Vitrea® Image Denoising software is intended to assist radiologists and specialists in the enhancement of CT and 3D-XA image presentation by enabling noise reduction and contrast enhancement technique.

Device Description

The Vitrea Image Denoising software is a tool available on the Vitrea platform. It assists radiologists and specialists in the enhancement and viewing of CT and 3D-XA images from a variety of diagnosis imaging systems by noise reduction and contrast enhancement. Vitrea Image Denoising software employs 3D analysis of the image structure of each voxel. Random noise does not have a 3D structure and can thus be separated from dominant structures. Once the structure has been determined, the denoising tool suppresses noise by averaging voxel information without removing important structural details for reducing the noise.

It provides a control to turn on or off a denoising preset in Multi-planar Reformatting (MPR) and 3D views to reduce noise and enhance contrast in reconstructed CT and 3D-XA image datasets, while preserving structural details of contrast, spatial size, and 3D structure in the native images for visual assessment. The user can interactively apply and remove the noise reduction filter during the image review to assess the effect of the noise reduction on the images and generate a new series of denoised snapshots for further review in other workstations or PACS. The denoised images can be used in conjunction with the original images as the user can switch between the original image and the denoised image while conducting image review. It also enables the user to create new denoising presets, edit existing denoising presets, and save the current denoising values as a custom preset.

AI/ML Overview

Vitrea® Image Denoising Software (K140395) - Acceptance Criteria and Study Summary

This device is a software tool intended for image enhancement via noise reduction and contrast enhancement in CT and 3D-XA images. It does not diagnose or manage disease, but rather improves the visual quality of existing images for radiologists and specialists.

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not explicitly state quantitative acceptance criteria for device performance in terms of specific metrics like Signal-to-Noise Ratio (SNR) improvement, resolution maintenance, or contrast enhancement percentages. Instead, the acceptance criteria are framed qualitatively around the preservation of diagnostic information and the perception of noise reduction by experts.

Acceptance Criteria (Qualitative)	Reported Device Performance
Noise Reduction: The software reduces noise in reconstructed CT and 3D-XA image datasets.	Internal Validation (Phantom Testing): Phantom tests validated that the amount of noise reduction is clinically significant considering the clinical use of the filter. External Validation: Experienced Radiologists and an Interventional Cardiologist felt that the Vitrea Image Denoising software reduces noise.
Contrast Enhancement: The software enhances contrast in reconstructed CT and 3D-XA image datasets.	External Validation: Experienced Radiologists and an Interventional Cardiologist felt that the Vitrea Image Denoising software... enhances contrast.
Preservation of Structural Details: Structural details of contrast, spatial size, and 3D structure in the native images are preserved.	Internal Validation (Phantom Testing): Phantom tests validated that the resulting spatial resolution, the level of image sharpness or spatial resolution after noise reduction remains acceptable for the diagnostic purposes and the low contrast resolution is not degraded after the noise reduction. External Validation: Experienced Radiologists and an Interventional Cardiologist felt that the Vitrea Image Denoising software... preserv[es] structural details of contrast, spatial size, and 3D structure in the native images for clinically relevant visual assessment.
Safety and Effectiveness: The device is as safe and effective as the predicate device and raises no new issues of safety and effectiveness.	The submission concludes that "The testing reported in this 510(k) establishes that Vitrea Image Denoising software is substantially equivalent to the Sapheneia Clarity (K063391) Image Enhancement System and is as safe and effective for its intended use." This is based on comparative analysis with the predicate device and the internal/external validation summarized above.

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

Sample Size for Test Set: The document does not specify a numerical sample size of medical images used for the external validation (usability testing). It states "various Catphan phantoms" were used for internal validation, and "previously acquired medical images" were used for software testing.
Data Provenance:
- Internal Validation (Phantom Testing): Catphan phantoms (likely synthetically generated or physical phantoms used in a controlled environment).
- External Validation: "Previously acquired medical images" were used. No specific country of origin is mentioned, but the review was conducted by US-based radiologists and an interventional cardiologist. The data is retrospective as it refers to "previously acquired" images.

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

Number of Experts: "Experienced Radiologists and an Interventional Cardiologist" were used for external validation. The exact number is not explicitly stated, but the phrasing suggests more than one radiologist.
Qualifications of Experts: They are described as "experienced Radiologists and an Interventional Cardiologist." Specific years of experience are not provided.

