Spectral Bone Marrow is an automated image processing software application, utilizing deep learning technology for bone segmentation, to facilitate optimized visualization of bone marrow in spectral body and extremity CT images. Spectral Bone Marrow's output can be used during the review of traumatic and non-traumatic bone pathologies.

Device Description

Spectral Bone Marrow is a deep-learning based software analysis package designed for the visualization of bone marrow based on GE HealthCare's spectral CT acquisitions data. Spectral Bone Marrow assists clinicians by providing an automatically generated fused material density image of the segmented bone region over a base monochromatic image optimized for the visualization of bone marrow during the review of traumatic or non-traumatic bone pathologies. The software creates a fully automated post processing workflow for creating these images and improving reader efficiency.

The Spectral Bone Marrow application involves generating a bone mask with a deep learning bone segmentation algorithm and uses this segmented region to define bone regions of water minus hydroxyapatite (Water(HAP)) material density images, which are subsequently colored. The application outputs the colored Water(HAP) material density images overlayed on monochromatic CT images or Virtual Unenhanced (VUE) images.

Additionally, the Spectral Bone Marrow application has the optional ability to automatically set the window width and window level of the color overlay images to provide for optimal visualization of bone marrow. The software provides multiplanar export of the fused images. Spectral Bone Marrow is hosted on GE's Edison Health Link (EHL) computational platform.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study details for the Spectral Bone Marrow device, based on the provided FDA 510(k) summary:

Acceptance Criteria and Device Performance

The provided document does not explicitly present a table of quantitative acceptance criteria for device performance. However, it states that the engineering bench testing showed that the algorithm is capable of accurately segmenting bones and is safe and effective for its intended use. Furthermore, the clinical assessment validated that the Spectral Bone Marrow software provides additional diagnostic value for the evaluation of bone marrow and increased overall reader efficiency.

This implies that the acceptance criteria revolved around demonstrating accurate bone segmentation, diagnostic value, and improved reader efficiency. The specific metrics and thresholds for "accuracy," "additional diagnostic value," and "increased efficiency" are not quantified in this summary.

Inferred Acceptance Criteria:

Criterion	Reported Device Performance
Bone Segmentation Accuracy	The engineering bench testing demonstrated that the algorithm is "capable of accurately segmenting bones."
Diagnostic Value	The clinical assessment "validated that the Spectral Bone Marrow software provides additional diagnostic value for the evaluation of bone marrow." The radiologists provided an assessment of "image quality related to diagnostic use according to a Likert scale."
Reader Efficiency Enhancement	The clinical assessment "validated...increased overall reader efficiency." Readers were asked to "rate their efficiency when using the algorithm compared to using without."
Safety and Effectiveness (Overall)	The engineering bench testing showed the algorithm is "safe and effective for its intended use." The submission concludes that the device is "substantially equivalent and hence as safe and as effective as the legally marketed predicate device." "GE's quality system's design, verification, and risk management processes did not identify any unexpected results, or adverse effects stemming from the changes to the predicate." The substantial equivalence is based on the software documentation for a "Moderate" level of concern.

Study Details

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

Test Set Sample Size: 146 retrospective Spectral CT series.
Data Provenance: Retrospective, with the country of origin not explicitly stated, but the mention of "US board certified radiologists" suggests the data could be from the US or at least interpreted by US experts.

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

Number of Experts: Three.
Qualifications: US board certified radiologists with expertise in both the evaluation of bone marrow and dual energy imaging review.

3. Adjudication Method for the Test Set

The document does not explicitly state a specific adjudication method like "2+1" or "3+1." It mentions that the ground truth for the 146 retrospective Spectral CT series was generated by three US board certified radiologists. This implies an expert consensus approach, but the specific decision-making process (e.g., majority vote, agreement by all three) is not detailed.

4. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Was an MRMC study done? Yes, a form of clinical assessment involving multiple readers was conducted. The clinical testing involved "three board certified radiologists" assessing a "representative set of clinical sample images" processed by the software. They evaluated "image quality related to diagnostic use according to a Likert scale" and rated "their efficiency when using the algorithm compared to using without." This setup resembles an MRMC study, focusing on reader performance with and without the AI.
Effect size of human readers improve with AI vs without AI assistance: The document states that the assessment validated that the Spectral Bone Marrow software provides additional diagnostic value for the evaluation of bone marrow and increased overall reader efficiency. However, it does not provide quantitative effect sizes (e.g., specific percentage improvement in diagnostic accuracy or time saved). It merely confirms an improvement was observed and validated.

5. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Yes, a standalone study (referred to as "engineering bench testing") was done to evaluate the bone segmentation algorithm itself. This testing used a database of 146 retrospective Spectral CT series. The "result of the engineering bench testing showed that the algorithm is capable of accurately segment bones and is safe and effective for its intended use."

6. Type of Ground Truth Used

Expert Consensus: The ground truth for the engineering bench testing (bone segmentation evaluation) was "generated by three US board certified radiologists."
Clinical Assessment by Experts: For the clinical evaluation of diagnostic value and reader efficiency, the "assessment used retrospectively collected clinical cases" and each image was "read by each board certified radiologist who provided an assessment of image quality related to diagnostic use according to a Likert scale." This also relies on expert interpretation and assessment as the ground truth for these subjective measures.

7. Sample Size for the Training Set

The document does not specify the sample size for the training set used to develop the deep learning bone segmentation algorithm. It only refers to the training of a "deep learning bone segmentation algorithm."

8. 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 that the bone segmentation algorithm uses deep learning technology. Typically, ground truth for training deep learning models involves manual annotation by experts, but this detail is not provided in the summary.

Summary

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March 9, 2023

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GE Medical Systems, LLC. % Katelyn Rowley Senior Regulatory Affairs Leader 3000 N. Grandview Blvd. WAUKESHA WI 53188

Re: K223514

Trade/Device Name: Spectral Bone Marrow Regulation Number: 21 CFR 892.1750 Regulation Name: Computed Tomography X-Ray System Regulatory Class: Class II Product Code: JAK, QIH Dated: February 21, 2023 Received: February 22, 2023

Dear Katelyn Rowley:

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

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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for 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 mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See 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,

Lu Jiang

Lu Jiang, Ph.D. Assistant Director Diagnostic X-Ray Systems Team 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) K223514

Device Name Spectral Bone Marrow

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)

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510(k) SUMMARY OF SAFETY AND EFFECTIVNESS

This 510(k) summary of Safety and Effectiveness information is submitted in accordance with the requirement of 21 CFR Part 807.87(h):

Date: November 22, 2022 Submitter: GE Medical Systems, LLC 3000 N. Grandview Blvd. Waukesha, Wisconsin 53188
Primary Contact: Katelyn Rowley Senior Regulatory Affairs Leader Phone: 262-309-5888 Email: Katelyn.rowely@ge.com
Secondary Contacts: Helen Peng Senior Regulatory Affairs Director Phone: 262-424-8222 Email: hong.peng@med.ge.com

Device Trade Name:	Spectral Bone Marrow
Device Classification	Class II
Regulation Number/	21 CFR 892.1750 Computed tomography x-ray system / JAK
Product Code:	21 CFR 892.2050 Automated Radiological Image Processing Software / QIH

Predicate Device Information
Device Name:	GSI Viewer with VUE Option
Manufacturer:	GE Medical Systems, LLC
510(k) Number:	K121827 cleared on September 13, 2012
Regulation Number/Product Code:	21 CFR 892.1750 Computed tomography x-ray system / JAK

Device Description

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marrow during the review of traumatic or non-traumatic bone pathologies. The software creates a fully automated post processing workflow for creating these images and improving reader efficiency.

Indications for Use

Comparisons

The Spectral Bone Marrow software is substantially equivalent to the predicate device GSI Viewer with VUE Option (K121827). The fundamental technology, i.e generating the material density (MD) images, monochromatic images and overlaying the MD images over base images, remains unchanged from the predicate. The table below summarizes the substantive feature/technological differences between the predicate device and the proposed device. The changes described below do not change the fundamental technology and do not raise any issues of safety and effectiveness.

