The SIGNA Prime is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and short scan times. It is indicated for use as a diagnostic imaging device to produce axial, sagittal, coronal, and oblique images, spectroscopic images, parametric maps, and/or spectra, dynamic images of the structures and/or functions of the entire body, including, but not limited to, head, neck, TMI, spine, abdomen, pelvis, joints, prostate, blood vessels, and musculoskeletal regions of the body.
Depending on the region of interest being imaged, contrast agents may be used. The images produced by SIGNA Prime reflect the spatial distribution or molecular environment of nuclei exhibiting magnetic resonance.
These images and/or spectra when interpreted by a trained physician yield information that may assist in diagnosis.

Device Description

SIGNA™ Prime is a whole body magnetic resonance scanner designed to support high resolution, high signal to-noise ratio, and short scan times. The systems use a combination of time-varying magnet fields (Gradients) and RF transmissions to obtain information regarding the density and position of elements exhibiting magnetic resonance. The system can image in the sagittal, coronal, axial, oblique, and oblique planes, using various pulse sequences, imaging techniques and reconstruction algorithms. The system features a 1.5T superconducting magnet with 60cm bore size. The system is designed to conform to NEMA DICOM standards (Digital Imaging and Communications in Medicine).

AI/ML Overview

The provided text is a 510(k) summary for the GE Healthcare SIGNA Prime magnetic resonance diagnostic device. The summary states that the device did not require clinical studies to support substantial equivalence and instead relied on non-clinical tests and sample clinical images to demonstrate acceptable diagnostic image performance.

Therefore, the study details requested cannot be fully provided as a formal comparative effectiveness study or standalone performance study as typically understood for AI/CADe devices was not conducted with predefined acceptance criteria for diagnostic metrics.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance:

No specific numerical acceptance criteria for diagnostic performance (e.g., sensitivity, specificity, AUC) are provided in the document. The general acceptance criterion was that the image quality of the SIGNA Prime is "substantially equivalent" to that of the predicate device (SIGNA Creator, K143251).

Acceptance Criteria (Implicit)	Reported Device Performance
Image quality substantially equivalent to predicate device.	Sample clinical images demonstrate acceptable diagnostic image performance and substantial equivalence to the predicate device.
Compliance with voluntary standards (e.g., IEC, NEMA, ISO).	The device complies with listed voluntary standards.
Passed risk management testing.	Risk management testing was successfully conducted.

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

Sample Size: The document mentions "Sample clinical images have been included in this submission" but does not specify the number of images or cases used as a "test set."
Data Provenance: Not specified. It's unclear if these were retrospective or prospective, or the country of origin.

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

The document states that "These images and/or spectra when interpreted by a trained physician yield information that may assist in diagnosis." However, it does not specify the number or qualifications of experts who interpreted the "sample clinical images" for the purpose of demonstrating substantial equivalence. The mechanism for establishing ground truth for these sample images is not detailed.

4. Adjudication method for the test set:

Not specified. Given that a formal clinical study with a detailed ground truth process is not described, an adjudication method for a test set is not mentioned.

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:

No. The document explicitly states: "The subject of this premarket submission, the SIGNA™ Prime, did not require clinical studies to support substantial equivalence." Therefore, an MRMC comparative effectiveness study involving human readers with and without AI assistance was not performed or reported.

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

The SIGNA Prime is a magnetic resonance scanner, not an AI algorithm or CADe device. Therefore, the concept of "standalone (algorithm only without human-in-the-loop performance)" is not applicable in this context. The device itself produces images for human interpretation.

7. The type of ground truth used:

For the "sample clinical images" used to demonstrate acceptable diagnostic image performance, the ground truth is implicitly expert interpretation by a "trained physician" as stated in the Indications for Use. However, the exact methodology for establishing this ground truth for the purpose of the submission is not detailed (e.g., expert consensus vs. pathology vs. outcomes data).

8. The sample size for the training set:

Not applicable. The SIGNA Prime is a hardware device (MRI scanner) with associated software, not an AI/ML algorithm that is "trained" on a dataset in the typical sense. While the software platform and reconstruction algorithms were likely developed and refined, the document does not describe a "training set" in the context of an AI algorithm evaluation.

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

Not applicable. (See point 8).

