The CT Dual Energy Image View application accepts CT images acquired using different tube voltages and/or tube currents of the same anatomical location. The material composition of body regions may be determined using the energy dependence of the attenuation coefficients of different materials. This approach enables images to be generated at multiple energies within the available spectrum to visualize and analyze information about anatomical and pathological structures.

Device Description

The Vitrea® CT Dual Energy Image View is a post-processing software application which functions on the Vitrea® Platform, cleared by K150258.This application allows you to load and combine two CT images, acquired from a Toshiba CT scanner with a Dual Energy protocol, of the same anatomical location; one obtained with low kV tube voltage and one obtained with high kV tube voltage. Vitrea® computes a Blended and an Enhanced image with adjustable virtual energy levels, a Virtual Non-Contrast (VNC) image, an lodine Map overlaid on one of the original or derived images, a CT graph, and a best Contrast-to-Noise Ratio (CNR) image. For the Raw Data Analysis workflow, Vitreally calculates a Monochromatic image.

The software supports Toshiba dual-energy studies containing image-based and projection-based reconstruction techniques.

lmage-based reconstructed data consists of a standard image reconstruction of the two ● scans. Use the Dual Energy Image Domain (Two Volumes) workflow for these datasets.
Projection-based reconstructed data consists of special material image reconstruction where . the two scans are combined to create two sets of images where a predefined material is defined, typically lodine/Water and/or Calcium/Water. Use the Dual Energy Raw Data Analysis (Four or Six Volumes) workflow for these datasets.
NOTE: It is important that a description of the material is contained in the DICOM Image Comments tag (0020, 4000) for each dataset at the time of the scan. For lodine/Water projection-based reconstruction, the lodine material image should be labeled "I/H20," and the corresponding Water material image should be labeled "H20/1." For the Calcium/Water projection-based reconstruction, the Calcium material image should be labeled "Ca/H20," and the corresponding Water material image should be labeled "H20/Ca."

NOTE: The dual-energy datasets must be coincident with the same frame of reference UID.

NOTE: Available with Toshiba datasets only.

AI/ML Overview

Here's a summary of the acceptance criteria and the study conducted for the Vital Images, Inc. Vitrea® CT Dual Energy Image View device, based on the provided text:

Important Note: The provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed independent study with specific numerical acceptance criteria and performance metrics for the new device. Therefore, the "acceptance criteria" discussed are largely qualitative and relate to the device functioning as intended and being comparable to the predicate, rather than precise quantitative thresholds. Similarly, "reported device performance" is described qualitatively as meeting those intentions.

Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Qualitative)	Reported Device Performance (Qualitative)
Software operates according to defined requirements (functional, performance, and safety).	All external validation testing passed with each expert confirming the Vitrea® CT Dual Energy Image View software fulfills the intended use and meets the needs of the user.
Functionality (e.g., Iodine maps, Virtual Non-Contrast, Monochromatic images, Best CNR, Blended images, Enhanced images at different energy levels) is present and works as intended.	The clinical radiologist rated the quality and performance of each feature as establishing equivalence to the predicate device.
User interface and usability are acceptable to trained professionals.	Two Radiological Technologists provided positive feedback regarding performance and usability of each feature.
Safety risks are reduced as low as possible, and benefits outweigh residual risks.	All risks for this feature were collectively reviewed to determine if the benefits outweigh the risk, and it was assessed that the benefits do outweigh the risks.
Substantial equivalence to the predicate device (K132813) in terms of intended use, indications for use, principle of operation, and technological characteristics.	The device was found substantially equivalent to the predicate device across all these criteria, with noted minor differences not raising new safety/effectiveness questions.

Study Details

2. Sample size used for the test set and the data provenance:

Test Set (External Validation):
- Clinical Radiologist: Evaluated "multiple test cases." The exact number of cases is not specified.
- Radiological Technologists (2): Provided feedback on "a series of questions."
- Data Provenance: The document does not explicitly state the country of origin or whether the data was retrospective or prospective. Given the context of comparing to a predicate device, it's likely existing data or a simulated environment was used, but this is not confirmed.
Test Set (Internal Validation / Phantom Testing):
- Sample Size: "Various phantoms." The exact number or types are not specified.
- Data Provenance: Not specified, but likely generated internally for phantom testing.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Number of Experts: Three experienced clinical experts were involved in the external validation of the software's features. Specifically, one clinical radiologist and two radiological technologists.
Qualifications: "Experienced clinical experts," "clinical radiologist," and "Radiological Technologists." Specific years of experience or board certifications are not provided.

