Visage PACS is a system for distributing, viewing, and processing medical images and reports within and outside health care environments. It is to be used only by trained and instructed health care professionals. Visage PACS consists of the following components:

Visage PACS Storage: Visage PACS Storage offers an archiving option for long-term storage of image data.

Visage PACS Web: Data that are stored on the Visage PACS Storage server can be accessed simultaneously by multiple web-based viewing stations within or outside a healthcare enterprise through web clients.

Visage CS: Visage CS is a client server system that uses thin client technology for distribution of 3D image data generated from image data of state-of-the-art scanning modalities.

Integration with other hospital information systems (HIS, RIS, CIS) is provided via special interfaces.

Only DICOM for presentation images can be used on an FDA approved monitor for mammography for primary image diagnosis. Only uncompressed or non-lossy compressed images must be used for primary image diagnosis in mammography.

Device Description

Visage PACS is a system to distribute, view, and process medical images and reports within and outside of health care environments. It consists of the following components:

Visage PACS Storage 1
-Visage PACS Web
Visage CS -

Visage PACS Storage: A server receives image data in DICOM format via the hospital network. This provides universal connections to archives, modalities and workstations. The modalities that are supported by Visage PACS Storage are listed in the DICOM Conformance Statement. Visage PACS Storage offers an archiving option for long-term storage of image data.

Visage PACS Web: Data that are stored on the Visage PACS Storage server can be accessed simultaneously by multiple web-based viewing stations within a healthcare enterprise or from elsewhere outside through web clients. The image data transfer is done in DICOM format via the Intranet or the Internet. Images can be viewed directly within a web browser (Internet Explorer). The system offers simple functions for image manipulation and measurements. Reports can be viewed together with the images on one page.

Visage CS: Visage CS is a client server system that uses thin client technology for distribution of 3D image data generated from image data of state-of-the-art scanning modalities. The thin client viewer allows to view and process 3D image data. No DICOM data is transferred to the client. Instead of image data, a stream of compressed screen content information is transmitted during interaction.

Modification: Implementation of the cardiac analysis option. With the new version of the software the user can import cardiac CT time series in order to utilize them for the LV analysis (analysis of the left ventricle). The LV analysis tool card helps with the analysis of the left ventricle in cardiac CT time series. This toolcard quides the user through an LV analysis step by step. The LV tools support the physician in finding the left ventricle in the image data. The LV tool card supports the user to find and display the long and short axes of the left ventricle and to segment the left ventricle. It supports the user to calculate the total volume of the left ventricle over one heart cycle, the stroke volume and the ejection fraction of the various LV regions and the accumulated wall motion.

AI/ML Overview

The provided 510(k) summary for K072205 (VISAGE PACS/CS 5.0) focuses on demonstrating substantial equivalence to a predicate device (AquariusNet Server/Thin client K012086) for its new cardiac analysis and other imaging features. It does not contain a detailed study with acceptance criteria and reported performance metrics in the format typically used for AI/ML device evaluations.

Instead, the submission emphasizes validation and effectiveness through a risk analysis, risk management plan, and software development process, stating that "hazard analysis, verification and validation tests (according to our software development process) and evaluations by hospitals" have been performed. However, specific quantitative acceptance criteria or detailed study results with sample sizes, expert qualifications, or ground truth methodologies are not included in the provided text.

The closest information provided related to "acceptance criteria" and "reported performance" is in the Substantial Equivalence Comparison Chart, which indicates the presence or absence of certain features in the new device and the predicate device. This is a functional comparison, not a performance study in the sense of accuracy, sensitivity, or specificity.

Given the information provided, here's what can be extracted and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

No specific quantitative acceptance criteria or reported performance metrics (e.g., sensitivity, specificity, accuracy) are provided in the document. The comparison chart below shows feature equivalence, not performance against specific clinical thresholds.

Feature	Acceptance Criteria (Not explicitly stated as numeric)	Reported Device Performance (Presence of feature)
Volume measurements	Functional capability as in predicate	Yes
Semi-automatic coronary artery segmentation	Functional capability as in predicate	Yes
Coronary artery navigation and measurement	Functional capability as in predicate	Yes
Functional analysis of the left ventricle	Functional capability as in predicate	Yes
Vessel segmentation tool with increased specificity and improved performance	Functional capability as in predicate	Yes
Fusion and side-by-side registration as separate concepts	Functional capability as in predicate	Yes
Pixel probing support in fusion mode	Functional capability as in predicate	Yes
Change of algorithm for curved slices	Functional capability as in predicate	Yes
Automatic generation of thick slices	Functional capability as in predicate	Yes
Improved bone removal for CT runoff studies	Functional capability as in predicate	Yes
Changed curved planar reformat (CPR) viewer	Functional capability as in predicate	Yes
Changed lumen view	Functional capability as in predicate	Yes
4D cardiac CT data support	Functional capability as in predicate	Yes
Automatic short/long axis view	Functional capability as in predicate	Yes
Semi-automatic segmentation of left ventricle and coronary artery	Functional capability as in predicate	Yes

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The provided document does not specify the sample size used for any test set or the data provenance for validation. It mentions "evaluations by hospitals" in a general sense but no details are given.

