ViTALConnect, Version 4.0 is a medical diagnostic software system intended to process, analyze, review, and distribute multi-dimensional digital images acquired from a variety of imaging devices including: CT, MR, CR/DR/DX, SC, US, NM, PET, XA, and RF, etc. In addition, the ViTALConnect system has the following specific intended uses:

Advanced Vessel Analysis is an option within the ViTALConnect system intended to aid clinicians in the study and analysis of selected vessels, the inspection of circulatory anatomy, the quantification of stenosis, distance measurements and cross-sectional diameters, volume measurements, and assist in the planning and monitoring of vascular therapies. The feature operates with CT and MRI data.

Pet Visualization is an option within the ViTALConnect system that provides for the overlay, inspection, and measurement of two different image modalities (primarily directed at PET/CT). The option also includes the ability to measure Standard Uptake Values on PET datasets.

The overlay operation enables clinicians to obtain a better understanding of the joint information that would otherwise have to be compared separately. It is important to note that the clinician retains the ultimate responsibility for making pertinent diagnosis based on their standard procedures, including visual comparison of separate images.

Collaboration Mode is a capability within the ViTALConnect system that allows multiple users to collaboratively interact with ViTALConnect system features and tools.

Device Description

The ViTALConnect 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.

The ViTALConnect system provides multi-dimensional visualization of digital images to aid clinicians in their analysis of anatomy and pathology. The ViTALConnect system 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

The provided text is a 510(k) summary for the VITALConnect™ 4.0 - Medical Image Processing Software. It describes the device, its intended use, and a comparison to a predicate device. However, it does not contain the specific details required to fully address your request regarding acceptance criteria and a study proving those criteria are met.

Here’s a breakdown of what can be answered based on the provided text, and what information is missing:

Acceptance Criteria and Device Performance (Missing Information)

The document does not explicitly state any quantitative acceptance criteria for the device's performance, nor does it provide a table of reported device performance against such criteria. The focus of this 510(k) summary is on establishing substantial equivalence to a predicate device rather than presenting a detailed performance study with metrics.

Study Details (Incomplete Information)

The document mentions "Summary of Studies" but provides very high-level descriptions, not a detailed study report.

Sample size used for the test set and the data provenance: Not specified. The document states "Software Beta testing/validation will be successfully completed prior to release," but it doesn't mention the size or origin of the data used for this testing.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not specified.
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: Not specified. The document focuses on the software as a processing and visualization tool, not an AI-assisted diagnostic aid that would typically warrant an MRMC study with improvement effect sizes.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not specified. While the software processes images, the descriptions always imply a clinician in the loop (e.g., "aid clinicians in the study and analysis," "clinician retains the ultimate responsibility").
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not specified.
The sample size for the training set: Not applicable/Not specified. The document describes software that processes and analyzes pre-acquired images. It doesn't describe a machine-learning model that undergoes "training" in the typical sense with a separate training set.
How the ground truth for the training set was established: Not applicable/Not specified.

Summary of Available Information from the Text:

Information Category	Details from Provided Text
Acceptance Criteria & Device Performance	Not explicitly stated. The document is a 510(k) summary focusing on substantial equivalence to a predicate device (VITALConnect System - K040876). It states: "The ViTALConnect 4.0 system will successfully complete integration testing/verification testing prior to Beta validation. Software Beta testing/validation will be successfully completed prior to release." This implies internal acceptance criteria for software quality and functionality were met, but these are not disclosed.
Sample size (Test Set)	Not specified. "Software Beta testing/validation will be successfully completed prior to release."
Data Provenance (Test Set)	Not specified.
Number of Experts / Qualifications (Test Set)	Not specified.
Adjudication Method (Test Set)	Not specified.
MRMC Comparative Effectiveness Study	No indication of an MRMC study. The device is described as a processing, review, analysis, and communication system. Its features aid clinicians but there is no mention of comparative effectiveness or "AI vs without AI assistance" which would suggest an MRMC study. The text primarily describes the device's functionality rather than a change in diagnostic accuracy for human readers.
Standalone Performance Study	Not explicitly stated as a "standalone" study in the sense of algorithm-only diagnostic performance. The entire description, particularly for features like Advanced Vessel Analysis and Pet Visualization, emphasizes the system aiding clinicians, with the clinician retaining responsibility for diagnosis. This suggests a human-in-the-loop context.
Type of Ground Truth Used	Not specified.
Sample Size (Training Set)	Not applicable/Not specified. The document describes a general medical image processing software, not a machine learning or AI algorithm that would typically have a "training set" for model development. The "studies" mentioned refer to general software development, testing, and validation according to written procedures, and risk management.
Ground Truth Establishment (Training Set)	Not applicable/Not specified. As there's no mention of a training set for a machine learning model, the method for establishing ground truth for such a set is not applicable here. The ground truth for software validation would typically involve comparing processed output against expected results or human expert evaluation for accuracy of measurements and visualizations, but these details are not provided in this summary.

