AGFA's WEB1000 software is intended for installation on standard hardware meeting minimum specifications. The system is intended for viewing, assembling, organizing, sharing, and displaying patient images and demographic information. Images stored on the WEB1000 can be part of your evolving workflow. The WEB1000 can also be used remotely over a hospital intranet or over the Internet.

When used by trained and qualified professionals the WEB1000 may be used for reviewing and referral image data collected from various modalities including mammography. When used for mammography the WEB1000 should never be used as a diagnostic tool.

Device Description

WEB1000™ is a software package, which may be marketed as a software only solution, as well was in conjunction with standard PC hardware. WEB1000™ is a PC-based, DICOM-compliant PACS device that is able to receive and display DICOM images. Images sent to WEB1000™ are converted into formats suitable for viewing in a web browser, and stored in a local cache (hard disk). The algorithms used by WEB1000™ to create JPEG and wavelet images follow known and accepted protocols.

Images sent to WEB1000™ can be viewed using a Java applet that runs within a web browser such as Netscape or Internet Explorer. The WEB1000™ applet can be used for the purposes of viewing images over a hospital intranet, or over the Internet from a remote location. Images stored on WEB1000™ are transient, as WEB1000™ is not intended to be an archiving device. WEB1000™ uses standard "off-the-shelf" PC hardware and communicates using the standard TCP/IP stack. The network hardware used to support the TCP/IP stack is superfluous to WEB1000™ . WEB1000™ is intended for reference viewing of medical data. It is not for the purposes of diagnosis. Images viewed from WEB1000™ are used from reference purposes only. Diagnostic reports created from diagnostic viewing application and distributed through WEB1000™ can be used for treatment of a patient.

AI/ML Overview

The provided 510(k) summary for K053458 for the AGFA WEB1000™ device is a summary of safety and effectiveness, focused on establishing substantial equivalence to a predicate device, rather than a detailed report of a study proving the device meets specific performance acceptance criteria.

The submission claims the device is substantially equivalent to General Electric Medical Systems' Centricity™ PACS System (Web Client Component). The basis for this claim is that: "Technological and functional characteristics of the Agfa's WEB1000™ software are identical to those of General Electric Medical Systems' Centricity™ PACS System (Web Client Component)."

Therefore, the document does not contain the information requested in points 1-9 regarding specific acceptance criteria, a study proving those criteria are met, sample sizes, ground truth establishment, or expert involvement. The entire premise of this 510(k) is that because it is functionally identical to a previously cleared device, it is considered safe and effective for its stated intended use.

Based on the provided text, the requested information (1-9) cannot be extracted because the submission relies on substantial equivalence to a predicate device and does not present a de novo study with acceptance criteria and performance data.

Here’s what can be inferred from the document regarding the lack of such a study:

No acceptance criteria or reported device performance are listed. The document states, "The algorithms used by WEB1000™ to create JPEG and wavelet images follow known and accepted protocols." This is a general statement, not a specific performance metric.
No mention of a study with a test set, data provenance, number of experts, adjudication method, MRMC study, or standalone performance study. The document focuses on technological and functional comparison to the predicate.
The type of ground truth used is not applicable as no study with a ground truth is described.
No sample size for a training set is mentioned, nor is how ground truth for a training set was established. This is because the submission is not describing the development and validation of a novel algorithm requiring these details.

In summary, the 510(k) for K053458 is a substantial equivalence submission, which typically does not include the detailed performance study data requested. The "study" here is the comparison of technological and functional characteristics to a predicate device, rather than a performance study against predefined acceptance criteria.