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

The provided document does not specify the number or qualifications of experts used to establish ground truth for any test set.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

The provided document does not describe any adjudication method for a test set.

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 is mentioned or detailed in the provided 510(k) summary. This submission predates the common requirement for such studies for many AI/ML devices.

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

The device, VISAGE PACS/CS, is a Picture Archiving and Communications System (PACS) with advanced visualization and analysis tools. Its description states: "A physician, providing ample opportunity for competent human interprets images and information delivered by VISAGE PACS/CS." This indicates that the device is intended for human-in-the-loop use. A standalone algorithm-only performance study is not described or implied. The focus is on providing tools to assist a human interpreter.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The provided document does not specify the type of ground truth used for any evaluations.

8. The sample size for the training set

The provided document does not specify details about a training set or its sample size. This is typical for submissions preceding the specific requirements for AI/ML device training data.

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

The provided document does not specify how ground truth for a training set was established, as it does not explicitly mention a training set.

Summary

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K072205

Mercury Computer Systems, Inc. 199 Riverneck Road Chelmsford, MA 01824-2820

August 22, 2007 United States of America

E. 510(k) Summary

AUG 2 9 2007

E.1 Company Identification

Company Contact: Mercury Computer Systems, Inc. 199 Riverneck Road Chelmsford, MA 01824-2820 United States of America Registration No : 3000131217 9040273 Owner/Operator No.:

E.2 Official Correspondent

Name/Contact:	David Quimby
	199 Riverneck Road
	Chelmsford, MA 01824-2820
	United States of America
	Tel.: 978-967-1699
	Fax: 978-256-0588

E.3 Date of Submission

August 22, 2007

E.4 Device Name

Trade name:	VISAGE PACS/CS
Release Version:	5.0
Common name:	VISAGE PACS/CS
Classification Name:	Picture Archiving and Communications System
Reference:	per 21 CFR 892.2050
Class:	II
Review Panel:	Radiology
Product Classification:	90 LLZ, Picture Archiving and Communications System
Previous 510(k) No.:	K062490
Guidance document:	Guidance for the submission of premarket notifications formedical image management systems (issued on July 272000)

E.5 Substantial Equivalence

The Visage PACS/CS 5.0 Software is substantially equivalent, in the opinion of Mercury Computer Systems Inc., to:

Trade name: AquariusNet Server/Thin client K012086 510(k) No.:

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Mercury Computer Systems, Inc. 199 Riverneck Road Chelmsford, MA 01824-2820

August 22, 2007 United States of America

Picture Archiving and Communications System Classification Name: per 21 CFR 892.2050 Reference: Class: II Review Panel: Radiology 90 LLZ, Picture Archiving and Communications System Product Classification: TeraRecon, Inc. Manufacturer: 200 Gregory Lane, Suite C-100 Pleasant Hill, CA 94523-3389 USA

E.6 Device Description

Visage PACS is a system to distribute, view, and process medical images and reports within and outside of health care environments. It consists of the following components:

Visage PACS Storage 1
-Visage PACS Web
Visage CS -

Visage PACS Storage

A server receives image data in DICOM format via the hospital network. This provides universal connections to archives, modalities and workstations. The modalities that are supported by Visage PACS Storage are listed in the DICOM Conformance Statement.

Visage PACS Storage offers an archiving option for long-term storage of image data. Only the data consistency on archive media is guaranteed, the system provider has to take own appropriate means (e.g. redundancy) for safety against data loss caused by media destruction. Without the archiving option, the Visage PACS system features no components for long-term data archiving. Additional archiving on film or in digital form is therefore necessary.

Visage PACS Web

Data that are stored on the Visage PACS Storage server can be accessed simultaneously by multiple web-based viewing stations within a healthcare enterprise or from elsewhere outside through web clients.

The image data transfer is done in DICOM format via the Intranet or the Internet, for example to stations located in a doctor's office, throughout hospitals or a physician's home. Strong data encryption is provided (SSL) to ensure a secure data transfer. Images can be viewed directly within a web browser (Internet Explorer). The system offers simple functions for image manipulation and measurements. Reports can be viewed together with the images on one page.