4. Adjudication Method for the Test Set

The document does not describe a formal adjudication method (e.g., 2+1, 3+1). The external validation involved experts evaluating the software and providing feedback ("Each user felt that..."). This suggests individual assessment rather than a consensus-driven adjudication process for ground truth establishment. Since the device enhances images for visual assessment, subjective expert opinion on image quality is a primary measure.

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

No MRMC comparative effectiveness study is mentioned, nor is an effect size indicating how much human readers improve with AI vs. without AI assistance. The study focuses on evaluating the standalone performance of the denoising software and its perceived impact on image quality.

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

Yes, a standalone performance assessment was conducted implicitly through the internal validation using phantom testing. This measured the impact of the software on noise reduction, spatial resolution, sharpness, and low contrast resolution in a controlled environment. The external validation also assesses the algorithm's output directly, as users "assess the effect of the noise reduction on the images."

7. Type of Ground Truth Used

Internal Validation: Defined characteristics of phantom images were used as ground truth (e.g., expected noise levels, spatial resolution, low contrast details).
External Validation: The subjective opinion and visual assessment of experienced medical professionals (Radiologists and an Interventional Cardiologist) served as the ground truth for evaluating the clinical relevance and effectiveness of the image enhancement. There is no mention of pathology or outcomes data being used as ground truth for this device.

8. Sample Size for the Training Set

The document does not provide information on the sample size for the training set. The device description focuses on its algorithmic approach (3D analysis of image structure, separating random noise) rather than explicitly mentioning machine learning or a training phase specific to a dataset.

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

Given the absence of information regarding a training set and the description of the denoising method as an algorithmic approach (3D analysis of image structure), it is not explicitly stated how ground truth for a training set was established. It's possible the algorithm relies on inherent image properties and mathematical models rather than a supervised learning approach with labeled training data in the traditional sense of AI/ML.

Summary

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K140395
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Vitrea® Image Denc 510(k) Pre-market Notification

VITAL
A Tepton Microsystems Group Company

510(k) Summarv

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

Purpose ofSubmission:	Vital Images, Inc. hereby submits this traditional 510(k) to providenotification submission of Vitrea Image Denoising software as an additionto the existing tools on the 510(k) cleared Vitrea platform.
Submitter:	Vital Images, Inc.5850 Opus ParkwaySuite 300Minnetonka, MN 55343-4414
EstablishmentRegistration:	2134213
Contact Person:	Parthiv ShahSr. Regulatory Affairs SpecialistPhone : 952-487-9574Fax: 952-487-9510E-mail: pshah@vitalimages.com
510(k) Type:	Traditional
Summary Date:	February 14, 2014
Device NameTrade Name:	Vitrea® Image Denoising Software
Common Name:	Image Enhancement System
Classification Name:	System, Image Processing, Radiological (21 C.F.R. 892.2050, LLZ)
Regulatory Description:	Picture Archiving and Communications System

Predicate Device: Sapheneia Commercial Products AB, Sapheneia Clarity™ (K063391)

Device Description:

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Vitrea® Image Denoising Software 510(k) Pre-market Notification

A Toshiba Medical Systems Group Company

Intended Use / Indications for Use:

Intended for Disease / Condition / Patient Population:

Not applicable as this is a medical image post processing software tool for image enhancement.

Substantial Equivalence:

With regards to safety, the Vitrea Image Denoising software is substantially equivalent to the currently marketed post-processing noise reduction software products that analyze data from medical images. Specifically, intended use, design, function and performance characteristics of Vitrea Image Denoising software are substantially equivalent to the Sapheneia Clarity (K063391) Image Enhancement System, which is manufactured by Sapheneia Commercial Products AB ("predicate device").

