The indications for use for the 3.0T Signa®VH/i (Signa® 3.0T MR System) Transmit/Receive Body Imaging Coil expands the imaging capability of the 3.0T Signa®VH/i MR Imaging System.

The Transmit/Receive Body Imaging Coil is intended for imaging of the Neck, Spine, Abdomen/Thorax and the extremities.

Device Description

The Signa" 3.0T magnetic resonance system is a diagnostic imaging device that produces transverse, coronal, sagittal and oblique images of the internal structures of the head, neck, spine, abdomen/thorax and the extremities. The Signa® 3.0T system is designed to support high resolution imaging and multinuclear spectroscopy. Previously cleared software options, coils, and other accessories may be used with the Signa® 3.0T MR System.

AI/ML Overview

The provided text describes a 510(k) summary for the GE Signa® 3.0T Magnetic Resonance System. However, it does not contain detailed information about specific acceptance criteria, device performance metrics (like sensitivity, specificity, or accuracy), or the methodology of a study designed to prove the device meets such criteria in the way typically expected for an AI/ML device.

Instead, this document focuses on demonstrating substantial equivalence to a predicate device, which is a different regulatory pathway than proving performance against pre-defined clinical metrics for a novel device or an AI/ML product. The "studies" mentioned are more likely engineering and safety tests to confirm that the modifications to the MR system operate as intended and are safe, rather than clinical performance studies measuring diagnostic accuracy.

Here's an analysis based on the information provided, highlighting the absence of typical AI/ML study details:

1. Table of acceptance criteria and the reported device performance

Acceptance Criteria	Reported Device Performance
Not specified	Not specified

Explanation: The document states, "Testing was performed to demonstrate that the design modifications to the Signa® 3.0T MR System meet predetermined acceptance criteria." However, it does not describe what those acceptance criteria were in terms of specific performance metrics (e.g., image resolution, signal-to-noise ratio requirements, diagnostic accuracy targets). It also does not report any specific device performance metrics against such criteria. The conclusion only states "the Signa® 3.0T MR System is substantially equivalent to the currently cleared 3.0T Signa® VH/i transmit/Receive Body Imaging Coil and the 3.0 T Signa® VH/i system magnetic resonance system." This indicates that the "performance" demonstrated was primarily in terms of equivalency, not in meeting novel diagnostic performance benchmarks.

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

This information is not provided in the document. The text refers to "testing" performed but does not elaborate on the nature of this testing, including details about test sets, patient data, or study design. Since this is an MR system (hardware) rather than an AI/ML diagnostic algorithm, the "test set" would likely refer to physical testing or phantom studies, rather than a dataset of patient images with ground truth.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not provided and is not relevant for the type of submission this appears to be. For substantial equivalence of an MR system, expert consensus on diagnostic images or ground truth establishment by multiple readers is not typically required in the same way it would be for an AI-powered diagnostic tool. The "ground truth" for an MR system often relates to its physical performance characteristics.

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

This information is not provided. Adjudication methods are typically associated with studies involving human interpretation of diagnostic data, especially for AI/ML devices where ground truth can be subjective or require expert consensus. This document does not describe such a study.

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

No, an MRMC comparative effectiveness study was not conducted based on the provided text. The device described is an MR imaging system (hardware), not an AI-assisted diagnostic tool. Therefore, the concept of comparing human reader performance with and without AI assistance is not applicable to this submission.

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

No, a standalone performance study in the context of an algorithm or AI was not done. The device is a magnetic resonance system, which by its nature operates with a human operator and interpretation. There is no independent algorithm performance being assessed here.

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

This information is not provided. Given that this is a 510(k) for an MR system, the "ground truth" for the tests performed (undescribed in detail) would more likely relate to engineering specifications, image quality metrics, or safety parameters, rather than clinically derived ground truth like pathology or outcomes data.

8. The sample size for the training set

This information is not provided as there is no mention of an algorithm requiring a training set in this submission.

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

This information is not provided as there is no mention of an algorithm or a training set in this submission.

Summary of the document's content:

The document describes a 510(k) submission for the GE Signa® 3.0T Magnetic Resonance System. Its purpose is to demonstrate substantial equivalence to previously cleared MR systems (K990550 and K003613). The modifications involve combining existing components. The "studies" mentioned relate to proving that these design modifications meet "predetermined acceptance criteria," which are not detailed but are implied to be related to safety and performance characteristics for an MR system, allowing it to be considered substantially equivalent. This is a regulatory filing for a medical imaging device (hardware), not an AI/ML software product, and therefore the types of studies, criteria, and performance metrics expected differ significantly from those required for AI-driven diagnostic tools.

Summary

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GE Medical Svstems

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

510(k) Summary

K022397

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:	July 16, 2002

Device Name:

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

Marketed Device:

The Signa® 3.0T Magnetic Resonance System is substantially equivalent to the currently marketed 3.0T Signa® VH/i transmit/Receive Body Imaging Coil (K003613) and the 3.0 T Signa® VH/i system (K990550).

Device Description:

Indications for Use:

The indications for use for the 3.0T Signa®VH/i (Signa® 3.0T MR System) Transmit/Receive Body Imaging Coil expands the imaging capability of the 3.0T Signa®VH/i MR Imaging System.

The Transmit/Receive Body Imaging Coil is intended for imaging of the Neck, Spine, Abdomen/Thorax and the extremities.

Comparison with Predicate Device:

The Signa® 3.0T Magnetic Resonance System is a modification of the 3.0T Signa® VH/i MR system (K990550) by combining the 3.0T Signa® VH/i T/R Body Imaging Coil (K003613) with the 3.0T Signa® VH/i MR system (K990550). It has the same basic technological characteristics, and, uses the

Image /page/0/Picture/18 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'GE' intertwined within a circular border. The letters and the border are black, creating a strong contrast against the white background.

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Image /page/1/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'G' and 'E' intertwined within a circular border. The letters and the border are black, creating a strong contrast against the white background.

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

same basic design, construction, and materials. It has the same intended use, and operating modes as the predicate device.

Summary of Studies:

Testing was performed to demonstrate that the design modifications to the Signa® 3.0T MR System meet predetermined acceptance criteria.

Conclusion:

The results of the testing described above demonstrate that the Signa® 3.0T MR System is substantially equivalent to the currently cleared 3.0T Signa® VH/i transmit/Receive Body Imaging Coil and the 3.0 T Signa® VH/i system magnetic resonance system.

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, with three parallel lines forming the snake. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 2 2 2002

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

Re: K022397

Trade/Device Name: GE Signa® 3.0T MR system Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device

Regulatory Class: II Product Code: 90 LNH Dated: July 18, 2002 Received: July 23, 2002

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 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 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): _ KO22397

Device Name: GE Signa® 3.0T Magnetic Resonance System

Indications For Use:

The indications for use for the 3.0T Signa®VH/i (Signa® 3.0T MR System) Transmit/Receive Body Imaging Coil expands the imaging capability of the 3.0T Signa®VH/i MR Imaging System.

The Transmit/Receive Body Imaging Coil is intended for imaging of the Neck, Spine, Abdomen/Thorax and the extremities.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use	✓	OR	Over-The-Counter Use
(Per 21 CFR 801.109)

Nancy hogdon

(Division Sign-Off)
Division of Reproductive, Abdominal, and Radiological Devices
510(k) Number	K022397

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.