Echo-View 5.x
Easy-View 2.x
Omni View 2.x
Cardio-View 1.x
LV Analysis 1.x
Surgical View 1.x
are intended to retrieve, analyze and store digital ultrasound images and Color Doppler images for computerized 3-dimensional and 4-dimensional (dynamic 3D) image processing.

Echo-View 5.x , Easy-View 2.x, Omni-View 2.x, Cardio-View 1.x, LV Analysis 1.x and Surgical View 1.x can import certain digital 2D or 3D image file formats for 3D tomographic reconstructions and surface rendering. It is intended as a general purpose digital 3D ultrasound image processing tool for cardiology, radiology, neurology, gastro-enterology, urology, surgery, obstetrics and gynecology.

Device Description

The Review Software products

. Echo-View 5.x
Easy-View 2.x ●
Omni-View 2.x
Cardio-View 1.x ●
LV Analysis 1.x .
Surgical View 1.x ●
are software modules for high performance computer systems based on Microsoft Windows 2000/XP™ operating system standards. These Review Software products are proprietary software for the analysis, storage, retrieval and reconstruction of digitized ultrasound B-mode images and Color Doppler images. The data can be acquired by a TomTec acquisition station or by a 3D capable ultrasound system. The result of acquired images allows a 3-dimensional volume to be reconstructed by Echo-View. The digital 3D / 4D data set can be used for 2D and 3D measurements.

AI/ML Overview

The provided document KD22824 (TomTec Echo-View 5.x and related products) offers a limited description of the testing and validation performed. It does not contain a detailed study proving the device meets specific acceptance criteria in the format requested.

Here's a breakdown of the information available and what is missing:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria Category	Reported Device Performance
Functional Performance	"actual device performance satisfies the design intent."
System Specifications	"Actual device performance as tested internally conforms to the system performance specifications."
Software Quality	"Software testing and validation were done at the module and system level according to written test protocols established before testing was conducted."

Missing information: The document does not explicitly list quantitative or qualitative acceptance criteria for specific functionalities such as image analysis accuracy, speed, measurement precision, or reliability. It only provides high-level statements about meeting design intent and system specifications.

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

Sample Size for Test Set: Not specified.
Data Provenance (e.g., country of origin, retrospective/prospective): Not specified.

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

Number of Experts: Not specified.
Qualifications of Experts: Not specified.

4. Adjudication method for the test set

Adjudication Method: Not specified.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done

MRMC Study: No, there is no mention of an MRMC comparative effectiveness study involving human readers with or without AI assistance. The document predates widespread AI in medical imaging as we know it today (2002).

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

Standalone Study: The document describes "Software testing and validation" and that "Test results were reviewed by designated technical professionals." This implies standalone testing of the software's functionality, but the nature and metrics of this 'performance' are not detailed. It's not a standalone AI algorithm in the modern sense.

7. The type of ground truth used

Type of Ground Truth: Not specified. The document globally states "Test results support the conclusion that actual device performance satisfies the design intent" and "conforms to the system performance specifications," implying internal validation against expected outcomes or predefined standards, but the basis of these standards (e.g., expert consensus, pathology, other validated tools) is not mentioned.

8. The sample size for the training set

Sample Size for Training Set: Not applicable/Not specified. This device (from 2002) is described as a "Digital Ultrasound Image Analysis System" and "image processing tool," implying rule-based or conventional algorithmic analysis rather than a machine learning/AI model that would require a distinct "training set."

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

Ground Truth for Training Set: Not applicable/Not specified, as it's not an AI/ML device that would typically have a distinct training set with established ground truth in the current understanding.

Summary of what's provided by the document:

The document describes the device as a "Digital Ultrasound Image Analysis System" and outlines its intended use for retrieving, analyzing, and storing digital ultrasound images for 3D/4D processing. It states that "Testing was performed according to internal company procedures" and that "Software testing and validation were done at the module and system level according to written test protocols." The conclusion is that "actual device performance satisfies the design intent" and "conforms to the system performance specifications."

The main limitation is that this 510(k) summary provides a high-level overview and does not include the detailed technical report or study data that would contain the specific acceptance criteria, test methodologies, sample sizes, and expert qualifications required for a comprehensive answer to your questions. The technology described is from 2002 and predates the rigorous clinical validation studies typically associated with AI/ML-based medical devices today.

Summary

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KD22824

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" 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.

