The SIGNA 7.0T System is a whole-body magnetic resonance scanner designed to support high signal-tonoise 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 head and extremities.

The images produced by the SIGNA 7.0T System 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.

The device is intended for patients > 20 kg / 44 lbs.

Device Description

SIGNA 7.0T is a high performance magnetic resonance imaging system designed to support high resolution imaging at 7.0T in particular anatomical regions determined by the available RF coils. The system includes a 7.0T superconducting magnet and an ultra-high performance gradient coil with a 60 cm patient bore, supporting scanning in axial, coronal, sagittal, oblique, and double oblique planes using a variety of pulse sequences, imaging techniques, acceleration methods, and reconstruction algorithms.

AI/ML Overview

Here's an analysis of the acceptance criteria and the study conducted for the GE SIGNA 7.0T Magnetic Resonance Diagnostic Device, based on the provided text:

Important Note: The provided text is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed clinical study for novel claims or specific performance metrics against pre-defined acceptance criteria for a new AI-powered diagnostic. Therefore, some of the requested information (like specific quantitative acceptance criteria for image quality, expert qualifications beyond "radiologist," or a detailed MRMC study effect size) is not explicitly present in the given document. The analysis below extracts what is available and makes inferences where appropriate based on the nature of a 510(k) submission for an imaging device.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Implied)	Reported Device Performance
Image Diagnostic Quality	Equivalent to predicate 3.0T system for head and extremities. Assessed for diagnostic quality, usability, personal preferences, and general commentary.
PNS (Peripheral Nerve Stimulation) Limits	Established for the SIGNA 7.0T system.
Safety and Effectiveness	At least as safe and effective as the legally marketed predicate device. No new hazards, adverse effects, or safety/performance concerns identified that are significantly different from general MR imaging.
Compliance with Standards	Complies with ANSI/AAMI ES60601-1, AAMI/ANSI/IEC 60601-1-2, IEC 60601-2-33, AAMI/ANSI/IEC 62304, AAMI/ANSI/ISO 10993-1, applicable NEMA MS standards for MRI, and NEMA PS3 standards for DICOM.

Explanation of Implied Acceptance Criteria: The document describes the study's purpose as evaluating image diagnostic quality and usability against the predicate device. For a 510(k), the acceptance criterion for image quality is generally that the new device's images are diagnostically equivalent or non-inferior to the predicate device's images for the stated indications for use. "Acceptance" here means that the FDA agreed that the device met the requirements for substantial equivalence.

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

Sample Size for Image Quality Study (Test Set):
- Subjects: Not explicitly stated, but images were acquired from "normal subjects and subjects with self-reported common neuropathology" for brain scans, and individuals over a "broad age range representative of a range of knee health" for knee images. The specific number of subjects/cases is not provided.
- Image Series: Included brain MR scans and knee images.
Sample Size for PNS Limits Study: Not explicitly stated, but involved "adult human volunteers without reported pathology."
Data Provenance: Not explicitly stated, but given it's a US submission and refers to "U.S. board-certified radiologists," it is highly probable the data was collected in the United States. The study was prospective in the sense that the images were acquired specifically for this evaluation using both the proposed and predicate devices.

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

Number of Experts: 4
Qualifications: "U.S. board-certified radiologists." No specific years of experience are provided, but board certification implies a certain level of expertise.

4. Adjudication Method for the Test Set

The document states, "The study involved 4 U.S. board-certified radiologists evaluating proposed device's image diagnostic quality and usability, personal preferences, and general commentary using radiology terms against same subject images scanned on the predicate device."

This description suggests that the radiologists independently evaluated images from both devices. It does not explicitly describe a formal adjudication method (like 2+1 or 3+1 consensus). It's more likely that their individual assessments were collected and analyzed, potentially looking for consistency or a majority opinion on diagnostic quality comparison. Without further detail, we cannot definitively state a formal adjudication method was used, beyond individual evaluations.

