The GE Signa Infinity line of products are whole body magnetic resonance scanners designed to support high resolution, high signal-to-noise ratio and short scan times. The Signa Infinity System is indicated for use as a diagnostic imaging device to produce transverse, sagittal, coronal and oblique images, spectroscopic images, and/or spectra, dynamic images of the internal structures and organs of the entire body, including, but not limited to, head, neck, TMJ, spine, breast, heart, abdomen, pelvis, joints, prostate, blood vessels, and musculoskeletal regions of the images produced by the Signa Infinity systems reflect the spatial distribution of protons (hydrogen nuclei) exhibiting magnetic resonance. These images and/or spectra when interpreted by a trained physician yield information that may assist in diagnosis.

Device Description

The Signa Infinity Magnetic Resonance System is a modification to the Signa TwinSpeed Magnetic Resonance System (K012200) which utilizes a superconducting magnet to acquire 2D single-slice and multi-slice, and 3D volume images. The Signa Infinity Magnetic Resonance System features a superconducting magnet operating at 1.5T. The system can image in the sagittal, coronal, axial, oblique and double oblique planes, using various pulse sequences. Images are acquired and reconstructed using 2D and 3D Fourier transformation techniques. The system is intended for high resolution anatomical applications and short scan times. Previously cleared software options, coils, and other accessories may · be used with the Signa Infinity Magnetic Resonance System.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the GE Signa Infinity MRI System:

Based on the provided 510(k) summary, the GE Signa Infinity Magnetic Resonance System is presented as a modification of an existing device, the Signa TwinSpeed MR system (K012200). The submission focuses on demonstrating substantial equivalence rather than a new device with novel performance claims requiring extensive clinical outcome acceptance criteria.

Therefore, the "acceptance criteria" for this device are primarily related to performance and safety standards adherence and substantial equivalence to the predicate device, rather than diagnostic accuracy or effectiveness against a specific disease state. The "study" described is a technical evaluation rather than a clinical trial.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria	Reported Device Performance
Substantial Equivalence	Demonstrates equivalence to predicate device (Signa TwinSpeed MR system, K012200) with described modifications.	"The Signa Infinity Magnetic Resonance System is substantially equivalent to the Signa TwinSpeed Magnetic Resonance System." "Usage of the Signa Infinity Magnetic Resonance System does not result in any new potential hazards."
Technical Performance	Compliance with appropriate NEMA performance standards.	"The Signa Infinity Magnetic Resonance System was evaluated to the appropriate NEMA performance standards."
Electrical Safety	Compliance with IEC 601-1 International Medical Equipment Safety standard.	"The Signa Infinity Magnetic Resonance System was evaluated... as well as the IEC 601-1 International Medical Equipment Safety standard."
MR Equipment Safety	Compliance with IEC 601-2-33 Particular Requirements for Safety of Magnetic Resonance Equipment for Medical Diagnosis.	"The Signa Infinity Magnetic Resonance System was evaluated... and IEC 601-2-33 Particular Requirements for Safety of Magnetic Resonance Equipment for Medical Diagnosis."
New Hazards	The modifications (eight independent receive channels, updated Computer and RF Pulse Control subsystems, ASSET imaging for eight channels) do not introduce new hazards.	"Usage of the Signa Infinity Magnetic Resonance System does not result in any new potential hazards."

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

Sample Size: The document does not describe a "test set" in the context of clinical images or patient data for evaluating diagnostic performance. The evaluation focused on device performance against technical and safety standards and comparison to a predicate device.
Data Provenance: Not applicable, as there was no clinical test set described. The "data" would be engineering and performance measurements.

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

Number of Experts: Not applicable. Ground truth typically refers to clinical diagnosis or pathology for a medical image analysis device. This submission is for an MRI system itself, not an AI or image analysis tool.
Qualifications: Not applicable.

4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set

Adjudication Method: Not applicable. No clinical test set requiring expert adjudication was described.

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

MRMC Study: No, an MRMC comparative effectiveness study was not done. This device is the MRI scanner itself, not an AI assistance tool for human readers.
Effect Size: Not applicable.

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

Standalone Performance: Not applicable. This document describes an MRI system, which produces images for interpretation by a human physician, not a standalone algorithm for diagnosis.

