Registration and Fusion (Basic and Extended) is indicated for the simultaneous visualization of multiple medical images of the same patient. The application can assist the user in visually matching and comparing anatomical studies taken at different times or acquired via different imaging modalities (Basic: CT-CT, CT-MR, MR-MR, Extended: CT-PET, MR-PET) as well as assist in making measurements. It is primarily used in the fields of diagnostic radiology, neurology and oncology.

Device Description

Medical Data Registration and Fusion R 1.0 is a PACS plug-in (accessory). It is an image analysis software package that establishes the geometrical relationship between different DICOM 3.0 compliant 3-D medical data sets from PET, MR and CT imaging (registration"). The matched images are displayed (fusion') by either the use of semitransparent overlays or by displaying them side-by-side. Registration and fusion facilitates the comparison of PET/CT, PET/MRI, CT/CT, MRI/MRI, CT/MRI image data sets for use in: The general radiology department for various lesions. The oncology department for various cancerous lesions. The neurology department for various lesions. The rigid registration used in the application, aims to help the clinician navigate to the same anatomical location in both image sets. The Medical Data Registration and Fusion software runs on Agfa's PACS workstations (Impax 5.3 and 6.3 workstations).

AI/ML Overview

The provided 510(k) summary for Agfa's Registration and Fusion software does not contain specific acceptance criteria or a detailed study proving the device meets those criteria in the way typically expected for a medical AI/CAD device.

Instead, this submission focuses on demonstrating substantial equivalence to a predicate device (Mirage 5.5, K043441) by highlighting similar indications, intended use, and technological characteristics. The "Testing" section is extremely brief and only states: "Registration and Fusion has been tested for compatibility with Agfa's Impax® PACS Systems." This implies functional testing and integration testing, rather than a clinical performance study with predefined acceptance criteria.

The information sought in your request (sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types and establishment for training sets) is not present in this 510(k) summary. This is common for devices like PACS accessories that primarily provide visualization and registration tools, where the safety and effectiveness are often derived from the predicate device and the basic functionality of the software.

Therefore, I cannot populate the table or answer the specific questions as the required information is not disclosed in the provided document.

Summary of available information regarding acceptance criteria and study:

The document states:

Acceptance Criteria: Not explicitly defined or listed in terms of clinical performance metrics (e.g., sensitivity, specificity, accuracy). The implicit acceptance criteria revolve around functional compatibility with Agfa PACS systems and achieving substantial equivalence to the predicate device in terms of intended use and technological characteristics.
Study Proving Acceptance: The document mentions "testing for compatibility with Agfa's Impax® PACS Systems." This suggests internal functional and integration testing, but not a formal clinical performance study with human readers, ground truth, or statistical analysis of diagnostic accuracy.

Regarding the specific questions you asked:

A table of acceptance criteria and the reported device performance:
- Acceptance Criteria: Not explicitly stated.
- Reported Device Performance: Not reported in terms of clinical metrics. The performance described is functional (image registration and fusion capabilities).
Sample sizes used for the test set and the data provenance: Not provided.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not provided, as a formal test set with expert-established ground truth for diagnostic performance is not described.
Adjudication method for the test set: Not provided.
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: Not done/not reported. This device is a visualization and registration tool, not an AI/CAD system designed to directly improve diagnostic accuracy in that manner.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not done/not reported for diagnostic performance. The device's function (registration and fusion) is inherently an assist to a human user.
The type of ground truth used: Not provided.
The sample size for the training set: Not applicable/not provided. This device is not described as an AI/machine learning system that requires a training set in the typical sense. It performs rule-based image registration and fusion.
How the ground truth for the training set was established: Not applicable/not provided.

Summary

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K080013
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510(k) Summary

Agfa Registration and Fusion

Common/Classification Name: Picture Archiving and Communications System (PACS), 21 CFR 892.2050 Proprietary Name: Registration and Fusion

Agfa HealthCare Corporation 10 South Academy Street Greenville, SC 29602-9048

Contact: Tom Holbrook, Prepared: November 9, 2007 Telephone: (519) 746-6210 ext. 3297 Facsimile: (519) 746-3745

JAN 17 2008

A. LEGALLY MARKETED PREDICATE DEVICES

This is a 510(k) for Agfa's Registration and Fusion software. The predicate device, Mirage 5.5 (K043441), manufactured by Segami Corporation.