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

MRMC Study: Yes, a reader evaluation study was performed. It involved multiple readers (4 radiologists) evaluating multiple cases (brain and knee images).
Effect Size (AI Assistance): This device is an MR scanner, not an AI diagnostic algorithm. Therefore, the study did not involve human readers improving with AI assistance. The comparison was between the image quality from the new 7.0T MR scanner versus the predicate 3.0T MR scanner.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

No, this question is not applicable. The SIGNA 7.0T is an imaging device, not an AI algorithm. No standalone algorithm performance was evaluated.

7. The Type of Ground Truth Used

For the image quality evaluation, the "ground truth" was established by expert consensus/opinion (or individual expert assessments, given the lack of explicit adjudication) regarding the diagnostic quality and usability of the images. They compared images from the proposed 7.0T system against the predicate 3.0T system. There is no mention of pathology, clinical outcomes, or other objective ground truth for the diagnostic findings themselves, but rather whether the images produced were suitable for diagnosis.

For the PNS limits, the ground truth was direct determination in human volunteers.

8. The Sample Size for the Training Set

This device is an MR scanner, not an AI algorithm that requires a "training set" in the machine learning sense. Therefore, this question is not applicable. The device's "training" would refer to its engineering development and calibration, which is a different concept.

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

This question is not applicable, as there is no "training set" in the context of an AI algorithm.

Summary

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October 15, 2020

Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

GE Medical Systems, LLC % Mr. Brian R. Zielski Regulatory Affairs Leader 3200 N. Grandview Blvd. WAUKESHA WI 53188

Re: K201615

Trade/Device Name: SIGNA 7.0T Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: Class II Product Code: LNH Dated: August 28, 2020 Received: August 31, 2020

Dear Mr. Zielski:

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/cfpmp/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 devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see

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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 medical devices and radiation-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

Thalia T. Mills, Ph.D. 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) K201615

Device Name SIGNA 7.0T

Indications for Use (Describe)

The device is intended for patients > 20 kg / 44 lbs.

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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510(k) Summary

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

Date:	June 10, 2020
Submitter:	GE Medical Systems, LLC (GE Healthcare)3200 N. Grandview Blvd.,Waukesha, WI 53188USA
Primary Contact Person:	Brian R. ZielskiRegulatory Affairs LeaderPhone: 262-521-6609Email: Brian.Zielski@GE.com
Secondary Contact Person:	James McMahonSenior Director, Regulatory AffairsPhone: 508-382-2858Email: James.D.McMahon@GE.com
Device Trade Name:	SIGNA 7.0T
Common/Usual Name:	Magnetic Resonance Diagnostic Device
Classification Names:	Magnetic Resonance Diagnostic Device
Regulation Number:	21 CFR 892.1000
Product Code:
Primary:	LNH
Secondary:	LNI, MOS