4. Adjudication method for the test set:

The document does not describe a formal adjudication method (like 2+1 or 3+1 consensus).
Instead, it states that the clinical radiologist evaluated test cases comparing the subject device to the predicate device and rated "quality and performance." The two radiological technologists provided feedback on performance and usability.
The conclusion states that "All external validation testing passed with each expert confirming the Vitrea® CT Dual Energy Image View software fulfills the intended use and meets the needs of the user," implying individual expert agreement rather than a formal consensus process between them for ground truth.

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 MRMC comparative effectiveness study was done in the sense of evaluating human reader performance with and without AI assistance to quantify improvement.
The study involved comparing the new device's output and usability to a predicate device by expert users. It was a comparison of tool equivalence rather than an assessment of human performance augmentation.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

The device is a "post-processing software application."
"Internal Validation (Phantom Testing)" included "side-by-side visual comparisons of dual energy algorithm outputs with Toshiba Display Console as the predicate device using phantom data." This indicates some form of standalone evaluation against a reference/predicate system, but it's not explicitly framed as an "algorithm-only" performance study in isolation from any human interpretation. However, the direct comparison of "algorithm outputs" suggests an assessment of the algorithm's results themselves.

7. The type of ground truth used:

For the external validation, the ground truth was effectively the expert opinion/comparison of the clinical radiologist against the output of the predicate device (Toshiba Dual Energy System Package K132813). The experts assessed whether the new device's features produced images of comparable "quality and performance" and fulfilled the "intended use."
For internal validation (phantom testing), the "Toshiba Display Console" served as the reference for "side-by-side visual comparisons of dual energy algorithm outputs," implying its output was considered the reference or "ground truth" for comparison.

8. The sample size for the training set:

The document does not mention a training set or any machine learning/AI model training. The Vitrea® CT Dual Energy Image View is described as a "post-processing software application" that "computes" various images based on acquired CT data. It does not appear to be an AI/ML device that requires a training set in the conventional sense. The "algorithm" mentioned refers to the computational methods for generating the dual-energy derived images, not a learned model.

9. How the ground truth for the training set was established:

As no training set is mentioned (see point 8), this information is not applicable.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

November 3, 2016

Vital Images, Inc. % Mr. Vince Swenson Senior Director of Quality and Regulatory 5850 Opus Parkway, Suite 300 MINNETONKA MN 55343

Re: K161157

Trade/Device Name: Vitrea® CT Dual Energy Image View Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: II Product Code: JAK Dated: September 29, 2016 Received: September 30, 2016

Dear Mr. Swenson:

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. 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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Michael D'Hara

For

Robert Ochs, 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) K161157

Device Name

Vitrea® CT Dual Energy Image View

Indications for Use (Describe)

The CT Dual Energy Image View application accepts CT images acquired using different tube voltages and/or tube currents of the same anatomical location. The material composition of body regions may be energy dependence of the attenuation coefficients of different materials. This approach enables images to be generated at multiple energies within the available spectrum to visualize and analyze information about anatomical structures.

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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510K Summary

This 510(k) summary is submitted in accordance with the requirements of 21 C.F.R. Part 807.92(c).

Basis for theSubmission:	To obtain 510k clearance for Vital's software application Vitrea® CTDual Energy Image View which is substantially equivalent to thecleared K132813 Dual Energy System Package manufactured byToshiba Medical Systems Corporation.
Submitter:	Vital Images, Inc.5850 Opus Parkway, Suite 300Minnetonka, MN, 55343-4414
EstablishmentRegistration:	2134213
Contact Person:	Vince SwensonSr. Dir. of Quality and Regulatory AffairsPhone: 952-487-9548Fax: 952-487-9510vswenson@vitalimages.com
510(k) Type:	Traditional
Summary Date:	September 29, 2016
Device Trade Name:	Vitrea® CT Dual Energy Image View
	Subject Device	Predicate Device
	Vitrea® CT Dual Energy ImageView	K132813 Dual Energy SystemPackage
Classification Name	Computed Tomography X-raySystem.	Computed Tomography X-raySystem.
Regulatory Number	892.1750	892.1750
Product Code	JAK	JAK
Classification	Class II	Class II
Review Panel	Radiology
Decision Date	Under Review	February 6, 2014

