MAGiC (MAGnetic resonance image Compilation) is a software option based on a combination and post processing software that is intended for use on GE imaging platforms. MAGiC generates multiple image contrasts from a single acquisition scan. MAGiC enables post-acquisition image contrast adjustment. MAGiC also allows for the generation of parametric maps for further analysis of MRI acquisition data. MAGiC is indicated for head imaging.

When interpreted by a trained physician, MAGiC images can provide information useful in determining diagnosis.

Device Description

MAGiC (MAGnetic resonance image Compilation) allows the user to generate multiple contrasts in a single scan. MAGiC utilizes a multi-delay, multi-echo acquisition (MDME). The data acquired is processed using a technique to generate multiple image contrasts simultaneously, such as T1, T2, PD and Inversion Recovery (IR) weighted images (including: T1-FLAIR, T2-FLAIR, STIR, Double IR and PSIR weighted images). MAGiC generates all the different image contrasts from the same acquisition, leading to enhanced image slice registration, owing to the absence of inter-acquisition patient movement. MAGiC provides the user the ability to change the contrast of the images after acquisition. This is performed by adjusting the TR, TE, and/or TI parameters post-acquisition, to generate the specific contrast desired. MAGiC also enables users to generate parametric maps, such as T1, T2, R1, R2, PD, for further analysis of MRI acquisition data.

AI/ML Overview

The provided text is a 510(k) Premarket Notification Submission for the MAGiC (MAGnetic resonance image Compilation) device. Based on the document, here's a detailed breakdown of the acceptance criteria and the study conducted:

1. Table of Acceptance Criteria and Reported Device Performance

Criterion	Acceptance Criteria	Reported Device Performance
Image Quality (Diagnostic Acceptability)	To demonstrate that MAGiC images are of acceptable diagnostic image quality, which is defined as "usable for clinical diagnosis" and equivalent to that of the predicate device.	The study found that MAGiC images are statistically equivalent to the predicate device in terms of diagnostic image quality. Inter-reader agreement between MAGiC and predicate scans was also statistically significant.
Radiologic Finding Classes Equivalence	To demonstrate that the radiologic finding classes identified using MAGiC images are equivalent to those identified using images from the predicate device.	The study demonstrated equivalency in radiologic finding classes between MAGiC and predicate device images.
Parametric Map Accuracy (T1, T2, PD)	Not explicitly stated as acceptance criteria, but addressed in the study. The study intended to evaluate the accuracy of the quantitative values derived from MAGiC's parametric maps (T1, T2, PD) compared to reference values.	Quantitative values obtained from MAGiC's synthetic images (T1, T2, PD) showed high correlation (R² > 0.98) with reference values, and the differences in these values were within acceptable limits. The parametric measurements were accurate and consistent.
Signal-to-Noise Ratio (SNR) and Contrast-to-Noise Ratio (CNR) in Synthetic Images	Not explicitly stated as acceptance criteria, but mentioned in the study's scope of evaluation.	MAGiC-derived synthetic images demonstrated comparable or improved SNR and CNR values relative to the predicate device's acquired images, particularly for synthetic FLAIR images. This suggests the synthetic images maintain diagnostic utility.
Software Compliance & Quality Assurance	Compliance with AAMI/ANSI 62304, AAMI/ANSI ES60601-1, IEC 60601-2-33, and NEMA PS3.1-3.18 (DICOM conformance). Development under quality assurance design controls including Risk Analysis, Requirements Reviews, Design Reviews, Unit/Module Testing, Integration Testing, Performance Testing, Safety Testing, and Simulated Use Testing.	MAGiC is a software-only feature and complies with all listed voluntary standards. All quality assurance measures were applied, and testing was completed with passing results per the defined pass/fail criteria. This supports substantial equivalence.

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

Sample Size: The document states that a "reader study was conducted to demonstrate acceptable diagnostic image quality and equivalent radiologic finding classes compared to the predicate device." However, the exact sample size (number of cases/patients) used for this reader study (test set) is not explicitly stated in the provided text.
Data Provenance: The document does not specify the country of origin of the data or whether it was retrospective or prospective.

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

The document mentions a "reader study" where images were "interpreted by a trained physician" (in the Indications for Use). However, it does not specify the number of experts who participated in establishing the ground truth or their specific qualifications (e.g., "radiologist with 10 years of experience").

4. Adjudication Method for the Test Set

The document does not explicitly state the adjudication method used for the reader study (e.g., 2+1, 3+1, none). It only refers to a "reader study."

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

A reader study was performed to compare MAGiC images to the predicate device. This is a form of comparative effectiveness study.
Effect Size of Human Readers Improvement with AI vs. Without AI Assistance: The document does not report an effect size for how much human readers improve with MAGiC (AI) assistance versus without it. The study's focus was on demonstrating "acceptable diagnostic image quality" and "equivalent radiologic finding classes" compared to the predicate device, implying non-inferiority or equivalence rather than a direct measure of human reader improvement. The device generates images (synthetic contrasts and parametric maps) rather than providing diagnostic assistance in the sense of an CAD system.

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

The evaluation of parametric map accuracy (T1, T2, PD) and SNR/CNR in synthetic images could be considered a form of standalone performance evaluation, as it assesses the quantitative outputs and image characteristics of the algorithm itself.
The document indicates that quantitative values obtained from MAGiC's synthetic images had high correlation (R² > 0.98) with reference values, and differences were within acceptable limits. Also, SNR and CNR values in synthetic images were comparable or improved. This suggests robust standalone performance for these specific aspects.

