The modifications include: new imaging sequences: FSAGE, Multishot EPI, Long ETL FSE, SSE, SSV, and diffusion weighted imaging, automated image filtering, MPR, PCA color coded velocity maps, Time Lapse post processing, Real-Time Localizer, double oblique localization, and multiple presaturation.

AI/ML Overview

Here's an analysis of the provided text regarding the Elscint MRI Software Version 3.0, focusing on acceptance criteria and the study proving its performance:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Metric (Software Version 3.0)	Predicate Device Performance	Conclusion (Met/Not Met)
Minimum TE	2ms	4.3ms	Met (Improved)
Minimum TR	7ms	11ms	Met (Improved)
Minimum FOV	4cm	6.4cm	Met (Improved)
Maximum 2D Acquisition Matrix	$1024^2$	$512^2$	Met (Improved)
Maximum 3D Acquisition Matrix	$256^3$ or 128x512x512	$256^3$ or 128x512x512	Met (Equivalent)
Maximum Number of Echoes	8	8	Met (Equivalent)
Maximum Number of Slices	80	80	Met (Equivalent)
Minimum Slice Width	0.5mm	0.7mm	Met (Improved)
Safety (SAR, dB/dt, acoustic noise, Bo)	Same as predicate devices	(Same as predicate devices)	Met (Equivalent)
Software Safety Hazards	Minimized by design reviews, code reviews, and testing	(Not explicitly stated for predicate, assumed safe)	Met (Addressed)

Note: The "acceptance criteria" here are implicitly defined by comparison to the predicate devices. The submission claims the device is "substantially equivalent in safety and effectiveness" and that effectiveness is "improved in non-substantial ways." The actual "study" presented is a direct comparison of technical specifications.

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

Sample Size for Test Set: Not applicable. The submission does not describe a clinical study with a "test set" of patient data. The effectiveness evaluation is based on a technical parameter comparison to predicate devices, not on a dataset of images or patients.
Data Provenance: Not applicable. No clinical data is mentioned.

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

Not applicable. No ground truth for a test set was established. The "truth" is based on the technical specifications of the device and its predicate.

4. Adjudication Method for the Test Set

Not applicable. There was no test set or expert adjudication process described.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC comparative effectiveness study was done. The document does not describe human reader performance or the impact of AI assistance. The focus is on the inherent technical capabilities of the MRI system's software version.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Not explicitly described as a "standalone study" in the modern sense of AI algorithm evaluation. However, the performance metrics (e.g., minimum TE, TR, FOV) inherently represent the standalone capabilities of the MRI "algorithm" or system software without direct human intervention during the acquisition process. The assessment is purely on the system's technical output.

7. Type of Ground Truth Used

The "ground truth" for this submission is the technical specifications and performance parameters of the predicate MRI devices. The new software version's performance is compared directly to these established technical benchmarks. There is no biological or clinical ground truth (e.g., pathology, outcomes data) discussed.

8. Sample Size for the Training Set

Not applicable. This submission describes software updates to an MRI system, not an AI or machine learning model that would require a "training set" of data.

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

Not applicable, as there is no training set for an AI/ML model.

Summary

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Submitter's Name and Address: Elscint, Inc., 505 Main Street, Hackensack, NJ 07601

Contact Person and Telephone No.: Steven M. Kay, (201) 342-2020

Date of Summary: 11 January, 1998

APR - 2 1998

Device Name:	Elscint MRI Software Version 3.0
Trade/Proprietary Name:	Elscint MRI Software Version 3.0
Common Name:	MRI System
Classification Name:	Magnetic Resonance Diagnostic Device

Gyrex 2T Prestige (K945791), 3. Predicate Device(s): Gyrex Privilege (K954039), Gyrex V-EP (K962618), Gyrex Prima 1TG (K970990)

4. Device Description:

5. Intended Use:

Anatomical Region:	Whole Body and Organ Specific imaging
Nuclei Excited:	Hydrogen
Diagnostic Use:	The production of Magnetic Resonance Images

6. Safety:

The SAR, dB/dt, acoustic noise, and Bo are the same as the predicate devices.

All potential software safety hazards were minimized by design reviews, code reviews, and testing.

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7. Effectiveness:

Acquisition Parameter Comparison

	Version 3.0	Predicate Devices
Minimum TE	2ms	4.3ms
Minimum TR	7ms	11ms
Minimum FOV	4cm	6.4cm
Maximum 2D Acquisition Matrix	$1024^2$	$512^2$
Maximum 3D Acquisition Matrix	$256^3$ or 128x512x512	$256^3$ or 128x512x512
Maximum Number of Echoes	8	8
Maximum Number of Slices	80	80
Minimum Slice Width	0.5mm	0.7mm

The system performance parameters are not protocol dependent, and no acquisition software or hardware modifications which affect the system performance parameters are included in Version 3.0. The system performance parameters are therefore not affected by the current modification.

8. Equivalency Information Summary:

The FDA recommended MRI safety limits are not exceeded, and the effectiveness of the devices is improved in non-substantial ways from that of the predicate devices. It is Elscint's opinion that the Elscint MRI Systems with Software Version 3.0 are substantially equivalent in safety and effectiveness to their predicate devices.

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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus or a bird-like figure.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Steven M. Kay Director, Regulatory Affairs and Quality Assurance Elscint. Inc. 505 Main Street Hackensack, NJ 07601

Re:

K980306

APR - 2 1998

· Software Version 3.0 for the Gyrex Magnetic Resonance Imaging Systems Dated: January 23, 1998 Received: January 27, 1998 Regulatory class: II 21 CFR 892.1000/Procode: 90 LNH

Dear Mr. Kay:

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 devices marketed in interstate commerce prior to May 28, 1976, the ensement date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Councilic 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 and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either 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 (OS) for Medical Devices: General regulation (2) CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure 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 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 80) and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for question 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/cdr/dsmala.html".

Sincerely yours,

Lillian Yin, Ph.D.

Lillian Yin, Ph.D. 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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K48 030 6 510(k) Number (if known):

VERSION 3.0 Device Name: _

Indications For Use:

MAGNETIC RESONANCE IMAGINE BODY WHOLE

(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)

Over-The-Counter Use_

Kermit C. Biegner

(Division Sign-Off) … Division of Reproductive, Abdominal, ENT and Radiological Devic

510(k) Number K960306

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.