Image-Com software is intended for reviewing and measuring of digital medical data of different modalities. It can be driven by Image-Arena or other third party platforms and is intended to launch other commercially available analysis and quantification tools.

Device Description

Image-Com is a clinical application package software for reviewing and measuring of digital medical data. Image-Com is either embedded in Image-Arena™ platform or can be integrated into Third Party platforms, such as PACS or CVIS.

AI/ML Overview

The provided document is a 510(k) summary for the TomTec Imaging Systems Image-Com 5.0 software. This device is classified as a Picture Archiving and Communications System (PACS) and is intended for reviewing and measuring digital medical data. The submission focuses on demonstrating substantial equivalence to predicate devices rather than proving a new clinical claim with specific performance metrics.

Therefore, the document does not contain the detailed information typically found in a study designed to establish new acceptance criteria and prove a device meets them through clinical performance data. Instead, it relies on non-clinical software testing and a literature review to demonstrate safety and effectiveness comparable to predicate devices.

Here's an analysis based on the information available:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not specify quantitative acceptance criteria in terms of clinical performance metrics (e.g., sensitivity, specificity, accuracy) for Image-Com 5.0. It primarily focuses on demonstrating that the software functions as intended and is as safe and effective as its predicate devices.

Acceptance Criteria Category	Reported Device Performance
Non-Clinical Performance
Automated Tests	All reviewed and passed
Feature Complete Test	Completed without deviations
Functional Tests	Completed
Measurement Verification	Completed without deviations
Multilanguage Tests	Completed without deviations
Bug Evaluation	Non-verified bugs rated as minor deviations, deferred to next release
OTS Software Validation	Considered validated by tests or absence of abnormalities during V&V
Clinical Performance
Clinical Acceptance	Overall product concept clinically accepted
Safety & Effectiveness	"as safe as effective, and performs as well as or better than the predicate devices" (Clinical evaluation based on literature review)
Risk-Benefit Assessment	Benefit superior to risk (Risk rated as low)
Compliance with Essential Requirements	Data sufficient to demonstrate compliance with essential requirements for safety and performance
Labeling Substantiation	Claims made in device labeling substantiated by clinical data (via literature review)

2. Sample size used for the test set and the data provenance:

Test Set Sample Size: The document does not specify a distinct "test set" in the context of clinical performance data with a defined sample size (e.g., number of patient cases or images). The "testing" mentioned pertains to internal software verification and validation activities.
Data Provenance: The clinical performance data assessment was primarily based on a literature review. This means the data was retrospective, gathered from published studies related to the concepts and techniques employed by the device, or similar devices. The country of origin of this literature is not specified, but the applicant company is German.

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

This information is not provided as the device's clinical performance was assessed via a literature review rather than a de novo clinical study with a new dataset requiring independent expert ground truthing. The "ground truth" implicitly relies on established medical knowledge and clinical consensus as presented in the reviewed literature.

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

No explicit adjudication method is mentioned for establishing ground truth, as no specific clinical test set was created for this 510(k) submission requiring such a process. The reliance on a literature review means that the adjudication (or consensus) would have occurred within the original studies being reviewed.

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:

A multi-reader multi-case (MRMC) comparative effectiveness study was not explicitly conducted or described in this 510(k) summary. The Image-Com 5.0 is a software package for review and measurement, not an AI-assisted diagnostic tool in the typical sense that would necessitate an MRMC study to show improvement over human readers. The document states its purpose is to demonstrate substantial equivalence to existing PACS and image analysis software.

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

The document discusses "automated tests" as part of non-clinical performance data, which would imply standalone algorithm testing. However, this refers to software functionality and measurement verification, not clinical diagnostic performance of an AI algorithm in isolation. Image-Com 5.0 aids in reviewing and measuring, implying a human-in-the-loop workflow, but the submission doesn't contain a standalone clinical performance study typical for an AI-powered diagnostic device.

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

For the clinical evaluation, the "ground truth" was established through existing medical literature and accepted clinical standards for reviewing and measuring digital medical data, as referenced in the clinical evaluation. This would encompass expert consensus and established diagnostic criteria reflected in published studies. No new pathology or outcomes data was generated for this submission.

8. The sample size for the training set:

Image-Com 5.0 is a software for reviewing and measuring medical data, not a machine learning model that undergoes a "training" phase with a specific dataset. Therefore, there is no "training set" sample size mentioned or applicable in the context of this submission. The software's algorithms and functionalities are presumably developed based on established image processing techniques and clinical guidelines.

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

As there is no "training set" in the machine learning sense, this question is not applicable. The underlying principles and measurement methodologies within the software would be based on established medical and engineering knowledge.

Summary

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K122289

Image /page/0/Picture/1 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.

Traditional 510(k) Summary

OCT 24 2012

Image-Com 5.0 .