The new device is similar in indications and intended use as the predicate device.

DEVICE DESCRIPTION B.

The matched images are displayed (fusion') by either the use of semitransparent overlays or by displaying them side-by-side.

Registration and fusion facilitates the comparison of PET/CT, PET/MRI, CT/CT, MRI/MRI, CT/MRI image data sets for use in:

The general radiology department for various lesions. ●
The oncology department for various cancerous lesions. .

Definitions

Image Registration: The alignment of one or more [medical] images to a reference image in order to facilitate geometric comparison. This is a numerical operation that results in the computation of an explicit mathematical transformation between every point in the registered image sets.

mage Fusion: Registration forms the basis of image fusion in the sense that the geometrical alignment of images is a prerequisite. The notion of "fusion" takes this a step further by considering how to visualize the ttent of different images representing the same object [organ, anatomical region, etc.]. Such techniques include the use of overlays, semi-transparent renderings, etc.

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K080013
pg-2 of 3

The neurology department for various lesions. .
The rigid registration used in the application, aims to help the clinician navigate to the same anatomical location in both image sets.

The Medical Data Registration and Fusion software runs on Agfa's PACS workstations (Impax 5.3 and 6.3 workstations).

Typical users of this system are trained professionals, including but not limited to radiologists, referring physicians, radiation therapists, and physicists. Registration may also be used by radiographers for use of the images by radiologists. Registration and fusion has application in general radiology, oncology and neurology.

C. INTENDED USE

Registration and Fusion (Basic and Extended) are intended for the simultaneous visualization of multiple medical images of the same patient. The application can assist the user in visually matching and comparing anatomical studies taken at different times or acquired via different imaging modalities (Basic: CT-CT, CT-MR, MR-MR, Extended: CT-PET, MR-PET) as well as assist in making measurements. It is primarily used in the fields of diagnostic radiology, neurology and oncology.

SUBSTANTIAL EQUIVALENCE SUMMARY D.

Agfa's Registration and Fusion Software has similar indications and intended use as the legally marketed predicate devices.

The differences do not modify the intended diagnostic or therapeutic effect. It is intended for registering and fusing volumetric medical image data sets for the purpose of diagnosis and treatment follow-up.

Registration and Fusion is used primarily in the fields of general radiology department for various lesions, oncology for various cancerous lesions and neurology for various lesions.

Descriptive characteristics and data provided in this submission are sufficiently precise to assure substantial equivalence.

ய் TECHNOLOGICAL CHARACTERISTICS

The technological characteristics are the same in the proposed and predicate device. All devices use similar, commercially available, computers with Windows® operating systems. All operate on DICOM images. All provide rigid registration of CT, MR and PET image data sets

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K080013
PG. 3 of 3

and SUV / Image intensity quantification.

F. TESTING

Registration and Fusion has been tested for compatibility with Agfa's Impax® PACS Systems.

G. CONCLUSIONS

This 510(k) has demonstrated Substantial Equivalence as defined and understood in the Federal Food Drug and Cosmetic Act and various guidance documents issued by the Center for Devices and Radiological Health.

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Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized representation of three wavy lines, which are meant to symbolize the department's mission of promoting health and well-being. The seal is simple and recognizable, and it is used on official documents and materials produced by the HHS.

Public Health Service

JAN 17 2008

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Agfa HealthCare Corporation % Mr. Mark Job Responsible Third Party Official Regulatory Technology Services LLC 1394 25th Street NW BUFFALO MN 55313

Re: K080013

Trade/Device Name: Registration and Fusion Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: January 2, 2007 Received: January 3, 2007

Dear Mr. Job:

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 (PMA), 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.

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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.

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 Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at one 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" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely vours.

Nancy C. Brogdon

Nancy C. B rogdon 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

510(k) Number (if known): Koloo13

Device Name: Registration and Fusion 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 OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Arrih Whang
(Division Sign-Off)

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

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).