Thoracic VCAR is a CT, non-invasive image analysis software package, which may be used in conjunction with CT lung images to aid in the assessment of thoracic disease. The software provides automatic segmentation of the lungs and automatic segmentation and tracking of the airway tree. Thoracic VCAR also provides quantification of Hounsfield units and display by color of thresholds within a segmented region.

Thoracic VCAR also supports Gemstone Spectral Imaging (GSI) acquisitions for the evaluation of pulmonary perfusion. It provides additional information to aid in visualization of variations of perfusion within the lungs and to quantitatively assess lung volumes. It is intended to be used as an adjunct to current standard methods utilizing color coded displays of iodine attenuation differences in the lungs to aid in identifying segments of relative perfusion differences which may be useful in assessing thoracic disease. Thoracic diseases that may be associated with changes in perfusion include pulmonary embolism and COPD.

Device Description

Thoracic VCAR is a software analysis package for the Advantage Workstation (AW) platform, CT Scanner, Cloud or PACS stations which can be used in the analysis of CT images. It is designed for the analysis and processing of volumetric CT chest data. It provides quantitative information to aid in the assessment of thoracic diseases.

The primary features of the software are: lung and lobe segmentation to obtain threshold-based volume measurements; bronchial tree segmentation and tracking to determine wall thickness measurements; lung maps based on HU values to help the physician in determining the location and extent of disease across both lungs a well as each lobe. Additionally, GSI datasets can be used for the evaluation of relative perfusion within the lungs.

AI/ML Overview

This document describes the Thoracic VCAR with GSI Pulmonary Perfusion device and its acceptance criteria and supporting studies.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are not explicitly stated in a quantitative manner (e.g., minimum sensitivity, specificity, or F1 score). Instead, the document describes the validation in terms of demonstrating effectiveness and improvement in diagnostic value.

Acceptance Criterion (Implicit)	Reported Device Performance
1. Demonstration of Effectiveness in Identifying and Separating Iodine Distributions (Simulated Perfusion)	Simulated bench testing with a phantom demonstrated that the algorithm correctly segmented/thresholded modeled lung regions with relative perfusion differences (iodine concentrations).
2. Compliance with DICOM Standard	The software complies with NEMA PS 3.1 - 3.20 (2016) Digital Imaging and Communications in Medicine (DICOM) Set (Radiology) standard.
3. Completeness of Required Design Control Testing (Quality System)	The device successfully completed required design control testing per GE's quality system, designed and manufactured under 21CFR 820 and ISO 13485. Applied quality assurance measures include Risk Analysis, Requirements Reviews, Design Reviews, Performance Testing (Verification, Validation), and Safety Testing (Verification).
4. Improved Diagnostic Value, Reader Confidence, and Efficiency in Evaluating Iodine Distribution (Clinical Assessment)	A clinical assessment of 15 CT cases by three board-certified radiologists using a 5-point Likert scale demonstrated that the proposed device improves diagnostic value, reader confidence, and efficiency in evaluating relative distribution of iodine within the lungs, such as in the presence of pulmonary emboli.

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

Test Set (Clinical): 15 CT cases.
Data Provenance: The document states this data is "representative of routine clinical imaging from thoracic acquisition perspective." It does not specify the country of origin, but given the FDA submission, it's likely from the US or a region with comparable clinical practices. It is a retrospective assessment as radiologists reviewed existing cases.
Test Set (Phantom): Not explicitly quantified, but described as "a phantom test with a test setup that simulates regions of relative perfused and non-perfused volumes."

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

Number of Experts: Three board-certified radiologists.
Qualifications: "board certified radiologists." No specific years of experience are mentioned.

4. Adjudication Method for the Test Set

The document does not explicitly describe an adjudication method (e.g., 2+1 or 3+1) for the clinical test set to establish a definitive "ground truth" or to resolve discrepancies between readers. It states that the radiologists "assessed" the cases using a 5-point Likert scale, implying their individual assessments were used to determine improvement.

