The Automated Bone Mineral Density Software Module (ABMD) is a post-processing AI-powered software intended to measure bone mineral density (BMD) from existing CT scans by averaging Hounsfield units in the trabecular region of vertebral bones. ABMD is not intended to replace DXA or any other tests dedicated to BMD measurement. It is solely designed for measuring BMD in existing CT scans ordered for reasons other than BMD measurement. In summary, ABMD 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.

Device Description

The Automated Bone Mineral Density (ABMD) Software is a software module that estimates bone mineral density in the vertebral bones by averaging Hounsfield Units (HU) in the trabecular area. ABMD Software is a post-processing software that works on existing CT scans. ABMD Software measurements are to be reviewed by radiologists and should be used by healthcare providers in conjunction with clinical evaluation.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the ABMD Software based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Correlation with Manual QCT-based BMD Measurement	Strong correlation reported (`t = 0.97, p<0.01`).
Correlation with DXA BMD Measurement	Significant correlation reported (`r = 0.72, p<0.01`). This closely matched correlations reported in literature between DXA and manual QCT (`r=0.5` to `r=0.75`).
Sample Volume Placement (relative to cortical bone)	Software passes if the sample volume is at least 1 pixel away from the cortical border.
Functional Requirements and Performance Specifications	All functional requirements and performance specifications were met.
Agreement with Manual QCT-based BMD Measurement	Strong agreement reported.
Agreement with DXA BMD Measurement	Modest but significant agreement reported.

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

Study 1 (Reference Dataset):
- Sample Size: 993 cases.
- Data Provenance: Not explicitly stated, but indicated as a "cohort of asymptomatic cases who underwent CT scans." The geographical origin (country) is not specified. It is retrospective as it uses "existing CT scans."
Study 2:
- Sample Size: 172 asymptomatic cases.
- Data Provenance: Not explicitly stated, but indicated as cases who underwent "whole-body DXA scans as well as CT scans." The geographical origin (country) is not specified. It is retrospective as it uses "existing CT scans."

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 in terms of a specific count. However, the ground truth was established by "trained operators."
Qualifications of Experts: Described as "trained operators" for both manual QCT measurements and DXA scan derivations. Specific qualifications like "radiologist with 10 years of experience" are not provided.

4. Adjudication Method for the Test Set

The document does not specify an adjudication method (e.g., 2+1, 3+1, none) for the test set's ground truth. It states that "QCT BMD, T-score, and Z-score values derived from manual measurement by trained operators" were used for ground truthing. This implies a single measurement by a "trained operator" formed the ground truth for QCT, and DXA values were also used, presumably from standard reports.

5. 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 was not explicitly described in the provided text. The studies focused on comparing the ABMD software to manual QCT measurements and DXA measurements, not on how human readers perform with or without AI assistance.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done

Yes, standalone performance was assessed. The studies directly compare the ABMD Software's measurements (which are algorithm-driven) to established ground truth methods (manual QCT and DXA). The text states, "The ABMD Software strongly correlated with manual QCT-based BMD measurement" and "The ABMD Software also correlated with DXA BMD measurement." This indicates the algorithm's performance independent of human-in-the-loop interaction for the measurement itself, though the results are intended for review by radiologists.

7. The Type of Ground Truth Used

Study 1:
- Type: Expert consensus (implicitly, from "trained operators") for QCT BMD, T-score, and Z-score values derived from manual measurements.
Study 2:
- Type: Combined expert consensus (implicitly, from "trained operators") for QCT BMD, T-score, and Z-score values derived from manual measurements, and clinical outcomes/measurements from DXA scans (DXA T-score and Z-score values).

8. The Sample Size for the Training Set

The document does not explicitly state the sample size for the training set. It mentions the ABMD Software uses "an AI trained model," but the details of the training data are not provided in this summary.

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

The document does not explicitly state how the ground truth for the training set was established. It only mentions the ground truthing process for the test/reference datasets.

Summary

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July 29, 2022

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HeartLung Corporation % Lauren Lee Regulatory Consultant 1124 W Carson St TORRANCE CA 90502

Re: K213760

Trade/Device Name: ABMD Software Regulation Number: 21 CFR 892.1170 Regulation Name: Bone Densitometer Regulatory Class: Class II Product Code: KGI Dated: June 22, 2022 Received: June 29, 2022

Dear Lauren Lee:

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 (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 located 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.