July 318t , 2001

Special 510(k) Summary

Echo-View 5.x Easy-View 2.x Omni-View 2.x Cardio-View 1.x LV Analysis 1.x Surgical View 1.x

OCT 1 7 2002

Name and Address

TomTec Imaging Systems GmbH Edisonstrasse 6 D-85716 Unterschleissheim

Contact Person

Florian Eisenberger Director, Requlatory Affairs & Quality Assurance ++49-89-32175-830 Phone ++49-89-32175-750 fax

Common, Classification & Proprietary Names

Common Name: Classification Name: Proprietary Name(s): Digital Ultrasound Image Analysis System Ultrasonic Pulsed Echo Imaging System Echo-View 5.x Easy-View 2.x Omni-View 2.x Cardio-View 1.x LV Analysis 1.x Surgical View 1.x

Predicate Device

TomTec Echo-View K993398

{1}------------------------------------------------

Image /page/1/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.

Device Description

The Review Software products

. Echo-View 5.x
Easy-View 2.x ●
Omni-View 2.x
Cardio-View 1.x ●
LV Analysis 1.x .
Surgical View 1.x ●

are software modules for high performance computer systems based on Microsoft Windows 2000/XP™ operating system standards. These Review Software products are proprietary software for the analysis, storage, retrieval and reconstruction of digitized ultrasound B-mode images and Color Doppler images. The data can be acquired by a TomTec acquisition station or by a 3D capable ultrasound system. The result of acquired images allows a 3-dimensional volume to be reconstructed by Echo-View. The digital 3D / 4D data set can be used for 2D and 3D measurements.

Intended Use

The Review Software products

Echo-View 5.x .
Easy-View 2.x .
Omni-View 2.x .
Cardio-View 1.x .
LV Analysis 1.x .
. Surgical View 1.x

are intended to retrieve, analyze and store digital ultrasound images and Color Doppler images for computerized 3-dimensional and 4-dimensional (dynamic 3D) image processing.

Echo-View 5.x , Easy-View 2.x. Omni-View 2.x, Cardio-View 1.x, LV Analysis 1.x and Surqical View 1.x can import certain digital 2D or 3D image file formats for 3D tomographic reconstructions and surface rendering. It is intended as a general purpose digital 3D ultrasound image processing tool for cardiology, radiology, neurology, gastroenterology, urology, surgery, obstetrics and aynecology.

Technological Characteristics Comparison

Echo-View 5.x , Easy-View 2.x, Omni-View 2.x, Cardio-View 1.x, LV Analysis 1.x and Surgical View 1.x are modified version and follow-up products of the filed Echo-View / Easy-View system, which has been transferred to Windows 2000/XP ™ operating system standards. The graphic user interface has been improved for faster and easier application.

While Echo-View includes the full functionality the products Cardio-View, LV Analysis, Surgical View, Easy-View and Omni-View are subsets of the Echo-

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Image /page/2/Picture/0 description: The image shows the logo for Tomtec Imaging Systems. The word "Tomtec" is in large, bold, black letters. Below that, in smaller letters, are the words "Imaging Systems."

View Software where the functionality is limited for easier software handling with respect to the software application.

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.

July 31st , 2002

Florian Eisenberger

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Image /page/3/Picture/1 description: The image shows a circular logo with a stylized eagle in the center. The eagle is depicted with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES" is arranged around the upper half of the circle, following its curvature. The logo appears to be a seal or emblem, possibly representing a government agency.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Florian Eisenberger Manager Regulatory Affairs TomTec Imaging System Edisonstrasse 6 D-85716 Unterschleissheim Germany

Re: K022824

Trade/Device Name: TomTec Echo-View 5.x, Fasy-View 2.x. Omni-View 2.x. Cardio-View 1.x. LV Analysis 1.x, and Surgical View 1.x 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 Regulatory Class: II Product Code: 90 LLZ and IYO Dated: September 16, 2002 Received: September 24, 2002

Dear Mr. Eisenberger:

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 adultcration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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 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:

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" (21 CFR Part 807.97). 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. Snogdon

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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510(k) Number (if known):

Device Name: . TomTec Echo-View 5.x, Easy-View 2.x, Omni-View 2,x Cardio-View 1.x, LV Analysis 1.x, Surgical-View 1.x

Indications For Use

The products:

Echo-View 5.x ●
Easy-View 2.x
Omni View 2.x
Cardio-View 1.x ●
LV Analysis 1.x ●
Surgical View 1.x ●

are intended to retrieve, analyze and store digital ultrasound images and Color Doppler images for computerized 3-dimensional and 4-dimensional (dynamic 3D) image processing.

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

Concurrence of CDRH, Office of Device Evaluation (ODF)

Trink M. Segmen

(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K022824
OR
Over-The-Counter Use

Prescription Use V (Per 21 CFR 801.109)

Over-The-Counter Use

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).