Summary of the Study:

The K211980 submission for the SIGNA Prime focused on demonstrating substantial equivalence to a predicate device (SIGNA Creator, K143251). This was primarily achieved through:

Non-clinical tests: Compliance with various electrical, safety, software, and biocompatibility standards (e.g., ANSI/AAMI ES60601-1, IEC 60601-1-2, IEC 60601-2-33, IEC 62304, IEC 60601-1-6, IEC 62366-1, ISO 10993-1, NEMA MS, NEMA PS3 DICOM).
Risk management activities: Including risk analysis, design reviews, and various levels of testing (unit, integration, performance, simulated use).
Sample clinical images: These images were provided to demonstrate acceptable diagnostic performance and visual equivalence to the predicate device. However, the specific methodology for selecting, evaluating, or establishing ground truth for these sample images is not detailed, nor are any quantitative metrics provided for their performance.

The submission explicitly states that clinical studies were not required to support substantial equivalence. Therefore, the detailed information typically sought for the evaluation of AI/CADe devices (such as sample sizes for test/training, expert qualifications, adjudication methods, or MRMC study results) is not present in this document.

Summary

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U.S. FOOD & DRUG
ADMINISTRATION

GE Healthcare (Tianjin) Company Limited % Glen Sabin Regulatory Affairs Director GE Healthcare (GE Medical Systems, LLC) 3200 N Grandview Blvd. WAUKESHA WI 53188

Re: K211980

Trade/Device Name: SIGNA Prime Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: Class II Product Code: LNH Dated: December 14, 2021 Received: December 15, 2021

Dear Glen Sabin:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 of medical device-related adverse events) (21 CFR 803) for

January 16, 2022

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devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

For

CAPT Patrick Hintz, MSIH, CIH, USPHS Associate Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known)

K211980

Device Name SIGNA Prime

Indications for Use (Describe)

Depending on the region of interest being imaged, contrast agents may be used. The images produced by SIGNA Prime reflect the spatial distribution or molecular environment of nuclei exhibiting magnetic resonance.

These images and/or spectra when interpreted by a trained physician yield information that may assist in diagnosis.

X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

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Image /page/3/Picture/1 description: The image shows the logo for General Electric (GE). The logo consists of the letters "GE" written in a stylized, cursive font, enclosed within a blue circle. There are also small, white, flame-like shapes surrounding the circle, giving the impression of energy or innovation.

