The Image-Arena/Research-Arena Applications software tool package is intended to acquire, store, retrieve, analyze and report digital ultrasound studies. The Image-Arena Platform and the Research-Arena Platform are based on a SQL - database intended as image management system especially for medical ultrasound studies.

The Image-Arena/Research-Arena Applications software can import certain digital 2D or 3D image file formats for 2D/3D and 4D tomographic reconstructions and surface rendering.

The software is suited to stand-alone workstations as well as networked multisystem installations and is therefore an image management system for research and routine use in both physician practices and hospitals. It is intended as a general purpose digital medical image processing tool for cardiology, radiology, neurology, gastroenterology, urology, surgery, obstetrics and gynecology.

Device Description

The hardware requirements are based on an Intel Pentium high performance computer system and Microsoft® Windows XP Professional™ or Microsoft® Windows 2000 Professional™ Operating System standards. The Image-Arena/Research-Arena Applications are a software tool package designed for analysis, documentation and archiving of ultrasound studies in multiple dimensions. The Image-Arena/Research-Arena Applications software tools are modular structured and consist of different software modules, combining the advantages of the previously FDA 510(k) cleared TomTec software product lines Echo-View and Echo-Com and Siemens Axius™ software applications. The different modules can be combined on the demand of the users to fulfil the requirements of a clinical researcher or routine oriented physician.

The Image-Arena/Research-Arena Applications offer features to import different digital 2D, 3D and 4D (dynamic 3D) image formats based on defined file format standards (DICOM-, HPSONOS-, TomTec- file formats) as well as analogue video acquisition in one system, thus making image analysis independent of the ultrasound-device or other imaging devices used.

Offline measurements, documentation in standard report forms, the possibility to implement user-defined report templates and instant access to the stored data through digital archiving make it a flexible tool for image analysis and storage of different imaging modalities data including B-mode, M-mode, Pulsed (PW) Doppler mode, Continuous (CW) wave Doppler mode, Power Amplitude Doppler mode, Color Doppler mode, Doppler Tissue Imaging and 3D/4D imaging modes.

AI/ML Overview

The provided 510(k) summary for the TomTec Imaging Systems Image-Arena/Research-Arena Applications does not contain the detailed information necessary to answer all parts of your request. This document is focused on demonstrating substantial equivalence to predicate devices and detailing the intended use and technological characteristics, rather than providing a detailed report on a specific performance study with acceptance criteria.

While the document states that "Testing was performed according to internal company procedures. Software testing and validation were done at the module and system level according to written test protocols established before testing was conducted. Test results were reviewed by designated technical professionals before software proceeded to release," it does not provide the specifics of these tests.

However, I can extract what is available and indicate where information is missing:

Acceptance Criteria and Study for TomTec Image-Arena/Research-Arena Applications

1. Table of Acceptance Criteria and Reported Device Performance

Performance Metric	Acceptance Criteria	Reported Device Performance
Overall Performance	Not explicitly stated in the document. The general acceptance criteria inferred is that the software functions as designed for analysis, documentation, and archiving of ultrasound studies.	"Test results support the conclusion that actual device performance satisfies the design intent. Actual device performance as tested internally conforms to the system performance specifications."
Specific Functionality (e.g., Image Import, Analysis, Archiving)	Not explicitly stated. Internal test protocols would define these.	The device "offers features to import different digital 2D, 3D and 4D ... image formats based on defined file format standards (DICOM-, HPSONOS-, TomTec- file formats)." It also provides "offline measurements, documentation in standard report forms, the possibility to implement user-defined report templates and instant access to the stored data through digital archiving." This implies these functions were validated against internal specifications.
System Compatibility	Not explicitly stated.	"The hardware requirements are based on an Intel Pentium high performance computer system and Microsoft® Windows XP Professional™ or Microsoft® Windows 2000 Professional™ Operating System standards." The software "has been transferred to Microsoft® Windows XP Professional™ operating system standards."
User Interface Improvement	Not explicitly stated.	"The graphic user interface has been improved for faster and easier application."

Missing Information: The document does not provide specific quantitative acceptance criteria (e.g., sensitivity, specificity, measurement accuracy thresholds) or the numerical results from performance tests. It relies on a general statement of conformance to internal specifications.

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

Test Set Sample Size: Not specified. The document only mentions "Software testing and validation were done at the module and system level."
Data Provenance: Not specified. It's unclear if the test data was retrospective or prospective, or its country of origin. Given the company is German-based, it's possible some data was from Germany, but this is an inference.

