Vitrea 2 is a medical diagnostic system that allows the processing, review, analysis, communication and media interchange of multi-dimensional digital images acquired from a variety of imaging devices. In addition, the Vitrea 2 system has the following specific indication:

Fusion7D is an option within the Vitrea 2 system and is intended to register pairs of anatomical and functional volumetric images (e.g., MRI-SPECT, MRI-PET, CT-SPECT, CT-PET), or pairs of anatomical volumetric images (e.g., MRI-MRI, CT-CT, and MRI-CT) as a means to ease the comparison of image data. The result of the registration operations aims to help the clinician obtain a better understanding of the joint information that would otherwise have to be compared separately. This is useful for a wide range of clinical and therapeutic applications. It is important to note that the clinician retains the ultimate responsibility for making the pertinent diagnosis based on their standard procedures, including visual comparison of the separate unregistered images. Fusion7D is a complement to these standard procedures.

Softread, is an option within the Vitrea 2 system and is intended to allow the examination and manipulation of a series of 2D images in a variety of modalities, including CT, MR, CR/DR/DX, SC, US, NM, PET, XA, and RF, etc. The option also enables clinicians to compare multiple series' for the same patient, side-by-side, and to switch to Vitrea to further examine the data in a 3D volume.

Device Description

The Vitrea 2 system is a medical diagnostic device that allows the processing, review, analysis, communication and media interchange of multi-dimensional digital images acquired from a variety of imaging devices. Vitrea 2, Version 3.5 is an upgrade to Vitrea 2, Version 3.4 (cleared under K032748).

The Vitrea 2 system provides multi-dimensional visualization of digital images to aid clinicians in their analysis of anatomy and pathology. The Vitrea 2 user interface follows typical clinical workflow patterns to process, review, and analyze digital images, including:

. Retrieve image data over the network via DICOM
. Display images that are automatically adapted to exam type via dedicated protocols
. Select images for closer examination from a gallery of up to six 2D or 3D views
. Interactively manipulate an image in real-time to visualize anatomy and pathology
. Annotate, tag, measure, and record selected views
Output selected views to standard film or paper printers, or post a report to an Intranet Web server or export views to another DICOM device
. Retrieve reports that are archived on a Web server

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the Vitrea 2, Version 3.5 Medical Image Processing Software:

Summary of Acceptance Criteria and Device Performance:

The provided document describes the Vitrea 2, Version 3.5 software as an upgrade to a previously cleared device (Vitrea 2, Version 3.4) and for image processing, review, analysis, communication, and media interchange of multi-dimensional digital images. It also includes specific options: Fusion7D for image registration and Softread for 2D image examination and manipulation.

However, the document does not explicitly state specific quantitative acceptance criteria or detailed device performance metrics in a structured table. The primary "acceptance criteria" presented is the determination of substantial equivalence to predicate devices. The study's conclusion is that the device "has the same intended use as the predicate device and has very similar technological characteristics. Minor technological differences do not raise any new questions regarding safety or effectiveness of the device."

Therefore, based on the provided text, a table summarizing quantitative acceptance criteria and reported performance cannot be generated as these details are not present. The "study" described is a declaration of compliance with internal development and testing procedures, culminating in a finding of substantial equivalence by the FDA.

Detailed Breakdown of Study Information (based on available text):

Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criterion	Reported Device Performance
General:
Substantial Equivalence to Predicate Devices	"The Vitrea 2, Version 3.5 system has the same intended use as the predicate device and has very similar technological characteristics. Minor technological differences do not raise any new questions regarding safety or effectiveness of the device. Thus, the Vitrea 2, Version 3.5 system is substantially equivalent to the predicate device."
Compliance with Design, Development, Testing Procedures	"The software utilized was designed, developed, tested, and validated according to written procedures. These procedures specify individuals within the organization responsible for developing and approving product specifications, coding, testing, validating and maintenance."
Integration/Verification Testing	"The Vitrea 2, Version 3.5 system will successfully complete integration testing/verification testing prior to Beta validation."
Beta Testing/Validation	"Software Beta testing/validation will be successfully completed prior to release."
Risk Management	"potential hazards have been studied and controlled by a Risk Management Plan."
Specific Functionality (Inferred):	(No quantitative performance criteria or results are provided for specific functionalities like image registration accuracy or display performance beyond the general statement of substantial equivalence.)

Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Sample Size: Not specified. The document mentions "integration testing/verification testing" and "Software Beta testing/validation" but does not provide details on the number of cases or images used in these tests.
- Data Provenance: Not specified.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- Not specified. The document mentions "clinicians" in the intended use description but does not detail their involvement in establishing ground truth for any testing.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not specified.
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 is described. The document focuses on showing substantial equivalence based on technical characteristics and internal testing, not on comparative clinical performance or human reader improvement. The device's function (image processing, registration, visualization) is supportive of clinical analysis but is not presented as an AI solution for automated diagnosis or a system designed to improve human reader performance in a measurable way through a specific "AI assistance" metric in this context.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No specific standalone performance study with quantitative results for the algorithm is described. The "study" pertains to internal software development and validation processes, and a general assertion of substantial equivalence. The discussion around "Fusion7D" explicitly states that the "clinician retains the ultimate responsibility for making the pertinent diagnosis based on their standard procedures, including visual comparison of the separate unregistered images." This indicates a human-in-the-loop expectation rather than a standalone diagnostic claim for the algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not specified. Given the nature of the device (image processing and visualization tools), ground truth would likely relate to the accuracy of image registration, quality of visualization, and correctness of measurements rather than diagnostic accuracy against pathology or outcomes data. However, the document does not elaborate on how this ground truth would be established or used.
The sample size for the training set:
- Not specified. The document describes a software upgrade and general development processes, not a machine learning model requiring a distinct training set. If there are any learning components within the device (e.g., for image recognition or feature extraction), the document does not detail their training.
How the ground truth for the training set was established:
- Not specified, as a training set and its associated ground truth are not mentioned in the context of this submission.