The comparison table below shows the equivalence between Vitrea Image Denoising software and the predicate device:

Vitrea Image Denoising(Submission Subject)	Sapheneia Clarity (K063391)(Predicate Device)	Noted Differences
Intended Use:
Vitrea® Image Denoising software isintended to assist radiologists andspecialists in the enhancement of CTand 3D-XA image presentation byenabling noise reduction and contrastenhancement technique.	The Sapheneia Clarity is intendedfor use by radiologists for transfer,storage, noise reduction, contrastenhancement and viewing of multi-modality images from a variety ofdiagnostic systems.The device is also intended to beused by trained/qualifiedtechnologists for installation andmaintenance of the software. Foryour legal protection, it is stronglyrecommended that you backup youroriginal data.For digital mammography, onlyDICOM 'For Presentation' imagesshould be displayed for primaryimage diagnosis.	None
Intended Users:
Radiologists and specialists.	Radiologists and technologists.	None

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: 上一篇:

Vitrea Image Denoising(Submission Subject)	Sapheneia Clarity (K063391)(Predicate Device)	Noted Differences
Modality Support:
CT and 3D-XA.	Multi-modality (CT, MR, 3D-XA).	Our software supportsCT and 3D-XA datasetsas the predicate device.Note: Our softwaredoes not support MRdatasets.

The technological comparison table below shows the equivalence between Vitrea Image Denoising software and the predicate device:

Vitrea Image Denoising(Submission Subject)	Sapheneia Clarity (K063391)(Predicate Device)	Noted Differences
Device Description:
Vitrea Image Denoising software is asoftware tool available on the Vitreaplatform. It assists radiologists andspecialists in the enhancement andviewing of CT and 3D-XA modalityimages from a variety of diagnosisimaging systems by noise reductionand contrast enhancement.	The Sapheneia Clarity imageprocessing software reduces noiseand enhances contrast of relevantstructures to increase image qualitythrough structure adaptation, tissueadaptation, scale adaptation, andnoise adaptation.	None
Random noise does not have a 3Dstructure and can thus be separatedfrom dominant structures.	Using robust estimation methodsthe dominant structures areseparated from the embeddingnoise.	None
Once the structure has beendetermined, it is possible to suppressnoise by averaging voxel informationwithout removing important structuraldetails for reducing the noise.	Once the structure has beendetermined, it is possible tostrengthen the interesting partswhile simultaneously reducing thenoise.	None
The acquisition remains the same,i.e., the image processing can begenerated from CT and 3D-XAmodalities and with predefined orspecific acquisition protocol settings.	The acquisition remains the same,i.e. the image processing can begenerated from multiple modalitiesand with predefined or specificacquisition protocol settings.	None

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100 - 100 - 100 -

Vitrea Image Denoising(Submission Subject)	Sapheneia Clarity (K063391)(Predicate Device)	Noted Differences
Characteristics:
ImageEnhancement System.	ImageEnhancement System.	None
Where Used (Hospital, Home, Ambulance, etc.)
Medical facility.	Medical facility.	None
User Interface:
The software is designed for use on aradiology workstation.	The software is designed for use on aradiology workstation.	None
DICOM Standard Compliance:
The software processes DICOM 3.0compliant image data.	The software processes DICOM 3.0compliant image data.	None
Noise Reduction Method:
Image-space noise reduction method.	Image-space noise reductionmethod.	None
Separation of embedding noise fromdominant structures.	Separation of embedding noisefrom dominant structures.	None
Level:
Voxel (volumetric pixel) level noisereduction.	Pixel level noise reduction.	None

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Vitrea® Image Denoising Software 510(k) Pre-market Notification

Vitrea Image Denoising(Submission Subject)	Sapheneia Clarity (K063391)(Predicate Device)	Noted Differences
Vitrea Image Denoising softwareemploys 3D analysis of the imagestructure in the neighborhood of eachvoxel.	Sapheneia Clarity employs asophisticated statistical analysis ofthe image structure in theneighborhood of each pixel.	Both methods aim atdistinguishing structurefrom noise.Statistical analysisdistinguishes betweenthe two by studying thestatistical distribution ofthe data whereas 3Danalysis studies the firstand second orderderivatives of the imagedata to determine thedominant direction ofstructure if it exists.

Vital Images believes that Vitrea Image Denoising software has the same intended use i.e. enhancement of CT and 3D-XA images, similar indication statement i.e. to be used by trained radiologists and specialists at a medical facility, and similar technological characteristics i.e. image-space noise reduction method as the predicate device.

The above noted difference in the method of image structure analysis, i.e. Vitrea Image Denoising software uses 3D analysis and Sapheneia Clarity uses statistical analysis method to analyze image structure; does not alter the end result of the software, which is to distinguish structure from noise.