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

Number of Experts: Not specified. The document states "Test results were reviewed by designated technical professionals," but does not specify their number, roles, or qualifications (e.g., radiologists, cardiologists).
Qualifications of Experts: Not specified.

4. Adjudication Method for the Test Set

Adjudication Method: Not specified. The document only indicates review by "designated technical professionals." No details on how discrepancies or disagreements were handled are provided.

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

MRMC Study: No, this document does not describe an MRMC comparative effectiveness study. The device is a "software tool package designed for analysis, documentation and archiving" and an "image management system," not an AI diagnostic algorithm meant to directly improve human reader performance in interpreting images. Therefore, an MRMC study comparing human readers with and without AI assistance would not be directly applicable or expected for this type of device.

6. Standalone (Algorithm Only) Performance Study

Standalone Study: Yes, implicitly. The document describes "Software testing and validation were done at the module and system level." This implies that the software's functionality, such as image import, processing, measurement capabilities, and archiving, was evaluated for its accuracy and functionality in isolation, conforming to its "design intent" and "system performance specifications." However, no specific details or results of these standalone tests are provided, particularly for advanced analysis features like "Axius Quantitative Strain Rate Imaging" or "Axius Edge Assisted Ejection Fraction."

7. Type of Ground Truth Used

Type of Ground Truth: Not specified. For a software suite of this nature, ground truth would likely refer to objective verification of its functionality (e.g., successful import/export, accurate calculation of measurements against known inputs, proper archiving and retrieval) rather than clinical diagnostic ground truth like pathology or outcomes data. If clinical features like "Axius Edge Assisted Ejection Fraction" involve automated measurements, the ground truth would be precise, independently verified measurements from the images, potentially established by expert consensus or comparison to gold standard techniques. However, this is not detailed.

8. Sample Size for the Training Set

Training Set Sample Size: Not applicable/Not specified. This 510(k) summary describes a software platform and applications that combine functionalities of previously cleared devices and update them for new operating systems. There is no indication that this specific submission involves a machine learning algorithm requiring a "training set" in the modern sense. It appears to be rule-based or algorithmic, rather than data-driven AI that learns from a large training dataset.

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

Ground Truth for Training Set: Not applicable/Not specified. As there's no mention of a traditional "training set" for a machine learning model, the establishment of ground truth for such a set is not discussed.

Summary

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K040 546

APR 2 7 2004

Image /page/0/Picture/2 description: The image shows the logo for Tomtec Imaging Systems. The logo is in black and white and features the word "Tomtec" in large, bold letters. Below the word "Tomtec" is the phrase "Imaging Systems" in smaller letters. The logo is simple and modern.

Feb. 12th, 2004

Traditional 510(k) Summary

Image-Arena Applications Research-Arena Applications

Image-Arena Platform 3.x Research-Arena Platform 1.x 4D Cardio-View 2.x 4D LV-Analysis 2.x 4D Surgical-View 2.x 4D Echo-View 6.x 4D Easy-View 3.x 4D Omni-View 3.x 4D Parametric-View 1.x Echo-Com 3.x Image-Com 3.x Doku-Com 3.x Axius Quantitative Strain Rate Imaging (Axius QSI) Axius M-Mode DTI (Axius M-Mode DTI) Axius Advanced Contrast Quantification (Axius ACQ) Axius Edge Assisted Ejection Fraction (Axius Edge Assisted EF)

Name and Address

TomTec Imaging Systems GmbH Edisonstrasse 6 D-85716 Unterschleissheim

Contact Person

Ralf Janitz QM & RA Manager ++49-89-32175-830 Phone Phone ++49-89-32175-750 Fax

Common, Classification & Proprietary Names Common Name: Various Ultrasound Image Analysis Software & System

Classification Name:

Ultrasonic Pulsed Echo Imaging System

Image /page/0/Picture/14 description: The image shows a series of black, angled lines arranged in a somewhat circular or spiral pattern. The lines are thick and appear to be oriented in a way that suggests movement or rotation. The overall impression is abstract and geometric, with a focus on the repetition and arrangement of the angled lines.

summarv

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TOMTEC
IMAGING SYSTEMS

Proprietary Name(s):

Image-Arena Applications Research-Arena Applications

Predicate Device

Tom Tec	Echo-View	K022824
TomTec	Echo-Com	K001592
Siemens	Sequoia™ Diagnostic Ultrasound System Signature II,Axius™ SW Applications	K022567
Siemens	Sequoia™ Diagnostic Ultrasound SystemAxius™ SW Applications	K032114

Device Description

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Image /page/2/Picture/0 description: The image shows the logo for Tomtec Imaging Systems. The logo is in black and white, with the word "Tomtec" in large, bold letters. Below the word "Tomtec" is the phrase "Imaging Systems" in smaller letters. The logo is simple and modern, and it is likely used to represent the company's brand.

different modules can be combined on the demand of the users to fulfil the requirements of a clinical researcher or routine oriented physician.

