Bone VCAR is a post processing application for use in the analysis of CT images. The software is intended to support clinicians in the review of images that include the spine by providing tools to label the spine and optimize the display of anatomy within the CT image.

Bone VCAR is designed to support the clinician in visualization of the spine, by providing initial identification of vertebrae to assist in report dictation.

The software also assists the user by providing optimized display settings for easier identification of anatomy to facilitate fast image review and reporting of findings. Bone VCAR may be used for multiple care areas and is not specific to any disease state. It can be utilized during the review of exams including trauma, oncology, and routine body.

Device Description

Bone VCAR is a software analysis package utilizing a deep learning technique that assists in the analysis and visualization of CT data. It is intended to provide clinicians with an optimized display and quick access to tools that improve the reading experience and efficiency for anatomy. Bone VCAR is a post processing application option for the Advantage Workstation (AW) platform, CT Scanner, Cloud or PACS stations which can be used in the analysis of CT images.

Bone VCAR is designed to support the clinician in easy visualization of spine and to provide identification of those structures to assist in report dictation. This post processing solution combines the following tools and functionality:

· Multiplanar Reconstruction (MPR) displays of axial, sagittal, coronal, oblique, x-section and curved views which can be displayed in thin/thick, Average, Maximum Intensity Projection (MIP), Minimum intensity Projection (MinIP), Volume Rendering (VR) modes

· Display of anatomical labels automatically with editing capability of all labels such as the spine.

• Display of curved views automatically and editing capability of curved views through anatomical regions such as the spine for enhanced display options

· Access to all standard volume viewer tools for measuring distances, areas, Hounsfield unit values and annotating within the images

· Synchronization of views when multiple series are loaded with spine labeling for all series loaded.

The software will assist the user by providing optimized display settings to enable fast review of the images along with easy identification of anatomy to ease reporting of findings. Bone VCAR may be used for multiple care areas and is not specific to any disease state. It can be utilized during the review of various types of exams including trauma, oncology, and routine body.

Bone VCAR is compatible with both single energy and Gemstone Spectral Imaging (GSI) acquisition methods.

AI/ML Overview

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

Acceptance Criteria and Device Performance

Acceptance Criteria	Reported Device Performance
Spine Labeling Success Rate	Greater than 90%

Study Details

2. Sample Size Used for the Test Set and Data Provenance:

Test Set Size: Not explicitly stated as a number, but referred to as "a database of exams" and "a representative set of clinical sample images."
Data Provenance: The "database of exams is considered as a representative of the clinical scenarios where Bone VCAR is intended to be used, with consideration of acquisition parameters, image quality, pathologies and anatomy variations." No specific country of origin is mentioned. It is implied to be retrospective, as it's a "database of exams" used for validation.

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

Number of Experts: Three.
Qualifications: Board-certified radiologists. No specific experience length is provided.

4. Adjudication Method for the Test Set:

Not explicitly stated. The document mentions "assessed by three board certified radiologists using 5-point Likert scale," but the process for resolving disagreements or establishing a consensus ground truth isn't detailed.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

Was it done? Yes, a comparative assessment was done.
Effect Size (Improvement with AI vs. without AI assistance): The assessment "demonstrated that the capability of automatic labeling of spine by Bone VCAR is faster than manually labeling and it also increases reading and reporting efficiency whilst providing accurate identification of vertebra." An explicit effect size (e.g., percentage improvement in speed or efficiency) is not provided.

6. Standalone Performance Study (Algorithm only without human-in-the-loop):

Was it done? Yes. The engineering validation of the algorithm's capability "provided a success rate greater than 90% for the capability of automatically labeling the spine." This indicates a standalone assessment.

7. Type of Ground Truth Used:

For the standalone algorithm validation, the ground truth for "automatically labeling the spine" would have been established by presumably highly accurate manual labeling or anatomical expert review.
For the human reader assessment, the "accurate identification of vertebra" suggests expert consensus or established "correct" labels against which the readers' performance (with and without AI assistance) was compared. The document doesn't specify the exact method for generating this gold standard.

8. Sample Size for the Training Set:

Not explicitly mentioned. The document states that "Bone VCAR is a software analysis package utilizing a deep learning technique," which implies a training set was used, but its size is not provided.

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

Not explicitly mentioned. For deep learning models, ground truth for training would typically be established through expert annotation of the images to provide the algorithm with the correct spine and vertebral labels.

Summary

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April 8, 2019

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GE Medical Systems SCS % Ms. Elizabeth Mathew Senior Regulatory Affairs Manager 283 rue de la Miniere Buc. 78530 FRANCE

Re: K183204

Trade/Device Name: Bone VCAR (BVCAR) Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: Class II Product Code: JAK, LLZ Dated: March 18, 2019 Received: March 19, 2019

Dear Elizabeth Mathew:

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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

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/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

Michael D'Hara
For

Thalia T. Mills, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K183204

Device Name

Bone VCAR

Indications for Use (Describe)

Bone VCAR is designed to support the clinician in visualization of the spine, by providing initial identification of vertebrae to assist in report dictation.