7. Type of Ground Truth Used

For the reader study, the ground truth for diagnostic image quality and radiologic finding classes was established through expert interpretation (trained physicians).
For the evaluation of parametric map accuracy (T1, T2, PD), the ground truth was reference values, implying a comparison against established quantitative measurements (e.g., obtained from standard phantoms or established acquisition sequences).

8. Sample Size for the Training Set

The document does not provide information on the sample size used for the training set for the MAGiC software or any underlying AI algorithms. It focuses on the validation of the final product.

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

Since the document does not mention data used for training or a training set sample size, it consequently does not describe how ground truth for a training set was established.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

August 31, 2016

GE Medical Systems, LLC Mary Mayka Regulatory Affairs Manager 3200 Grandview Blvd WAUKESHA WI 53188

Re: K161397 Trade/Device Name: MAGiC Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: LNH Dated: July 29, 2016 Received: August 1, 2016

Dear Dr. Mayka:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Michael D'Hara

For

Robert Ochs. Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K161397

Device Name MAGiC

Indications for Use (Describe)

When interpreted by a trained physician, MAGiC images can provide information useful in determining diagnosis.

Type of Use (Select one or both, as applicable)

☑ Prescription Use (Part 21 CFR 801 Subpart D)	☐ Over-The-Counter Use (21 CFR 801 Subpart C)
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GE Healthcare 510(k) Premarket Notification Submission

510(k) Summary

In accordance with 21 CFR 807.92 the following summary of information is provided:

Date:	July 28, 2016
Submitter:	GE Medical Systems, LLC (GE Healthcare)3200 N. Grandview Blvd.,Waukesha, WI 53188USA
Primary Contact Person:	Mary A. Mayka, Ph.D.Regulatory Affairs ManagerGE HealthcarePhone: 262-527-3148Fax: 262-364-2785
Secondary Contact Person:	Glen SabinRegulatory Affairs DirectorGE HealthcarePhone: 262-521-6848Fax: 262-364-2785
Device Trade Name:	MAGiC (MAGnetic resonance image Compilation)
Common/Usual Name:	Magnetic Resonance Diagnostic Device
Classification Names:	Magnetic Resonance Diagnostic Device per 21 CFR892.1000
Product Code:	LNH
Predicate Device(s):	Discovery MR750 3.0T, Discovery MR450 1.5T,Discovery MR750w 3.0T, Optima MR450w 1.5T(K142085)
Device Description:	MAGiC (MAGnetic resonance image Compilation)allows the user to generate multiple contrasts in a singlescan. MAGiC utilizes a multi-delay, multi-echoacquisition (MDME). The data acquired is processedusing a technique to generate multiple image contrastssimultaneously, such as T1, T2, PD and InversionRecovery (IR) weighted images (including: T1-FLAIR,T2-FLAIR, STIR, Double IR and PSIR weighted images).MAGiC generates all the different image contrasts fromthe same acquisition, leading to enhanced image sliceregistration, owing to the absence of inter-acquisitionpatient movement. MAGiC provides the user the ability tochange the contrast of the images after acquisition. This isperformed by adjusting the TR, TE, and/or TI parameterspost-acquisition, to generate the specific contrast desired.MAGiC also enables users to generate parametric maps,such as T1, T2, R1, R2, PD, for further analysis of MRIacquisition data.
Intended Use:	MAGiC (MAGnetic resonance image Compilation) is asoftware option based on a combination of acquisition andpost processing software that is intended for use on GEimaging platforms. MAGiC generates multiple imagecontrasts from a single acquisition scan. MAGiC enablespost-acquisition image contrast adjustment. MAGiC alsoallows for the generation of parametric maps for furtheranalysis of MRI acquisition data. MAGiC is indicated forhead imaging.When interpreted by a trained physician, MAGiC imagescan provide information useful in determining diagnosis.
Technology:	MAGiC employs the same fundamental scientifictechnology as its predicate devices.
Determination ofSubstantial Equivalence:	Summary of Non-Clinical Tests:
	MAGiC is a software only feature and complies with thefollowing voluntary standards:• AAMI/ANSI 62304• AAMI/ANSI ES60601-1• IEC 60601-2-33In addition, MAGIC complies with NEMA PS3.1-3.18 forDICOM conformance.The following quality assurance measures were applied tothe development of the device:• Risk Analysis• Requirements Reviews• Design Reviews• Testing on unit level (Module verification)• Integration testing (System verification)• Performance testing (Verification)• Safety testing (Verification)• Simulated use testing (Validation)The non-clinical tests have been summarized in theverification and validation testing for MAGiC. The testingwas completed with passing results per the pass/failcriteria defined in the test cases. This supports substantialequivalence to its predicates because it was alsodeveloped under quality assurance Design Controls. Inaddition, the software complies with the same applicableStandards.Summary of Clinical Tests:A reader study was conducted to demonstrate acceptablediagnostic image quality and equivalent radiologic findingclasses compared to the predicate device.
Conclusion:	GE Healthcare considers MAGiC to be as safe, aseffective, and performance is substantially equivalent tothe predicate devices.

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GE Healthcare 510(k) Premarket Notification Submission

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GE Healthcare 510(k) Premarket Notification Submission

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.