Vital Images believes that the verification and validation results demonstrate that Vitrea Image Denoising software is as safe and effective as the predicate device and raises no new issues of safety and effectiveness as compared to the predicate devices. Therefore, Vital Images believes that FDA should find Vitrea Image Denoising software to be substantially equivalent to the predicate device, Sapheneia Clarity.

Summary of Non-Clinical Tests:

The software was designed, developed and tested according to written procedures that included applying risk management. Software testing was completed to ensure the new feature operates according to its requirements and without impact to existing functionality. Testing included verification, validation, and evaluation of previously acquired medical images.

The following quality assurance measures were applied to the development of Vitrea Image Denoising software:

Risk analysis .
Requirements reviews .
Design reviews .
Verification of the software that included performance and safety testing .
Validation of the software that included phantom testing and simulated usability testing by . independent experienced medical professionals.

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Risk analvsis:

Vital Images performed a risk analysis, referring to software hazards associated with the intended use, including severity assessment and mitigation. The analysis was based upon the application of ISO 14971:2012 risk management to medical devices, in compliance with medical device ISO 13485:2012 and IEC 62304:2006 requirements.

All identified risks were reduced as low as possible. The medical benefits of the software outweigh the residual risk for each individual risks together. The overall residual risk for the software was deemed acceptable.

Verification:

The software verification team's primary goal is assuring the software fully satisfies all expected system requirements and features. Test cases were executed against the system features and requirements. As 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 is 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 Image Denoising software. Internal validation included internal beta testing and internal user acceptance testing using various Catphan phantoms. The performed phantom tests validated that the amount of noise reduction is clinically significant considering the clinical use of the filter and the resulting spatial resolution, the level of image sharpness or spatial resolution after noise reduction remains acceptable for the diagnostic purposes and the low contrast resolution is not degraded after the noise reduction.

External Validation:

During external validation of Vitrea Image Denoising software, experienced Radiologists and an Interventional Cardiologist evaluated the Vitrea Image Denoising software. Each user felt that the Vitrea Image Denoising software reduces noise and enhances contrast in reconstructed CT and 3D-XA image datasets, while preserving structural details of contrast, spatial size, and 3D structure in the native images for clinically relevant visual assessment.

Summary of Clinical Tests:

The subject of this traditional 510(k) notification. Vitrea Image Denoising software, did not require clinical studies to support safety and effectiveness of the software.

Cyber and Information Security:

Confidentiality .
The Vitrea platform 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.
· Intearity
The Vitrea platform complies with the DICOM standard for transfer and storage of this data and does not modify the contents of DICOM instances. Vitrea platform identifies the data it produces, marking and encoding the appropriate DICOM fields.
. Availability
The Vitrea platform is always available to the logged on user as long as the Windows machine itself is properly maintained.

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K140395
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Vitrea® Image Deñoising Software 510(k) Pre-market Notification

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Accountability

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 Standard:

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 inMedicine (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

Vitrea Image Denoising software complies with following voluntary recognized consensus standards:

Conclusion:

The testing reported in this 510(k) establishes that Vitrea Image Denoising software is substantially equivalent to the Sapheneia Clarity (K063391) Image Enhancement System and is as safe and effective for its intended use.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/7/Picture/1 description: The image shows a circular seal with text around the perimeter and a symbol in the center. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". The symbol in the center consists of three stylized lines that appear to be flowing or waving.

Public Health Service

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

May 13, 2014

Vital Images, Inc. % Mr. Parthiv Shah Sr. Regulatory Affairs Specialist 5850 Opus Parkway, Suite 300 MINNETONKA MN 55343

Re: K140395

Trade/Device Name: Vitread Image Denoising Software Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: 11 Product Code: LLZ Dated: February 14, 2014 Received: February 18, 2014

Dear Mr. Shah:

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 svstems (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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Page 2-Mr. Shah

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/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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.hum.

Sincerely yours,

. Smh.7)

for

Janine M. Morris 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 Form

510(k) Number (if known): _K140395

Device Name: Vitrea® Image Denoising Software

Indications for Use:

Prescription Use × (Part 21 CFR 801 Subpart D)

AND/OR

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

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)

Sm.h.7)

Division Sign-Off Office of In Vitro Diagnostics and Radiological Health

K140395 510(k) -

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Regulation Number and Section

§ 892.2050 Medical image management and processing system.

(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).