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Predicate Device(s):

Predicate Device	Manufacturer	FDA 510(k) Number
Dual Energy SystemPackage	Toshiba Medical Systems Corporation2441 Michelle Drive,Tustin, CA 92780	K132813

General Description of Dual Energy Technology:

Standard computed tomography (CT) scanners use normal X-rays to make cross-sectional pictures or images of the body. A dual energy CT scanner is a technology that uses both a normal X-ray and also a second less powerful X-ray to make the CT images. This can facilitate making some abnormalities in the body more clear on the images taken. lodine for example, is a commonly used substance in X-ray contrast agents, and using a dual energy CT can facilitate improved images of blood vessels which might allow the radiologist to obtain more accurate information about a patient's condition. Dual Energy images can be obtained using a single examination instead of two separate examinations.

In addition, dual energy CT allows for the decomposition of materials and thus the differentiation of materials with high atomic numbers such as iodine map image data set using dual energy methodology can display the distribution of iodine and thus differentiate regions of vascularity within the organ post scanned. The iodine enhancement map is usually a color over an anatomical image to emphasize the differences in vascularity and to allow anatomical localization.

Device Description:

The software supports Toshiba dual-energy studies containing image-based and projection-based reconstruction techniques.

lmage-based reconstructed data consists of a standard image reconstruction of the two ● scans. Use the Dual Energy Image Domain (Two Volumes) workflow for these datasets.
Projection-based reconstructed data consists of special material image reconstruction where . the two scans are combined to create two sets of images where a predefined material is defined, typically lodine/Water and/or Calcium/Water. Use the Dual Energy Raw Data Analysis (Four or Six Volumes) workflow for these datasets.
NOTE: It is important that a description of the material is contained in the DICOM Image Comments tag (0020, 4000) for each dataset at the time of the scan. For lodine/Water projection-based reconstruction, the lodine material image should be labeled "I/H20," and the corresponding Water material image should be labeled "H20/1." For the Calcium/Water projection-based reconstruction, the Calcium material image should be labeled "Ca/H20," and the corresponding Water material image should be labeled "H20/Ca."

NOTE: The dual-energy datasets must be coincident with the same frame of reference UID.

NOTE: Available with Toshiba datasets only.

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Intended Use / Indications for Use:

Intended for Disease / Condition / Patient Population:

The CT Dual Energy Image View is a viewing option that allows users to combine different energy scans for the purpose of creating derived images. Specific information of intended for disease, condition, and patient population is not applicable as Dual Energy Image View can be used on variant diseases and conditions.

Substantial Equivalence Comparison:

	Subject Device	Predicate Device
Criteria	Vitrea® CT Dual EnergyImage View	K132813 Dual Energy SystemPackage	Comparison
Indicationsfor Use	The CT Dual EnergyImage View applicationaccepts CT imagesacquired using differenttube voltages and/or tubecurrents of the sameanatomical location. Thematerial composition ofbody regions may bedetermined using theenergy dependence of theattenuation coefficients ofdifferent materials. Thisapproach enables imagesto be generated at multipleenergies within theavailable spectrum tovisualize and analyzeinformation aboutanatomical andpathological structures.	The Dual Energy System allowsthe system to acquire two CTimages of the same anatomicallocation using distinct tubevoltages and/or tube currentsduring two tube rotations. The x-raydose will be the sum of the dose ofeach tube rotation at its respectivetube voltage and current.Information regarding the materialcomposition of various organs,tissues, and contrast materials maybe gained from the differences in x-ray attenuation between thesedistinct energies.This information may also be usedto reconstruct images at multipleenergies within the availablespectrum, and to reconstruct basisimages that allow the visualizationand analysis of anatomical andpathological materials.The visualization of thedifferentiation between uric acidand others is provided with theDual Energy system. When usedby a qualified physician, a potentialapplication is to determine thecourse of treatment.	SimilarThe subjectdevice doesnot have thecapacity toevaluate uricacid.