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GE HealthCare

510(k) Premarket Notification Submission – Spectral Bone Marrow

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Specification/Attribute	GSI Viewer with VUE Option(Predicate Device, K121827)	Spectral Bone Marrow(Proposed Device)
BoneSegmentationTechnology	Manual segmentation	Deep learning based segmentation
Clinical Workflow	Manual	Automated - In the predicate device, the userhas to manually segment the bone region,generate the MD images and fuse it/overlaythem onto the monochromatic base images,and then export the output images as DICOMsecondary captures and send them to desiredDICOM destinations.In the subject device, a fully automatedworkflow generates the desired images(colored MD images of the segmented boneregion overlaid on the monochromatic base orVirtual Unenhanced images) as secondarycapture DICOM objects and networks them tothe preconfigured DICOM destinations (e.g.PACS) for the user to review.This change in the subject device greatlyimproves the overall efficiency of the reviewworkflow.
DeploymentEnvironment	CT Console, AW Workstation(K110834), AW Server (K081985)	CT Console, Edison Health Link (EHL)
Algorithm Input	Dual energy DICOM images	Same
AlgorithmOutput	Dual energy images, includingmonochromatic, VirtualUnenhanced, and materialdensity images and has theability to output fused coloredmaterial density (MD) images(e.g Water (HAP)) of asegmented bone region overlaidon a monochromatic image assecondary capture DICOMseries.	Fused image of colored material density (MD)images (e.g water (HAP)) of the segmentedbone region overlaid onto the basemonochromatic spectral CT images or VirtualUnenhanced images, as secondary captureDICOM series.

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Determination of Substantial Equivalence

Summary of Non-Clinical Testing

Spectral Bone Marrow has successfully completed the design control testing per our quality system. No additional hazards were identified, and no unexpected test results were observed. Spectral Bone Marrow was designed under GE HealthCare's QMS per the Quality System Regulations of 21CFR 820 and ISO 13485.

The following quality assurance measures have been applied to the development of the system:

Requirement Definition
Risk Analysis and Control
Technical Design Reviews
Formal Design Reviews
Software Development Lifecycle
- O Code Review
- Software Unit Implementation O
- Software Integrations and Integration Testing O
System Testing
- O Safety Testing (Verification)
- Image Performance Testing (Verification) O
- Simulating Use Testing (Validation) O
. Software Release

The testing and results did not raise different questions of safety and effectiveness than associated with predicate device. We consider the proposed device, Spectral Bone Marrow, is substantially equivalent to the predicate device.

The substantial equivalence is also based on the software documentation for a "Moderate" level of concern.

The non-clinical testing also included engineering bench testing that was carried out to verify the Spectral Bone Marrow's bone segmentation algorithm ability to accurately segment bone using a database of 146 retrospective Spectral CT series across a variety of GEHC Spectral Imaging CT Scanners. This database of exams is representative of the clinical scenarios where Spectral Bone Marrow is intended to be used. The ground truth for this dataset was generated by three US board certified radiologists, which was used to evaluate the Spectral Bone segmentation. The result of the engineering bench testing showed that the algorithm is capable of accurately segment bones and is safe and effective for its intended use.

Clinical Testing

A representative set of clinical sample images was assessed by three board certified radiologists with expertise in both the evaluation of bone marrow and dual energy imaging review. The assessment used retrospectively collected clinical cases that were processed using the Spectral Bone Marrow software. Each image generated from the subject device were read by each board certified radiologist who

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provided an assessment of image quality related to diagnostic use according to a Likert scale. Additionally, the readers were asked to rate their efficiency when using the algorithm compared to using without.

The result of this assessment validated that the Spectral Bone Marrow software provides additional diagnostic value for the evaluation of bone marrow and increased overall reader efficiency.

Substantial Equivalence

The changes associated with Spectral Bone Marrow do not change the Intended Use from the predicate and represent equivalent technology.

Spectral Bone Marrow was developed under GE HealthCare's quality system. Design verification, along with bench and clinical testing provided in this submission demonstrates that Spectral Bone Marrow is substantially equivalent and hence as safe and as effective as the legally marketed predicate device. GE's quality system's design, verification, and risk management processes did not identify any unexpected results, or adverse effects stemming from the changes to the predicate.

GE HealthCare believes that Spectral Bone Marrow is substantially equivalent to the predicate device and hence is safe and effective for its intended use.

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.