The Signa OpenSpeed Magnetic Resonance System is an open, whole body scanner designed to support improved higher resolution imaging and shorter scan times. The Signa OpenSpeed Magnetic Resonance System is indicated for use as a diagnostic imaging device to produce transverse, sagittal, coronal and oblique images of the internal structures and organs of the entire body, including, but not limited to, the musculocskeletal, vascular, cardiac, and neuro systems. The images produced by the Signa OpenSpeed 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, spinlattice 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.

Due to the 'open' design of the system, the Signa OpenSpeed may also be used for imaging during interventional procedures when performed with MR compatible devices such as, in-room display and MR safe biopsy needles.

Device Description

The Signa OpenSpeed Magnetic Resonance System is a modification to the Signa HFO/i Magnetic Resonance System (K992746) which utilizes a superconducting magnet to acquire 2D single-slice and multi-slice, and 3D volume images. The Signa OpenSpeed Magnetic Resonance System is an open style magnet operating at 0.7T. 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 shorter scan times. Previously cleared software options, coils, and other accessories may be used with the Signa OpenSpeed Magnetic Resonance System.

AI/ML Overview

This document is a 510(k) summary for the GE Signa OpenSpeed Magnetic Resonance System, which is a modification of an existing device. The summary primarily focuses on demonstrating substantial equivalence to a predicate device rather than providing detailed acceptance criteria and a study to prove performance against those criteria as would be done for a novel device or a device with significant performance claims requiring extensive clinical validation.

Based on the provided text, it's not possible to extract the detailed information requested in the prompt because the submission is for a modification of an existing device, and the evaluation relies on established safety and performance standards rather than a comparative effectiveness study with specific acceptance criteria for a new AI algorithm.

Here's an breakdown of why the requested information cannot be fully provided based on the input:

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

Cannot be provided: The document states, "The Signa OpenSpeed Magnetic Resonance System was evaluated to the appropriate NEMA standard and performance criteria as well as International Medical Equipment Safety standard and performance criteria..." However, specific numerical acceptance criteria (e.g., sensitivity, specificity, image quality metrics) and reported performance values against these criteria are not detailed in this 510(k) summary. The evaluation focuses on compliance with established safety and performance standards for MR systems generally, not specific performance metrics against an AI-driven task.

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

Cannot be provided: There is no mention of a "test set" in the context of evaluating a specific algorithm's performance on a dataset of patient images. The evaluation described is related to the physical and functional aspects of the MR system itself (gradient strength, slew rate, new imaging option).

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):

Cannot be provided: No ground truth establishment mechanism is described as there is no specific performance validation related to interpreting images or making a diagnosis with an AI algorithm. The document mentions that images are interpreted by a "trained physician," but this refers to the standard medical practice of a human interpreting MR images, not the establishment of ground truth for an AI study.

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

Cannot be provided: No adjudication method is mentioned as there's no test set or expert evaluation process described for an AI algorithm.

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:

Cannot be provided: This document describes an MR system, not an AI algorithm intended for human-in-the-loop assistance. Therefore, no MRMC study or effect size for AI assistance is mentioned.

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

Cannot be provided: This document relates to an MR imaging system, not a standalone AI algorithm.

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

Cannot be provided: There is no mention of a ground truth for an AI algorithm's performance.

8. The sample size for the training set:

Cannot be provided: As this is about an MR system modification, not an AI model, there is no concept of a "training set" in the context of this submission.

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

Cannot be provided: No training set or ground truth establishment relevant to an AI algorithm is discussed.

Summary of Studies mentioned in the document:
The "Summary of Studies" section in the document states: "The Signa OpenSpeed Magnetic Resonance System was evaluated to the appropriate NEMA standard and performance criteria as well as International Medical Equipment Safety standard and performance criteria, comparable to the currently marketed Signa HFO/i Magnetic Resonance System."

This indicates that the studies performed were focused on demonstrating that the modified MR system meets established safety and performance standards generally applicable to MR equipment, and that its performance is comparable to the predicate device. This is typical for a 510(k) submission for a device modification where the primary goal is to show substantial equivalence and adherence to existing regulatory benchmarks, rather than to validate the performance of a new diagnostic algorithm using specific patient data.

Summary

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NOV 2 0 2001

Page 1 of 2

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

510(K) SUMMARY

Ko12875

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:	August 23, 2001

Device Name:

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

Marketed Device:

The Signa OpenSpeed Magnetic Resonance System is substantially equivalent to the currently marketed The organ of Magnetic Resonance System (K992746) with the main differences being an increase in gradient strength from 15mT/m, and an increase in slew rate from SR25 to SR40. In addition, Diffusion imaging is now offered as an imaging option.

Device Description:

Indications for Use:

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Image /page/1/Picture/1 description: The image shows a circular logo with a stylized design. The logo appears to be a vintage or retro design, possibly representing a company or brand. The design consists of intertwined or overlapping elements within the circle, creating a visually complex and abstract pattern. The logo is black and white, with the design elements appearing in black against a white background.

Page 2 of 2

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

physician, these images provide information that can be useful in determining a diagnosis.

Comparison with Predicate Device:

The Signa OpenSpeed Magnetic Resonance System is a modification of the Signa HFP/i MR system (K992746) with the main differences being an increase in gradient strength from 15mT/m, (1892140) with the main differences oong an more and and the maging is now offered as an imaging option.

Summary of Studies:

The Signa OpenSpeed Magnetic Resonance System was evaluated to the appropriate NEMA The Signa Openspece Magnetic Robertanoon J. International Medical Equipment Safety standard and performance buildiana as as "quirements for Safety of Magnetic Resonance Equipment for Medical IEC 001-2-53 I articular Nequilions for SReey of MSS. Somparable to the currently marketed Signa HFO/i Magnetic Resonance System.

Conclusion:

It is the opinion of GE that the Signa OpenSpeed Magnetic Resonance System is substantially equivalent it is the Signa HFO/i Magnetic Resonance System. The Signa OpenSpeed Magnetic Resonance System to the bight III Ori Haghetions for use, nor does use of this device result in any new potential hazards.

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features the department's name encircling a stylized emblem. The emblem consists of a stylized caduceus, a symbol often associated with medicine and healthcare, with three lines representing the branches of government.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 2 0 2001

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

Re: K012875 Trade/Device Name: Signa OpenSpeed Magnetic

Resonance System Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: 90 LNH Dated: August 23, 2001 Received: August 27, 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 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 nouthoution. The I Drivinention 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 If you done 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 Actively reliable 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 of reference to premainted from the 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. Snugden

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

Enclosures

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NOV 2 0 2001

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: Signa OpenSpeed Magnetic Resonance System

Indications For Use:

Due to the 'open' design of the Signa OpenSpeed may also be used for imaging during interventional procedures when performed with MR compatible devices such as, in-room display and MR safe biopsy needles.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

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

Nancy brigton

Division Sign-Off

Division of Reproductive, Abdominal,

Radiological Devices

510(K) Number K012875

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.