Advantage Windows Fusion provides an easy means for comparison of three dimensional (3D ) images from computed tomography ( CT ) and magnetic resonance ( MR). It allows 3D registration between two volumetric acquisitions, which may come from different acquisition modalities ( CT / MR), for use in diagnostic radiology or radiation therapy planning.

Device Description

Advantage Windows Fusion is a software option for the Advantage Windows Workstation that provides easy comparison of three dimensional (3D) images from computed tomography (CT) and magnetic resonance (MR). It allows 3D registration between two volumeric acquisitions, which may come from different acquisition modalities ( CT / MR).

Application examples include:

a use of previously recorded diagnostic information from follow-up studies.
o combination of CT and MR for better volume definition.
· definition of a volume of interest within one patient model,
with automatic report in the other model ..
" fusion of functional and anatomical images.
a medical education.
6 better communication of clinical results to referring physicians.

AI/ML Overview

The provided document for K983256, "ADVANTAGE WINDOWS FUSION SUMMARY OF SAFETY AND EFFECTIVENESS," does not contain information related to specific acceptance criteria or a detailed study proving the device meets such criteria.

The document is a 510(k) summary, which focuses on establishing substantial equivalence to a predicate device. It describes the device, its intended use, and compares it to a previously cleared device (K941223, "Fusion and Registration feature of Advance Analysis Software").

Here's what can be extracted from the document regarding studies and validation:

Acceptance Criteria and Reported Device Performance: This information is not provided in a quantifiable or tabular format. The document states, "The AW Fusion option will be fully verified/validated per the program test plans," but does not present the results of these tests or any specific performance metrics against acceptance criteria.
Sample size used for the test set and the data provenance: Not mentioned.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not mentioned.
Adjudication method: Not mentioned.
Multi-reader multi-case (MRMC) comparative effectiveness study: Not mentioned. The document primarily focuses on the device's functionality and its equivalence to a predicate, not on its comparative effectiveness with human readers.
Standalone (algorithm only without human-in-the-loop performance) study: Not explicitly mentioned as a separate study. The document describes the software option's capabilities, implying standalone operation for image fusion. However, no performance metrics are provided.
Type of ground truth used: Not mentioned.
Sample size for the training set: Not mentioned.
How the ground truth for the training set was established: Not mentioned.

Conclusion from the document:

The document emphasizes that:

The Advantage Windows Fusion provides 3D information that allows comparison of volumetric acquisitions from different studies and modalities.
The potential hazards are controlled by a risk management plan (Hazard Analysis/Risk Management Summary, Software Development and Validation Process, Software Verification Plan).
The product provides images comparable to the predicate device.

The 510(k) process primarily relies on demonstrating substantial equivalence, meaning the new device is as safe and effective as a legally marketed predicate device. In this case, the justification for safety and effectiveness is largely based on the similarity to the predicate device and the implementation of standard software development and validation processes, rather than a detailed performance study with quantifiable acceptance criteria.

Summary

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K983256

Image /page/0/Picture/4 description: The image shows a black and white drawing of a round object. The object appears to be a sphere with an uneven surface. The surface has a mottled texture, with light and dark patches distributed across it.

GE Medical Systems P.O. Box 414, W-709 Milwaukee, WI 53201 USA

DEC 15 1998

ADVANTAGE WINDOWS FUSION SUMMARY OF SAFETY AND EFFECTIVENESS

This 510(k) summary of safety and effectiveness information is submitted in accordance with the requirements of 21 CFR Part 807.87(h)

Identification of Submitter:

Larry A. Kroger, Ph.D. Senior Regulatory Program Manager Telephone: (414) 544-3894 Date Prepared: September 15, 1997 (revised December 11, 1998)

Identification of Product:

Name :	Advantage Windows Fusion
Manufacturer :	General Electric Medical Systems
	283, rue de la Miniere
	78533 Buc Cedex, FRANCE
Distributor :	General Electric Medical Systems, Milwaukee, WI

Marketed Devices:

The Advantage Windows Fusion is substantially equivalent to the device listed below:

Model:	Fusion and Registration feature of Advance Analysis Software
Manufacturer:	General Electric Medical Systems, Milwaukee, WI
510(k) #:	K941223

Device Description:

Application examples include:

a use of previously recorded diagnostic information from follow-up studies.
o combination of CT and MR for better volume definition.
· definition of a volume of interest within one patient model,
with automatic report in the other model ..
" fusion of functional and anatomical images.
a medical education.
6 better communication of clinical results to referring physicians.

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Image /page/1/Picture/3 description: The image shows a dark, round object with a slightly irregular surface. The object appears to be solid and opaque, with no visible internal details. The lighting on the object suggests a smooth, reflective surface, with a highlight on the upper right side. The background is plain and white, which helps to isolate the object and emphasize its shape and texture.

GE Medical Systems P.O. Box 414, W-709 Milwaukee, WI 53201 USA

Indications for Use :

Advantage Windows Fusion provides an easy means for comparison of three dimensional (3D) images from computed tomography (CT) and magnetic resonance (MR). It allows 3D registration between two volumetric acquisitions, which may come from different acquisition modalities (CT/MR), for use in diagnostic radiology or radiation therapy planning.

Comparison with Predicate:

The Advantage Windows Fusion option allows comparison of 3D images similar to the comparison of 2D images performed with the Fusion and Registration feature of the Advanced Analysis software. This product provides 3D composite images comparable to the 2D composite images produced by the predicate device .

Summary of studies :

The AW Fusion option will be fully verified/validated per the program test plans

Conclusions :

The Advantage Windows Fusion option provides 3D information that allows comparison of volumetric acquisitions from different studies and modalities. The potential hazards are controlled by a risk management plan including:

· a Hazard Analysis/Risk Management Summary
· a Software Development and Validation Process
· a Software Verification Plan

This product provides images comparable to the predicate device.

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Image /page/2/Picture/2 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three heads, representing the department's mission to protect the health of all Americans and provide essential human services. The eagle is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement. The text is in all capital letters and is evenly spaced around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 1 5 1998

Larry A. Kroger, Ph.D. Senior Regulatory Programs Manager GE Medical Systems P.O. Box 414 , W-709 Milwaukee, WI 53201

Re:

K983256 Advantage Windows (AW) Fusion Dated: September 15, 1998 Received: September 16, 1998 Regulatory class: II 21 CFR 892.2050/Procode: 90 LLZ

Dear Dr. Kroger:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 III (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Regulations. Title 21. Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. 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 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers 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,

J.J.T.

Capt. Daniel G. Schultz, M.D. Acting Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, 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: Advantage Windows Fusion

Indications for Use

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use	✓	OR Over-The-Counter Use
(Per 21 CFR 801-109)

(Division Sign-Off)
Division of Reproductive, Abdominal, ENT, and Radiological Devices
510(k) Number	K983256

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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).