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

Was an MRMC study done? Yes, a form of clinical assessment with multiple readers (three radiologists) was performed to evaluate the diagnostic value, reader confidence, and efficiency.
Effect Size of Human Readers' Improvement with AI vs. Without AI Assistance: The document states the assessment "demonstrated the proposed device improves diagnostic value, reader confidence and efficiency." However, it does not provide a specific quantitative effect size (e.g., AUC increase, specific percentage improvement in diagnosis, or a statistical measure of confidence increase). The Likert scale was used, but the results of this scale (e.g., average Likert score, p-values) are not presented in the summary provided. It's implied the improvement is qualitative in nature based on the radiologists' feedback.

6. Standalone (Algorithm Only) Performance Study

Was a standalone study done? Yes, the phantom study can be considered a standalone performance test for the algorithm's core function of identifying and separating iodine/water distributions. It verifies the algorithm's capability to correctly segment/threshold modeled lung regions based on perfusion differences.

7. Type of Ground Truth Used

Phantom Study: Simulated ground truth, based on known iodine concentrations in designed regions of the anthropomorphic lung phantom.
Clinical Study: Expert consensus or individual expert opinion using a 5-point Likert scale. Given there's no mention of adjudication, it's likely based on the aggregated individual expert opinions or a qualitative assessment of general improvement agreed upon by the experts. It's not explicitly stated that an independent "true" ground truth (e.g., pathology, follow-up outcomes) was established for these clinical cases against which the AI or human reader performance was objectively measured.

8. Sample Size for the Training Set

The document does not provide information on the sample size used for the training set of the algorithm.

9. 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.

Summary

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GE Medical Systems SCS % Ms. Helen Peng Director, Regulatory Affairs Leader, MICT & AW GE Medical Systems, LLC 3000 North Grandview Blvd. WAUKESHA WI 53188

March 29, 2019

Re: K183210

Trade/Device Name: Thoracic VCAR with GSI Pulmonary Perfusion Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: Class II Product Code: LLZ, JAK Dated: March 19, 2019 Received: March 20, 2019

Dear Ms. Peng:

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. O'Hara For

Thalia 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) K183210

Device Name

Thoracic VCAR with GSI Pulmonary Perfusion

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

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

Date:	November 16, 2018
Submitter:	GE Medical Systems SCS
	Establishment Registration Number - 9611343
	283, rue de la Minière
	78530 Buc, France
Primary Contact Person:	Peter Uhlir
	Regulatory Affairs Leader
	Tel: 00 36 1 4793318
	Email: Peter.Uhlir@ge.com
Secondary Contact Person:	Helen Peng
	Director, Regulatory Affairs Leader, MICT & AW
	Tel: (262) 424-8222
	Email: Hong.Peng@ge.com
Device Trade Name:	Thoracic VCAR with GSI Pulmonary Perfusion
Common/Usual Name:	Thoracic VCAR
Proposed Device:
Primary Regulation Number/	21CFR 892.2050, Picture archiving and communications
Primary Product Code:	System/LLZ
Secondary Product Code:	JAK
Classification Panel:	Radiology
Regulatory Class:	Class II
Predicate Device:	Thoracic VCAR
510(k) number	K103480, cleared on March 7, 2011
Regulation Number/	21CFR 892.2050, Picture archiving and communications
Product Code:	system/LLZ
Classification Panel:	Radiology
Regulatory Class:	Class II
Manufacturer:	GE Healthcare (GE Medical Systems LLC)
Device Description:	Thoracic VCAR is a software analysis package for the AdvantageWorkstation (AW) platform, CT Scanner, Cloud or PACS stationswhich can be used in the analysis of CT images. It is designed forthe analysis and processing of volumetric CT chest data. Itprovides quantitative information to aid in the assessment ofthoracic diseases.The primary features of the software are: lung and lobesegmentation to obtain threshold-based volume measurements;bronchial tree segmentation and tracking to determine wallthickness measurements; lung maps based on HU values to helpthe physician in determining the location and extent of diseaseacross both lungs a well as each lobe. Additionally, GSI datasetscan be used for the evaluation of relative perfusion within thelungs.
Intended Use:	Thoracic VCAR is a CT, non-invasive image analysis softwarepackage, which may be used in conjunction with CT lung imagesto aid in the assessment of thoracic disease diagnosis andmanagement.
Indications for Use:	Thoracic VCAR is a CT, non-invasive image analysis softwarepackage, which may be used in conjunction with CT lung imagesto aid in the assessment of thoracic disease. The software willprovide automatic segmentation of the lungs and automaticsegmentation and tracking of the airway tree. The software willprovide quantification of Hounsfield units and display by colorthe thresholds within a segmented region.Thoracic VCAR also supports Gemstone Spectral Imaging (GSI)acquisitions for the evaluation of pulmonary perfusion. Itprovides additional information to aid in visualization ofvariations of perfusion within the lungs and to quantitativelyassess lung volumes. It is intended to be used as an adjunct tocurrent standard methods utilizing color coded displays ofiodine attenuation differences in the lungs to aid in identifyingsegments of relative perfusion differences which may beuseful in assessing thoracic disease. Thoracic diseases thatmay be associated with changes in perfusion includepulmonary embolism and COPD.
Technology:	The Thoracic VCAR with GSI Pulmonary Perfusion softwareemploys the same fundamental scientific technology as itspredicate device.The GSI Pulmonary Perfusion protocol relies on the predicatedevice's capability to provide tools to review thoracic datasets. Ituses the lungs and lung vessels segmentation already present in