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Predicate Device(s):	SIGNA Premier (K193282)
Device Description:	SIGNA 7.0T is a high performance magnetic resonanceimaging system designed to support high resolutionimaging at 7.0T in particular anatomical regionsdetermined by the available RF coils. The system includesa 7.0T superconducting magnet and an ultra-highperformance gradient coil with a 60 cm patient bore,supporting scanning in axial, coronal, sagittal, oblique,and double oblique planes using a variety of pulsesequences, imaging techniques, acceleration methods,and reconstruction algorithms.
Indications for Use	The SIGNA 7.0T system is a whole-body magnetic resonancescanner designed to support high resolution, high signal-to-noise ratio, and short scan times. It is indicated for use as adiagnostic imaging device to produce axial, sagittal, coronal,and oblique images, spectroscopic images, parametric maps,and/or spectra, dynamic images of the structures and/orfunctions of the head and extremities.
	The images produced by the SIGNA 7.0T system reflects thespatial distribution or molecular environment of nucleiexhibiting magnetic resonance. These images and/or spectrawhen interpreted by a trained physician yield information thatmay assist in diagnosis.
	The device is intended for patients > 20 kg / 44 lb.
Comparison of Indications forUse	The changes in technology do not impact the indicationsfor use. The indications for use have not changed, otherthan to reflect the SIGNA 7.0T product name andsimplified anatomy of head and extremities, and patientweight limit.
	Therefore, the intended use is the same as the predicatedevice in accordance with FDA's guidance document “The510(k) Program: Evaluating Substantial Equivalence inPremarket Notifications [510(k)]”, dated 28 July 2014.
Technology:	The SIGNA 7.0T employs the same fundamental scientifictechnology as the predicate device.System Design:The most notable technological difference between theSIGNA 7.0T and the predicate device is the 7.0T B0magnetic field compared to 3.0T. The SIGNA 7.0T designenables the capabilities that this higher B0 magnetic fieldcontributes to MR imaging through the following keydifferences:
	RF Transmit chain: The SIGNA 7.0T employsmultiple and independent channels for RFtransmission, and dedicated receiver array coilsand detectors for high sensitivity signal reception. Gradient system: The SIGNA 7.0T can deliver amaximum gradient amplitude of 113 mT/m andmaximum gradient slew rate of 260 T/m/scompared to the predicate's maximum gradientamplitude of 80 mT/m and maximum gradientslew rate of 200 T/m/s. Applications: The SIGNA 7.0T uses the SIGNAWorks suite of applications, optimized for theadvanced hardware and for the higher fieldstrength to generate high resolution functional,structural, anatomical, vascular, andspectroscopic images.
Operating Principles:	The SIGNA 7.0T functions using thesame operating principles as the predicate device.
Materials:	The SIGNA 7.0T and the predicate device bothuse flame retardant materials.
Safety and Performance Testing:	Both the SIGNA 7.0Tand the predicate device comply with the same safetyand performance testing (see Determination ofSubstantial Equivalence, below).
	These technological differences do not raise any differentquestions regarding safety and effectiveness. Bothdevices must address questions of whether they providean adequate level of image quality appropriate fordiagnostic use. The performance data described in thissubmission include results of both bench testing andclinical testing that show the image quality performanceof SIGNA 7.0T compared to the predicate device.
Determination of SubstantialEquivalence:	Summary of Non-Clinical Tests:The SIGNA 7.0T and the predicate device were subject tosimilar risk management testing to demonstrate substantialequivalence of safety and performance. Testing to thefollowing voluntary standards includes:ANSI/AAMI ES60601-1 AAMI/ANSI/IEC 60601-1-2 IEC 60601-2-33 AAMI/ANSI/IEC 62304 AAMI/ANSI/ISO 10993-1
	In addition, the SIGNA 7.0T complies with applicable NEMA MSstandards for MRI and NEMA PS3 standards for DICOM, asdoes the predicate device.The following quality assurance measures were applied to thedevelopment of the subject device, as they were for thepredicate device: 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:	To evaluate the image quality performance of the SIGNA 7.0T system, assessments were performed by GE MR internal Clinical Applications Specialists and external Radiologist as part of a Reader Evaluation Study.The reader study was performed on images acquired on the proposed 7.0T system and predicate 3.0T system. Image series ranged from brain MR scans performed on normal subjects and subjects with self-reported common neuropathology, as well as knee images over a broad age range representative of a range of knee health.The study involved 4 U.S. board-certified radiologists evaluating proposed device's image diagnostic quality and usability, personal preferences, and general commentary using radiology terms against same subject images scanned on the predicate device.To set the PNS limits for the SIGNA 7.0T system, a direct determination study was conducted with adult human volunteers without reported pathology.
Conclusion:	The proposed SIGNA 7.0T was developed under GE Healthcare's quality system and is at least as safe and effective as the legally marketed predicate device. The performance testing did not identify any new hazards, adverse effects, or safety or performance concerns that are significantly different from those associated with MR imaging in general.In conclusion, GE Healthcare believes that SIGNA 7.0T is substantially equivalent to the predicate device, and is safe and effective for its intended use.

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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.