KIKA Imaging Lab is intended to be used for diagnostic image management, archiving, annotation, acceptance, transfer, display, storage, image processing of diagnostic ultrasound, CD, MRI, and X-ray images, including manipulation, compression and quantification of images.

The KIKA Imaging Lab brings is typically used in web data sharing domains, especially in clinical trial management, post marketing surveillance, adverse event management, tele-expertise or telemedicine.

When interpreted by a trained physician, reviewed images can be used as an element for diagnosis.

Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretations. Mammographic images may only be interpreted using an FDA approved monitor that offers at least 5 Mpixel resolution and meets other technical specifications reviewed and accepted by FDA.

Device Description

The KIKA Imaging Lab is a Web-based medical image and workflow management system that allows reviewing, manipulating, interpreting, archiving and interchanging medical multi-modality image in the DICOM format. The functions of this workflow management system provide image viewing and manipulation in a diagnostic imaging setting. KIKA Imaging Lab Viewer is a secured web communication platform, to handle image management needs between all users of web clinical trials (investigators, experts, data managers etc.). The investigator may upload images from a CD source to a web based patient database, add annotations, adjusts display of images, scroll all the images of a DICOM series, and show cine playbacks.

Images are stored in a DICOM 3.0 compliant format using various different standard compression methods. Parameters and measurements are saved into a file attached to the image on the remote server. The original image is never altered.

The expert can then review images in a DICOM browser interface, retrieve images to local hard disc, do measurements (calibration, distance, area, angle) and display images in double view layout useful to compare images from different visits or series.

AI/ML Overview

This submission (K051127) for the KIKA Imaging Lab Viewer is a 510(k) premarket notification claiming substantial equivalence to predicate devices, namely the eFilm™ Workstation™ with Modules (K020995) and UltrPro PACs. The provided text describes the device, its intended use, and a general statement about testing, but it does not include specific acceptance criteria or a dedicated study protocol with performance results in the format requested.

The document states:

"The KIKA Imaging Lab Viewer is tested according to the specifications that are documented in a Verification and Validation Test Description and Plan."
"In all instances, the KIKA Imaging Lab Viewer functioned as intended and was all tests and validations observed as expected."
"Performance Data demonstrate that the KIKA Imaging Lab Viewer is as safe and effective as the UltrPro PACs and E-Film Workstation."

However, no actual performance data (e.g., measured accuracy, precision, speed, or specific metrics like sensitivity/specificity) is provided. Therefore, I cannot meaningfully fill out a table of acceptance criteria and reported device performance from the given information. The submission focuses on demonstrating substantial equivalence based on intended use, technological characteristics, and principles of operation, rather than on detailed clinical performance metrics for a specific diagnostic task.

Here's an attempt to answer the questions based on the lack of specific information provided in the document:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (e.g., Sensitivity, Specificity, ROC AUC, Accuracy, Processing Time)	Reported Device Performance (Value/Range)
Not specified in the provided document.	Not specified in the provided document.

Explanation: The 510(k) summary states that the device was tested per "Verification and Validation Test Description and Plan" and "functioned as intended." It concludes that "Performance Data demonstrate that the KIKA Imaging Lab Viewer is as safe and effective as the UltrPro PACs and E-Film Workstation." However, no specific quantitative or qualitative acceptance criteria (e.g., for image quality, diagnostic accuracy, processing speed, or user interface performance) or the corresponding measured performance values are provided in the document.

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

Sample Size (Test Set): Not specified.
Data Provenance (e.g., country of origin, retrospective/prospective): Not specified. The document briefly mentions "clinical trials (investigators, experts, data managers etc.)" and "web data sharing domains, especially in clinical trial management," implying that images from clinical trials could be a source, but it doesn't describe the test set used for the claims of "performance data."

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. The document mentions that "When interpreted by a trained physician, reviewed images can be used as an element for diagnosis," but this refers to the intended use, not the ground truth establishment for a validation study.

4. Adjudication method for the test set

Adjudication Method: Not specified.

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

MRMC Study: No. This submission describes a PACS viewer, not an AI-assisted diagnostic tool. Therefore, an MRMC study comparing human readers with and without AI assistance is not applicable to the documented claims.

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

Standalone Performance Study: No specific standalone performance study with detailed metrics is described. The device is a "viewer" and "workflow management system," implying human interaction is integral to its intended use for interpretation.

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

Type of Ground Truth: Not specified. Given the nature of the device as a PACS viewer, the "performance data" likely refers to technical validation (e.g., image display accuracy, functionality of measurement tools, data integrity during transfer/storage) rather than diagnostic accuracy against a clinical ground truth.

8. The sample size for the training set

Sample Size (Training Set): Not applicable. This device is not described as an AI/ML diagnostic algorithm that requires a training set in the conventional sense. It's a software viewer and management system.

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

Ground Truth Establishment (Training Set): Not applicable, as it's not an AI/ML diagnostic algorithm.

