Anatomical Region: General body anatomy, including head, spine, torso, and extremities
Nucleus excited: 1H nuclei (Proton)
Diagnostic uses: Images correspond to the distribution of 1H nuclei exhibiting nuclear magnetic resonance, with image intensity dependent upon NMR parameters, including spin-lattice relaxation time (T1) spin-spin relaxation time (T2) density of nuclei (p) flow velocity chemical shift (δ)
Clinical use: lmages may be interpreted by a trained physician to yield information that can be useful in the determination of a diagnosis
RF Coils: Head - quadrature Cervical Spine - quadrature Lumbar Spine, Thoracic Spine, and Abdomen - quadrature Knee - linear
Image Acquisition Spin Echo Gradient Echo (GE,RGE) Fast Spin Echo (FSE) Fast Dual Echo (FDE) 3D Fast Gradient Echo (3DGE, 3DRGE) Inversion Recovery with Fast Spin Echo (FSE STIR, FSE FLAIR)

Device Description

Identical to the IMiG-MRI 510(k) K963953. The original IMiG-MRI system was renamed as TREX MRI in 510(k) submission K982157. As a result of changing business arrangements, the TREX MRI is now renamed as the Field Effects MRI System. In addition, following successful FDA determination of substantial equivalence of this 510(k) submission for the Image Processing software, Field Effects will cease commercialization efforts and support for the Field Effects MRI System. Service Support will be available through SMIS (refer to ttem 9, Address of Manufacturing Facilities for SMIS contact information). With the exception of the device modifications identified in this 510(k) submission, and the renaming of the product, the Field Effects MRI System is identical to the original IMiG-MRI system (and to the TREX.MRI).

The Field Effects MRI 0.15T Elliptical MRI Magnetic Resonance Diagnostic Device is being enhanced by image processing software to increase the clinical utility of the Field Effects MRI System in the stationary configuration.

AI/ML Overview

The provided document, K983902, is a 510(k) Summary of Safety and Effectiveness for the Field Effects MRI device, specifically regarding an enhancement to its image processing software. It is a premarket notification from 1999.

Crucially, this document is a 510(k) submission applying to an MRI system itself, not an AI/ML-driven medical device in the contemporary sense. The "Image Processing Software" mentioned is part of the core functionality of the MRI to produce images, not a separate AI algorithm designed to interpret or enhance those images beyond the standard function of forming the image.

Therefore, the concepts of acceptance criteria, study design to prove device performance relative to a specific diagnostic task, sample sizes for test sets, ground truth establishment for AI, MRMC studies, or standalone algorithm performance as requested in the prompt, do not apply in the context of this 1999 MRI device submission.

The acceptance criteria for this device would have been related to the performance characteristics of an MRI system (e.g., field strength, image quality parameters, safety parameters) and its substantial equivalence to a predicate device, not the diagnostic performance of an AI algorithm. The study described is simply the 510(k) submission itself, asserting substantial equivalence to predicate MRI systems.

Below is an attempt to address the prompt using the limited and anachronistic information available in the 1999 document. Many fields will be "Not Applicable" or "Not Provided" because the regulatory and technological landscape for AI/ML devices did not exist in this form at that time.

Acceptance Criteria and Study for K983902 (Field Effects MRI Image Processing Software)

Based on the provided 510(k) summary, the "acceptance criteria" and "study" described are in the context of demonstrating substantial equivalence to predicate MRI devices, focusing on the safe and effective operation of the MRI system with its enhanced image processing software. It is not an AI/ML device with specific performance metrics against a defined diagnostic task.

