The Embrace™ Diagnostic PACS Workstation is intended for softcopy reading and diagnosis by Radiologists. It is also intended for use with regionally approved digital mammography modalities presenting processed images (DICOM "For Presentation" images) and the display of multi-modality general imaging DICOM images including adjunct breast imaging modality studies (i.e. Breast MR and Breast US).

The Embrace™ DS3000 Diagnostic PACS Workstation is intended for use with rno Embraoo ved digital mammography modalities presenting processed images (DICOM "For Presentation" images) and the display of multi-modality images (1800) images including adjunct breast imaging modality studies (i.e. Breast MR and Breast US).

The Embrace™ DS3000 Diagnostic PACS Workstation when intended for diagnostic/screening Mammography viewing must do so only when used with EDA approved monitors and only when viewing Lossless format images.

The Embrace™ DS3000 Diagnostic PACS Workstation is also intended for softcopy reading and diagnosis by Radiologists.

Device Description

IMPAX Client Embrace™ delivers a diagnostic softcopy breast imaging workstation for the Women's Care initiative at AGFA.

The following features are available:

· Display of regionally approved DICOM DR Digital Mammography Images (MG SOP class)

· Display of regionally approved DICOM CR Digital Mammography Images (CR SOP class)

· Embrace™ product branding

The Hardware configuration of Embrace™ will consist of the following:

System (Per Host Machine):	Dell Precision™ Workstation 650;Compaq xw6000
Number & Details of CPU's	1 or 2 CPU's depending on configuration
Hard Drive space:	40GB IDE
CD-ROM:	Yes
Floppy:	Yes
Network interfaces:	System comes with an integrated10/100/1000 Ethernet adapter
Power Supplies:	Default
Chassis:	Tower
Peripherals:	Microsoft IntelliMouse or IntelliMouseExplorer; Keyboard

Embrace™ will support the following monitors:

BARCO Mammography MeDis 5MP CRT monitor package -- MGD . 521M
BARCO Mammography 5MP and 3MP Flat Panel LCD's (EU) .

AI/ML Overview

This K040553 submission is for a PACS workstation (Embrace™ Workstation), which is a medical image display system. The provided text does not include a description of any specific study that establishes acceptance criteria for device performance in the way one might assess an AI algorithm. Instead, it focuses on demonstrating substantial equivalence to a predicate device based on technological and functional similarity.

Therefore, many of the requested sections (e.g., sample size for test/training set, expert ground truth, adjudication methods, MRMC studies, standalone performance) are not applicable or cannot be extracted from this document, as they pertain more to performance evaluation of an analytical or diagnostic algorithm rather than a display system.

However, I can extract information related to the device itself and its intended use.

Acceptance Criteria and Device Performance (Not applicable in the context of an AI-driven study)

For a PACS workstation like Embrace™, "acceptance criteria" are generally related to its ability to correctly display DICOM images, integrate with other systems, and meet performance specifications (e.g., image loading speed, display quality). This document primarily establishes "substantial equivalence" to a predicate device. Performance criteria would typically be met through technical specifications and validation rather than a clinical study with reported performance metrics like sensitivity/specificity for a diagnostic task.

The document states: "Technological and functional characteristics of the Agfa's Embrace™ software are identical to those of Seno Advantage." This implies that the acceptance criteria are met by demonstrating this identity, rather than by achieving specific quantitative performance targets.

Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Implied by Substantial Equivalence)	Reported Device Performance (Implied by Substantial Equivalence)
Ability to display DICOM DR Digital Mammography Images (MG SOP class)	Identical to Seno Advantage
Ability to display DICOM CR Digital Mammography Images (CR SOP class)	Identical to Seno Advantage
PACS workstation for softcopy reading and diagnosis by Radiologists	Intended for softcopy reading and diagnosis by Radiologists, identical to Seno Advantage
Display of multi-modality general imaging DICOM images	Intended for such display, identical to Seno Advantage
Display of adjunct breast imaging modality studies (e.g., Breast MR and Breast US)	Intended for such display, identical to Seno Advantage
Use with FDA approved monitors for diagnostic/screening Mammography	Explicitly stated as a condition for diagnostic/screening Mammography viewing
Use with Lossless format images for diagnostic/screening Mammography	Explicitly stated as a condition for diagnostic/screening Mammography viewing

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not Applicable. This submission is for a PACS workstation, not a diagnostic algorithm that would typically undergo a test set evaluation with specific diagnostic performance metrics. The submission focuses on demonstrating substantial equivalence to a predicate device (General Electric Medical Systems' Seno Advantage) based on technological and functional characteristics. No specific "test set" of patient data for performance evaluation is described.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not Applicable. As no diagnostic test set is described, there is no mention of experts establishing ground truth for a test set.

