iPACS Prism™ from RealTimeImage Inc. is a device that receives medical images and data from various imaging sources. Images and data can be stored, communicated, processed and displayed within the system and or across computer networks at distributed locations. Typical users of this system are trained professionals, including but not limited to physicians, nurses, and technicians.

Device Description

iPACS Prism™ is a complete PACS solution designed to be Internet friendly for easy deployment over local area networks and/or wide area networks. The system is modular and will be offered under different brand names depending upon customer implementation and which system components of iPACS Prism are needed. iPACS™ handles various images and data objects in a Picture Archive and Communication System (PACS) environment. These objects can be images, requests, patients, examination etc. PACS transmits digital electronic images and generates reports over a high-speed network to centralized storage. After transmission, patient information and images are available throughout the facility to many users simultaneously.

AI/ML Overview

The provided text describes a 510(k) submission for the iPACS Prism™ system. The document focuses on establishing substantial equivalence to a predicate device and does not contain specific acceptance criteria, a detailed study proving device performance against such criteria, or the types of information requested in the prompt related to clinical performance testing (sample sizes, expert qualifications, adjudication, MRMC studies, standalone performance, or ground truth details for training or testing).

The document is a regulatory filing for a Picture Archiving and Communication System (PACS), which primarily handles the storage, communication, processing, and display of medical images and data. Its substantial equivalence is based on its technological characteristics being similar to a legally marketed predicate device (ISITE RADIOLOGY, K013630).

Therefore, based on the provided text:

1. A table of acceptance criteria and the reported device performance:
Not available in the provided text. The document focuses on regulatory equivalence rather than specific performance metrics against pre-defined acceptance criteria.

2. Sample size used for the test set and the data provenance:
Not applicable. No clinical or performance test set is described.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. No ground truth establishment for a test set is described.

4. Adjudication method for the test set:
Not applicable. No test set or its adjudication 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 system, not an AI-powered diagnostic tool, and no MRMC study is mentioned.

6. If a standalone (i.e. algorithm only, without human-in-the-loop performance) was done:
Not applicable. This device is an image management system, not a standalone diagnostic algorithm. The text explicitly states, "A physician, providing ample opportunity for competent human intervention interprets images and information being displayed and printed."

7. The type of ground truth used:
Not applicable. No ground truth for performance evaluation is described.

8. The sample size for the training set:
Not applicable. No training set for an AI algorithm is described.

9. How the ground truth for the training set was established:
Not applicable. No training set or its ground truth establishment is described.

Summary of what the document does provide:

Device Name: iPACS Prism™
Common Name: Picture Archiving Communications System
Device Classification: 892.2050 (System, Image Processing, Radiological)
Predicate Device: ISITE RADIOLOGY (K013630)
Indications for Use: Receives medical images 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. Typical users are trained professionals (physicians, nurses, technicians).
Technological Characteristics: Medical device image software used with computer hardware in a PACS environment. Does not contact the patient, nor does it control any life-sustaining devices. A physician interprets images and information with human intervention.
Conclusion: The device is substantially equivalent to the predicate device.

Summary

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103 0751

MAY 2 9 2003

Page 1

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: March 2, 2003

Submitter's Information: 21 CFR 807.92(a)(1) RealTimeImage Inc. Zvi Eintracht, CEO 1111 Bayhill Dr. Suite 290 San Bruno, CA 94066

Trade Name, Common Name and Classification: 21 CFR 807.92(a)(2) Trade Name: iPACS Prism™ bv RealTimeImage Inc. Common Name: Picture Archiving Communications System Device Classification: 892 2050 Name: System, Image Processing

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

SYSTEM, IMAGE PROCESSING, Device Classification Name RADIOLOGICAL

Regulation Number	892.2050
510(k) Number	K013630
Device Name	ISITE RADIOLOGY
Applicant	STENTOR, INC.16303 PANORAMIC WAYSAN LEANDRO, CA 94578
Product Code	LLZ
Date Received	11/05/2001
Decision Date	12/05/2001

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

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Image /page/1/Picture/0 description: The image shows a square filled with a dot pattern in the upper left corner. Below the square, the word "RealTime" is written in a stylized font. Underneath "RealTime", the word "image" is written in a smaller, dotted font, giving it a faded appearance.

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

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

The device is medical device image software that is used with computer hardware in a picture archiving and communications system user environment. The device 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 iPACS Prism™ contains adequate information and data to enable FDA - CDRH to determine substantial equivalence to the predicate device. The system has been and 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 border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized eagle or bird-like symbol with three horizontal lines extending from its head, resembling feathers or wings.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 2 9 2003

Real Time Image Inc. c/o Mr. Carl Alletto OTech, Inc. 1100 Lakeview Blvd. DENTON TX 76208

Re: K030751

Trade/Device Name: iPACS Prism" Regulation Number: 21 CFR §892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: 90 LLZ Dated: February 9, 2003 Received: March 10, 2003

Dear Mr. Alletto:

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 Cbrogdon

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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Image /page/4/Picture/0 description: The image shows a logo with a square pattern at the top left. Below the pattern, the words "RealTime" are printed in a stylized font. Underneath "RealTime", the word "Image" is printed in a similar font, completing the logo design.

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(Indications for Use Form)

Ko30751

510(k) Number:

Device Name:

iPACS Prism™ from Real Time Image Inc.

Indications for Use:

Typical users of this system are trained professionals, including but not limited to physicians, nurses, and technicians.

(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)

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)

David R. Leggerson

(Division Sign-Off) Division of Reproductive, Abdo and Radiological 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).