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 803) for

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

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

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

Laurel Burk Assistant Director DHT8B: Division of Imaging Devices and Electronic Products OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K213760

Device Name ABMD Software

Indications for Use (Describe)

X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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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 1124 W Carson St. The Lundquist Institute, MRL Building, Floor 3 Torrance, CA 90502 Tel: (650) 448-8089 Contact: Dr. Morteza Naghavi Date Prepared: November 24, 2021

2. Device

Subject Device: Automated Bone Mineral Density Software Trade Name: ABMD Software Common Name: ABMD Software Classification: Class II, 21 CFR 892.1170 Product Code: KGI

3. Predicate Device

Manufacturer: Mindways Trade Name: QCT Bone Mineral Density Analysis Software Predicate 510(k): K894854 Classification: Class II, 21 CFR 892.1170 Product Code: KGI

4. Reference Device

Manufacturer: Mindways Trade Name: QCT Pro Asynchronous Calibration Module, CliniQCT Predicate 510(k): K140342 Classification: Class II, 21 CFR 892.1170 Product Code: KGI

5. Device Description

General Description

The Automated Bone Mineral Density (ABMD) Software is a software module that estimates bone mineral density in the vertebral bones by averaging Hounsfield Units (HU) in the trabecular

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area. ABMD Software is a post-processing software that works on existing CT scans. ABMD Software measurements are to be reviewed by radiologists and should be used by healthcare providers in conjunction with clinical evaluation.

Intended Patient Population

ABMD Software is for post-processing analysis of bone mineral density in people who underwent a CT scan that includes vertebral bone.

Principles of Ops

ABMD Software reads a CT scan (in DICOM format) and extracts patient-specific metadata such as age, gender, and scan specific information like acquisition time, pixel size and scanner type. The ABMD Software uses an AI trained model to segment out vertebral bones in the field of view and subsequently measures the average of the Hounsfield unit, HU, in a cylinder volume within the trabecular tissue of each vertebral bone without including the cortical bone. The bone mineral density (BMD) is calculated by the mean of those averages for vertebral bones found in the field of view. Subsequently, the Z-score and T-scores are calculated based on the age and gender of the person and the calibration factor for the CT scan. The snapshots of the spinal bones and measured area along with the average HU and the scores are exported for review and confirmation by a human expert.

Software will output the segmentation of trabecular bone used in calculation of BMD as determined by the sample volume being a minimum of 1 pixel away from the cortical bone.

Software passes if the sample volume is at least 1 pixel away from the cortical border.

Software fails if the sample volume crosses or intersects with the cortical border.

The end user cannot change or edit the segmentation or results of the device. The end user must accept or reject the region where the BMD measurement is done. If rejected, the end user must conduct an alternate method such as manual measurement using the same methods described in QCT-based manual measurement of BMD.

This device is not intended to replace DXA scanners. It is only intended to be used on the existing CT scans or CT scans ordered for reasons other than measuring BMD so that it will prevent extra radiation dose being introduced to the patients.

Conditions of Use:

The ABMD Software is a post-processing software module that only works on existing CT scans that include spinal bones.

6. Intended Use

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K213760 HeartLung Corporation 1124 W Carson St The Lundquist Institute, MRL Building, Floor 3 Torrance, CA 90502

The Automated Bone Mineral Density (ABMD) Software is a post-processing AI-powered software intended to measure bone mineral density (BMD) from existing CT scans by averaging Hounsfield units in the trabecular region of vertebral bones. ABMD Software is not intended to replace DXA or any other tests dedicated to BMD measurement. It is solely designed for measuring BMD in existing CT scans or CT scans ordered for reasons other than BMD measurement. In summary, ABMD Software 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.

Comparison of Technological Characteristics & Intended Use to Predicate Device The table below provides a summary of the technological characteristics of the ABMD Software in comparison to the predicate device. The indications for use for the predicate device are similar to the indications for the use of the ABMD Software. There are no major technological differences between the two systems that raise new issues of safety and/or effectiveness. Thus, the ABMD Software is substantially equivalent to the predicate device.