Summary

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FEB 2 4 2004

6.0 510(k) Summary

Submitter's Name / Contact Person

Timothy J. Kappers, RAC Manager, Regulatory Affairs Vital Images, Inc. 3300 Fernbrook Lane N, Suite 200 Plymouth, MN 55447

General Information

Trade Name	Vitrea 2, Version 3.5 Medical Image Processing Software
Common / UsualName	System, Image Processing, Radiological
Classification Name	LLZ, Class II, CFR 21 892.2050
Predicate Devices	Vitrea 2, Version 3.4 (K032748)Vital Images, Inc.Fusion7D (K020546)Mirada Solutions, Ltd.

Device Description

. Retrieve image data over the network via DICOM
. Display images that are automatically adapted to exam type via dedicated protocols
. Select images for closer examination from a gallery of up to six 2D or 3D views
. Interactively manipulate an image in real-time to visualize anatomy and pathology
. Annotate, tag, measure, and record selected views
� Output selected views to standard film or paper printers, or post a report to an Intranet Web server or export views to another DICOM device
. Retrieve reports that are archived on a Web server

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Intended Use

Vitrea" 2 is a medical diagnostic system that allows the processing, review, analysis, communication and media interchange of multi-dimensional digital images acquired from a variety of imaging devices. In addition, the Vitrea 2 system has the following specific indication:

Fusion?D™ is an option within the Vitrea 2 system and is intended to register pairs of anatomical and functional volumetric images (e.g., MRI-SPECT, MRI-PET, CT-SPECT, CT-PET), or pairs of anatomical volumetric images (e.g., MRI-MRI, CT-CT, and MRI-CT) as a means to ease the comparison of image data. The result of the registration operations aims to help the clinician obtain a better understanding of the joint information that would otherwise have to be compared separately. This is useful for a wide range of clinical and therapeutic applications. It is important to note that the clinician retains the ultimate responsibility for making the pertinent diagnosis based on their standard procedures, including visual comparison of the separate unregistered images. Fusion7D is a complement to these standard procedures.

Predicate Device Comparison

The Vitrea 2, Version 3.5 system and its predicate devices allow for the analysis, communication and media interchange of digital images acquired from a variety of acquisition devices support the DICOM protocol for communication of images with other medical imaging devices.

Summary of Studies

The software utilized was designed, developed, tested, and validated according to written procedures. These procedures specify individuals within the organization responsible for developing and approving product specifications, coding, testing, validating and maintenance.

The Vitrea 2, Version 3.5 system will successfully complete integration testing/verification testing prior to Beta validation. Software Beta testing/validation will be successfully completed prior to release. In addition, potential hazards have been studied and controlled by a Risk Management Plan.

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Conclusion

The Vitrea 2, Version 3.5 system has the same intended use as the predicate device and has very similar technological characteristics. Minor technological differences do not raise any new questions regarding safety or effectiveness of the device. Thus, the Vitrea 2, Version 3.5 system is substantially equivalent to the predicate device.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling a stylized caduceus or a bird in flight, composed of three curved lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 2 4 2004

Vital Images, Inc. % Mr. Mark Job Responsible Third Party Regulatory Technology Services LLC 1394 25th Street NW BUFFALO MN 55313

Re: K040305 Trade/Device Name: Vitrea™ 2 Version 3.5 Medical Image Processing Software Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: 90 LLZ Dated: February 4, 2004 Received: February 9, 2004

Dear Mr. Job:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); 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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This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of the letter:

8xx. 1xxx	(301) 594-4591
876.2xxx, 3xxx, 4xxx, 5xxx	(301) 594-4616
884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx	(301) 594-4616
892.2xxx, 3xxx, 4xxx, 5xxx	(301) 594-4654
Other	(301) 594-4692

Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Nancy C. Brogdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

Page 2

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INDICATIONS FOR USE STATEMENT

510(k) Number (if known):

Device Name: Vitrea 2, Version 3.5 Medical Image Processing Software

K646205

Indications for Use:

Fusion7D" is an option within the Vitrea 2 system and is Intended to register pairs of anatomical and functional volumetric images (e.g., MRI-SPECT, MRI-PET, CT-SPECT, CT-PET), or pairs of anatomical volumetric images (e.g., MRI-MRI, CT-CT, and MRI-CT) as a means to ease the comparison of image data. The result of the registration operations aims to help the clinician obtain a better understanding of the joint information that would otherwise have to be compared separately. This is useful for a wide range of clinical and therapeutic applications. It is important to note that the clinician retains the ultimate responsibility for making the pertinent diagnosis based on their standard procedures, including visual comparison of the separate unregistered Images. Fusion?D is a complement to these standard procedures.

Softread, is an option within the Vitrea 2 system and is intended to allow the examination and manipulation of a series of 2D images in a variety of modalities, including CT, MR, CR/DR/DX, SC, US, NM, PET, XA, and RF, etc. The option also enables clinicians to compare multiple serles' for the same patient, side-by-side, and to switch to Vitroa to further examine the data in a 3D volume.

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

oncurrence of CDRH, Office of Device Evaluation (ODE

Prescription Use

Daniel R. Legere

Reproductive, Abdominal,

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).