The GEMS AW Pasting 1.1 software package is a display option, which combines a series of MR images acquired in multiple stations of the body into a single image. AW Pasting 1.1 provides the convenience of viewing a single image rather than several images.

Device Description

The GEMS AW Pasting 1.1 software package is a display option, which provides the convenience of viewing a single image resulting from the automatic pasting of multiple images acquired in different stations of the body.

AI/ML Overview

The provided text is a 510(k) summary for the GE Medical Systems Advantage Workstation Pasting 1.1 software. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed study with acceptance criteria and device performance metrics. Therefore, much of the requested information regarding specific study details is not available in the provided document.

Here's a breakdown of what can and cannot be extracted from the text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not specify quantitative acceptance criteria or report specific performance metrics (e.g., accuracy, sensitivity, specificity, processing time) for the AW Pasting 1.1 software. Instead, it states that the device "performs as well as devices currently on the market" and its features are "equivalent to those of AW X-Ray Pasting (K973270)." This indicates a qualitative assessment of substantial equivalence rather than meeting predefined numerical acceptance criteria.

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

This information is not provided in the document. There is no mention of a dedicated "test set" and thus no sample size or data provenance (e.g., country of origin, retrospective/prospective).

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

This information is not provided in the document. The concept of "ground truth" established by experts for a test set is not discussed.

4. Adjudication Method for the Test Set:

This information is not provided in the document. As there's no mention of a test set or ground truth establishment, there's no adjudication method described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done:

Based on the provided text, a multi-reader multi-case (MRMC) comparative effectiveness study was not conducted or reported. The submission focuses on demonstrating substantial equivalence through functional comparison rather than a human-in-the-loop performance study. Therefore, there is no information on the effect size of how much human readers improve with AI vs. without AI assistance.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study Was Done:

The document mentions "Software Development, Validation and Verification Process to ensure performance to specifications, Federal Regulations and user requirements." This implies internal testing and validation of the algorithm's functionality. However, specific details of a standalone study, quantitative results, or performance metrics are not provided. The assessment appears to be based on whether the pasting function works as intended and is comparable to the predicate.

7. The Type of Ground Truth Used:

The concept of "ground truth" as typically understood in medical device AI (e.g., pathology, outcomes data) is not explicitly mentioned or used in this submission. The validation seems to rely on the software's ability to combine MR images correctly and produce a single, viewable image, functionally equivalent to a predicate device. The "ground truth" would implicitly be the established correctness of the image pasting process against its design specifications and the performance of the predicate device.

8. The Sample Size for the Training Set:

This information is not provided in the document. The device is a software package for image display and pasting, and it's from 2003, predating the widespread use of deep learning and large training datasets as we understand them today for diagnostic algorithms. It's likely that "training" involved software development and testing rather than machine learning model training on a distinct dataset.

9. How the Ground Truth for the Training Set Was Established:

This information is not provided in the document, for the reasons mentioned above.

Summary of Available Information from the Provided Text:

The provided 510(k) summary for K031396 focuses on establishing substantial equivalence for the AW Pasting 1.1 software package to a predicate device (AW X-Ray Pasting, K973270). The equivalence is based on the device's functional features: combining a series of MR images acquired in multiple stations into a single image for convenient viewing.

The document highlights the following:

Device Description: The software automatically pastes multiple images acquired in different stations of the body into a single image.
Indications for Use: To combine a series of MR images acquired in multiple stations of the body into a single image, providing convenience of viewing.
Comparison with Predicate: Stated to be "substantially equivalent" in functional features to the AW X-Ray Pasting (K973270).
Safety and Effectiveness: Potential hazards are identified and controlled through "Software Development, Validation and Verification Process to ensure performance to specifications, Federal Regulations and user requirements" and "Adherence to industry and international standards." The conclusion is that it "does not result in any new potential safety risks and performs as well as devices currently on the market."

In conclusion, this document is a regulatory submission for substantial equivalence based on functional equivalence and risk management, not a detailed scientific study outlining specific performance metrics against acceptance criteria using a defined test set and ground truth establishment methodology.

Summary

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K031396

MAY 1 3 2003

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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).

Submitter Larry A. Kroger, Ph.D. Senior Regulatory Programs Manager Telephone: (262) 544-3894 Fax: (262) 548-4768 GE Medical Systems W-400 3000 North Grandview Blvd. Waukesha, WI 53188 USA Date Prepared: April 7, 2003.

K973270

PRODUCT IDENTIFICATION

Name:	Advantage Workstation Pasting 1.1
Classification Name:	Accessory to Magnetic Resonance Diagnostic Device
Manufacturer :	General Electric Medical Systems283, rue de la Minière78533 Buc Cedex, FRANCE
Distributor:	General Electric Medical Systems, Buc, France.
Marketed Devices	The AW Pasting 1.1 is substantially equivalent to the devices listed below:
Model:	AW X-Ray Pasting (Leg'Map)
Manufacturer:	General Electric Medical Systems. Milwaukee. WI

Device Description:

510(k) #:

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Indications for Use:

1. 2.2

Comparison with Predicate:

The functional features of the AW Pasting 1.1 software package are substantially equivalent to that of the following device:

Device Name	010 Alearance Number
. A W Y V Y11 BUISEA120 HeoMan	120000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000

Adverse Effects on Health:

The potential hazards are identified in a risk management summary (hazard analysis) and are controlled by:

· Software Development, Validation and Verification Process to ensure performance to specifications, Federal Regulations and user requirements.
· Adherence to industry and international standards.

Conclusions:

The AW Pasting does not result in any new potential safety risks and performs as well as devices currently on the market. GE considers features of the AW Pasting 1.1 to be equivalent to those of AW X-Ray Pasting (K973270).

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Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with three lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle. The text is in all capital letters and is evenly spaced around the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 1 3 2003

GE Medical Systems-Europe % Mr. Heinz-Joerg Steneberg Division Manager Medical Division TUV Rheinland of North America 12 Commerce Road NEWTON CT 06470

Re: K031396

Trade/Device Name: Pasting 1.1 Software Option for MRI Systems Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: 90 LNH Dated: May 1, 2003 Received: May 2, 2003

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 r 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 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. Brogdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

Page 2

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K03 1394

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General Electric Medical Systems

STATEMENT OF INTENDED USE

Device name: Advantage Workstation Pasting 1.1

Intended Use:

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use $\surd$ 1. 1. string

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Regulation Number and Section

§ 892.1000 Magnetic resonance diagnostic device.

(a)
Identification. A magnetic resonance diagnostic device is intended for general diagnostic use to present images which reflect the spatial distribution and/or magnetic resonance spectra which reflect frequency and distribution of nuclei exhibiting nuclear magnetic resonance. Other physical parameters derived from the images and/or spectra may also be produced. The device includes hydrogen-1 (proton) imaging, sodium-23 imaging, hydrogen-1 spectroscopy, phosphorus-31 spectroscopy, and chemical shift imaging (preserving simultaneous frequency and spatial information).(b)
Classification. Class II (special controls). A magnetic resonance imaging disposable kit intended for use with a magnetic resonance diagnostic device only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.