The Image-Arena VA Platform software is intended to serve as a data management platform for clinical application packages. As the Image-Arena Applications software tool package is modular structured, the clinical application packages are indicated as software packages for the ventricular analysis of the heart.

Device Description

The Image-Arena Applications are a software tool package designed for analysis. documentation and archiving of ultrasound and magnetic resonance studies in multiple dimensions. The Image-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 line Image-Arena Applications and Research-Arena 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 Applications offer features to import different digital 2D. 3D and 4D (dynamic 3D) image formats based on defined file format standards (DICOM-, HPSONOS-, GE-, TomTec- file formats) 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.

AI/ML Overview

The provided text is a 510(k) summary for the TomTec Image-Arena Applications. It describes the device, its intended use, and compares it to predicate devices. However, it does not contain the specific details required to answer all parts of your request regarding acceptance criteria and a study proving device performance.

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

Acceptance Criteria and Device Performance

The document states, "The overall product concept was clinically accepted and the clinical test results support the conclusion that the device is as safe as effective, and performs as well as or better than the predicate device." However, it does not explicitly define quantitative acceptance criteria or provide a table of performance metrics.

Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria	Reported Device Performance
Not explicitly defined in the document. The general criteria appear to be "as safe as effective, and performs as well as or better than the predicate device."	The document states that "clinical test results support the conclusion that the device is as safe as effective, and performs as well as or better than the predicate device." No specific performance metrics or quantitative results are provided.

Study Details

Here's a breakdown of the requested study information based on the provided text:

Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Information Missing: The document states that "clinical test results support the conclusion that the device is as safe as effective," but it does not specify the sample size of the test set, the country of origin of the data, or whether the study was retrospective or prospective.
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):
- Information Missing: The document does not provide any details about the number of experts, their qualifications, or how ground truth was established for the clinical testing.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Information Missing: The document does not describe any adjudication method used for the test set.
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:
- Information Missing: The document does not mention a multi-reader multi-case (MRMC) comparative effectiveness study. The device is described as a software tool package for analysis, documentation, and archiving. The primary focus of the 510(k) is demonstrating substantial equivalence, not necessarily an improvement in human reader performance with AI assistance.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Information Missing: While the device is "a software tool package designed for analysis, documentation, and archiving," the 510(k) summary does not explicitly describe a standalone algorithm-only performance test or present its results in isolation from a human workflow. The comparison is generally against predicate devices which also involve human interaction with the software.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Information Missing: The document does not specify the type of ground truth used for the clinical performance evaluation.
The sample size for the training set:
- Information Missing: The document does not mention a training set sample size. This type of detail is often critical for machine learning-based devices, but the provided text focuses on the device's function as an imaging analysis, documentation, and archiving platform, suggesting its core functionality might not be a deep learning model that requires a distinct "training set" in the common sense, or if it is, the details are not disclosed here.
How the ground truth for the training set was established:
- Information Missing: As no training set is described, there's no information on how its ground truth might have been established.

Summary of what is present:

Non-clinical performance data: "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." This indicates internal testing processes but no specific metrics or study details.
Clinical performance data: "The overall product concept was clinically accepted and the clinical test results support the conclusion that the device is as safe as effective, and performs as well as or better than the predicate device." This is a general statement of conclusion, not a detailed study report.

In conclusion, this 510(k) summary provides a high-level overview of the device and claims of substantial equivalence but lacks the detailed study information, specific acceptance criteria, and quantitative performance measures requested. This is typical for many 510(k) summaries which focus on demonstrating equivalence rather than a full clinical trial report with detailed performance metrics.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for Tomtec Imaging Systems. The logo is in black and white and features the word "Tomtec" in bold, sans-serif font. Below the word "Tomtec" are the words "Imaging Systems" in a smaller font. The logo is simple and modern.

KO82510

Sept. 18th, 2008

Traditional 510(k) Summary

Image-Arena Applications

Image-Arena VA Platform 1.0 4D LV-Analysis 2.5 4D LV-Analysis MR 1.0

FDA CDRH DMC

SEP 2 3 2008

Received

Owner's Name and Address

TomTec Imaging Systems GmbH Edisonstrasse 6 D-85716 Unterschleissheim

Contact Person

Inge Scheidt QM & RA Officer Phone ++49-89-32175-515 Fax ++49-89-32175-750

Common, Classification & Proprietary Names

Common Name: Classification Name: Proprietary Name(s): Various Image Analysis System Software Picture archiving and communications system Image-Arena Applications

Image-Arena VA Platform 1.0 4D LV-Analysis 2.5 4D LV-Analysis MR 1.0

Image /page/0/Picture/18 description: The image shows a series of black, right-angle shapes arranged in a curved line. The shapes are oriented in different directions, creating a dynamic and somewhat abstract pattern. The overall impression is one of movement or a winding path formed by these angular elements.