Intended Use Comparison with Predicate Device:

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Criteria	Subject DeviceVitrea® CT Dual EnergyImage View	Predicate DeviceK132813 Dual Energy SystemPackage	Comparison
IntendedUsers	Trained radiologists,clinicians or technologists.	Radiologic technologists or othermedical personnel who arequalified to operate X-ray CTscanners	Similar
ModalitySupport	CT /CTA	CT /CTA	Same

Device Description Comparison with Predicate Device:

Subject Device	Predicate Device	Comparison
Vitrea® CT Dual Energy Image View	K132813 Dual Energy SystemPackage
CT Dual Energy Image View softwareallows you to load and combine twoToshiba CT volumes, one obtained withlow kV tube voltage and one obtainedwith high kV tube voltage. Vitreacomputes a Blended and an Enhancedimage with adjustable virtual energylevels, a virtual non-contrast (VNC)image, an Iodine map overlaid on oneof the original or derived images, a CTgraph, and a best contrast-to-noiseratio (CNR) image. For the Raw DataAnalysis workflow, Vitrea calculates amonochromatic image.The software supports Toshiba dual-energy studies containing image- and	Dual Energy System Package,CSDP-001A, consists of threesoftware packages intended to beused on Toshiba CT systems whichallows for the acquisition of two CTimages of the same anatomicallocation using different tubevoltages and/or tube currentsduring two tube rotations.CSDP-001A/1 (Dual EnergySystem) allows the same region tobe scanned at two different tubevoltages and tube currents andpermits the CT values and ratio inthe selected region to be measuredbased on the two image data sets	SimilarThe subjectdevice is a post-processingsoftwareapplication andonly has a subsetof capabilities ofthe predicatedevice. Thesubject device isable to displayiodine maps andmonochromaticimages. However,it does not
projection- based reconstructiontechniques.	obtained, providing information thatis useful for identifying materials.	evaluate uric acidstudies or haveCT scannercapabilities.
• Image-based reconstructed dataconsists of a standard imagereconstruction of the two scans.Use the Dual Energy ImageDomain (Two Volumes) workflowfor these datasets.• Projection-based reconstructeddata consists of special materialimage reconstruction where the two	CSDP-001A/2 (Dual Energy RawData Analysis) allowsmonochromatic images to begenerated and permits images inwhich contrast enhancement isvisualized to be generated basedon the datasets acquired byscanning the same positions withdifferent tube voltages, making itpossible to perform analysis.
scans are combined to create twosets of images where a predefinedmaterial is defined, typicallyIodine/Water and/or	CSDP-001A/3 (Dual EnergyComposition Analysis) reads dataacquired by scanning the same

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Subject Device	Predicate Device
Vitrea® CT Dual Energy Image View	K132813 Dual Energy System Package	Comparison
Calcium/Water. Use the Dual Energy Raw Data Analysis (Four or Six Volumes) workflow for these datasets.	positions with different tube voltages and extracts suspected uric acids from the acquired images.

Similarities in Technology with Predicate Device:

