UbiPACS™ by ICM Co. Ltd. is a device that receives medical images (including mammograms) and data from various imaging sources. Images and data can be stored, communicated, processed and displayed within the system or across computer networks at distributed locations. 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. Typical users of this system are trained professionals, i.e. physicians, radiologists, nurses, medical technicians, and assistants.

Device Description

The system is a server-based software application. UbiPacs™ is a distributed image management system that manages the archival, retrieval, and distribution of medical images within a Picture Archiving and Communication System (PACS) environment. UbiPacs™ provides network access to patients' current and historical radiological images and relevant examination data. The system is designed for facilitating the clinical practice of radiologists and physicians. UbiPacs™ implementation is based on the Digital Imaging and Communication in Medicine (DICOM) standard. The standard allows communications of images and relevant information such as patient demographics and examination data between the system and other DICOM-compliant imaging devices such as CT scanners, MR imager, CR systems, digital modalities and image viewing workstations.

AI/ML Overview

The provided text is a 510(k) summary for the UbiPACS™ device, which is a Picture Archiving Communications System. Based on the document, this device is a software application for managing medical images and data.

The document does not contain information about specific acceptance criteria related to performance metrics (e.g., sensitivity, specificity, accuracy) that would typically be associated with AI or CADx devices. It primarily focuses on demonstrating substantial equivalence to a predicate device (SmartPACS™) and describing the device's intended use and technological characteristics as a PACS system.

Therefore, many of the requested items related to performance studies, sample sizes, expert qualifications, and ground truth establishment for AI/CADx devices are not applicable or not provided in this regulatory submission.

Here's a breakdown of the information available based on your request:

1. Acceptance Criteria and Reported Device Performance

The document does not specify quantitative acceptance criteria or reported device performance in terms of clinical accuracy (e.g., sensitivity, specificity, AUC) for the UbiPACS™ system. As a PACS system, its "performance" is generally related to its ability to store, retrieve, communicate, and display images effectively in compliance with standards like DICOM. The acceptance criteria for such a device are typically related to:

Functionality: Does it perform the stated functions (archiving, retrieval, distribution, display)?
Interoperability: Does it comply with DICOM standards to communicate with other compliant devices?
Safety/Risk Mitigation: Is it designed to minimize potential hazards (e.g., preventing loss of data, ensuring proper image display as per regulations)?
Substantial Equivalence: It must be as safe and effective as a legally marketed predicate device.

The "reported device performance" is essentially that it "contains adequate information and data to enable FDA - CDRH to determine substantial equivalence to the predicate device."

Acceptance Criteria (Implied for PACS)	Reported Device Performance (Summary)
Archival, Retrieval, Distribution	Manages archival, retrieval, and distribution of medical images.
Network Access	Provides network access to images and data.
DICOM Compliance	Implementation based on the Digital Imaging and Communication in Medicine (DICOM) standard.
Image Display	Displays images (with specific cautions for mammograms and lossy compression).
Hazard Analysis	Potential hazards classified as Minor.
Substantial Equivalence	Determined to be substantially equivalent to the predicate device (SmartPACS™ K022710).
Safety	Software application, does not contact patient, does not control life-sustaining devices.
Human Intervention	A physician interprets images, providing ample opportunity for competent human intervention.
Regulatory Compliance	Will be manufactured in accordance with voluntary standards; meets general controls provisions of the Act.

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

Not applicable/Not provided. This is a PACS system, not a device that processes images to produce a diagnostic output that would be evaluated with a test set of medical cases. The "test set" would likely be a functional verification and validation of the software itself.

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

Not applicable/Not provided. As above, this information is typically relevant for diagnostic AI/CADx devices, not for a PACS system which manages and displays images.

4. Adjudication method for the test set

Not applicable/Not provided.

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. The document does not describe any MRMC or comparative effectiveness study involving human readers or AI assistance. The device is a PACS system, not an AI or CADx tool designed to assist human interpretation.

