(249 days)
Not Found
Yes.
The "Intended Use" section explicitly states "AI-powered software," and the "Device Description" mentions "deep-learning-based computer vision and post-processing algorithms," which are types of AI models. It also mentions "deep-learning algorithms" directly.
No
The device is described as an AI-powered software intended to assess bone mineral density and output a flag for low bone density. It is used for assessment and identification, not for treating or rehabilitating a condition.
Yes
The device assesses estimated bone mineral density and outputs a flag for low bone density, which is a key step in diagnosing bone-related conditions. While it is not intended to replace primary diagnostic tests, it provides information to assist clinicians in identifying "findings of interest," indicating a diagnostic support role.
Yes
The device explicitly states in its "Device Description" that "The Bunkerhill BMD application is a software only medical device (SaMD)". It processes existing CT images and does not include any hardware components.
No.
This device analyzes existing CT scans (medical images), rather than testing biological samples or specimens.
No
The provided text does not contain any explicit statement that the FDA has reviewed and approved or cleared a Predetermined Change Control Plan (PCCP) for this specific device.
Intended Use / Indications for Use
The Bunkerhill BMD Algorithm is a post-processing AI-powered software intended for adults 30 years and above to assess estimated DXA-measured average areal bone mineral density of spinal bones from existing CT scans and outputs a flag for low bone density below a pre-specified threshold. It is not intended to replace DXA or any other tests dedicated to BMD measurement.
Bunkerhill BMD is an opportunistic AI-powered tool that enables:(1) retrospective assessment of bone density from CT scans acquired for other purposes, (2) assessment of bone density in conjunction with another medically appropriate procedure involving CT scans, and (3) assessment of bone density without a phantom as an independent measurement procedure
Product codes
KGI
Device Description
The Bunkerhill BMD application is a software only medical device (SaMD) that includes deep- learning-based computer vision and post-processing algorithms that estimates the bone mineral density from previously obtained computed tomography (CT) images.
The results from Bunkerhill BMD are not intended to be used as the primary input for clinical decision making, but rather are intended to provide information that may assist the clinician to identify 'findings of interest' within existing imaging studies.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Yes
Input Imaging Modality
Computed tomography (CT)
Anatomical Site
Spinal bones
Indicated Patient Age Range
Adults 30 years and above
Intended User / Care Setting
Healthcare provider
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
The pivotal testing dataset consisted of 371 CT studies from four (4) geographically diverse sites.
Summary of Performance Studies
Bunkerhill BMD performance was validated in a stand-alone retrospective study for overall agreement of the device output compared to the established ground truth. The pivotal testing dataset consisted of 371 CT studies from four (4) geographically diverse sites. The Bunkerhill BMD algorithm achieved a sensitivity of 81.0 (74.0 - 86.8) and specificity of 78.4 (72.3 - 83.7), which passed the acceptance criteria for the primary endpoint with lower bound 95% confidence interval of both Sensitivity and Specificity being greater than 70%. Additionally, the device achieved was evaluated across multiple secondary metrics, including a Pearson correlation coefficient of 0.791 (95% CI: 0.752–0.830), AUROC of 0.883 (95% CI: 0.849–0.916), PPV of 73.6% (95% CI: 66.4%–79.9%), and NPV of 84.8% (95% CI: 79.0%–89.5%), further supporting the robustness and reliability of the algorithm.
Generalizability of the device performance was evaluated through subgroup analyses across key variables including patient age, sex, CT manufacturer, slice thickness, reconstruction kernel, and data collection site. The device demonstrated consistent sensitivity and specificity across all subgroups, with no statistically significant performance differences observed. These results support the generalizability of the device across the intended use population.
Key Metrics
Sensitivity of 81.0 (74.0 - 86.8), specificity of 78.4 (72.3 - 83.7), Pearson correlation coefficient of 0.791 (95% CI: 0.752–0.830), AUROC of 0.883 (95% CI: 0.849–0.916), PPV of 73.6% (95% CI: 66.4%–79.9%), and NPV of 84.8% (95% CI: 79.0%–89.5%).
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.1170 Bone densitometer.
(a)
Identification. A bone densitometer is a device intended for medical purposes to measure bone density and mineral content by x-ray or gamma ray transmission measurements through the bone and adjacent tissues. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.
