The Signa Magnetic Resonance System is a whole body scanner. The Signa Magnetic Resonance System is indicated for use as a diagnostic imaging device to produce transverse, sagittal, coronal and oblique images of the internal structures of the head or body. The images produced by the Signa Magnetic Resonance System reflect the spatial distribution of protons (hydrogen nuclei) exhibiting magnetic resonance. The NMR properties that determine the image appearance are proton density, spin-lattice relaxation time (T1), spin-spin relaxation time (T2) and flow. When interpreted by a trained physician, these images provide information that can be useful in determining a diagnosis.

Device Description

ASSET (Array Spatial Sensitivity Encoding Technique) is an image reconstruction technique used in A conjunction with phased array coils in which the number of phase encode steps is reduced by increasing the distance between steps, or equivalently, by reducing the field of view. Aliasing or wrapping caused by the object extending outside the reduced field of view is eliminated using knowledge of the B1 fields of the coils.

AI/ML Overview

The provided 510(k) summary for the GE Signa ASSET Imaging Option primarily focuses on demonstrating substantial equivalence to predicate devices and detailing the reconstruction technique. It does not contain information about specific acceptance criteria, a detailed study proving performance against those criteria, or the typical elements of a modern AI/device performance study.

Here's an analysis based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

This information is not provided in the document. The submission states "Evaluation testing was done to verify the performance of the option," but it does not specify what those performance metrics were, what the acceptance criteria were, or the results of that evaluation.

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

This information is not provided in the document.

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

This information is not provided in the document.

4. Adjudication Method for the Test Set

This information is not provided in the document.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

This information is not provided in the document. The ASSET Imaging Option is described as an image reconstruction technique, not an AI-assisted diagnostic tool for human readers in the way modern AI devices are studied.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done

The document does not describe a standalone performance study in the modern sense of an algorithm making diagnostic interpretations without human intervention. The ASSET Imaging Option is a component of a diagnostic imaging system, designed to produce images that are then "interpreted by a trained physician" to aid in diagnosis.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

This information is not provided in the document. Given the description, any "ground truth" would likely relate to the accuracy of the image reconstruction itself rather than diagnostic accuracy.

8. The Sample Size for the Training Set

This information is not provided in the document. The ASSET option is a reconstruction technique, and while it involves software, the concept of a "training set" in the context of machine learning as understood today is not applicable or discussed in this submission from 2001.

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

This information is not provided in the document, as the concept of a training set and its ground truth is not elaborated upon for this type of device and submission from 2001.

Summary of the Study Mentioned in the Document:

The document states: "The ASSET Imaging Option was developed in conformance with design control requirements as specified in 21 C.F.R. 820.30. Software hazard analysis and verification test procedures were completed. Evaluation testing was done to verify the performance of the option."

This indicates that standard design control and verification/validation activities were performed, as required for medical devices. However, the details of these tests (e.g., acceptance criteria, sample sizes, specific performance metrics, and results) are explicitly omitted from this 510(k) summary, as was common practice for submissions of this era, especially for modifications to existing predicate devices related to image acquisition/reconstruction rather than novel diagnostic algorithms. The primary "study" presented is a comparison to predicate devices, asserting substantial equivalence based on intended use and operating modes.

Summary

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Ko12970

SEP 2 4 2001

Page 1 of 2

GE Medical Systems

eral Flectric Company 0. Box 414, Milwaukee, WI 53201

510(k) Summary

This 510(k) summary of safety and effectiveness information is submitted in accordance with the requirements of 21 CFR Part 807.92(c).

Submitter:	GE Medical SystemsPO Box 414Milwaukee, WI 53201
Contact Person:	Larry A. Kroger Ph.D.Manager, Regulatory Program
Telephone:	262- 544-3894
Fax:	262- 544-3863
Date Prepared:	August 30, 2001

Device Name:

GE Signa ASSET Imaging Option Magnetic Resonance Diagnostic System, 21 CFR 892.1000, 90-LNH

Marketed Device:

The Signa ASSET Imaging Option is substantially equivalent to the Array Processor subsystem and reconstruction techniques of the currently marketed Signa 1.5T TwinSpeed Magnetic Resonance System rconstruction recemiques of the outsions of the Supers on K006313) and Signa HFO/i MR System (K992746).

Device Description:

Indications for Use:

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Image /page/1/Picture/0 description: The image shows the text "GE Medical Systems". The text is in a bold, sans-serif font. The text is black and the background is white. The text is centered in the image.

Image /page/1/Picture/1 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'g' and 'e' intertwined within a circular border. The logo is black and white.

Page 1 of 2

General Electric Company P.O. Box 414, Milwaukee, WI 53201

Comparison with Predicate Device:

It is the opinion of GE Medical Systems that the ASSET Imaging Option is substantially equivalent to the Array Processor subsystem and Reconstruction Techniques used in the currently cleared Signa 1.5T TwinSpeed Magnetic Resonance System (K012200), Signa VH/i MR System (K990550; K003575; and I winspect hilghout Resorted (K992746). It has the same intended use, and operating modes as the predicate devices.

Summary of Studies:

The ASSET Imaging Option was developed in conformance with design control requirements as specified in 21 C.F.R. 820.30. Software hazard analysis and verification test procedures were completed. Evaluation testing was done to verify the performance of the option.

Conclusion:

It is the opinion of GE that the ASSET Imaging option does not result in any new potential hazards.

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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 and Human Services. The logo features a stylized image of three human profiles facing right, stacked on top of each other. The profiles are connected by flowing lines that resemble a ribbon or wave. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the image.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 2 4 2001

Larry Kroger, Ph.D. Regulatory Programs Manager GE Medical Systems General Electric Company P.O. Box 414 MILWAUKEE WI 53201

Re: K012970 Trade/Device Name: GE Signa Asset Imaging Option for MRI Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic Resonance Diagnostic Device Regulatory Class: II Product Code: 90 LNH Dated: August 30, 2001 Received: September 4, 2001

Dear Dr. Kroger:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave rovewary our becamined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for associated in the Merceded)76, the enactment date of the Medical Device Amendments, or to conniner of the 11th 11th 2011-05-12, 11:22 accordance with the provisions of the Federal Food, Drug, de nees mar nat o boon resulted require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The r ou may , itereror mains 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 or any I 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 (21 OFF Part 801), accems (QS) regulation (21 CFR Part 820); and if applicable, the electronic rordly and ation 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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KO12970 510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: Signa ASSET Imaging Option

Indications For Use:

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

om Concurrence of DRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

OR Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________

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.