1. Table of Acceptance Criteria and Reported Device Performance

Feature/Parameter	Acceptance Criteria (Implied by Substantial Equivalence)	Reported Device Performance (as stated in 510(k))
Safety Parameters	Identical or equivalent to predicate device (IMiG-MRI, Hitachi MRP-5000)	Maximum static magnetic field: 0.15 Tesla
		Maximum rate of magnetic field change: 18.4 Tesla/sec
		Maximum RF power deposition: 0.05 W/kg
		Acoustic noise levels: 114dB peak; 95dB A-weighted RMS
Performance Parameters	Identical or equivalent to predicate device for producing cross-sectional images with diagnostic utility.	Function: Identical to IMiG-MRI (K963953).
		Performance Parameter Summary: "Identical to the Predicate Device."
Image Processing Software Functionality	Enhance clinical utility in the stationary configuration.	Enhances clinical utility of the Field Effects MRI System in stationary configuration. (Specific quantitative metrics not provided for enhancement)
Intended Use	Consistent with predicate device for general body anatomy MRI.	Produces cross-sectional images of general body anatomy, exciting 1H nuclei, with images useful for diagnosis. (Identical to predicate)
Technological Characteristics	Identical or equivalent to predicate device.	"Identical to the Predicate Device."

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

Sample Size for Test Set: Not applicable/Not provided. This submission is for an MRI system's fundamental image processing, not an algorithm's diagnostic performance on a dataset. The "test" for substantial equivalence would involve comparing system specifications and intended use against predicate devices, likely through engineering analysis, not a clinical study with a specific patient test set in the modern AI sense.
Data Provenance: Not applicable/Not provided in this document. The concept of "data provenance" for a test set of images for AI evaluation is not relevant here.

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

Number of Experts: Not applicable. Ground truth establishment for an AI algorithm's diagnostic performance is not relevant to this submission. The "ground truth" for an MRI system's performance is its ability to generate images according to physical principles and specifications, and its safety parameters.
Qualifications of Experts: Not applicable.

4. Adjudication Method for the Test Set

Adjudication Method: Not applicable. This relates to AI performance evaluation, which is not the subject of this 510(k). Substantial equivalence is adjudicated by the FDA based on the provided documentation, comparisons to predicate devices, and regulatory standards.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

MRMC Study: No. This type of study is used to compare human reader performance with and without AI assistance, which is not relevant to this 1999 submission for an MRI system.

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

Standalone Performance: No. The "Image Processing Software" is an integral part of the MRI system, not a standalone algorithm. The concept of "standalone performance" for an AI algorithm did not apply.

7. The Type of Ground Truth Used

Type of Ground Truth: Not applicable in the context of AI evaluation. The "truth" for this submission revolves around the MRI system's physical and technical specifications, safety, and its ability to produce images that are "useful in the determination of a diagnosis" when interpreted by a trained physician, consistent with predicate devices.

8. The Sample Size for the Training Set

Sample Size for Training Set: Not applicable/Not provided. This is an MRI system, not an AI model that undergoes "training." The image processing software would have been developed through engineering and physics principles, not machine learning on a training set of data.

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

Ground Truth for Training Set Establishment: Not applicable. As above, the concept of a training set and its ground truth does not apply to this type of device development.

Summary

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K983902

JAN 7 1999

Attachment 1 510(k) Summary of Safety and Effectiveness

{1}------------------------------------------------

1.0 SUBMITTER INFORMATION:

Field Effects, a division of Intermagnetics General Corporation 1.1 Submitter: 300 Vesper Executive Park Tynasborough, MA 01879 PH: 978 649-8590 FX: 978 649-8520 Email: GHURST@IGC.com
Grea Hurst, Ph.D. 1.2 Contact: Mar., Imaging Science and Applications
1.3 Date: October 30, 1998
1.4 Regulatory Counsel: Jonathan S. Kahan, Attorney at Law Hoaan & Hartson 555 Thirteenth St. NW Washington, DC 20004-1109 PH: 202 637-5794 FX: 202 637-5910

2.0 DEVICE NAME:

2.1 Classification Panel: Radiology
1. 1000 Maanetic Resonance Diagnostic Device 2.2 Classification Number:
2.3 Product Nomenclature: System, Nuclear Magnetic Resonance Imaging
2.4 Product Code(s): 90LNH
2.5 Trade/Proprietary Name: Field Effects MRI
2.6 Predicate Device(s): IMiG-MRI, K963953 Hitachi MRP-5000 with Version 5.0 Operating System Software, K943799