Intended Use

The Image-Arena/Research-Arena Applications software tool package is intended to acquire, store, retrieve, analyze and report digital ultrasound studies. The Image-Arena Platform and the Research-Arena Platform are based on a SQL database intended as image management system especially for medical ultrasound studies.

The Image-Arena/Research-Arena Applications software can import certain digital 2D or 3D image file formats for 2D/3D and 4D tomographic reconstructions and surface rendering.

Technological Characteristics Comparison

The Image-Arena/Research-Arena Applications software tool package is modular structured and consists of different software modules, combining the advantages of the previously FDA cleared software products:

TomTec Echo-View, K022824

TomTec Echo-Com, K001592

Siemens Sequoia™ Diagnostic Ultrasound System Signature II, Axius™ SW Applications K022567 and K032114.

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summan

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Image /page/3/Figure/0 description: This image shows a diagram of the TomTec imaging systems. The diagram shows the different product lines, including the TomTec Echo-Com Product Line, the TomTec Echo-View Product Line, and the Siemens Sequola Product Line. The diagram also shows the different applications that are available for each product line, as well as the different interfaces that are available.

From single programs to a modular structured tool package

Image /page/3/Picture/2 description: The image shows a series of black, angled lines arranged in a curved pattern. The lines are oriented in a similar direction, creating a sense of movement or flow. The overall composition is abstract and lacks a clear focal point, with the lines appearing to be randomly distributed along the curve.

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summary

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Image /page/4/Picture/0 description: The image shows the logo for TOMTEC Imaging Systems. The logo is in black and white, with the word "TOMTEC" in large, bold letters. Below the word "TOMTEC" are the words "IMAGING SYSTEMS" in smaller letters. The logo is simple and modern, and it is likely used to represent the company's brand.

The Image-Arena/Research-Arena Applications software is the combined modified modular structured version and follow-up product and has been transferred to Microsoft® Windows XP Professional™ operating system standards. The graphic user interface has been improved for faster and easier application. The Image-Arena Platform/Research-Arena Platform based on SQL – database has a generic interface that enables the professional practitioners to combine the Image-Arena/Research-Arena Applications software very easy and generate image management systems especially for medical ultrasound studies.

Test Discussion

Testing was performed according to internal company procedures. Software testing and validation were done at the module and system level according to written test protocols established before testing was conducted. Test results were reviewed by designated technical professionals before software proceeded to release.

Test Conclusions

Test results support the conclusion that actual device performance satisfies the design intent. Actual device performance as tested internally conforms to the system performance specifications.

Munich, Feb. 12th 2004

Ralf Janitz
QM & RA Manager

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Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 2 7 2004

Mr. Ralf Janitz Manager, Regulatory Affairs TomTec Imaging Systems Edisonstr.6, D-85716 Unterschleissheim GERMANY

Re: K040546

Trade/Device Name: Image-Arena Applications, Research-Arena Applications Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulation Number: 21 CFR 892.1560 Regulation Name: Ultrasonic pulsed echo imaging system Regulation Number: 21 CFR 892. 1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: 90 LLZ, IYN, and IYO Dated: February 27, 2004 Received: March 9, 2004

Dear Mr. Janitz:

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 111 (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. Brydon

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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Indications for use

510(k) Number (if known): K040546

Device Name: Image-Arena Applications, Research-Arena Applications

Indications For Use:

Intended Use Summary for Image-Arena/Research-Arena Applications

The Image-Arena/Research-Arena Applications software can import certain digital 2D or 3D image file formats for 2D/3D and 4D tomographic reconstructions and surface rendering.

Prescription Use V (Per 21 CFR 801 Subpart D)

AND/OR

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

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

Concurrence of CDRH, Of+fice of Device Evaluation (ODE)

David R. Seymore

Division Sign-Off) Sision of Reproductive. Abdominal ans Radiological Devices 510 k) Number

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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).