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Thoracic VCAR, applied to GSI datasets and combines thesegmentation to GSI material density (MD) images.
Comparison: The most notable change in Thoracic VCAR with GSI PulmonaryPerfusion as compared to Thoracic VCAR is that it allows to useGSI datasets for the evaluation of relative perfusion within thelungs.The table below summarizes the feature/technologicalcomparison between the predicate device and the proposeddevice:
Specification	Predicate DeviceThoracic VCAR(K103480)	ProposedThoracic VCARwith GSIPulmonaryPerfusion
Modality imagessupported	CT chest dataset	Same +GSI CT chestdataset
Automatic lungs,Lobe, Airway treesegmentation	Yes	Yes
Manual editing ofsegmentationresults	Yes	Yes
Relative perfusiondeficit map in thelung parenchymaregions with GSIPulmonaryPerfusion protocol	No	Yes
Summary Tableautomaticallydisplays totalvolume ofsegmented lungsas well as relativehypo-perfusionvolumes	No	Yes

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Determination of SubstantialEquivalence:	Summary of Non-Clinical Tests:
	Engineering has validated the algorithm for Thoracic VCAR withGSI Pulmonary Perfusion in order to prove the capabilities of thealgorithm for the evaluation of relative perfusion within thelungs.
	In order to demonstrate the effectiveness of the algorithm inidentifying and separating the iodine(water) distributions withinthe lungs we designed a phantom test with a test setup thatsimulates regions of relative perfused and non-perfused volumesinside of a commercially available anthropomorphic lungphantom. This simulated bench testing demonstrates that thealgorithm correctly segmented/thresholded the modeled lungregions that had relative perfusion differences (lodineconcentrations).
	The Thoracic VCAR with GSI Pulmonary Perfusion softwarecomplies with NEMA PS 3.1 - 3.20 (2016) Digital Imaging andCommunications in Medicine (DICOM) Set (Radiology) standard.
	Thoracic VCAR with GSI Pulmonary Perfusion has successfullycompleted the required design control testing per GE's qualitysystem. Thoracic VCAR with GSI Pulmonary Perfusion wasdesigned and will be manufactured under the Quality SystemRegulations of 21CFR 820 and ISO 13485.
	The following quality assurance measures were applied to thedevelopment of the system:■ Risk Analysis■ Requirements Reviews■ Design Reviews■ Performance testing (Verification, validation)■ Safety testing (Verification)
	The substantial equivalence determination is also based on thesoftware documentation for a MODERATE level of concerndevice.
	Summary of Clinical tests:
	A representative clinical sample image set of 15 CT cases wereassessed by three board certified radiologists using 5 point Likertscale. This data is representative of routine clinical imaging fromthoracic acquisition perspective, in which such a tool is mostlikely to be utilized. The assessment demonstrated the proposeddevice improves diagnostic value, reader confidence andefficiency in evaluating relative distribution of iodine within thelungs such as in the presence of pulmonary emboli.
Conclusion:	GE Healthcare considers the Thoracic VCAR with GSI PulmonaryPerfusion software application to be as safe, as effective, andperformance is substantially equivalent to the predicate device.

Regulation Number and Section

N/A