The GE Signa® MR750 System is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and short scan times. It is indicated for use as a diagnostic imaging device to produce axial, sagittal, coronal, and oblique images, spectroscopic images, parametric maps, and/or spectra, dynamic images of the structures and/or functions 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 body. Depending on the region of interest being imaged, contrast agents may be used.

The images produced by the GE Signa® MR750 System reflect the spatial distribution or molecular environment of 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 3.0T GE Signa® MR750 System is a new MR system that is substantially equivalent to previously cleared 3.0T MR systems. All utilize superconducting magnets to acquire 2D single-slice and 3D volume images. The 3.0T GE Signa® MR750 System features a superconducting magnet operating at 3.0Tesla. The data acquisition system accommodates up to 32 independent receive channels increments and multiple independent coil elements per channel during a single acquisition series. The system uses a combination of time-varying magnetic fields (gradients) and RF transmissions to obtain information regarding the density and position of elements exhibiting magnetic resonance. 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. The 3.0T GE Signa® MR750 System is designed to conform to NEMA DICOM standards (Digital Imaging and Communications in Medicine).

AI/ML Overview

The provided text is a 510(k) Premarket Notification for the GE 3.0T Signa® MR750 System. This document focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria through a clinical study with a test set, ground truth, and expert readers in the way an AI/ML device submission would.

Therefore, many of the requested elements for describing "acceptance criteria and the study that proves the device meets the acceptance criteria" are not applicable or extractable from this type of submission.

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

1. A table of acceptance criteria and the reported device performance:

The document lists performance parameters that were measured and documented through testing to NEMA, IEC, or ISO standards, but it does not provide specific acceptance criteria (e.g., "SNR must be > X dB") or reported performance values beyond stating that the device has been designed to comply and has been measured and documented.

Performance Parameter	Acceptance Criteria (Not explicitly stated as numerical values)	Reported Device Performance (No numerical performance given, only compliance)
Signal-to-noise ratio (SNR)	N/A (Implied compliance with standards)	Measured and documented through testing to NEMA, IEC or ISO standards.
Geometric distortion	N/A (Implied compliance with standards)	Measured and documented through testing to NEMA, IEC or ISO standards.
Image uniformity	N/A (Implied compliance with standards)	Measured and documented through testing to NEMA, IEC or ISO standards.
Slice thickness	N/A (Implied compliance with standards)	Measured and documented through testing to NEMA, IEC or ISO standards.
Spatial resolution	N/A (Implied compliance with standards)	Measured and documented through testing to NEMA, IEC or ISO standards.

For safety parameters:

Safety Parameter	Acceptance Criteria (Not explicitly stated as numerical values)	Reported Device Performance (No numerical performance given, only compliance)
Static field strength	N/A (Implied compliance with standards)	Measured and documented through testing to NEMA, IEC or ISO standards.
Acoustic noise	N/A (Implied compliance with standards)	Measured and documented through testing to NEMA, IEC or ISO standards.
DB/dt	N/A (Implied compliance with standards)	Measured and documented through testing to NEMA, IEC or ISO standards.
RF heating (SAR)	N/A (Implied compliance with standards)	Measured and documented through testing to NEMA, IEC or ISO standards.
Biocompatibility	N/A (Implied compliance with standards)	Measured and documented through testing to NEMA, IEC or ISO standards.

The document states: "The 3.0T MR750 MR system has been designed to comply with applicable IEC standards. It shall be certified by a Nationally Recognized Testing Laboratory to conform to IEC, UL and CSA standards prior to commencement of system production." This indicates the intent and plan for compliance rather than presenting specific performance results from a study.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

Not applicable. This is not a study assessing an algorithm's performance on a dataset of patient images. It's a submission for an imaging device (MRI scanner) demonstrating substantial equivalence based on technical specifications and compliance with safety and performance standards.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

Not applicable. No ground truth establishment for a patient image test set is described. The "trained physician" mentioned in the "Indications for Use" refers to the user of the device, not an expert establishing ground truth for a study within this document.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Not applicable. No test set 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 is a submission for an MRI scanner, not an AI or CAD device. There is no mention of human readers or AI assistance.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:

Not applicable. This is not an algorithm, but an MRI hardware system.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

Not applicable. There is no concept of "ground truth" used in the context of an image interpretation study within this document. The "ground truth" for verifying the performance of the MR system itself would be established through a variety of engineering and physics measurements and certifications against standards.

8. The sample size for the training set:

Not applicable. This is not an AI/ML device; there is no training set mentioned.

9. How the ground truth for the training set was established:

Not applicable. No training set is involved.

