smith
Partner
Hogan Lovells LLP
555 Thirteenth Street, NW
WASHINGTON, DC 20004

Re: K250662
Trade/Device Name: Bunkerhill MAC
Regulation Number: 21 CFR 892.1750
Regulation Name: Computed tomography x-ray system
Regulatory Class: Class II
Product Code: JAK
Dated: February 18, 2025
Received: September 2, 2025

Dear John Smith:

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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K250662 - John Smith Page 2

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 (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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K250662 - John Smith Page 3

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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FORM FDA 3881 (6/20) Page 1 of 1

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120
Expiration Date: 06/30/2023
See PRA Statement below.

510(k) Number (if known): K250662

Device Name: Bunkerhill MAC

Indications for Use (Describe)

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.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

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"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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510(K) SUMMARY

Bunkerhilll MAC

K250662

BunkerHill Health Inc.
436 Bryant Street
San Francisco CA 94107
Phone: (516) 305-3956
Contact Person: Eren Alkan
Date Prepared: September 29, 2025

Proposed Device

Proprietary Name	Bunkerhill MAC
Classification Name	Computed tomography x-ray system
Regulation Number	21 CFR 892.1750
Product Code	JAK
Regulatory Class	II

Primary Predicate Device

Proprietary Name	Bunkerhill AVC
Premarket Notification	K243229
Classification Name	Computed tomography x-ray system
Regulation Number	21 CFR 892.1750
Product Code	JAK
Regulatory Class	II

Secondary Predicate Device

Proprietary Name	iCAC Device
Premarket Notification	K230223
Classification Name	Computed tomography x-ray system
Regulation Number	21 CFR 892.1750
Product Code	JAK
Regulatory Class	II

Device Description

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Detection of mitral annulus calcification at an Agatston-equivalent score threshold of 0 AU.
Quantification of the overall mitral annulus calcification burden in the form of an estimated Agatston Score up to 5000 Agatston-equivalent units
Localization of estimated calcium burden in the form of circular region of interest applied to a copy of the original CT scan.

Intended Use / Indications for Use

Note: The only difference in intended use between subject and primary predicate device is that while predicate device is used in aortic valve calcification, subject device is used to estimate calcification of the mitral annulus. The only difference in intended use between subject and secondary predicate device is that while predicate device is used in coronary artery calcification, subject device is used to estimate calcification in mitral annulus. Given the identical principles of operation and technological characteristics, the differences in anatomical area do not raise any new questions of safety and effectiveness. Both subject and predicate devices assist the medical professionals in detecting presence and location of calcifications. Both subject and predicate devices are to aid medical professionals in viewing and analyzing cardiac computed tomography (CT) data to determine presence and extent of calcification.

Proposed Device:	Predicate Device:	Predicate Device:
Bunkerhill MAC	Bunkerhill AVC (K243229)	iCAC (K230223)
Intended use / Indications for use	Bunkerhill MAC is a software device intended for use in detecting presence and estimating quantity of mitral annulus calcification for adult patients aged 40 years and above. The device automatically analyzes non-gated, non-	Bunkerhill AVC is a software device intended for use in detecting presence and estimating quantity of aortic valve calcification for adult patients aged 40 years and above. The device automatically analyzes non-

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Proposed Device:	Predicate Device:	Predicate Device:
Bunkerhill MAC	Bunkerhill AVC (K243229)	iCAC (K230223)
contrast chest computed tomography (CT) images collected during clinical care and outputs the region of interest (intended for informational purposes only) and quantification of detected calcium. The device-generated quantification can be viewed in the patient report at the discretion of the physician, and the physician also has the option of viewing the device-generated calcium region of interest in a diagnostic image viewer. The subject device output in no way replaces the original patient report or the original non-gated, non-contrast CT scan; both are still available to be viewed and used at the discretion of the physician. The device is intended to provide information to the physician to provide assistance during review of the patient's case. Results of the subject device are not intended to be used on a stand-alone basis and are solely intended to aid and provide information to the physician. In all cases, further action taken on a patient should only come at the recommendation of the	gated, non- contrast chest computed tomography (CT) images collected during clinical care and outputs the region of interest (intended for informational purposes only) and quantification of detected calcium. The output of the subject device is made available to the physician on-demand as part of his or her standard workflow. The device-generated quantification can be viewed in the patient report at the discretion of the physician, and the physician also has the option of viewing the device-generated calcium region of interest in a diagnostic image viewer. The subject device output in no way replaces the original patient report or the original non-gated, non-contrast CT scan; both are still available to be viewed and used at the discretion of the physician. The device is intended to provide information to the physician to provide assistance during review of the patient's case. Results of the subject device are not intended to be used on a stand- alone basis and are solely intended to aid and provide information to the physician. In all cases, further action taken on a patient should	automatically analyzes non- gated, non-contrast chest computed tomography (CT) images collected during routine care and outputs a visual representation of estimated coronary artery calcium segmentation (intended for informational purposes only) and both exact and four-category quantitative estimates of the patient's coronary artery calcium burden in Agatston units. The output of the subject device is made available to the physician on-demand as part of his or her standard workflow. The device generated calcium score or score group can be viewed in the patient report at the discretion of the physician, and the physician also has the option of viewing the device- generated calcium segmentation in a diagnostic image viewer. The subject device output in no way replaces the original patient report or the original chest CT scan; both are still available to be viewed and used at the discretion of the physician.

