The Centricity PACS Plus system is used to transmit, store and display images throughout a clinical environment. The Centricity PACS Plus is an image display software application that is intended for use by qualified physicians and other personnel for reading, diagnostic review, and analysis of digital images acquired from imaging devices such as CT, MR, CR, DX, MG, US, NM, PET, and other devices. As a part of the PACS Plus system the Centricity RA1000 is used to view digital images that are obtained from a GE Centricity PACS System, or another DICOM device.

Device Description

See Attachment #2

AI/ML Overview

The provided text is a 510(k) Summary for the Centricity PACS Plus device. This document focuses on demonstrating substantial equivalence to predicate devices for regulatory clearance, rather than presenting a detailed study with acceptance criteria and performance metrics typically found in clinical trials or validation studies for novel AI/CADe devices.

Therefore, much of the requested information regarding acceptance criteria, study details, sample sizes, ground truth establishment, expert qualifications, and MRMC effectiveness studies is not available in the provided text.

Based on the available information, here's what can be extracted:

1. Table of acceptance criteria and the reported device performance:

The document does not explicitly state quantitative acceptance criteria or detailed performance metrics. The core "acceptance criterion" for this type of 510(k) is demonstrating substantial equivalence to existing legally marketed predicate devices. The performance is reported as:

Acceptance Criterion (Implied)	Reported Device Performance
Substantial Equivalence to Predicate	"Centricity PACS Plus provides images comparable to the predicate devices."
Integration with workflow	"Centricity PACS Plus brings additional features in order to integrate seamlessly into the Radiology Department Workflow."
Safety	"The entire potential new hazards has been studied by a Risk Management Plan."

2. Sample size used for the test set and the data provenance:

Sample size for test set: Not specified.
Data provenance: Not specified. This document refers to displaying images acquired from various imaging devices (CT, MR, CR, DX, MG, US, NM, PET), but does not detail the origin of data used for any testing.
Retrospective or prospective: Not specified.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not specified. The document does not describe the establishment of a ground truth for a test set in the context of device performance evaluation.

4. Adjudication method for the test set:

Not specified.

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:

No MRMC study mentioned. This document pertains to a Picture Archiving and Communication System (PACS), which is software for transmitting, storing, and displaying images, not typically a device that directly assists with diagnostic interpretation in the same way a CADe system would, hence an MRMC study for reader improvement with AI assistance is not relevant or described here.

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

Not applicable/Not mentioned. This device is an image display software application intended for use by qualified personnel, implying human-in-the-loop use. It is not an algorithm that performs standalone diagnostic tasks without human oversight.

7. The type of ground truth used:

Not specified. This document primarily asserts functionality and comparability for image display and storage, rather than diagnostic accuracy that would require a ground truth for a specific disease or condition.

8. The sample size for the training set:

Not applicable/Not specified. This document describes a PACS system, which is a software application for image management, not a machine learning or AI algorithm that typically has a "training set" in the conventional sense.

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

Not applicable/Not specified. As there's no mention of a training set, the establishment of its ground truth is not discussed.

Summary

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7 2002 NOV

GE Medical Systems Information Technologies

1023557 Centricity PACS Plus 510 (k) 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)

1. Identification of submitter: Scott R. Evans Regulatory Affairs Specialist Telephone: 847-704-8878 Fax: 847-704-8560
  Date Prepared: September 26th, 2002

2. Identification of Product:

Device name	Centricity PACS Plus
Classification name	PACS per 21CFR Section 892.2050
Manufacturer/	General Electric Medical Systems
Distributor	800E. Business Center Drive
	Mount Prospect, IL 60056
	USA

3. Marketed Devices

Centricity PACS Plus is substantially equivalent to the devices listed below:

Model:	Platinum Reading and Review Workstation
Manufacturer:	General Electric Medical Systems
510 (k):	K981217

Model:	Siemens SieNET
Manufacturer:	General Electric Medical Systems
510 (k):	K920319

4. Device Description :

See Attachment #2

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5. Indications for Use

6. Comparison with Predicate Device

Centricity PACS Plus is substantially equivalent to the devices listed below:

Model:	Platinum Reading and Review Workstation
Manufacturer:	General Electric Medical Systems
510 (k):	K981217
Model:	Siemens SieNET
Manufacturer:	General Electric Medical Systems
510 (k):	K920319

These workstations allow easy selection, review, processing, filming and media interchange of multi-modality images from a variety of diagnosis imaging systems.

7. Conclusions

Centricity PACS Plus brings additional features in order to integrate seamlessly into the Radiology Department Workflow.

The entire potential new hazards has been studied by a Risk Management Plan:

. Risk Management Summary
A software development and validation process
A software verification plan .

Centricity PACS Plus provides images comparable to the predicate devices.

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Image /page/2/Picture/1 description: The image shows a black and white logo. The logo features a stylized depiction of an eagle's head and neck, composed of three parallel, curved lines. The eagle faces to the right. The words "DEPARTMENT OF TRANSPORTATION" are arranged in a circular fashion around the eagle, with the text oriented to follow the curve of the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

General Electric Medical Systems % Mr. Heinz Joerg Steneberg Division Manager Medical Division TÜV Rheinland of North America 12 Commerce Road NEWTOWN CT 06470

· Re: K023557

Trade/Device Name: Centricity PACS Plus Regulation Number: 21 CFR 892.2050 Regulation Name: Picture Archiving and Communications System Regulatory Class: II Product Code: 90 LLZ

Dated: October 21, 2002 Received: October 23, 2002

Dear Mr. Steneberg:

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 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.

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.

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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), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this 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" (21 CFR Part 807.97). 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. Brogdon

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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STATEMENT OF INTENDED USE

K023557 510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device name: Centricity PACS Plus

Indication For Use:

The Centricity PACS Plus system is used to transmit, store and display images throughout a clinical environment. The Centricity PACS Plus is an image display software application that is intended for reading, diagnostic review, and analysis of digital images acquired from imaging devices such as CT, MR, CR, DX, MG, US, NM, PET, and other devices. As a part of the PACS Plus system the Centricity RA1000 is used to view digital images that are obtained from a GE Centricity PACS System, or another DICOM device.

(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
----------------------	-------------

Nancy Corogdon
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices

510(k) Number	K023557
---------------	---------

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).