Criteria	Description of Feature	SubjectDevice	PredicateK132813	Comparison
Modality
CT	Computed Tomography	Yes	Yes	Same
Data Loading
DICOM	Digital Imaging andCommunications in Medicine	Yes	Yes	Same
Function(s)
Iodine Map/ IodineMap Generation	Description:A color scale of iodine regionsgenerated using the high kV andlow kV scans. The map is overlaidon one of the original or derivedvolumes.Purpose:Iodine map images indicate whetheror not the contrast-enhancedregions are present. Iodine Mappingis intended to visualize thepresence of contrast enhancement,more specifically, the uptake ofiodine.Input Data:Low and High kVp acquisition data.	Yes	Yes	Same
Criteria	Description of Feature	SubjectDevice	PredicateK132813	Comparison
Virtual-Non-Contrast	Description:An estimation of a comparableimage if no contrast agent wasadministered. The image isgenerated by replacing the iodineHU enhancement with an estimationof the original soft tissue texture.Purpose:Virtual-Non-Contrast imagesattempt to estimate a comparableimage as if no contrast agent wasadministered.Input Data:Low and High kVp acquisition data.	Yes	Yes	Same
Monochromatic	Description:Image created by combining thematerial pair volumes to simulatethe appearance of a single energylevel.The image initially displays at avirtual energy level of 66 keV. Thevirtual energy level is adjustable.Purpose:Monochromatic images simulate theappearance of a single energy level.Input Data:Material reconstruction of Low andHigh kVp acquisition data.	Yes	Yes	Same
Best CNR	Description:An image that displays the bestcontrast-to-noise ratio of all energylevels.Purpose:Best CNR images are used tominimize the trade-off betweencontrast and noise.Input Data:Low and High kVp data.	Yes	Yes	Same
Display BlendedImage	Description:Image created by combining thehigh kV and low kV images tosimulate the appearance of a singleenergy scan.	Yes	Yes	Same
Criteria	Description of Feature	SubjectDevice	PredicateK132813	Comparison
	The image initially displays at avirtual energy level of 120 kVp. Thevirtual energy level is adjustable.Purpose:Blended images are intended tosimulate the appearance of asingle-energy scan at a user-specified kVp valueInput Data:
	Low and High kVp acquisition data.
Display EnhancedImage	Description:Image created using a weightedaveraging for the estimatedcontrast-enhanced regions relativeto the Blended image.The image initially displays at avirtual energy level of 120 kVp. Thevirtual energy level is adjustable.Purpose:Enhance the previously blendedimages which simulate theappearance of a single-energy scanat a user-specified kVp valueInput Data:Low and High kVp acquisition data.	Yes	Yes	Same
Materialcomposition ofbody regions	Description:The software exploits the energydependence of the attenuationcoefficients of different materials toperform a decomposition into basismaterials. This fundamentaltechnique is used to generate theiodine map and virtual non-contrast(VNC) images.Purpose:A graph of Hounsfield unitattenuation vs. energy level isprovided within a user-definedregion of interest (ROI). The shapecharacteristics of the energyresponse curve can provideadditional information about thematerial composition within the ROI.	Yes	Yes	Same
Criteria	Description of Feature	SubjectDevice	PredicateK132813	Comparison
	Low and High kVp data.

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Differences in Technology with the Predicate Device:

	Subject Device	Predicate Device
Criteria	Vitrea® CT DualEnergy ImageView	K132813 DualEnergy SystemPackage	Comparison
Differentiation betweenUric Acid and othermaterials	No	Yes	The subject devicecontains a subset ofthe Dual EnergySystem Packagefeatures which doesnot include thesefeatures.
Dose	N/A	Yes	Vital is not makingany claims for thesefeatures.
Kidney StoneCharacterization	No	Yes
Uric Acid Characterization	No	Yes
Acquisition of Images	N/A	Yes

Currently, the Vitrea Dual Energy Image View application does not have the capability to differentiate between Uric Acid and other materials, it does not perform Kidney Stone Characterization and/or Uric Acid Characterization. As Vitrea Dual Energy image View is a post-processing software application and not a scanner, dosage and acquisition of images is not an applicable function. Furthermore, the acquisition of images is based on the scanner parameters, which are determined by the manufactures' protocol. The manufacturers' protocols would determine parameters such as scan extent, slice thickness, scan field of view, and the low and high kVp values.

Summary of Non-Clinical Tests:

The Vitrea® CT Dual Energy Image View software was designed, and tested according to written procedures that included risk management. Software testing was completed to ensure the new features operate according to defined requirements.

The following design control measures were applied to the development of the Vitrea® CT Dual Energy Image View software:

Risk Management ●
. Requirements Reviews
Code Designs
Code Development Testing .
Code Reviews
Design Reviews ●
Verification of the software that included performance and safety testing ●

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Validation of the software - that included phantom testing and simulated usability testing by experienced professionals.

Risk Management:

Each risk pertaining to these features have been individually assessed to determine if the benefits outweigh the risk. Every risk has been reduced as low as possible and has been evaluated to have a probability of occurrence of harm of "Improbable." All risks for this feature were collectively reviewed to determine if the benefits outweigh the risk. Because of the risk control measures included in this feature, it is believed that the risk for the feature as a whole is extremely low. Taking into account all risks aqainst the benefits of this feature. it has been assessed that the benefits do outweigh the risks for this feature.

During the design review, the following conclusions were reached:

All risks were reduced as low as possible ●
The medical benefits of the device outweigh the residual risk for each individual risk and all ● risks together
. The overall residual risk for the project is deemed acceptable

Verification:

The software verification team's primary goal was to assure that the software fully satisfies all expected system requirements and features. Test cases were executed against the system features and requirements. As a part of creating the test cases, the verification team reviewed and monitored the Requirements Traceability Matrix ("RTM") to ensure coverage of the items within the RTM.