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Proposed Device:	Predicate Device:	Predicate Device:
Bunkerhill MAC	Bunkerhill AVC (K243229)	iCAC (K230223)
physician after further reviewing the patient's results.	only come at the recommendation of the physician after further reviewing the patient's results.	The device is intended to provide information to the physician to provide assistance during review of the patient's case. Results of the subject device are not intended to be used on a stand-alone basis and are solely intended to aid and provide information to the physician. In all cases, further action taken on a patient should only come at the recommendation of the physician after further reviewing the patient's results.

Summary of Technological Characteristics

Both the predicate(s) and the subject device use deep-learning algorithms to identify the presence of calcification and estimate calcification.
Both devices analyze non-gated chest computed tomography (CT) images that are sent to the software in DICOM format.
Both the predicate and the subject device quantify the calcification by generating a metric (an estimated score). These metrics are both based on the Agatston-equivalent score.
Both devices serve as support tools to provide information to the physician. Both can be used on-demand or optionally by the physician and do not provide a definitive diagnosis. Both devices do not replace clinical evaluation and do not alter the standard of care. Both require the physician to use this information to decide next steps and/or additional diagnostic work up.
Both devices provide a visual representation of the region of the detected calcification for better explainability and for the physician to confirm the device output.

The following technological difference exists between the subject and predicate devices:

There are no technological differences between subject device and primary predicate device(s). The primary predicate device outputs an estimated Agatston-equivalent Score, visual output for reporting the aortic valve calcium score, whereas the subject device outputs an estimated Agatston-equivalent Score, visual output for reporting the mitral annulus calcium score. The only difference between the two devices lies in their anatomical focus. The technology behind both the AI algorithms is well-established and there

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are no new types of risks involved since the underlying mechanism for detecting and quantifying calcium does not differ between the aortic valve and the mitral valve.

A minor difference between subject device and secondary predicate device in the information-only device output is that while the predicate device displays estimated calcium segmentation, the subject device shows a visual output in the form of a Region of Interest (ROI). The rationale behind this was to ensure that the interpreting physician is able to visualize the underlying calcification. The user has the option to delete the visual outputs if they do not agree with the results in both the subject and predicate device.

Proposed Device:	Predicate Device:	Predicate Device:	Summary
Bunkerhill MAC	Bunkerhill AVC (K243229)	iCAC (K230223)
Product code	JAK	JAK	JAK
Regulation number	21 CFR §892.1750	21 CFR §892.1750	21 CFR §892.1750
Modality	Computed tomography (CT)	Computed tomography (CT)	Computed tomography (CT)
Image format	DICOM	DICOM	DICOM
Contrast	Non-contrast	Non-contrast	Non-contrast
Supported CT scan	Non-cardiac-gated CT scan	Non-cardiac-gated CT scan	Non-cardiac-gated CT scan
Slice thickness	Up to 5 mm	Up to 5 mm	Up to 5 mm
Calcification detection	Automatic	Automatic	Automatic
Main image quality	DICOM	DICOM	DICOM
Annotation of detected calcium	Yes	Yes	Yes
Visual Output format	Visual output in the form a Region of Interest or ROI (intended for informational purposes only). The estimated visual output can be viewed by the physician in a diagnostic image viewer. The physician's standard method for viewing unaltered chest CT scans in PACS will remain available to them even if the subject device is being used. However, the physician will also have an option to view the visual output estimated	Visual output in the form a Region of Interest or ROI (intended for informational purposes only). The estimated visual output can be viewed by the physician in a diagnostic image viewer. The physician's standard method for viewing unaltered chest CT scans in PACS will remain available to them even if the subject device is being used. However, the physician will also have an option to view the visual output estimated by the subject device as a	Outputs a visual representation of estimated coronary artery calcium segmentation (intended for informational purposes only). The estimated calcium segmentation can be viewed by the physician in a diagnostic image viewer. The physician's standard method for viewing unaltered chest CT scans in PACS will remain available to them even if the subject device is

