RA600/CA1000/Digital Hardcopy is intended for viewing and diagnostic interpretation of images acquired from CT, MR, CR, DR, US, XA and other DICOM-compliant medical imaging systems when installed on suitable commercial-standard PC hardware. RA600 / CA1000 is intended for use as a primary diagnostic and analysis workstation in Radiology/ Cardiology or other departments. It is also intended for use as a clinical review workstation throughout the healthcare facility and may be part of a larger PACS configuration.

Digital Hardcopy is intended for use primarily as a workstation for the high volume burning of CDs or DVDs containing DICOM medical images and associated diagnostic report or analysis information. CD /DVD burning and disk labeling are done via a commercially available external robotics device.

RA600/CA1000/Digital Hardcopy receives imaging studies and data over LAN, WAN, intranet or internet from a PACS server or directly from a DICOM -compliant modality or archive utilizing both lossless and lossy compression. It is the user's responsibility to ensure quality, ambient light conditions and image compression ratios are consistent with the clinical application. The R4600/CA1000/Digital Hardcopy workstation may interface with various information systems within the healthcare environment, such as the HIS, RIS, and CVIS. It may be sold as software only, or as a turnkey system

Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretations. Mammographic images may only be interpreted using an FDA approved monitor that offers at least 5 Mpixel resolution and meets other technical specifications reviewed and accepted by FDA.

Device Description

Centricity Radiology RA600 / Centricity Cardiology CA1000 / Centricity Digital Hardcopy is a PC-based DICOM workstation platform which provides scaleable image and data management solutions for medical imaging. This software-based product provides capabilities for the acceptance, transmission, printing, display, storage, editing and digital processing of medical images and associated data.

RA600/CA1000 / Digital Hardcopy may be combined with a PACS network or connected directly to a modality through the use of DICOM networking. The RA600/CA1000 / Digital Hardcopy software application may be sold as a standalone product for use with 'off the shelf' PC hardware that meets minimum specifications or as a turnkey solution integrated with hardware components to be configured to meet the users specific needs.

RA600 / CA1000 / Digital Hardcopy can also provide the hardware and OS platform for a user to operate 3rd party software and/or other GE software applications such as RIS, voice recognition, or advanced imaging analysis, and view any data presented through those applications.

RA600 / CA1000 can act as an image repository for the Centricity Web Viewer application.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the Centricity Radiology RA600 / Centricity Cardiology CA1000 / Centricity Digital Hardcopy, which are PC-based DICOM workstation platforms for medical image management. However, the submission does not contain information regarding objective acceptance criteria or a specific study designed to prove the device meets such criteria with quantitative performance metrics for AI/CAD functionality.

The document states that "The Centricity Radiology RA600 / Centricity Cardiology CA1000 / Technology: Centricity Digital Hardcopy employs the same functional scientific technology as its predicate devices" and concludes that "GE considers features of the Centricity Radiology RA600 / Centricity Cardiology CA1000 / Centricity Digital Hardcopy are equivalent to those of the predicate devices." This indicates a reliance on substantial equivalence to predicate devices rather than a de novo performance study with specific acceptance criteria.

Therefore, many of the requested details about acceptance criteria and study design for AI performance cannot be extracted from the provided text because they are not present. The submission focuses on the general function and safety of the PACS workstation and its equivalence to previously cleared devices.

Here's a breakdown of what can and cannot be answered based solely on the provided text:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria: Not explicitly stated as quantitative performance metrics for a specific AI/CAD function. The submission focuses on functional equivalence to predicate devices.
Reported Device Performance: No specific quantitative performance metrics are provided that would typically be associated with AI/CAD device performance (e.g., sensitivity, specificity, AUC). The "Performance testing" mentioned under "Test Summary" likely refers to system-level performance (e.g., speed, reliability, compliance with DICOM standards) rather than clinical diagnostic accuracy of an AI component.

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

Not provided. There is no mention of a test set, sample size, or data provenance for any diagnostic performance evaluation.

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 provided. No test set means no ground truth establishment for a diagnostic performance evaluation.

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

Not provided. No test set review process 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 provided. The submission does not describe an MRMC study or any AI assistance feature for human readers. This device is a PACS workstation, not an AI/CAD diagnostic tool in the sense of providing specific interpretations or improving reader performance on a task.

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

Not provided. The device described is a workstation for viewing and managing images, not a standalone AI algorithm that provides diagnostic findings independently.

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

Not applicable / Not provided. As no specific diagnostic performance study for an AI component is described, there's no mention of ground truth types.

8. The sample size for the training set

Not provided. The device is a software platform, and the submission does not discuss machine learning or AI model training.

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

Not applicable / Not provided. As no AI training is discussed, ground truth establishment for a training set is not mentioned.