Summary

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11051127

JUN 3 - 2005

510(k) SUMMARY

KIKA Medical's KIKA Imaging Lab Viewer

Date Prepared:

Submitted by:

Contact Name:

Contact Email:

Contact Telephone:

Contact Fax:

Device Trade Name:

Device Common Name:

Regulation Number: Device Classification: Name:

Predicate Device: Predicate Device Manufacture: Predicate Device 510(k) Number: Date Received: Decision Date : Decision: Panel Code Device Reviewed by: Panel Code Device Classified by: Product Code: Regulation Number: Device Classification:

April 14, 2005

KIKA Medical, Inc 6 Beacon Street, Suite 220 Boston, MA 02108

John J. Talarico

jtalarico@kikamedical.com

+1(617)619-9990 ext 3

+1(617)557-3136

KIKA Imaging Lab Viewer

Picture Archiving Communications System (PACS)

892.2050 Class II Image Processing System

eFilm™ Workstation™ with Modules eFilm Medical, Inc. K020995

Substantially Equivalent

LLZ 892.2050 Class II

Device Description:

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format. The functions of this workflow management system provide image viewing and manipulation in a diagnostic imaging setting. KIKA Imaging Lab Viewer is a secured web communication platform, to handle image management needs between all users of web clinical trials (investigators, experts, data managers etc.). The investigator may upload images from a CD source to a web based patient database, add annotations, adjusts display of images, scroll all the images of a DICOM series, and show cine playbacks.

Indications for Use

KIKA Imaging Lab is intended to be used for diagnostic image management. archiving, annotation, acceptance, transfer, display, storage, image processing of diagnostic ultrasound, CD, MRI, and X-rav images, including manipulation, compression and quantification of images.

The KIKA Imaging Lab is typically used in web data sharing domains. especially in clinical trial management, post marketing surveillance, adverse event management, tele-expertise or telemedicine.

When interpreted by a trained physician, reviewed images can be used as an element for diagnosis.

Technological Characteristics

The KIKA Imaging Lab Viewer is a stand alone product or plug-in module that can be used on more than one platform and can be fully integrated into a host web server solution. Minimum requirements are the use of an Internet Web Browser and a broadband Internet connection with a Pentium-based or equivalent personal computer.

The system allows for digital image processing and measurement capability.

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Testing

The KIKA Imaging Lab Viewer is tested according to the specifications that are documented in a Verification and Validation Test Description and Plan. Testing is part of KIKA Medical's software development process as described in KIKA Medical's Standard Operating Procedure 2.1.01SOP.en: Software Development Life Cycle. In all instances, the KIKA Imaging Lab Viewer functioned as intended and was all tests and validations observed as expected.

Substantial Equivalence

The KIKA Imaging Lab Viewer is as safe and effective as the UltrPro PACs and e-Film with Modules. The KIKA Imaging Lab Viewer has the same intended use and similar indications, technological characteristics, and principles of operation as its predicate devices. The minor technological differences between KIKA Imaging Lab, the UltrPro PACs and E-Film Workstation raise no new issues of safety or effectiveness. Performance Data demonstrate that the KIKA Imaging Lab Viewer is as safe and effective as the UltrPro PACs and E-Film Workstation. Thus, the KIKA Imaging Lab Viewer is substantially equivalent.

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Image /page/3/Picture/1 description: The image shows a logo for the Department of Health & Human Services. The logo is a circular seal with the words "Department of Health & Human Services" written around the perimeter. Inside the circle is an emblem of an eagle with its wings spread, with three bars running across the eagle's body.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20050

JUN 3 - 2005

John J. Talarico c/o Howard M. Holstein, Esq. Hogan & Hartson, L.L.P. 555 Thirteenth Street, N.W. WASHINGTON DC 20004

Re: K051127

Trade/Device Name: KIKA Imaging Lab Viewer Regulation Number: 21 CFR §892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: April 24, 2005 Received: May 3, 2005

Dear Mr. Talarico:

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.

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) I mb letter wification. The FDA finding of substantial equivalence of your device to a legally premarket notificate 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 If you doin't openits as a ne of the following numbers, based on the regulation number at the top of this letter:

21 CFR 876.xxxx	(Gastroenterology/Renal/Urology)	240-276-0115
21 CFR 884.xxxx	(Obstetrics/Gynecology)	240-276-0115
21 CFR 892.xxxx	(Radiology)	240-276-0120
Other		240-276-0100

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Nancy C. Brogdon

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 Statement

510(k) Number (if known): K051127

Device Name: KIKA Imaging Lab Viewer

Indications for Use:

When interpreted by a trained physician, reviewed images can be used as an element for diagnosis.

Prescription Use X (Part 21 C.F.R. 801 Subpart D) AND/OR

Over-The-Counter Use (21 C.F.R. 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Ra.C.Pelles

Division Sianand Radiological Dev 510k) Numb

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).