Summary

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K081028

GE Signa® MR750 M 510lk) Premarket Notification

GE Healthcare

510(k) Summary

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

Submitter:	GE Healthcare Technologies3200 N. Grandview Blvd.Waukesha, WI 53188	APR 25 2008
Contact Person:	Mark M. StaufferSafety and Regulatory Engineer
Telephone:	262 - 521 - 6891
Fax:	262 - 521 - 6379
Email:	Mark.X.Stauffer@ge.com
Date Prepared:	20 March 2008

Device Name:

GE 3.0T Signa® MR750 System Magnetic Resonance Diagnostic System, 21 CFR 892.1000, 90-LNH

Predicate Devices:

GE 3.0T Signa® HDx Magnetic Resonance System (K052293) Siemens MAGNETOM Verio 3T Magnetic Resonance System (K072237)

Device Description:

Indications for Use:

The GE Signa® MR750 System is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and short scan times. The GE Signa® MR750 System is indicated for use as a diagnostic imaging device to produce axial, sagittal, coronal, and oblique images, spectroscopic images, parametric maps, and/or spectra, dynamic images of the structures and organs of the entire body, including, but not limited to, head, neck, TM.), spine, breast, heart, abdomen, pelvis, joints, prostate, blood vessels, and musculoskeletal regions of the body.

The images produced by the GE Signa® MR750 System reflect the spatial distribution or molecular environment of nuclei exhibiting magnetic resonance. These images when interpreted by a troined physician yield information that may assist in diaqnosis.

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GE Healthcare

GE Signa® MR750 MR System

. 510(k) Premarket Notification

The indications for use for the 3.0T GE Signa® MR750 System are similar to those for the Signa® HDx Magnetic Resonance System and the Siemens MAGNETOM Verio MR System.

Comparison with Predicate Devices:

The GE Signa® 3.0T MR750 System is a new device design that is similar to the previously cleared 3.0T HDx MR system (K052293) with the main differences being new receive chain architecture that will support up to 32 channels in various channel increments, an increase in the amplitude and slew rate of the gradient of the radio frequency amplifiers, an increased patient table weight limit, faster image reconstruction, and new system pockaging. The new receive chain architecture supports up to 32 independent receive channels and will accommodate expansion to 128 channels through future product development. The amplitude and slew rate of the gradient output has been increased relative to the predicate Signa® HDx system. The patient table has been designed to support up to five hundred pounds. Electrical components have been updated to minimize obsolescence issues. Also, the system packaging has incorporated watering cooling and has been designed to support the new receive channel architecture, improved gradients, and future expandability to 128 channels. The GE 3.0T Signa® MR750 System is comparable to the currently marketed 3.0T Signa® HDx MR System.

In addition to the hardware improvements made in the DV system, there are applications improvements that resulted from developmental work done to the feature set included with the HDx system. In most cases the features and applications in DV are significantly equivalent to those in HDx. In some instances the comparative fationale fføls ് Pratilizes a second predicate device, Siemens' MAGNETOM Verio 3T MR System, to which substantial equivalence is asserted.

Summary of Safety and Effectiveness Concerns:

As stated in the FDA document "Guidance for the Submission of Premarket Notifications for Magnetic Resorvance Diagnostic Devices" the following parameters have been measured and documented through testing to NEMA, IEC or ISO standards (as referenced throughout this submission and listed in Tab A);

Performance:

Sianal-to-noise ratio (SNR) Geometric distortion Image uniformity Slice thickness Spatial resolution
Safety
Static field strength Acoustic noise DB/dt RF heating (SAR) Biocompatibility
The 3.0T MR750 MR system has been designed to comply with applicable IEC standards. It shall be certified by a Nationally Recognized Testing Laboratory to conform to IEC, UL and CSA standards prior to commencement of system production.

Conclusion:

It is the opinion of GE that the GE 3.0T Signa® MR750 System is substantially equivalent to the 3.0T Signa® HDx MR System and Siemens' MAGNETOM Verio 3T MR System.

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Image /page/2/Picture/1 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 2 5 2008

GE Medical System, LLC c/o Mr. Jay Y. Kogoma Intertek Testing Services 2307 East Aurora Road Unit B7 TWINSBURG OH 44087

Re: K081028

Trade/Device Name: GE 3.0T Signa® MR750 System Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: LNH Dated: April 9, 2008 Received: April 11, 2008

Dear Mr. Kogoma:

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 such 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.

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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.

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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter.

21 CFR 876.xxxx	(Gastroenterology/Renal/Urology)	240-276-0115
21 CFR 884.xxxx	(Obstetrics/Gynecology)	240-276-0115
21 CFR 892.xxxx	(Radiology)	240-276-0120
Other		240-276-0100

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely vours.

NancyCbrogdon

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

Enclosure

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GE Healthcare

GE Signa® MR750 MR System 510{k) Premarket Notification

Indications for Use

510(k) Number (if known):

K081028

Device Name:

GE 3.0T Signa® MR750 System

Indications for Use:

Prescription Use ਮ AND/OR (21 CFR 801 Subpart D)

Over-the-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Aogor Morthay

(Division Sign/Off Division of Reproductive, Abdominal and Radiological Devices K081028 510(k) Number

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.