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Image /page/1/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.

Predicate Device

TomTec

K071232 K 041682

Image-Arena Applications Research-Arena Applications CAAS MRV

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 Applications offer features to import different digital 2D. 3D and 4D (dynamic 3D) image formats based on defined file format standards (DICOM-, HPSONOS-, GE-, TomTec- file formats) 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.

Intended Use

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

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

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.

Image /page/1/Picture/13 description: The image contains 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 within the frame.

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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 and features 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.

Technological Characteristics Comparison

The Image-Arena Applications software tool package is modular structured and consists of different software modules, combining the advantages of the previously FDA cleared software product.

K071232 Image-Arena Applications Research-Arena Applications K041682 CAAS MRV, Pie Medical Imaging BV

Image /page/2/Picture/4 description: The image shows a series of black, right-angle shapes arranged in a curved line. The shapes are oriented in different directions, creating a dynamic and somewhat chaotic visual pattern. The overall effect is reminiscent of a winding path or a series of interconnected elements.

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Image /page/3/Picture/0 description: The image shows the logo for Tomtec Imaging Systems. The logo is in black and white and features the word "Tomtec" in a bold, sans-serif font. Below the word "Tomtec" is the phrase "Imaging Systems" in a smaller, sans-serif font. The logo is simple and modern, and it is likely used to represent the company's brand.

Image /page/3/Figure/1 description: The image shows a diagram of the evolution of the Image-Arena platform. The diagram shows the transition from Image-Arena Platform 3.0 and Research-Arena Platform 2.0 to Image-Arena VA Platform 1.0. The diagram also shows the different applications and functions that are included in each platform, such as Dicom Services, Import and Export Functions, Report and Archive Functions, and Basic Image Viewer.

Predicate Device:

TomTec Image-Arena and Research-Arena Applications K071232

K041682 CAAS MRV

New Device: TomTec Image-Arena Applications

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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. The words "Imaging Systems" are in smaller letters below the main logo. The logo has a modern and professional look.

Discussion according non-clinical performance data testing

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.

Discussion according clinical performance data testing

The overall product concept was clinically accepted and the clinical test results support the conclusion that the device is as safe as effective, and performs as well as or better than the predicate device.

Test Conclusions of non-clinical and clinical performance data

Test results support the conclusion, that the device is as safe as effective, and performs as well as or better than the predicate device.

Munich, September 18, 2008

J. J. Weida

Inge Scheidt QM & RA Officer

Image /page/4/Picture/10 description: The image contains a series of black, right-angle arrow shapes arranged in a slightly curved line. The arrows are oriented in different directions, but generally point towards the upper right of the image. The arrows are closely spaced, creating a sense of movement or directionality.

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

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 02 2008

Ms. Inge Scheit OM & RA Officer TomTec Imaging Systems GmbH Edisonstrasse 6 D-85716 Unterschleissheim GERMANY

Re: K082510

Trade/Device Name: Image-Arena Applications, Image-Arena VA Platform 1.0, 4D LV-Analysis 2.5, and 4D LV-Analysis MR 1.0 Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: September 19, 2008 Received: September 23, 2008

Dear Ms. Scheit:

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.

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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). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometrics' (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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/cdrh/industry/support/index.html.

Sincerely yours.

Jogue Thi Whang

Joyce M. Whang, Ph.D. Acting 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):

Device Name:

Image-Arena Applications lmage-Arena VA Platform 1.0 4D LV-Analysis 2.5 4D LV-Analysis MR 1.0

Indications for Use:

The Image-Arena VA Platform software is intended to serve as a data management platform for clinical application packages.

As the Image-Arena Applications software tool package is modular structured, the clinical application packages are indicated as software packages for the ventricular analysis of the heart.

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

(Division Sign-Off) Office of Device Evaluation (ODE)

Division of Reproductive, Abdominal and Radiological Devices

510(k) Number	K082516
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Page 1 of 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).