Visia Oncology is a medical software application intended for the visualization of images from a variety of image devices. The system provides viewing, quantification, manipulation, and printing of medical images. Visia Oncology is a noninvasive image analysis software package designed to support the physician in routine diagnostic oncology, staging and follow-up. Flexible layouts and automated image registration facilitate the synchronous display and navigation of multiple datasets for viewing data and easy follow-up comparison. The application provides a range of interactive tools specifically designed for segmentation and volumetric analysis of findings. The integrated reporting helps the user to track findings and note changes, such as shape or size, over time.

Device Description

Visia™ Oncology is a noninvasive medical image processing software application intended for the visualization of images from various sources such as Computed Tomography systems or from image archives. The system provides viewing, quantification, manipulation, and printing of medical images. Visia™ Oncology integrates within typical clinical workflow patterns through receiving and transferring medical images over a computer network. The software can be loaded on a standard off-the-shelf personal computer (PC) and can operate as a stand-alone workstation or in a distributed server-client configuration across a computer network. Visia™ Oncology is designed to support the physician in routine diagnostic oncology, staging and follow-up. Flexible layouts and automated image registration facilitate the synchronous display and navigation of multiple datasets for viewing data and easy follow-up comparison. The application provides a range of interactive tools specifically designed for segmentation and volumetric analysis of findings. The integrated reporting helps the user to track findings and note changes, such as shape or size, over time.

AI/ML Overview

The provided text indicates that "Visia™ Oncology" is a medical image processing software. However, the document does not contain specific acceptance criteria, a detailed study description, or performance metrics for the device. Instead, it focuses on demonstrating substantial equivalence to predicate devices for regulatory clearance.

Therefore, I cannot provide a table of acceptance criteria and reported device performance, nor details about a specific study proving the device meets acceptance criteria, an MRMC study, standalone performance, or training/test set details based on this document.

Here's what can be extracted based on the information provided, assuming the "nonclinical testing" mentioned broadly refers to the evaluation of the device:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria	Reported Device Performance
Not specified	Not specified

Explanation: The document states that "Validation testing indicated that as required by the risk analysis, designated individuals performed all verification and validation activities and that the results demonstrated that the predetermined acceptance criteria were met." However, the specific acceptance criteria themselves (e.g., minimum accuracy for a particular task, specific tolerance for volumetric measurements, success rate for image registration) and the actual reported performance metrics against those criteria are not detailed in this 510(k) summary.

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

Sample size for the test set: Not specified.
Data provenance: Not specified (e.g., country of origin, retrospective or prospective). The document only mentions "images from various sources such as Computed Tomography systems or from image archives."

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 beyond the general statement that "Diagnosis is not performed by the software but by Radiologists, Clinicians and referring Physicians." There's no mention of specific experience levels or board certifications for anyone involved in establishing ground truth for testing.

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

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 done: No, not mentioned in the document. The document describes the software as a tool to "support the physician" and provides "interactive tools," but it doesn't detail a study measuring improvement in human reader performance with or without the AI assistance.
Effect size of improvement: Not applicable, as no MRMC study is detailed.

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

The document implies the software is a standalone application but doesn't describe a standalone performance study of the algorithm itself in isolation from human interpretation. It emphasizes that "Diagnosis is not performed by the software but by Radiologists, Clinicians and referring Physicians." So, if "standalone" refers to the algorithm making independent diagnoses or interpretations without human oversight, then no such study is described, as that is explicitly not its intended use.

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

Not specified.

8. The sample size for the training set:

Not specified. The document does not describe a machine learning training process or a training set.

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

Not applicable, as no training set or machine learning model requiring ground truth for training is described. The device is characterized as "medical image processing software" that provides "viewing, quantification, manipulation, and printing." While it has "automated image registration" and "interactive tools specifically designed for segmentation and volumetric analysis," the underlying methods are not detailed as AI/ML that would require a distinct training phase.

Summary

{0}------------------------------------------------

1120484

510(k) Summary

Submitted By:

MeVis Medical Solutions AG Universitaetsallee 29 28359 Bremen, Germany

Establishment Name:

Establishment Registration Number:

Contact Person:

MeVis Medical Solutions AG

10039520

Thomas E. Tynes President & CEO MeVis Medical Solutions, Inc. N27 W24075 Paul Court - Suite 100 Pewaukee, WI 53072 USA Phone: +1-262-691-9530 Fax: +1-262-691-9531

Date Prepared:	2/14/2012
Trade Name:	Visia™ Oncology
Common Name:	Medical Image Processing Software
Classification Name:	Image Processing System
ClassificationRegulation Number:	892.2050
Class:	II
Panel:	Radiology
Product Code:	LLZ

Visia™ Oncology 510(k) 510(k) Summary - 2/14/2012 Page 1 of 3

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

Image /page/1/Picture/0 description: The image shows the logo for MeVis MEDICAL SOLUTIONS. The logo is in black and white, with the words "MeVis" in large, bold letters. Below the word "MeVis" is the phrase "MEDICAL SOLUTIONS" in smaller letters. The logo appears to be for a medical company.