510(k) Summary

K211980

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

Date:	January 10, 2022
Submitter:	GE Healthcare (Tianjin) Company LimitedNo. 266 Jingsan Road, Tianjin Airport Economic AreaTianjin, P.R. China 300308
Distributor	GE Medical Systems, LLC3200 N Grandview BLVD. Waukesha, WI USA 53188
Primary Contact Person:	Glen SabinDirector, Regulatory AffairsGE HealthcarePhone: 262- 5216848E-mail: glen.sabin@ge.com
Secondary Contact Person:	Huande LiRegulatory Affairs ManagerGE HealthcarePhone: 86-010-57083027E-mail: huande.li@ge.com
Device Trade Name:	SIGNA™ Prime
Common/Usual Name:	Magnetic Resonance Diagnostic Device
Classification Names:	Magnetic Resonance Diagnostic Device per 21 CFR892.1000
Product Code:	LNH
Predicate Device(s):	SIGNA™ Creator (K143251)
Reference Device:	SIGNA™ Premier (K193282)
DeviceDescription:	SIGNA™ Prime is a whole body magnetic resonance scannerdesigned to support high resolution, high signal to-noise ratio, andshort scan times. The systems use a combination of time-varyingmagnet fields (Gradients) and RF transmissions to obtaininformation regarding the density and position of elementsexhibiting magnetic resonance. The system can image in thesagittal, coronal, axial, oblique, and oblique planes, using variouspulse sequences, imaging techniques and reconstructionalgorithms. The system features a 1.5T superconducting magnetwith 60cm bore size. The system is designed to conform to NEMADICOM standards (Digital Imaging and Communications inMedicine).
Indications forUse	The SIGNA Prime is a whole body magnetic resonance scannerdesigned to support high resolution, high signal-to-noise ratio, andshort scan times. It is indicated for use as a diagnostic imagingdevice to produce axial, sagittal, coronal, and oblique images,spectroscopic images, parametric maps, and/or spectra, dynamicimages of the structures and/or functions of the entire body,including, but not limited to, head, neck, TMJ, spine, breast, heart,abdomen, pelvis, joints, prostate, blood vessels, andmusculoskeletal regions of the body.Depending on the region of interest being imaged, contrast agentsmay be used. The images produced by SIGNA Primereflect the spatial distribution or molecular environment of nucleiexhibiting magnetic resonance.These images and/or spectra when interpreted by a trainedphysician yield information that may assist in diagnosis.
Technology:	The SIGNA™ Prime employs the same fundamental scientifictechnology as its predicate devices.SIGNA™ Prime builds on the 1.5T IPM magnet, newly designedGradient Driver, new designed RF transmit architecture, new
	designed RF receiving chain and new software platform
	application suite.
Comparison ofIndicationsfor Use	The changes in technology do not impact the indications for use.The indications for use have not changed, other than to reflect theSIGNA™ Prime product name.Therefore, the intended use is the same as the predicate device inaccordance with the FDA's guidance document “The 510(k)Program: Evaluating Substantial Equivalence in PremarketNotifications [510(k)]”, dated 28 July 2014.
Comparison ofTechnologicalCharacteristics	Overall, the SIGNA™ Prime employs the same fundamentalscientific technology as the predicate device.System Design: There are five notable technological differencesbetween the SIGNA™ Prime and the predicate device: the 1.5TIPM magnet, newly designed Gradient Driver, new designed RFtransmit architecture, new designed RF receiving chain andnew software platform application suite.Operating Principles: The SIGNA™ Prime functions using thesame operating principles as the predicate device.Materials: The SIGNA™ Prime and the predicate device both useflame retardant materials.Safety and Performance Testing: Both the SIGNA™ Prime andthe predicate device comply with the same safety and performancetesting (see Determination of Substantial Equivalence, below).These technological differences do not raise any differentquestions regarding safety and effectiveness. Both devices mustaddress questions of whether they provide an adequate level ofimage quality appropriate for diagnostic use. The performancedata described in this submission include results of both benchtesting and clinical testing that show the image qualityperformance of SIGNA™ Prime compared to the predicate device.
Determination ofSubstantialEquivalence:	Summary of Non-Clinical Tests:
	The SIGNA™ Prime and the predicate device were subject tosimilar risk management testing to demonstrate substantialequivalence of safety and performance.
	Testing to the following voluntary standards included:
	ANSI/AAMI ES60601-1 IEC 60601-1-2 IEC 60601-2-33 IEC 62304 IEC 60601-1-6 IEC 62366-1 ISO 10993-1
	In addition, the SIGNA™ Prime complies with applicable NEMAMS standards for MRI and NEMA PS3 standard for DICOM, asdoes the predicate device.
	Both the SIGNA™ Prime and the predicate device have asuccessful biocompatibility track record, as demonstrated by ISO10993 testing and by their history of use in previously cleareddevices.
	The following quality assurance measures were applied to thedevelopment of the subject device, as they were for the predicatedevice:
	Risk Analysis Requirements Reviews Design Reviews Testing on unit level (Module verification) Integration testing (System verification) Performance testing (Verification) Simulated use testing (Validation)
	Summary of Clinical Tests:
	The subject of this premarket submission, the SIGNA™ Prime, didnot require clinical studies to support substantial equivalence.Sample clinical images have been included in this submission.

	The sample clinical images demonstrate acceptable diagnosticimage performance of the SIGNAT™ Prime in accordance with theFDA Guidance "Submission of Premarket Notifications forMagnetic Resonance Diagnostic Devices" issued on November 18,2016. The image quality of the SIGNA™ Prime is substantiallyequivalent to that of the predicate device.Substantial Equivalence Conclusion:The indications for use of the proposed device are comparable tothe claimed predicate device. The SIGNAT™ Prime employsequivalent technology to the claimed predicate device.Additionally, the results from the above non-clinical testsdemonstrate that the device performs as intended. Therefore, theSIGNA™ Prime is substantially equivalent to the predicate deviceto which it has been compared.
Conclusion:	In conclusion, GE Healthcare considers the SIGNAT™Prime to be as safe, as effective, with performance thatis substantially equivalent to the predicate device.

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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.