The GE Delta Software Option for MRI is an analytical software tool, which provides reproducible tools for the review and reporting of medical images. Delta can import medical images from a MR system and display them in a viewing area on the computer screen. The viewing area allows the access to multiple studies and series of multi-slice, multi-phase images. Multi-phase sequences of images can be displayed in a cine mode to facilitate visualization.

A report input interface is also available. Measurement tools on the report interface make it possible to quickly and reliably fill out a complete clinical report of an imaging exam. Available tools include: point, distance, area, and volume measurement tools such as ejection fraction, cardiac output, end-diastolic volume, end-systolic volume, and volume flow measurements.

The results of the measurement tools are interpreted by the physician and can be communicated to referring physicians.

When interpreted by a trained physician these tools may be useful in supporting the determination of a diagnosis.

Device Description

The GE Delta Software Option for MRI is an analytical software application intended to review and analyze medical images.

AI/ML Overview

The provided document does not contain acceptance criteria or a study that proves the device meets specific performance criteria. Instead, it details a 510(k) premarket notification for the GE Delta Software Option for MRI, focusing on substantial equivalence to predicate devices and adherence to safety standards.

Here's a breakdown of what is and is not in the document regarding your request:

1. Table of Acceptance Criteria and Reported Device Performance:

Not Found: The document does not specify any quantitative acceptance criteria (e.g., accuracy thresholds, precision targets) for the software's analytical capabilities (e.g., ejection fraction, cardiac output measurements). Consequently, there are no reported device performance metrics against such criteria. The "Summary of Studies" section only mentions evaluation against safety standards (IEC60601-1-4 and IEC 60601-2-33) for software and MR systems, not clinical performance.

2. Sample size used for the test set and data provenance:

Not Found: There is no mention of a test set, sample size, or data provenance (e.g., country of origin, retrospective/prospective) for evaluating the device's diagnostic or measurement accuracy. The studies mentioned are related to electrical and software safety, not clinical performance.

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

Not Found: Since no clinical performance study or test set is described, there's no information about experts used to establish ground truth.

4. Adjudication method for the test set:

Not Found: No clinical performance study, thus no adjudication method is mentioned.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance:

Not Found: The document describes the GE Delta Software as an "analytical software tool" with "reproducible tools for the review and reporting of medical images," including various measurement tools. It states that "When interpreted by a trained physician these tools may be useful in supporting the determination of a diagnosis." However, it does not describe any MRMC comparative effectiveness study, nor does it quantify any improvement in human reader performance with or without the AI assistance (as it's more of a quantitative measurement tool than a diagnostic AI).

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

Not Found: No standalone performance study, defined as "algorithm only without human-in-the-loop performance," is described. The device is presented as a tool to be used by a trained physician.

7. The type of ground truth used:

Not Found: No clinical performance study means no ground truth type (e.g., expert consensus, pathology, outcomes data) is mentioned.

8. The sample size for the training set:

Not Found: There's no mention of a training set as this is not a study describing the development or validation of a machine learning algorithm in the way modern AI devices are presented. It's a software option providing measurement tools.

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

Not Found: No training set, thus no ground truth establishment method.

In summary: The provided 510(k) pertains to the regulatory clearance of a software option for MRI that provides measurement and reporting tools, asserting its substantial equivalence to predicate devices (MEDIS Medical Imaging Systems FLOW and MASS). The evaluation focuses on safety standards (IEC60601-1-4, IEC 60601-2-33) for programmable electrical medical systems and MRI systems, rather than clinical performance metrics or studies involving patient data, ground truth, or reader performance.

Summary

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JUL 2 2003

SUMMARY OF SAFETY AND EFFECTIVENESS

This 510(k) summary of safety and effectiveness information is submitted in accordance with the requirements of 21 CFR Part 807.87(h).

ldentification of Submitter . Larry A. Kroger, Ph.D.,
Phone: . 262-544-3464
트 Fax: 262-548-4768
I Date Prepared: May 28, 2003
Identification of the Product ● GE Delta Software Option for MRI

Manufactured by: GE Medical Systems 3200 N Grandview Blvd. Waukesha, WI 53188

Common Name Software Option for MRI
. Classification Name Magnetic Resonance Diagnostic System, 21 CFR 892.1000, 90-LNH
Device Description The GE Delta Software Option for MRI is an analytical software application intended to review and analyze medical images.
Indications for Use .

The results of the measurement tools are interpreted by the physician and can be communicated to referring physicians.

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When interpreted by a trained physician these tools may be useful in supporting the determination of a diagnosis.

. Comparison with Predicate
The Delta Option is substantially equivalent to the features in currently marketed MEDIS Medical Imaging Systems FLOW (K994282) and MEDIS Medical Imaging Systems MASS (K994283). Both predicate devices are currently distributed by GE: Medical Systems and manufactured by MEDIS.

Summary of Studies .

The Delta Option was evaluated to the IEC60601-1-4, the Programmable Electrical Medical Systems standard, and IEC 60601-2-33 International medical equipment safety standard for Magnetic Resonance Systems.

Conclusions .

It is the opinion of GE that the Delta Option for MRI does not result in any new potential hazards.

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Image /page/2/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo is circular in shape and features the department's emblem in the center. The emblem is a stylized representation of an eagle with three stripes extending from its body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper half of the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 2 2003

GE Medical Systems % Mr. Heinz Joerg Steneberg Primary Third Party Reviewer TUV Rheinland of North America 12 Commerce Road NEWTOWN CT 06470

Re: K031927 Trade/Device Name: GE Delta Software Option for MRI Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: 90 LNH Dated: June 19, 2003 Received: June 23, 2003

Dear Mr. Steneberg:

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 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 Office of Compliance at one of the following numbers, based on the regulation number at the top of the 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" (21CFR Part 807.97) you may obtain. 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/dsmaldsmamain.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

Page 2

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510(k) Number (if known): _ Ko3 19 27

Device Name: GE Delta Software Option for MRI

Indications For Use:

The results of the measurement tools are interpreted by the physician and can be communicated to referring physicians.

When interpreted by a trained physician these tools may be useful in supporting the determination of a diagnosis.

(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)

(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices510(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.