Validation:

The software validation team's primary goal was assuring the software conforms to user needs and intended use. The validation team conducted workflow testing that provided evidence that the system requirements and features were implemented, reviewed and met.

Internal Validation (Phantom Testing):

The software validation team provided internal validation of Vitrea® CT Dual Energy Image View. Internal validation included internal user acceptance testing using various phantoms. Testing included side-by-side visual comparisons of dual energy algorithm outputs with Toshiba Display Console as the predicate device using phantom data. Details are included in Algorithm Verification and Validation.

External Validation:

During external validation, three experienced clinical experts evaluated the Vitrea CT Dual Energy Image View based on the following features: Iodine maps, Virtual non-contrast, monochromatic images, Best CNR, Blended images and Enhanced images at different energy levels. Two Radiological Technologists were provided a series of questions to obtain their feedback regarding performance and usability of each feature. In addition, a clinical radiologist evaluated multiple test cases comparing the Vitrea CT Dual Energy Image View to the Toshiba Dual Energy System Package (Predicate K132813). The radiologist was asked to rate the quality and performance of each feature to establish equivalence to the predicate device. All external validation testing passed with each expert confirming the Vitrea® CT Dual Energy Image View software fulfils the intended use and meets the needs of the user. Details of the external validation are included in the performance bench testing section.

Summary of Clinical Tests:

The subject of this 510(k) notification, Vitrea® CT Dual Energy Image View software, did not require clinical studies to support safety and effectiveness of the software.

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Cyber and Information Security:

Confidentiality

The Vitrea® platform (K150258) relies on built in Windows Login security to limit access to the system. The Vitrea platform can only be installed and configured by an administrator of the Windows machine.

Integrity

The Vitrea® platform complies with the DICOM standard for transfer and storage of this data and does not modify the contents of DICOM instances. New DICOM produced by Vitrea® is identified as such with the appropriate manufacturer tags per the DICOM standard.

Availability

The Vitrea® platform is always available to the logged on user as long as the Windows machine itself is properly maintained.

Accountabilitv

The Vitrea® platform includes an audit capability that enables accountability by tracking authenticated and authorized user operations along with information accessed. Vitrea® audit logs are time stamped, enabling correlation with Windows system logging to track information accessed by a user.

Performance Standards:

The FDA has not established mandatory performance standards and no special controls exist for this device. General software verification and validation tests were conducted to confirm proper function of the device's features.

Standard No.	StandardsOrganization	Standard Title	Version	Date
PS 3.1- 3.20 (2011)(RecognitionNumber 12-238)	NEMA	Digital Imaging andCommunications in Medicine(DICOM) Set (Radiology)	3	03/16/2012
ISO 14971:2007(RecognitionNumber 5-70)	AAMI / ANSI/ ISO	Medical Devices -Applications of RiskManagement to MedicalDevices	2007	03/16/2012
IEC 62304:2006(RecognitionNumber 13-32)	AAMI / ANSI/ IEC	Medical Device Software -Software Life CycleProcesses (Software /Informatics)	2006	08/20/2012

The Vitrea® software complies with the following voluntary recognized consensus standards:

Substantial Equivalence Analysis Conclusion:

Vital Images believes that the Vitrea® CT Dual Energy Image View software is substantially equivalent to the legally marketed Dual Energy System Package (K132813) based on a comparison of its features and its performance. The Vitrea® CT Dual Energy Image View accepts CT images acquired using different tube voltages and/or tube currents of the same anatomical location as does the Dual Energy System Package. Both predicate and subject devices are able to provide users with Monochromatic views and lodine Maps to allow for evaluation of images produced by low and high kV tube voltage.

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In addition, the verification and validation testing performed by Vital Images demonstrated the subject device is as safe and effective as the predicate device and does not raise different questions of safety and efficacy than the predicate device.

In conclusion, Vital Images believes the Vitrea® CT Dual Energy Image View software application has a similar intended use, indications for use, principle of operation, and technological characteristics as the legally marketed Dual Energy System Package (K132813).

Any noted minor differences have been explained and do not raise any different questions of safety or effectiveness when used as labeled. The implemented design controls, risk management activities, labeling, and performed tests demonstrate the safety and efficacy of the subject device. Based on the comparison information provided above, Vital Images believes the subject device should be found 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.