Visage CS

Visage CS is a client server system that uses thin client technology for distribution of 3D image data generated from image data of state-of-the-art scanning modalities. The thin client viewer allows to view and process 3D image data. No DICOM data is transferred to the client. It remains on the 3D Application Server at any time, ensuring safe and consistent access to large 3D data throughout the hospital enterprise. Instead of image data, a stream of compressed screen content information is transmitted during interaction.

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Mercury Computer Systems, Inc. 199 Riverneck Road Chelmsford, MA 01824-2820

August 22, 2007 United States of America

If Visage CS is used in un-secure networks (e.g. WAN) third party VPN (Virtual Private Network) solutions have to be used to secure the data transfer between the Visage Server and the client machines.

E.6.1 Description of Modification

This is to describe the significant changes associated with the implementation of the cardiac analysis option.

With the new version of the software the user can import cardiac CT time series in order to utilize them for the LV analysis (analysis of the left ventricle).

The LV analysis tool card helps with the analysis of the left ventricle in cardiac

CT time series, which show the heart in various phases of one heart beat. This toolcard quides the user through an LV analysis step by step. After the user has completed the last step the LV Results tool card is displayed as a floating window. The user can review his/her results now and export them to a report.

The LV tools support the physician in finding the left ventricle in the image data. The LV tool card supports the user to find and display the long and short axes of the left ventricle and to segment the left ventricle. It supports the user to calculate the total volume of the left ventricle over one heart cycle, the stroke volume and the ejection fraction of the various LV regions and the accumulated wall motion.

E.7 Intended Use

Visage PACS Storage: Visage PACS Storage offers an archiving option for long-term storage of image data.

Visage CS: Visage CS is a client server system that uses thin client technology for distribution of 3D image data generated from image data of state-ofthe-art scanning modalities.

Integration with other hospital information systems (HIS, RIS, CIS) is provided via special interfaces.

E.8 Substantial Equivalence Comparison Chart

Annotation:

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Mercury Computer Systems, Inc. 199 Riverneck Road Cheimsford, MA 01824-2820

Our Visage product line consists of 2D Web based PACS software and a separate 3D Visage Server and Thin Clients to give the end user a complete 2D/3D PACS experience.

Substantial Equivalence comparison chart regarding the modification:

	SE-DEVICE		PREDICATE DEVICES
Product	Visage PACS/CS 5.0	Visage PACS/CS 4.1	AquariusNetServer/Thin client
Company Name	Mercury ComputerSystems, Inc.	Mercury ComputerSystems, Inc.	TeraRecon, Inc.
510 (k) number	TBD	K062490	K012086
New Features inVersion 5.0
Cardiac AnalysisOption
Volume measure-ments	Yes	No	Yes
Semi-automaticcoronary arterysegmentation	Yes	No	Yes
Coronary arterynavigation andmeasurement	Yes	No	Yes
Functional analysisof the left ventricle(wall motion, ejec-tion fraction)	Yes	No	Yes
Additional Fea-tures
Vessel segmenta-tion tool with in-creased specificityand improved per-formance	Yes	No	Yes
Fusion and side-by-side registration asseparate concepts	Yes	No	Yes
Pixel probing sup-port in fusion mode	Yes	No	Yes
Change of algo-rithm for curvedslices	Yes	No	Yes
Automatic genera-tion of thick slices	Yes	No	Yes
Improved boneremoval for CTrunoff studies	Yes	No	Yes

Mercury Computer Systems, Inc.

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Mercury Computer Systems, Inc. 199 Riverneck Road Chelmsford, MA 01824-2820

August 22, 2007 United States of America

Product	SE-DEVICE	PREDICATE DEVICES
	Visage PACS/CS 5.0	Visage PACS/CS 4.1	AquariusNetServer/Thin client
Changed curvedplanar reformat(CPR) viewer	Yes	No	Yes
Changed lumenview	Yes	No	Yes
4D cardiac CT datasupport	Yes	No	Yes
Coronary arterynavigation andmeasurement	Yes	No	Yes
Automaticshort/long axis view	Yes	No	Yes
Semi-automaticsegmentation of leftventricle and coro-nary artery	Yes	No	Yes
Functional analysisof left ventricle	Yes	No	Yes
Volume measure-ment	Yes	No	Yes
Remaining feature as from K062490 see complete table in U.1

E.9 Safety and Effectiveness

E.9.1 General Safety and Effectiveness Concerns

VISAGE PACS/CS is a medical device that is to be used by trained health care professionals who are responsible for the correct and accurate use of medical images e.g. as a means for providing diagnosis.