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Proposed Device:	Predicate Device:	Predicate Device:	Summary
Bunkerhill MAC	Bunkerhill AVC (K243229)	iCAC (K230223)
by the subject device as a separate series within PACS.	separate series within PACS.	being used. However, the physician will also have an option to view the calcium segmentation estimated by the subject device as a separate series within PACS.
Generate patient report	Optional to copy result to clipboard, insert in report, DICOM Secondary Capture	Optional to copy result to clipboard, insert in report, DICOM Secondary Capture	Optional to copy result to clipboard, insert in report, DICOM Secondary Capture
Report of the calcium score	Yes, estimated exact Agatston-equivalent score and binary output (presence/absence)	Yes, estimated exact Agatston-equivalent score and binary output (presence/absence)	Yes, Coronary Calcium Detection Category and exact Agatston score 4 detection categories
Type of Interpretation	Adjunctive information	Adjunctive information	Adjunctive information
Intended User	Qualified medical professionals such as cardiologists or radiologists	Qualified medical professionals such as cardiologists or radiologists	Interpreting physicians
Patient population	Patients aged 40 years and above	Patients above the age of 40	Patients above the age of 30
Anatomical location	Chest (mitral annulus)	Chest (aortic valve)	Chest
Intended location	Medical facility	Medical facility	Medical facility
Rx or OTC	Rx	Rx	Rx
Measurement scale	Agatston-equivalent units	Agatston-equivalent units	Agatston units

Performance Data

Safety and performance of Bunkerhill MAC has been evaluated and verified in accordance with software specifications and applicable performance standards through Software Development and Validation & Verification Process to ensure performance according to specifications, User Requirements and Federal Regulations and Guidance documents, "Content of Premarket Submissions for Device Software Functions".

The Bunkerhill MAC performance was validated in a stand-alone retrospective study for detection, localization and agreement of the device output compared to the established reference standard. The pivotal dataset was curated from multiple sites across three geographical regions in the United States. The co-primary endpoints of Positive Agreement Rate, Negative Agreement Rate, Precision and Recall of the circular ROI, Bland Altman agreement analysis and correlation coefficient were met successfully. The

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acceptance criteria were derived from the performance of the predicate device and clinical literature in high impact journals that investigate the inter-reader agreement of manual segmentation. The observed bias in the pivotal study was –6.47 AU and lower and upper limits agreements were –399.57 AU and 386.64 AU, respectively. As result, Bunkerhill MAC met the mean difference and limits of agreement acceptance criteria, thus satisfying all the endpoints of the pivotal testing study. The low mean difference demonstrates that Bunkerhill MAC has a bias of low magnitude. The observed Precision was 0.885 (0.848, 0.919) and the observed Recall was 0.867 (0.834, 0.895). As a result, Bunkerhill MAC met all study acceptance criteria.

The testing demonstrates that the device is substantially equivalent to the predicate as required by 21 CFR 807.92(b)(3) since both the predicate and subject device demonstrated that with the cited mean difference and limits of agreement, the primary endpoint for calcium score was met.

Please note performance metrics represent agreement between the device and non-gated CT reference measurements. Non-gated CT may be subject to motion artifacts and scoring variability. Clinical interpretation should account for these methodological considerations.

Conclusions

Bunkerhill MAC is substantially equivalent to the primary predicate Bunkerhill AVC (K243229) and secondary predicate iCAC Device (K230223). The subject device has the same intended uses and similar indications, technological characteristics, and principles of operation as its predicate devices. The minor differences in indications do not alter the intended diagnostic use of the device and do not affect its safety and effectiveness when used as labeled. In summary, any minor differences between Bunkerhill MAC and the predicate devices do not raise any issues of safety or effectiveness.

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.