Conclusion from the provided text:

This 510(k) summary focuses on demonstrating that the VITALConnect™ 4.0 system is substantially equivalent to its predicate device (VITALConnect System - K040876) based on similar intended uses and technological characteristics. It mentions that the software was "designed, developed, tested, and validated according to written procedures" and would undergo "integration testing/verification testing" and "Software Beta testing/validation." However, it does not provide the detailed performance metrics, study designs, sample sizes, ground truth establishment, or expert involvement that your request specifically asks for. This type of detailed performance data is often found in the full 510(k) submission or supplementary documents, not typically in the summary provided.

Summary

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6.0 510(k) Summary

Submitter's Name / Contact Person

AUG 1 0 2006

Timothy J. Kappers, MBA, RAC Director, Quality Systems, Regulatory & Clinical Affairs Vital Images, Inc. 5850 Opus Parkway, Suite 300 Minnetonka, MN 55343

General Information

Device Trade Name	VITALConnect™ 4.0 - Medical Image Processing Software
Common / Usual Name	System, Image Processing, Radiological
Classification	892.2050 Picture Archiving and Communications System(LLZ; Class II)
Identification ofPredicate Devices	VITALConnect System- formally The iConnection System(K040876)Vital Images, Inc.

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 .

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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

Intended Use

Collaboration Mode is a capability within the ViTALConnect system that allows multiple users to collaboratively interact with ViTALConnect system features and tools.

Predicate Device Comparison

The ViTALConnect 4.0 system and its predicate device allow for the analysis, communication and media interchange of digital images acquired from a variety of acquisition devices. All 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.

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The ViTALConnect 4.0 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.

Conclusion

The ViTALConnect 4.0 system has the same intended uses 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 ViTALConnect 4.0 system is substantially equivalent to the predicate device.

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Image /page/3/Picture/1 description: The image is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around the edge. In the center of the seal is a stylized image of an eagle with its wings spread. The eagle is facing to the right and has three stripes on its wings.

Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850

AUG 1 0 2006

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

Re: K062154

Trade/Device Name: ViTAL Connect™ 4.0 Medical Image Processing Software Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: July 24, 2006 Received: July 28, 2006

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 (Premarket Approval), 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.

Image /page/3/Picture/10 description: The image is a black and white circular logo. The logo commemorates the centennial anniversary from 1906-2006. The letters "FDA" are in the center of the logo. The word "Centennial" is written below the letters "FDA".

Protecting and Promoting Public Health

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Page 2 -

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.

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 this letter:

21 CFR 876.xxx	(Gastroenterology/Renal/Urology)	240-276-0115
21 CFR 884.xxx	(Obstetrics/Gynecology)	240-276-0115
21 CFR 894.xxx	(Radiology)	240-276-0120
Other		240-276-0100

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 from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150

or at its Internet address http://www.fda.gov/cdrlvindustry/support/index.html.

Sincerely yours, .

Nancy Cbrogdon

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

Enclosure

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3.0 Intended Use Statement

510(k) Number (if known): __ K o L 2 15 1 Device Name: ViTALConnect™ 4.0 Medical Image Processing Software

Collaboration Mode is a capability within the ViTALConnect system that allows multiple users to collaboratively interact with ViTALConnect system features and tools.

Over-The-Counter Use Prescription Use X AND/OR (21 CFR 801 Subpart C) (Part 21 CFR 801 Subpart D) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Nancy C Hodgson

Page of

(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K062154

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).