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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GE Healthcare 510(k) Premarket Notification Submission

510(k) Summary

K183204

In accordance with 21 CFR 807.92 the following summary of information is provided:

Date:	April 8, 2019
Submitter:	GE Medical Systems SCSEstablishment Registration Number - 9611343283 rue de la Miniere78530 Buc, France
Primary ContactPerson:	Elizabeth MathewSenior Regulatory Affairs ManagerPhone: (262) 424-7774Email: Elizabeth.Mathew@ge.com
Secondary ContactPerson:	Helen PengRegulatory Affairs DirectorGE Healthcare, (GE Medical Systems, LLC)3000 N Grandview Blvd.,Waukesha, WI - 53188Phone: 262-424-8222Email: Hong.Peng@ge.com
Proposed Device:
Device Name:	Bone VCAR
Common/UsualName:	BVCAR
Primary Regulationnumber:	21 CFR 892.1750 Computed tomography x-ray system
Primary ProductCode:	JAK
Secondary ProductCode:	LLZ
Classification:	Class II

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Predicate Device:

Device Name:	Syngo.CT Bone Reading
510(k) number:	K123584 cleared on May 12, 2013
Regulation number/Product Code:	21 CFR 892.1750 Computed tomography x-ray system /JAK
Classification:	Class II
Manufacturer:	Siemens Medical Solutions, USA

Device Description/

Technology:

· Display of anatomical labels automatically with editing capability of all labels such as the spine.

• Display of curved views automatically and editing capability of curved views through anatomical regions such as the spine for enhanced display options

· Access to all standard volume viewer tools for measuring distances, areas, Hounsfield unit values and annotating within the images

· Synchronization of views when multiple series are loaded with spine labeling for all series loaded.

Bone VCAR is compatible with both single energy and Gemstone Spectral Imaging (GSI) acquisition methods.

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GE Healthcare 510(k) Premarket Notification Submission

The labeling tool can be activated and deactivated by the user at any time duringthe image review. Multiple volumes of data can be processed with the BoneVCAR tool at the same time. Volumes can be from the same or different exams.All labels can be moved, edited, hidden or deleted.
The dedicated display layout should assist in easy review of the anatomy. Usershave the flexibility for using all or a subset of the features within this applicationas they find suitable.
Intended Use:	Bone VCAR is a non-invasive image analysis software package which may beused in conjunction with CT images to aid in the assessment and reportingefficiency of images that include the spine.
Indication for Use:	Bone VCAR is a post processing application for use in the analysis of CT images.The software is intended to support clinicians in the review of images that includethe spine by providing tools to label the spine and optimize the display ofanatomy within the CT image.
	Bone VCAR is designed to support the clinician in visualization of the spine, byproviding initial identification of vertebrae to assist in report dictation.
	The software also assists the user by providing optimized display settings foreasier identification of anatomy to facilitate fast image review and reporting offindings. Bone VCAR may be used for multiple care areas and is not specific toany disease state. It can be utilized during the review of various types of examsincluding trauma, oncology, and routine body.
TechnologicalCharacteristic:	The goal of the Bone VCAR software algorithm is to extract from a CT scan thepositions and labels of the patient vertebrae in the image. The algorithm takes asinput a CT scan acquisition and is compatible with a wide range of acquisitionsfor dedicated spine work, trauma, oncology and routine exam. Bone VCARautomated vertebra detection algorithm returns the list of detected vertebraeposition in 3D coordinates and associated labels.
Comparison:	The table below summarizes the feature/technological comparison between thepredicate device and the proposed device:
Specification	Syngo CT Bone Reading(K123584)	Proposed Device:Bone VCAR
Spine LabelingTool	Automated labeling withmanual editing capability	Automated labeling withmanual editing capability
Display ofcurved spinestructures	Yes	Yes
MeasurementTool	geometricmeasurementtools (distance line,polyline, marker, arrow,angle), HU measurementtools (Pixel lens, ROIcircle, ROI polygonal, ROIfreehand, VOI sphere)	Access to all standardVolume Viewer tools formeasuring distances, areas,Hounsfield unit values andannotating within the images
Image Displayformats	Multiplanar reconstruction(MPR) thin/thick,maximum intensityprojection (MIP) thin/thick,inverted MIP thin/thick,volume rendering technique(VRT)	Multiplanar Reconstruction(MPR) displays of axial,sagittal, coronal, oblique, x-section and curved viewswhich can be displayed inthin/thick, Average,Maximum IntensityProjection (MIP), Minimumintensity Projection (MinIP),Volume Rendering (VR)modes.

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GE Healthcare 510(k) Premarket Notification Submission

Determination of Substantial Equivalence:

Engineering has validated Bone VCAR algorithm's capability of using deep learning technique to automatically label spine using a dataset of CT exams. This database of exams is considered as a representative of the clinical scenarios where Bone VCAR is intended to be used, with consideration of acquisition parameters, image quality, pathologies and anatomy variations. The result of the algorithm validation provided a success rate greater than 90% for the capability of automatically labeling the spine.

A representative set of clinical sample images was assessed by three board certified radiologists using 5-point Likert scale. The assessment demonstrated that the capability of automatic labeling of spine by Bone VCAR is faster than

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manually labeling and it also increases reading and reporting efficiency whilst providing accurate identification of vertebra.

Bone VCAR has successfully completed the required design control testing per GE's quality system. Bone VCAR was designed and will be manufactured under the Quality System Regulations of 21CFR 820 and ISO 13485. The following quality assurance measures have been applied to the development of the device:

Risk Analysis
Requirements Reviews
. Design Reviews
Performance testing (Verification, Validation)
Safety testing (Verification)

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

Conclusion:

GE Healthcare considers Bone VCAR to be as safe, as effective, and performance is substantially equivalent to the predicate device.

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.