The device labeling contains instructions for use and the intended use/indications for use. Warnings, faults etc are explained in the user's manual.

Data that are compressed are properly identified in the image information as being compressed as specified by the DICOM standard. This compression identification remains with the image for the entire life of the image. The correctness of the compression 30 party software is validated by the testing routine for 30 party components during the system/integration test.

E.9.2 Validation and Effectiveness

The VISAGE PACS/CS 5.0 risk analysis has been performed to identify all potential safety or health hazards during system operation. The hazards are controlled by a risk management plan, including hazard analysis, verification and validation tests (according to our software development process) and evaluations by hospitals.

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Mercury Computer Systems, Inc. 199 Riverneck Road Chelmsford, MA 01824-2820

August 22, 2007 United States of America

According to our risk analysis and risk management there are no software components within the VISAGE PACS/CS 5.0 Software, whose failure or latent design flaw would be expected to result in death or injury to a patient.

Requirement tracing covering specification, design, implementation and verification/validation ensures the fulfillment of all phase requirements, EHR and DMR ensures direct access to all documents.

Integration test plan defines full testing at integration and system testing level. According to this test plan integration and system testing including full testing of hazard mitigation has been performed.

Decision Reviews at the conclusion of each software development phase ensure the fulfillment of the phase results and the validity of the Intended Use and the risk analysis. Testing is an integral part of our Software Design Process.

E.9.3 Substantial Equivalence

Any differences between the VISAGE PACS/CS 5.0 Software and the substantially equivalent device have no significant influence on safety and effectiveness.

E.9.4 Technological characteristics

VISAGE PACS/CS is a stand-alone software package used on general purpose hardware, as long as the minimum hardware requirements specified in the manuals are met.

It is based upon standard Microsoft™ technology.

The device does not contact the patient, nor does it control any life sustaining devices.

A physician, providing ample opportunity for competent human interprets images and information delivered by VISAGE PACS/CS.

E.9.5 Conclusion

We believe that the 510(k) premarket notification contains adequate information and data to enable FDA to determine substantial equivalence to the predicate device.

VISAGE PACS/CS has been and will be manufactured in accordance with the mandatory and voluntary standards listed in this submission.

This submission contains the result of the hazard analysis and all potential hazards have been classified as minor.

Mercury Computer Systems, Inc.

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Image /page/6/Picture/11 description: The image shows a circular logo with text around the perimeter and a stylized graphic in the center. The text reads 'Department of Health & Human Services USA' in a circular arrangement. The central graphic consists of three curved lines that appear to represent stylized human figures or flowing water, creating a sense of movement and connection.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850

Mercury Computer Systems, Inc. c/o Martin Gabler Prosystem AG BEIM STROHHAUSE 27 HAMBURG, GERMANY 20097

AUG 2 9 2007

Re: K072205

VISAGE PACS/CS 5.0 Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: August 6, 2007 Received: August 8, 2007

Dear Mr. Gabler:

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/6/Picture/10 description: The image shows a logo with the text "FDA Centennial" and the years "1906-2006" in a circular design. The letters "FDA" are prominently displayed in the center of the logo. Below the letters, the word "Centennial" is written in a smaller font. Three stars are arranged beneath the word "Centennial".

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Please be advised that FDA's issuance of a substantial equivalence determination does not mean i Nat FDA has made a determination that your device complies with other requirements of the Act that I Drines made a and regulations administered by other Federal agencies. You must or any I 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 forul in and quants bysteins (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) I his letter notification. The FDA finding of substantial equivalence of your device to a legally prematicated predicated 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 if you dosn't spother 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 (21 CF I T at 00 : 77). " roof 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/cdrl/industry/support/index.litml.

Sincerely vours.

Nancy C Hodgon

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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Mercury Computer Systems, Inc. 199 Riverneck Road Chelmsford, MA 01824-2820

August 22, 2007 United States of America

D. Statement of Indications for Use

510(k) Number (if known): _ Device Name: VISAGE PACS/CS 5.0 Indications for Use:

Visage PACS Storage: Visage PACS Storage offers an archiving option for long-term storage of image data.

Visage CS: Visage CS is a client server system that uses thin client technology for distribution of 3D image data generated from image data of state-of-the-art scanning modalities.

Integration with other hospital information systems (HIS, RIS, CIS) is provided via special interfaces.

Prescription Use (Part 21 CFR 801 Subpart D)	X
----------------------------------------------	---

AND/OR

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

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER

PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

JWhang

(Division Sign-Off)
Division of Reproductive, Abdominal and
Radiological Devices
510(k) Number	K072265

Page 1 of 1

Mercury Computer Systems, Inc.

D-1

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).