The SIGNA Victor is a whole body magnetic resonance scanner designed to support 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, breast, 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 Victor 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™ Victor is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and short scan time. The system uses 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 double 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

This document does not contain the information required to populate the requested table and answer the study-related questions. The provided text is a 510(k) summary for a Magnetic Resonance Diagnostic Device (SIGNA™ Victor).

Here's why and what information is available:

What the document does include:

Device Name: SIGNA™ Victor
Regulatory Status: 510(k) clearance, indicating substantial equivalence to predicate devices.
Indications for Use: Broad diagnostic imaging of the entire body.
Technology: 1.5T superconducting magnet, RF transmit/receive architecture, software application suite. Stated to employ the same fundamental scientific technology as predicate devices.
Comparison to Predicates: Emphasizes that indications for use, technology, operating principles, and materials are similar to predicate devices (SIGNA™ Explorer (K143251), SIGNA™ Prime (K211980), SIGNA Voyager (K161567), SIGNA Artist Evo (K213603)).
Non-Clinical Testing: Mentions compliance with various international standards (e.g., ANSI AAMI ES60601-1, IEC 60601-1-2, IEC 60601-2-33, IEC 62304, ISO 10993-1) and internal quality assurance measures (Risk Analysis, Requirements Reviews, Design Reviews, unit/integration/performance/simulated use testing). These tests demonstrate safety and performance but are usually technical safety and functional tests, not clinical performance metrics.
Clinical Testing (or lack thereof): Crucially, the document states: "The subject of this premarket submission, the SIGNA™ Victor, did not require clinical studies to support substantial equivalence. Sample clinical images have been included in this submission. The sample clinical images demonstrate acceptable diagnostic image performance of the SIGNA™ Victor..."

Why the requested information is largely absent:

Because the device was cleared via the 510(k) pathway and "did not require clinical studies to support substantial equivalence," the detailed clinical performance data, acceptance criteria, sample sizes for test/training sets, ground truth establishment, expert qualifications, and MRMC study details that you're asking for are typically not part of such a submission.

The FDA's 510(k) pathway primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving de novo safety and effectiveness through extensive clinical trials. The statement "The image quality of the SIGNA™ Victor is substantially equivalent to that of the predicate devices" is the core "acceptance criteria" and "proof" in this context, inferred from the non-clinical tests and sample images.

Therefore, I cannot generate the table or provide specific answers to most of the study-related questions based on the provided text. The document explicitly states no clinical studies were required, which means there was no formal "study" in the sense of a clinical trial to generate the kind of data you're requesting regarding accuracy, sensitivity, specificity, or specific performance metrics with defined acceptance criteria and comparator data.

Based on the available information, here's what could be inferred, though it doesn't directly meet all your criteria:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria (Implied for 510(k))	Reported Device Performance (Implied from the document)
Safety: Compliance with relevant electrical safety, EMC, software lifecycle, usability, and biocompatibility standards.	Safety: Complies with ANSI AAMI ES60601-1, IEC 60601-1-2, IEC 60601-2-33, IEC 62304, IEC 60601-1-6, IEC 62366-1, ISO 10993-1. Successful biocompatibility track record.
Performance (Technical): Functional operation of MRI system components (magnet, RF, software).	Performance (Technical): Passed risk analysis, requirements reviews, design reviews, unit/integration/performance testing, and simulated use testing. Complies with NEMA MS standards for MRI and NEMA PS3 standard for DICOM.
Performance (Clinical Equivalence): Image quality suitable for diagnostic use and substantially equivalent to predicate devices.	Performance (Clinical Equivalence): Sample clinical images demonstrate acceptable diagnostic image performance. Image quality is substantially equivalent to predicate devices.
Intended Use: Consistent with predicate devices.	Intended Use: Indications for use are comparable to predicate devices, reflecting only the product name change.

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

The document states "did not require clinical studies" and only "sample clinical images have been included." It does not specify a sample size for a formal test set or its provenance (country of origin, retrospective/prospective). This implies a very limited, possibly anecdotal, set of images used for visual comparison rather than a statistically powered study.

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

Not specified. Given the lack of a formal clinical study, the process for establishing ground truth (if any beyond visual review) for the "sample clinical images" is not detailed. The document mentions images are "interpreted by a trained physician," which is a general statement for MRI use, not specific to this submission.

4. Adjudication method for the test set

Not specified, as a formal test set and adjudication process are not described.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done

No, an MRMC study was not done. The document explicitly states "did not require clinical studies." Therefore, there is no effect size of human readers improving with AI vs. without AI assistance to report, as this is neither an AI device nor was such a study conducted.

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

This device is an MRI machine, not an AI algorithm. Therefore, "standalone" algorithm performance is not applicable in the way it usually refers to AI/CADe devices. The MRI system itself has a "standalone" performance, which is assessed through technical and functional tests and comparison to its predicate devices.

7. The type of ground truth used

For the "sample clinical images" (if any "ground truth" was formally established for them, which is unlikely given the context), it would implicitly be expert visual interpretation as determined by a trained physician for diagnostic purposes. It's not pathology or outcomes data from a formal study.