Summary of available information related to validation/testing based on the provided text:

The submission highlights the following quality assurance measures applied to the development, which are standard for software development and system validation, but do not constitute a clinical performance study with defined diagnostic acceptance criteria for an AI component:

Risk Analysis
Requirements Reviews
Design Reviews
Testing on unit level (Module verification)
Integration testing (System verification)
Final acceptance testing (Validation)
Performance testing
Safety testing

The core of the submission relies on the concept of substantial equivalence to predicate devices (K042525, K023178, K023100) rather than presenting novel clinical performance data for new AI algorithms. The device functions as a platform for image viewing and management, not as an AI-powered diagnostic aide.

Summary

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Centricity Radiology RA600 / Centricity Cardiology CA1000 / Centricity Digital Hardcopy 510k Premarket Notification Submission

K663628

Section 2 510(k) Summary of Safety and Effectiveness

Date:	December 19, 2006	DEC 26 2006
Submitter:	GE Healthcare Integrated IT Solutions540 W Northwest HighwayBarrington, IL 60010
Contact Person:	Karen M. LundeSr. Regulatory Affairs LeaderGE Healthcare Integrated IT SolutionsPhone: (847 277-6092Fax: (414) 755-0655
Device:
Trade Name:	Centricity Radiology RA600 / Centricity Cardiology CA1000 /Centricity Digital Hardcopy
Common/Usual Name:	Picture Archiving and Communications Systems and Workstation
Classification Names:	21 CFR 892.2050 System, Image Processing, Radiological
Predicate Device:	K042525 Centricity Radiology RA600 / Centricity Cardiology CA1000 /Centricity Digital Hardcopy WorkstationK023178 Innova 4100 (Specific features)K023100 Accusketch Cardiac Quantitative System W/ AdvancedAnalysis Components (Specific features)
Device Description:	Centricity Radiology RA600 / Centricity Cardiology CA1000 /Centricity Digital Hardcopy is a PC-based DICOM workstation platformwhich provides scaleable image and data management solutions formedical imaging. This software-based product provides capabilitiesfor the acceptance, transmission, printing, display, storage, editingand digital processing of medical images and associated data.
	RA600/CA1000 / Digital Hardcopy may be combined with a PACSnetwork or connected directly to a modality through the use of DICOMnetworking. The RA600/CA1000 / Digital Hardcopy softwareapplication may be sold as a standalone product for use with 'off theshelf' PC hardware that meets minimum specifications or as a turnkeysolution integrated with hardware components to be configured tomeet the users specific needs.
	RA600 / CA1000 / Digital Hardcopy can also provide the hardware andOS platform for a user to operate 3rd party software and/or other GEsoftware applications such as RIS, voice recognition, or advancedimaging analysis, and view any data presented through thoseapplications.
	RA600 / CA1000 can act as an image repository for the Centricity WebViewer application.
	Targeted users of this system are trained professionals, including

Targeted users of this system are trained professionals, including radiologists, cardiologists, physicians, technologists and nurses.

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Centricity Radiology RA600 / Centricity Cardiology CA1000 / Centricity Digital Hardcopy 510k Premarket Notification Submission

KUL 3628

RA600/CA1000/Digital Hardcopy is intended for viewing and Intended Use: diagnostic interpretation of images acquired from CT, MR, CR, DR, US, XA and other DICOM-compliant medical imaging systems when installed on suitable commercial-standard PC hardware. RA600 / CA1000 is intended for use as a primary diagnostic and analysis workstation in Radiology/ Cardiology or other departments. It is also intended for use as a clinical review workstation throughout the healthcare facility and may be part of a larger PACS configuration.

Digital Hardcopy is intended for use primarily as a workstation for the high volume burning of CDs or DVDs containing DICOM medical images and associated diagnostic report or analysis information. CD /DVD burning and disk labeling are done via a commercially available external robotics device.

RA600/CA1000/Digital Hardcopy receives imaging studies and data over LAN, WAN, intranet or internet from a PACS server or directly from a DICOM -compliant modality or archive utilizing both lossless and lossy compression. It is the user's responsibility to ensure quality, ambient light conditions and image compression ratios are consistent with the clinical application. The RA600/CA1000/Digital Hardcopy workstation may interface with various information systems within the healthcare environment, such as the HIS, RIS, and CVIS. It may be sold as software only, or as a turnkey system.

Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretations. Mammographic images may only be interpreted using an FDA approved monitor that offers at least 5 Mpixel resolution and meets other technical specifications reviewed and accepted by FDA.