Owner's Name and Address

TomTec Imaging Systems GmbH Edisonstrasse 6 D-85716 Unterschleissheim

Contact Person

B. Mumm COO Phone +49-89-32175-605 Fax +49-89-32175-750

Common, Classification & Proprietary Names

Common Name:	Various Image Analysis SystemSoftware
Classification Name:	Picture archiving and communications system

Proprietary Name(s):

lmage-Com 5.0

Predicate Devices

Predicate Device 1	K110667	Image-Arena Platform 4.5, Echo-Com 4.5,Image-Com 4.5
Predicate Device 2	K071232	Image-Arena Applications; Research-Arena Applications : 4D Cardio-View 2.x

Image /page/0/Picture/15 description: The image shows a series of black, angled lines arranged in a curved pattern. The lines are short and thick, and they are oriented at approximately 90-degree angles to each other. The overall arrangement of the lines creates a sense of movement or flow, as if they are following a curved path. The lines are closely spaced together, creating a dense and visually interesting pattern.

summary

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Image /page/1/Picture/0 description: The image shows the logo for TOMTEC Imaging Systems. The word "TOMTEC" is written in large, bold, black letters. Below the word "TOMTEC" is the phrase "IMAGING SYSTEMS" written in smaller, black letters.

Device Description

Indications for use and Intended use

Technological Characteristics Comparison

The Subject Device "Image-Com 5.0" is a CAP for analysis of medical studies containing 2D, 3D or 4D images.

The actual submission combines the advantages of the FDA cleared software products:

Predicate Device 1	K110667	Image-Arena Platform 4.5, Echo-Com 4.5, Image-Com 4.5
Predicate Device 2	K071232	Image-Arena Applications; Research-Arena Applications: 4D Cardio-View 2.x

The Subject Device includes the main functionalities as provided from Predicate Device 1 (Image-Com 4.6, TomTec Imaging Systems GmbH). The underlying technology of the Subject Device is identical to the predicate devices. It is a combined version of the Predicate Device 1 (Image-Com 4.5, TomTec Imaging Systems GmbH, for 2D analysis) and Predicate Device 2 (Cardio-View 2.x, TomTec Imaging Systems GmbH, for 3D/4D analysis) allowing the users to perform 2D, 3D and 4D image analysis within one software package.

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.

The test procedure was performed according to the Project Quality Plan. Test results were reviewed by designated technical professionals before software proceeded to release.

All requirements have been verified by tests or other appropriate methods.

summary

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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.

The incorporated OTS Software is considered validated either by particular tests or implied by the absence of OTS SW related abnormalities during all other V&V activities.

The summary conclusions state that:

all automated tests were reviewed and passed
feature complete test completed without deviations
functional tests are completed -
. measurement verification is completed without deviations
multilanquage tests are completed without deviations -
all non-verified bugs have been evaluated and are rated as minor deviations. They are deferred to the next 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 devices.

A clinical evaluation following the literature route based on the assessment of benefits, associated with the use of the device, was performed. The clinical evaluation shows that the published data are relevant and applicable to the relevant characteristics of the device under assessment and the medical procedure for which the device is intended.

Risk analysis aspects were treated in the risk management report. Based on this document the existing applied methods in the literature and the newly described techniques of the product (which are considered in the risk analysis) were evaluated.

No further risks were identified.

Conclusion from the analysis of the literature review

The Risk-Benefit Assessment that the Benefit is superior to the Risk. . Whereas the Risk is low. The benefit of the product is improving the accuracy of assessment and analyze-time. The product Image-Com is therefore harmless for patient and user and the advantages overbalance the probable risks of injury or illness for the patient.
The data are sufficient to demonstrate compliance with the essential . requirements covering safety and performance of the device in question under normal conditions of use.
. The claims made in the device labeling are substantiated by the clinical data.

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Image /page/3/Picture/0 description: The image shows the logo for TOMTEC IMAGING SYSTEMS. The word "TOMTEC" is in large, bold, black letters. Below the word "TOMTEC" is the phrase "IMAGING SYSTEMS" in smaller, black letters. The logo is simple and professional.

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 devices.

No reportable events or problems for the predicate devices exist. The overall product concept was clinically accepted and the test results support the conclusion that the subject device is as safe as effective and performs as well as the predicate devices.

July 23, 2012

L. Ulli-

B. Mumm COO

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Image /page/4/Picture/0 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" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or a stylized human figure with outstretched arms.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002

OCT
24
2012

Mr. Bernhard MUMM COO TomTech Imaging Systems GmbH Edisonstrasse 6 Unterschleissheim, Bavaria D-85716 GERMANY

Re: K122289

Trade/Device Name: Image-Com 5.0 Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: July 23, 2012 Received: July 30, 2012

Dear Mr. MUMM:

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 class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); medical device reporting (reporting of

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medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). 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 Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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 (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely Yours,

Janine M. Morris

Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): K122289

Device Name: Image-Com 5.0

Indications For Use:

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)

Michael D O'Hara

Page 1 of ____________________________________________________________________________________________________________________________________________________________________

(Division Sign Off) Division of Radiological Hea

Office of in Vitro Diagnostics and Ri

510/k

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).