8. The sample size for the training set

The device is an MRI scanner, not an AI algorithm trained on image data in the typical sense. Therefore, there is no "training set" of patient images as would be for a machine learning model. The system's "training" refers to its design, engineering, and testing against specifications and standards.

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

Not applicable as there is no "training set" of patient images for an AI algorithm.

Summary

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February 13, 2023

GE Healthcare (Tianjin) Company Limited % Huande Li Regulatory Affairs Manager No. 266 Jingsan Road, Tianjin Airport Economic Area Tianjin, Tianjin 300308 CHINA

Re: K223439

Trade/Device Name: SIGNA™ Victor Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic Resonance Diagnostic Device Regulatory Class: Class II Product Code: LNH Dated: November 15, 2022 Received: November 17, 2022

Dear Huande Li:

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

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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 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 (OS) 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,

D. K.

Daniel M. Krainak, Ph.D. Assistant Director Magnetic Resonance and Nuclear Medicine Team DHT8C: Division of Radiological Imaging and Radiation Therapy Devices OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Section 4 Indications for Use

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Indications for Use

510(k) Number (if known)

K223439

Device Name SIGNA™ Victor

Indications for Use (Describe)

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

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

X Prescription Use (Part 21 CFR 801 Subpart D)

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

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SIGNA Victor 510(k) Premarket Notification

Section 5 510(K) Summary

Section 5 Page 1 of 6

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510(k) Summary

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

Date:	November 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 ContactPerson:	Huande LiRegulatory Affairs ManagerGE HealthcarePhone: 86-18101131237E-mail: huande.li@ge.com
SecondaryContact Person:	Glen SabinDirector, Regulatory AffairsGE HealthcarePhone: 262- 5216848E-mail: glen.sabin@ge.com
Device TradeName:	SIGNA™ Victor
Common/UsualName:	Magnetic Resonance Diagnostic Device
ClassificationNames:	Magnetic Resonance Diagnostic Device per 21 CFR892.1000
Product Code:	LNH
PredicateDevice(s):	SIGNA™ Explorer (K143251)SIGNA™ Prime (K211980)
ReferenceDevice(s):	SIGNA Voyager (K161567)SIGNA Artist Evo (K213603)
DeviceDescription:	SIGNA™ Victor is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and short scan time. The system uses 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 double 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).
Indications forUse	The SIGNA Victor 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, TMJ, spine, breast, heart, 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 Victor 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.
Technology:	The SIGNA™ Victor employs the same fundamental scientific technology as its predicate devices.SIGNA™ Victor is built with superconducting magnet, RF transmit architecture, RF receive chain and software application suite.
Comparison ofIndicationsfor Use	The changes in technology do not impact the indications for use.The indications for use have not been changed, other than toreflect the SIGNA™ Victor product name.Therefore, the intended use is the same as the predicate devicesin accordance 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™ Victor employs the same fundamentalscientific technology as the predicate devices.System Design: Both SIGNA™ Victor and the predict devicesincludes the 1.5T magnets, RF transmit architecture, RF receivechain and software application suite.Operating Principles: The SIGNA™ Victor functions using thesame operating principles as the predicate devices.Materials: The SIGNA™ Victor and the predicate devices bothuse flame retardant materials.Safety and Performance Testing: Both the SIGNA™ Victor andthe predicate devices comply with the same safety andperformance testing (see Determination of SubstantialEquivalence, 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™ Victor compared to the predicatedevices.
Determination ofSubstantialEquivalence:	Summary of Non-Clinical Tests:The SIGNA™ Victor and the predicate devices were subject tosimilar risk management testing to demonstrate substantialequivalence of safety and performance.

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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™ Victor complies with applicable NEMA MS standards for MRI and NEMA PS3 standard for DICOM, as does the predicate devices.

Both the SIGNA™ Victor and the predicate devices have a successful biocompatibility track record, as demonstrated by ISO 10993 testing and by their history of use in previously cleared devices.

The following quality assurance measures were applied to the development of the subject device, as they were for the predicate devices:

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™ Victor, did not require clinical studies to support substantial equivalence. Sample clinical images have been included in this submission. The sample clinical images demonstrate acceptable diagnostic image performance of the SIGNA™ Victor in accordance with the FDA Guidance "Submission of Premarket Notifications for Magnetic Resonance Diagnostic Devices" issued on November 18,

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	2016. The image quality of the SIGNAT™ Victor is substantially
	equivalent to that of the predicate devices.
	Substantial Equivalence Conclusion:
	The indications for use of the proposed device are comparable to
	the claimed predicate devices. The SIGNAT™ Victor employs
	equivalent technology to the claimed predicate devices.
	Additionally, the results from the above non-clinical tests
	demonstrate that the device performs as intended. Therefore, the
	SIGNAT™ Victor is substantially equivalent to the predicate devices
	to which it has been compared.
Conclusion:	In conclusion, GE Healthcare considers the SIGNAT™
	Victor to be as safe, as effective, with performance that
	is substantially equivalent to the predicate devices.

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.