BrainViewRxTM provides visualization of functional and physiologic brain imaging data. The software package provides both analysis and viewing capabilities that promote the integration of physiologic and functional imaging data sets, including blood oxygen level dependent (BOLD) fMRI, magnetic resonance spectroscopy (MRS), and MR diffusion including diffusion tensor imaging (DT). The integration of these data, when interpreted by a trained physician, yields information that may assist in the diagnosis of brain pathology and the planning and monitoring of medical treatments.

Device Description

BrainViewRx is an image processing software package for the visualization and manipulation of clinical imagery of multiple kinds. It brings sets of anatomical, physiologic and/or functional imagery into alignment and provides a variety of display and analysis options for utilizing the imagery relationships.

AI/ML Overview

The Kyron™ Clinical Imaging BrainViewRx™ Viewer is an image processing software package for the visualization and manipulation of clinical imagery.

Here's an analysis of the acceptance criteria and study information provided in the 510(k) summary:

Acceptance Criteria and Device Performance: The document states that "FDA has not established special controls or performance standards for this device." This means there were no specific quantitative acceptance criteria set by the FDA for this device to meet to demonstrate performance for a 510(k) submission. Instead, the performance evaluation focused on verification and validation of the software's proper function and its substantial equivalence to predicate devices.

Therefore, a table of acceptance criteria and reported device performance as typically understood with quantitative metrics (e.g., sensitivity, specificity, accuracy) cannot be provided in this case, as such criteria were not explicitly defined or measured for this type of device in the context of this 510(k) submission. The "device performance" in this context refers to its ability to correctly implement its intended functions as a visualization and processing tool.

Study That Proves the Device Meets Acceptance Criteria:
The document indicates: "Software verification and validation was conducted to confirm proper function of the device's features." This statement describes the study performed.

Here's a breakdown of the requested information:

Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria (Implicit)	Reported Device Performance
Proper function of device features (visualization, manipulation, alignment, display options)	Software verification and validation confirmed proper function.
Substantial equivalence to predicate aesthetic imaging devices	BrainViewRx Viewer image display capabilities are substantially equivalent to Mirada Solutions Fusion 7D and MRI Devices Eloquence workstation. The selection of imagery displayed is substantially equivalent to Siemens syngo software.

Sample size used for the test set and the data provenance: Not specified. The document only mentions "software verification and validation," which typically involves testing with various types of input data but does not provide details on the size or origin of such test data.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not specified. For this type of software (visualization and processing), the "ground truth" would likely be the expected accurate rendering and manipulation of image data, as judged by software engineers, quality assurance personnel, and potentially medical professionals for usability and correctness of display. However, specific numbers or qualifications are not provided.
Adjudication method for the test set: Not specified.
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: No. This device is a viewer and processing tool, not an AI-powered diagnostic algorithm that assists human readers directly in interpretation to improve their performance in a way measurable by such a study. Its function is to present data.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: The "software verification and validation" study inherently evaluates the standalone performance of the algorithm in terms of its ability to process and display images as intended. However, no specific metrics for "standalone performance" in a diagnostic sense (e.g., sensitivity/specificity of an automatic detection or diagnosis) are provided as the device's function is not automated diagnosis.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not explicitly stated, but for software functionality, ground truth would be based on expected computational and display accuracy, possibly verified against known datasets or established imaging standards/benchmarks. Clinical correctness of displayed data would be implicitly verified by ensuring accurate representation of input medical images.
The sample size for the training set: Not applicable. As an image processing software for visualization and manipulation, this device is unlikely to utilize a "training set" in the machine learning sense. Its functionality is based on algorithms that process data deterministically rather than learning from a dataset.
How the ground truth for the training set was established: Not applicable, as there is no mention of a training set.

Summary

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DEC 2 0 2005

Image /page/0/Picture/1 description: The image shows the word "Kyron" in a stylized font. The word is slightly blurred, and there is a partial circle around the left side of the word. The background of the image is a grid of dots. The image appears to be a logo or brand name.