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

Not Applicable. No test set or ground truth establishment method is described.

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

Not Applicable. This device is a PACS workstation, not an AI-assisted diagnostic tool. No MRMC study is mentioned.

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

Not Applicable. The device is a workstation designed for human interaction (softcopy reading and diagnosis by Radiologists), not a standalone algorithm.

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

Not Applicable. No ground truth for diagnostic performance evaluation is described.

8. The sample size for the training set

Not Applicable. No training set for an algorithm is described.

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

Not Applicable. No training set or ground truth establishment method is described.

Summary

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K040553

510(K) SUMMARY OF SAFETY AND EFFECTIVENESS

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

1. Date Prepared February 25, 2004

1. Contact Person Phil Cuscuna Phone: (519) 746-2900 FAX: (519) 746-3745

3. Device Name and Classification

Embrace™ Workstation Trade Name: Picture archiving and communications system. Classification Name: Classification Panel: Radiology

CFR Section: 21 CFR § 892.2050 Device Class: Class II Device Code: LLZ

4. Intended Use

5. Substantial Equivalence

The predicate devices is General Electric Medical Systems' Seno Advantage (FDA's Clearance number: K033400; FDA's clearance date: 12/04/2003).

6. Device Description

IMPAX Client Embrace™ delivers a diagnostic softcopy breast imaging workstation for the Women's Care initiative at AGFA.

The following features are available:

· Display of regionally approved DICOM DR Digital Mammography Images (MG SOP class)

· Display of regionally approved DICOM CR Digital Mammography Images (CR SOP class)

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· Embrace™ product branding
The Hardware configuration of Embrace™ will consist of the following:

System (Per Host Machine):	Dell Precision™ Workstation 650;Compaq xw6000
Number & Details of CPU's	1 or 2 CPU's depending on configuration
Hard Drive space:	40GB IDE
CD-ROM:	Yes
Floppy:	Yes
Network interfaces:	System comes with an integrated10/100/1000 Ethernet adapter
Power Supplies:	Default
Chassis:	Tower
Peripherals:	Microsoft IntelliMouse or IntelliMouseExplorer; Keyboard

Embrace™ will support the following monitors:

BARCO Mammography MeDis 5MP CRT monitor package -- MGD . 521M
BARCO Mammography 5MP and 3MP Flat Panel LCD's (EU) .

7. Comparison of Technological Differences:

Technological and functional characteristics of the Agfa's Embrace™ software are identical to those of Seno Advantage. Both of these workstations allow easy selection, review, processing, filming and media interchange of multi-modality images from a variety of diagnosis imaging systems.

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Image /page/2/Picture/1 description: The image shows a logo for the Department of Health. The logo features a stylized eagle with three lines representing its wings. The text "DEPARTMENT OF HEALTH &" is arranged vertically along the left side of the logo.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 2 6 2004

Agfa Corporation % Mr. Phil Cuscuna Regulatory Affairs of the Americas Agfa Health Carc 455 Philip Street Waterloo, Ontario, N2L 3X2 CANADA

Re: K040555 Trade/Device Name: IMPAX® DS3000 Client Embrace Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: 90 LLZ Dated: February 16, 2004 Received: March 2, 2004

Dear Mr. Cuscuna:

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 proor 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 concerting 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 forth in the quality systems (QS) regulation (21 (FR 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) 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 one of the following numbers, based on the regulation number at the top of the letter:

8xx.1xxx	(301) 594-4591
876.2xxx, 3xxx, 4xxx, 5xxx	(301) 594-4616
884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx	(301) 594-4616
892.2xxx, 3xxx, 4xxx, 5xxx	(301) 594-4654
Other	(301) 594-4692

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" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained 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,

Nancy C. Brygdon

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

Enclosure

Page 2

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Indications for Use

510(k) Number (if known): K040555

Device Name: IMPAX® DS3000 CLIENT EMBRACE

Indications For Use:

The Embrace™ DS3000 Diagnostic PACS Workstation is also intended for softcopy reading and diagnosis by Radiologists.

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use

(21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Nancy Brogdon

(Division Sign-Off)
Division of Reproductive, Abdominel,
and Radiological Devices R040555

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).