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

Type of Ground Truth: For the "study" described (evaluation against standards and comparison to predicate), the "ground truth" would be the established NEMA, IEC 601-1, and IEC 601-2-33 standards for MRI system performance and safety, and the performance characteristics of the predicate Signa TwinSpeed MR system. There isn't a clinical "ground truth" in the sense of patient outcomes or pathology.

8. The Sample Size for the Training Set

Sample Size: Not applicable. This MRI system is not an AI model that requires a "training set" of patient data in the computational sense. The development of the system itself would involve extensive engineering and testing, but these are not referred to as "training sets" in this context.

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

How Ground Truth Was Established: Not applicable. As explained above, there is no "training set" for this type of medical device submission.

Summary

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KOI 3636

Image /page/0/Picture/1 description: The image shows the General Electric (GE) logo. The logo consists of the letters "G" and "E" intertwined within a circle. The letters are stylized and appear to be hand-drawn or calligraphic. The logo is black and white.

JAN 2 4 2002

GE Medical Systems

Page 1 of 2

General Electric Company P.O. 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 Programs
Telephone:	262-544-3894
Fax:	262-544-3863
Date Prepared:	November 1, 2001

Device Name:

GE Signa Infinity Magnetic Resonance System Magnetic Resonance Diagnostic System, 21 CFR 892.1000, 90-LNH

Marketed Device:

The Signa Infinity System is substantially equivalent to the currently marketed Signa TwinSpeed MR system (K012200) with the main differences being an addition of eight independent receive channels and an update of the technology used for the Computer subsystem as well as the RF Pulse Control subsystem. In addition, ASSET imaging (K012970) is now offered for eight receive channels.

Device Description:

Indications for Use:

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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, with the letters and border appearing in black against a white background.

Page 2 of 2

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

may assist in diagnosis.

Comparison with Predicate Device:

The Signa Infinity System is a modification of the Signa TwinSpeed MR system (K012200) with the main differences being the addition of eight independent receive channels and an update of the technology used for the Computer subsystem as well as the RF Pulse Control subsystem. Whereas these modifications are generally applicable across a range of field strengths, gradient and RF subsystems, the initial scope is limited to systems comparable to the currently marketed Signa TwinSpeed (K012200) 1.5T Magnetic Resonance Systems.

Summary of Studies:

The Signa Infinity Magnetic Resonance System was evaluated to the appropriate NEMA performance standards as well as the IEC 601-1 International Medical Equipment Safety standard and IEC 601-2-33 Particular Requirements for Safety of Magnetic Resonance Equipment for Medical Diagnosis. The Signa Infinity Magnetic Resonance System is comparable to the currently marketed Signa TwinSpeed Magnetic Resonance System.

Conclusion:

It is the opinion of GE that the Signa Infinity Magnetic Resonance System is substantially equivalent to the Signa TwinSpeed Magnetic Resonance System. Usage of the Signa Infinity Magnetic Resonance System does not result in any new potential hazards.

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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 is circular and features the department's name around the perimeter. In the center is a stylized image of an eagle with three lines extending from its back, representing the department's mission to promote health and well-being.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 2 4 2002

Larry A. Kroger, Ph.D. Regulatory Affairs Manager GE Medical Systems P.O. Box 414 MILWAUKEE WI 53201

Re: K013636

Trade/Device Name: Signa Infinity MRI System Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: 90 LNH Dated: November 1, 2001 Received: November 5, 2001

Dear Dr. Kroger:

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 nanufacturing 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 rr you debile 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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510(k) Number (if known): _ Ko / 36 36

Device Name: Signa Infinity Magnetic Resonance System

Indications For Use:

The GE Signa Infinity line of products are whole body magnetic resonance scanners designed to support The Off Siglia Inimity mic of products are misses. The Signa Infinity System is indicated for use as a diagnostic imaging device to produce transverse, sagittal, coronal and oblique images, spectroscopic images, and/or spectra, dynamic images of the internal structures and organs of the entire spectosopic miages, andror spoona, cymained to, head, heart, abdomen, pelvis, joints, prostate, blood vessels, and musculoskeletal regions of the images produced by the Signa Infinity systems reflect the spatial distribution of protors (fiydrogen nucle) exhibiting magnetic resonance. These images and/or spectra when interpreted by a trained physician yield information that may assist in diagnosis.

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

ption Use
(1 CFR 801.109)

OR Over-The-Counter Use

(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number	K013636

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescrip (Per 21

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.