Summary

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K053458

DEC 2 2 2005

510(K) SUMMARY OF SAFETY AND EFFECTIVENESS

Submitted by: Agfa Corporation 10 South Academy St. Greenville, SC 29602-9048

1. Date Prepared September 14, 2005
1. Contact Person Phil Cuscuna Phone: (519) 572-9339 FAX: (519) 746-3745

3. Device Name and Classification

Trade Name: WEB1000 ™ Picture archiving and communications Classification Name: system. Classification Panel: Radiology 21 CFR § 892.2050 CFR Section: Device Class: Class II Device Code: LLZ

4. Intended Use

The WEB1000™ software and the computer platform constitute a system for viewing of medical image data by trained and qualified professionals. The system is intended for use in the assembly, organization, sharing, and display of patient images and demographic information for review and referral purposes only. The WEB1000™ applet can be used for viewing images over a hospital intranet or over the Internet from a remote location. Images stored on WEB1000™ are transient, as WEB1000™ is not intended to be an archiving device.

5. Substantial Equivalence

The predicate device is General Electric Medical Systems' Centricity™ PACS System (Web Client Component) - a Class II device (FDA's Clearance number: K043415; FDA's clearance date: January 21, 2005)

6. Device Description

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for viewing in a web browser, and stored in a local cache (hard disk). The algorithms used by WEB1000™ to create JPEG and wavelet images follow known and accepted protocols.

7. Comparison of Technological Differences:

Technological and functional characteristics of the Agfa's WEB1000™ software are identical to those of General Electric Medical Systems' Centricity™ PACS System (Web Client Component). Both of these display stations allow for the ability to display images from a number of modalities including MG (Digital Mammography) class images for nondiagnostic purposes.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes representing the department's mission of promoting health, well-being, and human services. The eagle is encircled by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement. The logo is in black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 2 2 2005

AGFA Corporation % Mr. Jeffrey D. Rongero Senior Project Engineer Conformity Assessment Services Underwriters Laboratories, Inc. 12 Laboratory Drive Research Triangle Park, NC 27709 Re: K053458 Trade/Device Name: WEB1000 Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: December 7, 2005 Received: December 13, 2005

Dear Mr. Rongero:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced we have leviewed your becalent by equivalent (for the indications for use stated in above and nave acterim.rearketed predicate devices marketed in interstate commerce prior to the cherolors to regary mantonto of the Medical Device Amendments, or to devices that have been May 20, 1770, the chance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that recrassmed in accordal of a premarket approval application (PMA). You may, therefore, market the do not require approval of a provisions of the Act. The general controls provisions of the Act ut vice, subject to the general estimon, 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 If your de rice is classified (500 acch additional controls. Existing major regulations affecting your Apployal), It they of July of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA de view of to total a nouncements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that I rease be advised that i 22 the made complies with other requirements of the Act or any Fort has made a acterininations administered by other Federal agencies. You must comply with all the r cacraf statues and regulation but not limited to registration and listing (21 CFR Part 807): labeling Act srequirements moranmantacturing practice requirements as set forth in the quality systems (QS) (= C+1 e r (2 ) 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) This letter will anow you to begin manies of substantial equivalence of your device to a legally premarked nothleadon: "The PDF mining if and in the 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 desire specific acriee for your as 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 Also, production other general information on your responsibilities under the Act from the 807.77). Tou may obtain onto general and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrl/industry/support/index.html

Sincerely yours,

Nancy C. Hugdon

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

Kos 3458 510(k) Number (if known):

Device Name:_WEB1000

Indications For Use:

AGFA's WEB1000 software is intended for installation on standard hardware AGT A $ WED 1000 ookmailmum specifications. The system is intended for fileeting of Cxocoding minimand, sharing, and displaying patient images and viewing, assombling, organisms on the WEB1000 can be part of your evolving demographic information in also be used remotely over a hospital intranet or over the Internet.

When used by trained and qualified professionals the WEB1000 may be used for vincen used by trains and referral image data collected from various reviewing and rolling mammography. When used for mammography the WEB1000 should never be used as a diagnostic tool.

Prescription Use _____________________________________________________________________________________________________________________________________________________________ (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)

David h. hlynn

(Division Sicn-Off) Division of Reproductive, and Padiological 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).