Feature	Subject DeviceABMD Software	PredicateDeviceQCT BoneMineral DensityAnalysisSoftwareK894854	ReferenceDeviceQCT ProAsynchronousCalibrationModule,CliniQCTK140342	Summary
Indication forUse/IntendedUse	Estimate bonemineral densitywithin the spine.	Estimate bonemineral densitywithin the spine.	Estimate bonemineral densitywithin the spine.	Equivalent.
Modality	CT scan images(DICOM)	CT scan images(DICOM)	CT scan images(DICOM)	Equivalent.
Device providesestimates of	Yes	Yes	Yes	Equivalent.
bone mineraldensity from thespine.
Device providesthe bone mineraldensity value.	Yes	Yes	Yes	Equivalent.
Device providesZ-score.	Yes	Yes	Yes	Equivalent.
Device providesT-score.	Yes	Yes	Yes	Equivalent.
User	HealthcareProviders	HealthcareProviders	HealthcareProviders	Equivalent.
OperatingSystem	Linux	Windows	Windows	Equivalent,softwarefunction isindependentfromoperatingsystem.
Retrospectivemeasurementsfrom CT scans.	CT scan imagescan be selected andinputted to thesoftware.	CT scan imagescan be selectedand inputted tothe software.	CT scan imagescan be selectedand inputted tothe software.	Equivalent.
AutomaticAveragingHounsfieldUnits	Softwareautomaticallymeasures andaveragesHounsfield units inthe trabecular	Softwareautomaticallymeasures andaveragesHounsfield unitsin the trabecular	Softwareautomaticallymeasures andaveragesHounsfield unitsin the trabecular	Equivalent.
	region of spinalbones.	region of spinalbones.	region of spinalbones.
Calibration	Inputting CTscanner-specificcalibration factor isrequired. Softwareoutputs calibratedBMD score.	Simultaneousscanning ofcalibrationphantom isrequired.Software outputscalibrated BMDscore.	Asynchronousscanning ofcalibrationphantom isrequired.Software outputscalibrated BMDscore.	Equivalent.Softwareprovidesmeasurementscorrected forcalibrationdata.

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8. 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 the ABMD Software meets all its functional requirements and performance specifications.

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The ABMD Software strongly correlated with manual QCT-based BMD measurement. The scatter plot and regression lines show the range of bias to be limited and display a very strong correlation between BMD measured by manual method versus ABMD Software (t = 0.97, p<0.01). The ABMD Software also correlated with DXA BMD measurement (r = 0. 72, p<0.01). A summary of two studies performed is listed below.

	Study 1	Study 2
ReferenceDataset	993 quantitative CT (QCT) readings of acohort of asymptomatic cases whounderwent CT scans.	172 asymptomatic cases who underwentwhole-body DXA scans as well as CTscans.
Truthing Process	QCT BMD, T-score, and Z-score valuesderived from manual measurement bytrained operators.	DXA scans derived T-score, and Z-scorevalues plus QCT BMD, T-score, and Z-score values derived from manualmeasurement by trained operators.
Analysis methods	Pearson Correlation, DemingRegressions, and Bland AltmanAgreement	Pearson Correlation, DemingRegressions, and Bland AltmanAgreement
Results	Strong correlations and agreements werefound between manual QCT and ABMDSoftware	Strong correlations and agreements werefound between manual QCT and ABMDSoftware. Modest but significantcorrelations and agreement were foundbetween DXA, and ABMD Software.

ABMD Software Performance Studies

Significant correlations between BMD measurements by DXA and ABMD Software were found (r = 0.72 , p<0.01) which closely matched the correlations reported in literature between DXA and manual QCT (r=0.5 to r=0.75) measurements. While DXA BMD measurements at Ward Triangle correlate well with QCT BMD measurement in vertebral bones, the QCT measurement is exclusively focused on the trabecular bone tissue, as compared to DXA's combined measurement of cortical and trabecular bone tissues. Therefore, QCT based BMD measurement using ABMD Software is more specific to trabecular bone tissues and does not impose any additional safety or effectiveness concerns when compared to the predicate device.

Mechanical and Acoustic Testing

Not applicable for this software as a medical device.

Animal Study

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

Clinical Studies

Clinical testing was not required to demonstrate the safety and effectiveness of the device. Instead, substantial equivalence is based upon software verification and validation testing, or benchtop performance testing of the software as a medical device.

9. Conclusions

The body of testing summarized above indicates that the ABMD Software performs as intended and is substantially equivalent to the predicate device. The testing above demonstrates that the ABMD Software is as safe and effective as the predicate device. No new safety or effectiveness issues are raised by the ABMD Software.

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Regulation Number and Section

§ 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.