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

Not applicable. The UbiPACS™ device is a PACS system, not a standalone diagnostic algorithm. The description explicitly states a physician interprets images, "providing ample opportunity for competent human intervention."

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

Not applicable. Ground truth generation is not relevant for a PACS system in the same way it is for a diagnostic algorithm. The "truth" for a PACS is whether it correctly stores, retrieves, and displays the original image data and metadata.

8. The sample size for the training set

Not applicable/Not provided. PACS systems are not typically "trained" in the machine learning sense with a "training set" of medical images for diagnostic purposes. Their development involves software engineering, testing, and validation against functional specifications and standards.

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

Not applicable/Not provided.

Summary

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K04 2507

SEP 2 7 2004

510(k) Summary of Safety and Effectiveness

This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990.

Date Prepared: August 10, 2004

Submitter's Information: 21 CFR 807.92(a)(1) Mr. Yong-gee, Han ICM Co. Ltd. Medical Business Division ICM Building, 15F, #809-10 Yeoksam 1-dong, Gangnam-gu, Seoul 135-931, Republic of Korea

Trade Name, Common Name and Classification: 21 CFR 807.92(a)(2) UbiPACS™ Trade Name: Picture Archiving Communications System Common Name: 892.2050 Device Classification: System, Image Processing Name:

Predicate Device: 21 CFR 807. 92(a)(3)

Device Classification Name	SYSTEM, IMAGE PROCESSING, RADIOLOGICAL
Regulation Number	892.2050
510(k) Number	K022710
Device Name	SmartPACS™
Applicant	Taiwan Electronic Data Processing Corporation
Product Code	LLZ
Decision Date	10/11/2002
Decision	SUBSTANTIALLY EQUIVALENT (SE)

Device Description: 21 CFR 807 92(a)(4)

The system is a server-based software application.

UbiPacs™ is a distributed image management system that manages the archival, retrieval, and distribution of medical images within a Picture Archiving and Communication System (PACS) environment. UbiPacs™ provides network access to patients' current and historical radiological images and relevant examination data. The system is designed for facilitating the clinical practice of radiologists and physicians. UbiPacs™ implementation is based on the Digital Imaging and Communication in Medicine (DICOM) standard. The standard allows communications of images and relevant information such as patient demographics and examination data between the system and other DICOM-

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compliant imaging devices such as CT scanners, MR imager, CR systems, digital modalities and image viewing workstations.

Indications for Use: 21 CFR 807 92(a)(5)

Technological Characteristics: 21 CFR 807 92(a)(6)

UbiPacs™ is a software application and does not contact the patient, nor does it control any life sustaining devices. A physician, providing ample opportunity for competent human intervention interprets images and information being displayed and printed.

Conclusion: 21 CFR 807 92(b)(1)

The 510(k) Pre-Market Notification for UbiPacs™ contains adequate information and data to enable FDA - CDRH to determine substantial equivalence to the predicate device. UbiPacs™ will be manufactured in accordance with the voluntary standards listed in the enclosed voluntary standard survey.

The submission contains the results of a hazard analysis and the potential hazards have been classified as Minor.

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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 consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of several curved lines.

SEP 2 7 2004

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

ICM Co., Ltd.

1 % Mr. N. E. Devine, Jr. Responsible Third Party Entela, Inc.
3033 Madison Ave., SE GRAND RAPIDS MI 49548

Re: K042507

Trade/Device Name: UbiPACSTM Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system

Regulatory Class: II Product Code: 90 LLZ Dated: September 15, 2004 Received: September 15, 2004

· Dear Mr. Devine:

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.

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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Page 2

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. Bryden

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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510(k) Number: K & 42 ( 6 7

Device Name: UbiPACS™

Indications for Use:

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.

Typical users of this system are trained professionals, i.e. physicians, radiologists, nurses, medical technicians, and assistants.

Prescription Use APD/OR (Part 21 CFR 801 Subpart D)

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)

David A. Laymon

Division Sign-Off Division of Reproductive, Abdomina and Radiological Device 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).