The Centricity Radiology RA600 / Centricity Cardiology CA1000 / Technology: Centricity Digital Hardcopy employs the same functional scientific technology as its predicate devices.
Test Summary: The Centricity Radiology RA600 / Centricity Cardiology CA1000 / Centricity Digital Hardcopy complies with the voluntary standards as detailed in Section 12 Specific Standards and Guidance. The following quality assurance measures were applied to the development:
- Risk Analysis .
- . Requirements Reviews
- Design Reviews .
- . Testing on unit level (Module verification)
- . Integration testing (System verification)
- . Final acceptance testing (Validation)
- . Performance testing
- Safety testing .
- Conclusion: GE considers features of the Centricity Radiology RA600 / Centricity Cardiology CA1000 / Centricity Digital Hardcopy are equivalent to those of the predicate devices.

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11.00 11

Third Party Review Quality Assessment

Section 1 - Submission Information

510(k) No.:	K063628
Third Party Organization:	Underwriters
Third Party's Primary Reviewer(s):	Silvia Ankwa
ODE/OIVD Division:	DRARD
Branch/Team:	RDB

Section 2 - 510(k) Decision

Third party recommendation:	SE SE NSE ____ Other (specify): ________
ODE/OIVD final decision:	SE SE NSE ____ Other (specify): ________

Section 3 - Assessment of Third Party Review

Review Element	Rating (check one)
	Adequate	Minor Issue(s)	Major Issue(s)
a. Determination of device eligibility for third party review	✓
b. Extent of pre-submission consultation with ODE/OIVD division	✓
c. Organization and format of review documentation	✓
d. Determination of 510(k) administrative completeness (screening review)	✓
e. Summary of device characteristics, intended use, and performance (including accessories, if applicable) and reason for 510(k) submission	✓
f. Comparison to legally marketed devices-identification and analysis of key similarities and differences	✓
g. Rationale for conclusions and recommendation	✓
h. Use of guidance documents and standards	✓
i. Resolution of 510(k) deficiencies and FDA requests for additional information	✓
j. Scope of reviewer expertise and use of consulting reviewers	✓
k. Other (specify):

Comments (explanation of ratings/tssues):

Section 4 ODE/OIVD Assessar Information

Assessed by:

Date: 12-13-06
Tel. No.: 24

3-06 Tel. No.: 240-271-3664

Routing: Division Christompleted assessment (this page only) to inside front cover of 510(k). DMC Forward this page only to Fire Rechen, POS/ODE, Rm. 120J, Corp. Rival (HF/ 30) 1

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Image /page/3/Picture/1 description: The image shows a circular logo with text around the perimeter and a stylized graphic in the center. The text around the perimeter reads "DEPARTMENT OF HEALTH & HUMAN SERVICES". The graphic in the center appears to be a stylized representation of an eagle or bird, with three curved lines forming the wings and body.

DEC 2 6 2006

Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850

GE Healthcare Integrated IT Solution % Ms. Silvia Ankova Senior Project Engineer Underwriters Laboratories, Inc. 333 Pfingsten Rd. NORTHBROOK IL 60062

Re: K063628

Trade/Device Name: Centricity Radiology RA600 / Centricity Cardiology CA1000 / Centricity Digital

Hardcopy Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: December 5, 2006 Received: December 6, 2006

Dear Ms. Ankova:

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 (Premarket Approval), 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.

Image /page/3/Picture/11 description: The image is a black and white circular logo or seal. The text "1906-2006" is at the top of the seal. The letters "DA" are in the center of the seal in a bold, blocky font. The word "Centennial" is below the letters "DA" in a cursive font.

Protecting and Promoting Public Health

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Please be advised that FDA's issuance of a substantial equivalence determination does not mean I tods be actised has i Brinination that your device complies with other requirements of the Act that I Dri has made a actor regulations administered by other Federal agencies. You must or any I odolar bakated and strenging, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set CI K I at 0077, idocinig (21 CFR Part 820); and if applicable, the electronic forul in the quality by tions (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) I his letter will anow you to ough finding of substantial equivalence of your device to a legally prematicated 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 this letter:

21 CFR 876.xxx	(Gastroenterology/Renal/Urology)	240-276-0115
21 CFR 884.xxx	(Obstetrics/Gynecology)	240-276-0115
21 CFR 894.xxx	(Radiology)	240-276-0120
Other		240-276-0100

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 (21 cr 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/cdrl/industry/support/index.html.

Sincerely yours,

Nancy C. Hogdon

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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Page 1 of 1

510(k) Number (if known):

510(k) filed on October 16, 2006

Centricity Radiology RA600 / Centricity Cardiology CA1000 / Centricity Digital Device Name: Hardcopy

K063628;

Indications for Use:

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use × (Per 21 CFR 801.109) OR

Over-The-Counter Use_

(Optional Format 1-2-96)

Barbara Bucher for NCB

Division of Reproductive, Abdominal, and Radiological Devices

510(k) Number K063628

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).