5 510(k) Summary

K052467 - Kyron™ Clinical Imaging BrainViewRxTM Viewer

1. Contact Information

Contact Person Submitter Michael Schmainda, CEO Kyron Clinical Imaging, Inc. 2433 N. Mayfair Rd., Suite 103 Phone 414-727-1930 Wauwatosa, WI 53226 Fax 414-727-1939

Date Summary Prepared: November 10, 2005

2. Device Name and Classification

The proprietary name of the device to be introduced into interstate commerce is the BrainViewRx software package. It is image processing software running on a personal computer platform, and is classified under regulatory product code 90 LLZ (regulation # 892.2050), "Picture archiving and communications systems" as a class II medical device.

3. Identification of Legally Marketed Equivalent Predicate Devices

Predicate System	Manufacturer	Reg. Data
Fusion 7DMulti-modality registrationworkstation software	Mirada Solutions Ltd.Oxford Centre for Innov.Mill Street, Oxford OX2 OJXUnited Kingdom	K020546SE 10/11/2002Product code LLZClass II
Eloquence IntegratedFunctional ImagingSystem	MRI Devices Corp.1515 Paramount Dr.Waukesha, WI 53186	K023130SE 10/11/2002Product code LNHClass II
Syngo® MultimodalityWorkstation	Siemens Medical Systems186 Wood Ave. SouthIselin, NJ 08830	K010938SE 6/26/2001Product code LLZClass II

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K052467

Image /page/1/Picture/2 description: The image shows a logo for "Kyron". The logo is in a pixelated style, with the word "Kyron" in a sans-serif font. There is a circle around the "K" in "Kyron". The logo is black and white.

Description of Device 4.

Statement of Intended Use 5.

Brain ViewRx ™ provides visualization of functional and physiologic brain imaging data. The software package provides both analysis and viewing capabilities that promote the integration of physiologic and functional imaging data sets, including blood oxygen level dependent (BOLD) fMRI and magnetic resonance spectroscopy (MRS). The integration of these data, when interpreted by a trained physician, yields information that may assist in the diagnosis of brain pathology and the planning and monitoring of medical treatments.

Predicate Device Comparison of Technological Characteristics 6.

The BrainViewRx Viewer image display capabilities are substantially equivalent to the Mirada Solutions Fusion 7D software package, and the image processing software provided with the MRI Devices Eloquence workstation. The selection of imagery displayed by BrainViewRx is substantially equivalent to Siemens syngo software. BrainViewRx provides similar capabilities for processing and integrated display of clinical imagery from a variety of sources.

7. Performance Study

FDA has not established special controls or performance standards for this device. Software verification and validation was conducted to confirm proper function of the device's features.

8. Safety information

No new safety hazards are introduced by the use of the BrainViewRx software package in comparison to the software of the predicate devices.

rev. 12/2005

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three curved lines representing its wings. The words "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" are arranged in a circular pattern around the eagle.

Public Health Service

MAY 1 7 2006

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

James L. Reuss, Ph.D. Chief Technology Officer Kyron Clinical Imaging, Inc. 2457 N. Mayfair Rd., Suite 202 WAUWATOSA WI 53226

Re: K052467

Trade/Device Name: BrainViewRx™ Viewer Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: April 24, 2006 Received: April 28, 2006

Dear Dr. Reuss:

This letter corrects our substantially equivalent letter of December 20, 2005.

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 (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 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

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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 continue 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 (240) 276-0120. 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 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.

Nancyc brogdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

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Indications For Use 4

510(k) Number (if known): K052467 (corrected)

Kyron™ Clinical Imaging, Inc. - BrainViewRxTM Viewer Device Name:

INDICATIONS FOR USE:

Prescription Use X (Per 21 CFR 801 Subpart D) 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, Office of Device Evaluation (ODE)

Nancy Buxton

(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number

4-1

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).