The system, that is comprised of diagnostic reading software, is intended for use by radiologists as an interactive tool for analyzing radiological data and generating and viewing radiology reports based on their analysis.

Device Description

The MediPrime is a multi-modality radiology reading and reporting station for viewing and processing radiological images and generating and viewing radiology reports. It is based on off-the shelf Windows 2000 computers and a number of monitors (regular or high resolution) that comply with the accepted international standards for computer and monitor systems. The system also comprises software developed and validated by Algotec Systems Ltd. The modified device contains added features, including Multi-Planar Reformatting (MPR).

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the MediPrime device:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text does not contain any specific acceptance criteria or quantitative performance metrics for the MediPrime device. It describes the device as a "Radiology Reading and Reporting Station" and states that "The modifications to the MediPrime do not affect the intended use or alter the fundamental scientific technology of the device. The only device modification was to software. There are no labeling changes that affect the intended use of the device. The device modifications raise no new issues of safety or effectiveness."

This suggests that the 510(k) submission was for a modification (addition of Multi-Planar Reformatting (MPR)) to an already cleared device (K002894). Therefore, the "acceptance criteria" likely revolved around demonstrating that the new software feature did not introduce new safety or effectiveness concerns and maintained substantial equivalence to the predicate device. Without specific performance claims or a formal study outlining acceptance criteria, a table like the one requested cannot be generated from the given information.

2. Sample Size Used for the Test Set and Data Provenance

The provided text does not mention any specific sample size for a test set or data provenance (e.g., country of origin, retrospective/prospective). Given that this is a Special 510(k) for a software modification to an existing device, it's possible that a formal clinical validation with a new test set wasn't required or documented in this summary if the changes were deemed not to significantly impact clinical performance. The focus appears to be on demonstrating that the modification itself did not negatively affect safety or effectiveness.

3. Number of Experts Used to Establish Ground Truth and Qualifications

The provided text does not mention any experts being used to establish ground truth or their qualifications. This is consistent with the lack of a detailed clinical study described in this summary.

4. Adjudication Method

The provided text does not mention any adjudication method.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

The provided text does not indicate that a multi-reader multi-case (MRMC) comparative effectiveness study was done.

6. Standalone Performance Study

The provided text does not indicate that a standalone (algorithm only) performance study was done. The device itself is described as an "interactive tool for analyzing radiological data," implying human interaction is integral to its intended use, rather than being a fully automated standalone algorithm.

7. Type of Ground Truth Used

The provided text does not specify the type of ground truth used.

8. Sample Size for the Training Set

The provided text does not mention a sample size for a training set. The device is a radiology reading station, not an AI algorithm that learns from a training set in the typical sense. The software modification (MPR) is a feature, not a machine learning model.

9. How Ground Truth for the Training Set Was Established

The provided text does not mention how ground truth for a training set was established.

Summary of what can be gleaned from the text:

The provided document is a summary of a Special 510(k) premarket notification for a minor software modification (addition of Multi-Planar Reformatting, MPR) to an already cleared radiology reading and reporting station called MediPrime. The core argument for substantial equivalence relies on the assertion that the modification does not affect the intended use, alter fundamental scientific technology, or raise new issues of safety or effectiveness. As such, the document does not contain details about formal clinical studies, acceptance criteria, test sets, ground truth establishment, or performance metrics typically associated with novel device submissions or significant clinical claims. The FDA's clearance indicates that they agreed with the manufacturer's assessment that the modification did not warrant extensive new performance data.

Summary

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2 Summary of Safety and Effectiveness

Ko23936

This summary of 510(k) Safety and Effectiveness information is being submitted in accordance with the requirements of the SMDA 1990 and 21 CFR 807.92.

Submitter:

Algotec Systems Ltd. 4 Hamelacha St. P.O.Box 2408 Industrial Zone. Ra'anana ISRAEL 43000 +972-9-748-2442 Tel: +972-9-748-2411 Fax:

DEC 2 0 2002

Name of the Device: MediPrime

Predicate Device: This is a Special 510(k) for the MediPrime, a Radiology Reading and Reporting Station, that was cleared under K002894.
Description of the Device: The MediPrime is a multi-modality radiology reading and reporting station for viewing and processing radiological images and generating and viewing radiology reports. It is based on off-the shelf Windows 2000 computers and a number of monitors (regular or high resolution) that comply with the accepted international standards for computer and monitor systems. The system also comprises software developed and validated by Algotec Systems Ltd. The modified device contains added features, including Multi-Planar Reformatting (MPR).
Intended Use: The system, that is comprised of diagnostic reading software, is intended for use by radiologists as an interactive tool for analyzing radiological data and generating and viewing radiology reports based on their analysis.

Comparison of Technological Characteristics: The modifications to the MediPrime do not affect the intended use or alter the fundamental scientific technology of the device. The only device modification was to software. There are no labeling changes that affect the intended use of the device. The device modifications raise no new issues of safety or effectiveness.

November 19, 2002

Date

Mule Ber

Dr. Menashe Benjamin, President

Algotec Systems Ltd., 4 Hamelacha St., Indst. Zone, Ra'anana, Israel Phone: +972-9-7482411

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is an abstract symbol that resembles three human profiles facing to the right.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Algotec Systems, Ltd. % Dr. Eli M. Orbach Consultant International Regulatory Consultants P.O. Box 6718 Efrat 90435 ISRAEL

Re: K023936 Trade/Device Name: MediPrime Radiology Reading and Reporting Station Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II

Product Code: 90 LLZ Dated: November 19, 2002 Received: November 26, 2002

Dear Dr. Orbach:

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 vours.

Henry C. Snigdon

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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3 Indications For Use (separate page):

Page __ /_ of ________________________________________________________________________________________________________________________________________________________________

510(k) Number (if known) _ KO23936

Device Name: MediPrime

Indications For Use:

The system, that is comprised of diagnostic reading software, is intended for use rne systems as an interactive tool for analyzing radiological data and generating and viewing radiology reports based on their analysis.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off) Division of Reproductive, Abdomin and Radiological Devic 510(k) Number

Over The Counter I

Prescription Use_ (Per 21 CFR 801.109)

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).