FDA 510(k) Clearance Letter - BunkerHill BMD
Page 1
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
Doc ID # 04017.07.05
April 8, 2025
BunkerHill Health
℅ Eren Alkan
Director of AI Algorithms
436 Bryant Street
SAN FRANCISCO, CA 94107
Re: K242295
Trade/Device Name: BunkerHill BMD
Regulation Number: 21 CFR 892.1170
Regulation Name: Bone densitometer
Regulatory Class: Class II
Product Code: KGI
Dated: March 10, 2025
Received: March 11, 2025
Dear Eren Alkan:
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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K242295 - Eren Alkan
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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K242295 - Eren Alkan
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 Radiological Imaging Devices and Electronic Products
OHT8: Office of Radiological Health
Office of Product Evaluation and Quality
Center for Devices and Radiological Health
Enclosure
Page 4
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Form Approved: OMB No. 0910-0120
Expiration Date: 07/31/2026
See PRA Statement below.
Indications for Use
Submission Number (if known)
K242295
Device Name
Bunkerhill BMD
Indications for Use (Describe)
The Bunkerhill BMD Algorithm is a post-processing AI-powered software intended for adults 30 years and above to assess estimated DXA-measured average areal bone mineral density of spinal bones from existing CT scans and outputs a flag for low bone density below a pre-specified threshold. It is not intended to replace DXA or any other tests dedicated to BMD measurement.
Bunkerhill BMD is an opportunistic AI-powered tool that enables:(1) retrospective assessment of bone density from CT scans acquired for other purposes, (2) assessment of bone density in conjunction with another medically appropriate procedure involving CT scans, and (3) assessment of bone density without a phantom as an independent measurement procedure
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."
Page 5
Bunkerhill, Inc. Traditional 510(k)-- BMD Device
510(K) SUMMARY
[BUNKERHILL BMD]
Bunkerhill, Inc.
436 Bryant Street
San Francisco CA 94107
Ph: 650-8420198
Prepared By: Eren Alkan
Date Prepared: April 3, 2025
Proposed Device
| Proprietary Name | Bunkerhill BMD |
|---|---|
| Classification Name | Bone Densitometer |
| Regulation Number | 21 CFR 892.1170 |
| Product Code | KGI |
| Regulatory Class | II |
Predicate Device
| Proprietary Name | ABMD software |
|---|---|
| Premarket Notification | K213760 |
| Classification Name | Bone Densitometer |
| Regulation Number | 21 CFR 892.1170 |
| Product Code | KGI |
| Regulatory Class | II |
Device Description
The Bunkerhill BMD application is a software only medical device (SaMD) that includes deep- learning-based computer vision and post-processing algorithms that estimates the bone mineral density from previously obtained computed tomography (CT) images.
The results from Bunkerhill BMD are not intended to be used as the primary input for clinical decision making, but rather are intended to provide information that may assist the clinician to identify 'findings of interest' within existing imaging studies.
Page 6
Bunkerhill, Inc. Traditional 510(k)-- BMD Device
Intended Use / Indications for Use
The Bunkerhill BMD Algorithm is a post-processing AI-powered software intended for adults 30 years and above to assess estimated DXA-measured average areal bone mineral density of spinal bones from existing CT scans and outputs a flag for low bone density below a pre- specified threshold. It is not intended to replace DXA or any other tests dedicated to BMD measurement.
Bunkerhill BMD is an opportunistic AI-powered tool that enables:(1) retrospective assessment of bone density from CT scans acquired for other purposes, (2) assessment of bone density in conjunction with another medically appropriate procedure involving CT scans, and (3) assessment of bone density without a phantom as an independent measurement procedure
Summary of Technological Characteristics
At a high level, the subject and predicate devices are based on the following same technological elements:
- Both the predicate and the subject device use deep-learning algorithms to estimate the average bone mineral density in spinal bones.
- Both devices analyze computed tomography (CT) images that are sent to the software in DICOM format.
- Both devices serve as support tools to provide information to the physician. However, they do not replace clinical evaluation and do not alter the standard of care.
- Both devices provide and generate a report.
There are no technological differences between the subject and predicate device.