Device Description

Visia™ Oncology integrates within typical clinical workflow patterns through receiving and transferring medical images over a computer network. The software can be loaded on a standard off-the-shelf personal computer (PC) and can operate as a stand-alone workstation or in a distributed server-client configuration across a computer network.

Visia™ Oncology is designed to support the physician in routine diagnostic oncology, staging and follow-up. Flexible layouts and automated image registration facilitate the synchronous display and navigation of multiple datasets for viewing data and easy follow-up comparison. The application provides a range of interactive tools specifically designed for segmentation and volumetric analysis of findings. The integrated reporting helps the user to track findings and note changes, such as shape or size, over time.

Intended Use

Visia™ Oncology is a medical software application intended for the visualization of images from a variety of image devices. The system provides viewing, quantification, communication, and printing of medical images. Visia™ Oncology is a noninvasive image analysis software package designed to support the physician in routine diagnostic oncology, staging and follow-up. Flexible layouts and automated image registration facilitate the synchronous display and navigation of multiple datasets for viewing data and easy follow-up comparison. The application provides a range of interactive tools specifically designed for segmentation and volumetric analysis of findings. The integrated reporting helps the user to track findings and note changes, such as shape or size, over time.

Predicate Device Information

Product	Predicate Device Name	Predicate 510(k)Submission Reference
Visia™ Oncology	syngo CT Oncology	K071310
Visia™ Oncology	Vitrea®	K071331

Safety and Effectiveness

The Visia™ Oncology labeling contains instructions for use and necessary cautions, warnings and notes to provide for safe and effective use of the device. Risk Management is ensured via MeVis Medical Solution AG's Risk Management procedure, which is used to identify potential hazards. These potential hazards are controlled via software development and verification & validation testing.

{2}------------------------------------------------

Image /page/2/Picture/0 description: The image shows the logo for MeVis MEDICAL SOLUTIONS. The logo is in black and white, with the word "MeVis" in large, bold letters. Below the word "MeVis" is the phrase "MEDICAL SOLUTIONS" in smaller letters. The logo is simple and professional, and it is likely used to represent the company's brand.

Nonclinical Testing and Performance Information

The complete system configuration has been assessed and tested at the manufacturer's facility and has passed all in-house testing criteria. The Validation Test Plan was designed to evaluate all input functions, output functions, and actions performed by the software in each operational mode and followed the process documented in the Validation Test Plan.

Nonclinical testing results are provided in the 510(k). Validation testing indicated that as required by the risk analysis, designated individuals performed all verification and validation activities and that the results demonstrated that the predetermined acceptance criteria were met.

Technological Characteristics

Visia™ Oncology is a software device that does not contact the patient, nor does it control any life sustaining devices. Diagnosis is not performed by the software but by Radiologists, Clinicians and referring Physicians.

A physician, providing ample opportunity for competent human interprets images and information being displayed and printed.

The new device and predicate devices are substantially equivalent in the areas of technical characteristics, general function, and intended use. The new device does not raise any new potential safety risks and is equivalent in performance to the existing legally marketed devices.

Conclusion

The 510(k) Pre-Market Notification for Visia™ Oncology contains adequate information, data, and nonclinical test results to enable FDA - CDRH to determine substantial equivalence to the oredicate device. MeVis Medical Solutions has determined that its device, Visia™, is substantially equivalent to the identified predicate device listed above. A comparison with the legally marketed predicate device indicates that it is substantially equivalent to this device, and that it does not raise any new safety or efficacy concerns. Nonclinical tests demonstrate that the device is safe, effective, and is substantially equivalent to the predicate device.

Visia™ Oncology 510(k) 510(k) Summary - 2/14/2012 Page 3 of 3

{3}------------------------------------------------

Image /page/3/Picture/0 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, symbolizing the department's mission to protect the health of all Americans.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

MeVis Medical Solutions AG % Mr. Thomas E. Tynes President & CEO MeVis Medical Solutions, Inc. N27 W24075 Paul Court, Suite 100 PEWAUKEE WI 53072

Re: K120484

Trade/Device Name: Visia™ Oncology Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: February 14, 2012 Received: February 17, 2012

Dear Mr. Tynes:

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 11 your w 100 to 100 to 100 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

MAR 2 7 2012

{4}------------------------------------------------

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

Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

{5}------------------------------------------------

Image /page/5/Picture/0 description: The image shows the logo for MeVis Medical Solutions. The logo is in black and white, with the word "MeVis" in large, bold letters. Below the word "MeVis" are the words "MEDICAL SOLUTIONS" in smaller letters. The logo is simple and professional, and it is likely used to represent the company's brand.

Indications for Use Statement

510(k) Number (if known): _ |ん | 20484

Device Name: Visia™ Oncology

Indications for Use:

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

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Division Sign-Off Office of In Vitro Diaghostic Device Evaluation and Safety

510(k)

Visia™ Oncology 510(k) Indications for Use Statement - 2/14/2012 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).