3.0 DEVICE DESCRIPTION:

3.1 FUNCTION

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3.2 Safety Parameter Summary

Maximum static magnetic field	0.15 Tesla
Maximum rate of magnetic fieldchange	18.4 Tesla/sec
Maximum RF power deposition	0.05W/kg
Acoustic noise levels	114dB peak; 95dB A-weighted RMS

Performance Parameter Summary 3.3

ldentical to the Predicate Device.

3.4 General Safety and Effectiveness Summary

Safe and effective use of the machine is assured by the associated labeling. This labeling includes: advertising brochures, Site Planning Guide, and Instructions for Use (comprised of Clinical Users Guide, User Safety Guide, User Training Guide, User Applications Guide, and User QA & Maintenance Guide).

DEVICE INTENDED USE: 4.0

The Field Effects MRI system produces cross-sectional images:

· Anatomical Region: General body anatomy, including head, spine, torso, and extremities
1H nuclei (Proton) . Nucleus excited:
Diagnostic uses: Images correspond to the distribution of 1H nuclei exhibiting nuclear magnetic resonance, with image intensity dependent upon NMR parameters, including spin-lattice relaxation time (T1) spin-spin relaxation time (T2) density of nuclei (p) flow velocity chemical shift (δ)
· Clinical use: lmages may be interpreted by a trained physician to yield information that can be useful in the determination of a diagnosis

5.0 DEVICE TECHNOLOGICAL CHARACTERISTICS:

Identical to the Predicate Device.

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Image /page/3/Picture/0 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo is circular in shape, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter of the circle. In the center of the circle is an image of an eagle with its wings spread.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

10000 7 JAN

Ian L. Pykett, Ph.D., F.Inst.P. Vice President. Technology Development Intermagnetics General Corporation 450 Old Niskavuna Road P.O. Box 461 Latham, NY 12110-0461

Re:

K983902

Field Effects MRI Magnetic Resonance Diagnostic Device Dated: October 30, 1998 Received: November 3, 1998 Regulatory class: II 21 CFR 892.1000/Procode: 90 LNH

Dear Dr. Pykett:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Fallure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. 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 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers 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,

Capt. Daniel G. Schultz, M.D. Acting Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: Image Processing Software for Field Effects MRI

Indications for Use:

The Field Effects MRI system produces cross-sectional images:

•	Anatomical Region:	General body anatomy, including head, spine, torso, and extremities
•	Nucleus excited:	1H nuclei (Proton)
•	Diagnostic uses:	Images correspond to the distribution of 1H nuclei exhibiting nuclear magnetic resonance, with image intensity dependent upon NMR parameters, including- spin-lattice relaxation time (T1)- spin-spin relaxation time (T2)- density of nuclei (ρ)- flow velocity- chemical shift (δ)
•	Clinical use:	Images may be interpreted by a trained physician to yield information that can be useful in the determination of a diagnosis.
•	RF Coils:	Head - quadratureCervical Spine - quadratureLumbar Spine, Thoracic Spine, and Abdomen - quadratureKnee - linear
•	Image Acquisition	Spin EchoGradient Echo (GE,RGE)Fast Spin Echo (FSE)Fast Dual Echo (FDE)3D Fast Gradient Echo (3DGE, 3DRGE)Inversion Recovery with Fast Spin Echo (FSE STIR, FSE FLAIR)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)
	(Division Sign-Off)	(Division Sign-Off)
(Division Sign-Off)

Prescription Use (Per 21 CFR 801-109	✓
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	Division of Reproductive, Abdominal, ENT Over-The-Counter Use ______
	and Radiological Devices
510(k) Number	K983902

	(Optional Format 1-2-96)
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Regulation Number and Section

N/A