A table comparing the key features of the subject and predicate devices is provided below.
| Proposed Device: Bunkerhill BMD | Predicate Device: ABMD SW(K213760) | Summary | |
|---|---|---|---|
| Product code | KGI | KGI | Same |
| Regulation number | 21 CFR §892.1170 | 21 CFR §892.1170 | Same |
| Modality | Computed tomography (CT) | Computed tomography (CT) | Same |
| Image format | DICOM | DICOM | Same |
Page 7
Bunkerhill, Inc. Traditional 510(k)-- BMD Device
| Proposed Device: Bunkerhill BMD | Predicate Device: ABMD SW(K213760) | Summary | |
|---|---|---|---|
| Device provides estimates of bone mineral density, T- scores and Z-scores | Yes | Yes | Similar, subject device provides a subset of predicate device outputs i.e. only T- score group. |
| User | Healthcare provider | Healthcare Provider | Same |
| Proposed Device: Bunkerhill BMD | Predicate Device: ABMD SW(K213760) | Summary | |
|---|---|---|---|
| Retrospective measurements from CT scans | CT scan images can be selected and inputted to the software | CT scan images can be selected and inputted to the software. | Same |
| Automatic averaging Hounsfield Units | Software automatically measures and averages Hounsfield units in the regions of interest of spinal bones. | Software automatically measures and averages Hounsfield units in the trabecular region of the spinal bones. | Same |
| Main image quality | DICOM | DICOM | Same |
| Calibration | Software outputs calibrated BMD score. | Software outputs calibrated BMD score. | Same |
| 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 | Same |
| Proposed Device: Bunkerhill BMD | Predicate Device: ABMD SW(K213760) | Summary | |
|---|---|---|---|
| Device provides estimates of bone mineral density, T- scores and Z-scores | Yes | Yes | Similar, subject device provides a subset of predicate device outputs i.e. only T- score group. |
| User | Healthcare provider | Healthcare Provider | Same |
| Proposed Device: Bunkerhill BMD | Predicate Device: ABMD SW(K213760) | Summary | |
|---|---|---|---|
| Retrospective measurements from CT scans | CT scan images can be selected and inputted to the software | CT scan images can be selected and inputted to the software. | Same |
| Automatic averaging Hounsfield Units | Software automatically measures and averages Hounsfield units in the regions of interest of spinal bones. | Software automatically measures and averages Hounsfield units in the trabecular region of the spinal bones. | Same |
| Main image quality | DICOM | DICOM | Same |
| Calibration | Software outputs calibrated BMD score. | Software outputs calibrated BMD score. | Same |
| 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 | Same |
Page 8
Bunkerhill, Inc. Traditional 510(k)-- BMD Device
Performance Data
Safety and performance of the Bunkerhill BMD 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, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" and Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions.
Bunkerhill BMD performance was validated in a stand-alone retrospective study for overall agreement of the device output compared to the established ground truth. The pivotal testing dataset consisted of 371 CT studies from four (4) geographically diverse sites. The Bunkerhill BMD algorithm achieved a sensitivity of 81.0 (74.0 - 86.8) and specificity of 78.4 (72.3 - 83.7), which passed the acceptance criteria for the primary endpoint with lower bound 95% confidence interval of both Sensitivity and Specificity being greater than 70%. Additionally, the device achieved was evaluated across multiple secondary metrics, including a Pearson correlation coefficient of 0.791 (95% CI: 0.752–0.830), AUROC of 0.883 (95% CI: 0.849–0.916), PPV of 73.6% (95% CI: 66.4%–79.9%), and NPV of 84.8% (95% CI: 79.0%–89.5%), further supporting the robustness and reliability of the algorithm.
Generalizability of the device performance was evaluated through subgroup analyses across key variables including patient age, sex, CT manufacturer, slice thickness, reconstruction kernel, and data collection site. The device demonstrated consistent sensitivity and specificity across all subgroups, with no statistically significant performance differences observed. These results support the generalizability of the device across the intended use population.
Conclusions
Bunkerhill BMD is as safe and effective as the predicate ABMD device (K213760). The BMD Device has the same intended uses and similar indications, technological characteristics, and principles of operation as its predicate device. 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 addition, the minor technological differences between the BMD Device and its predicate devices raise no new issues of safety or effectiveness.