SIGNA 7.0T by GE Medical Systems, LLC

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 reflects 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 lb.

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.

This 510(k) submission is for the SIGNA 7.0T MR System, and has been triggered by the addition of the AIR Recon DL software feature and inclusion of installed base magnet system upgrades.

AI/ML Overview

The provided text describes a 510(k) submission for the GE SIGNA 7.0T MRI system, specifically focusing on the addition of the AIR Recon DL software feature. While it discusses performance testing and a reader study, it does not explicitly define specific numerical acceptance criteria for the device's performance in a table format, nor does it provide detailed quantitative results against such criteria. The document states that "The nonclinical testing passed the defined acceptance criteria," but these criteria are not enumerated.

However, based on the provided text, we can infer and report on the study details as much as possible:

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

As stated above, no explicit numerical acceptance criteria table is provided in the document. The text broadly states:

"The nonclinical testing passed the defined acceptance criteria, and did not identify any adverse impacts to image quality or other concerns related to safety and performance."
"The nonclinical testing demonstrated that AIR Recon DL does improve SNR and image sharpness while maintaining low contrast detectability."
"Objective measures of in vivo images were analyzed to confirm that AIR Recon DL improves SNR and image sharpness for typical clinical use cases."
"This study showed that AIR Recon DL feature provides images with better SNR and equivalent or better sharpness."
"The radiologists uniformly preferred the AIR Recon DL images for clinical evaluation."

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

Test Set Sample Size: Not explicitly stated for either the non-clinical or clinical tests. The text mentions "in vivo images" for clinical analysis and "typical clinical use cases," implying a dataset was used, but the size is absent.
Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective).

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

Number of Experts: "Radiologists" (plural), but the exact number is not specified.
Qualifications of Experts: Only stated as "trained physician" for general image interpretation within the Indications for Use, and "Radiologists" for the reader study. No specific experience levels (e.g., years of experience) are provided for the radiologists in the study.

4. Adjudication method for the test set

Adjudication Method: Not explicitly stated. The text says "Radiologists were asked to rate the images, and to comment on any notable aspects related to image quality," and that they "uniformly preferred" the AIR Recon DL images. This implies a consensus or preference-based evaluation rather than a formal adjudicated ground truth establishment process for specific findings.

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

MRMC Study: Yes, a reader study was performed comparing images "with and without AIR Recon DL feature."
Effect Size: No quantitative effect size (e.g., magnitude of improvement in diagnostic accuracy, AUC, or other metrics) is provided for how much human readers improved. The improvement is described qualitatively: "The radiologists uniformly preferred the AIR Recon DL images for clinical evaluation." and that images had "better SNR and equivalent or better sharpness."

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

Standalone Performance: The document describes "nonclinical testing" and "objective measures of in vivo images" where AIR Recon DL's impact on SNR and sharpness was evaluated. This implies an algorithmic evaluation independent of human readers, where the algorithm processes images and its output is analyzed for objective metrics (SNR, sharpness, low contrast detectability). However, specific performance metrics for this standalone performance (e.g., a specific SNR improvement percentage, or sharpness metric) are not quantified in the text.

7. The type of ground truth used

Clinical Study: For the reader study, the ground truth appears to be based on the radiologists' preference and qualitative assessment of image quality (SNR, sharpness, low contrast detectability) for clinical evaluation. It's not explicitly stated as a definitive "diagnosis" ground truth derived from pathology or outcomes data.
Non-Clinical/Objective Measures: For objective measures, the "ground truth" aligns with quantifiable physical properties like Signal-to-Noise Ratio (SNR) and image sharpness, which are inherent characteristics of the image output itself. Low contrast detectability was also assessed.

8. The sample size for the training set

Training Set Sample Size: Not specified in the provided text. The text mentions that "AIR Recon DL has been previously cleared for use with GE Healthcare's 3T SIGNA Premier system through K193282" and that "Due to the technical similarities, SIGNA Premier (K193282) is used as a reference device for this submission." This implies that the algorithm was likely trained on a separate dataset prior to this specific submission, but details of that training set are not in this document.

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

Training Set Ground Truth Establishment: Not specified in the provided text.

Summary

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May 13, 2021

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

Re: K211118

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, LNI, MOS Dated: April 14, 2021 Received: April 15, 2021

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)

Device Name SIGNA 7.0T

Indications for Use (Describe)

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

Type of Use (Select one or both, as applicable)
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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:	April 13, 2021
Submitter:	GE Medical Systems, LLC (GE Healthcare)3200 N. Grandview Blvd.,Waukesha, WI 53188USA
Primary Contact Person:	Brian R. ZielskiRegulatory Affairs LeaderPhone: 262-227-3596Email: Brian.Zielski@GE.com
Secondary ContactPerson:	Glen SabinSenior Director, Regulatory AffairsPhone: 262-894-4968Email: Glen.Sabin@GE.com
Device Trade Name:	SIGNA 7.0T
Common/Usual Name:	Magnetic Resonance Diagnostic Device
Classification Names:RegulationNumber:	Magnetic Resonance Diagnostic Device21 CFR 892.1000
Product Code:
	Primary:
	Secondary:
Predicate Device(s):	SIGNA 7.0T (K201615)
Device Description:	SIGNA 7.0T is a high performance magnetic resonanceimaging system designed to support high resolution imagingat 7.0T in particular anatomical regions determined by theavailable RF coils. The system includes a 7.0Tsuperconducting magnet and an ultra-high performancegradient coil with a 60 cm patient bore, supporting scanningin axial, coronal, sagittal, oblique, and double oblique planesusing a variety of pulse sequences, imaging techniques,acceleration methods, and reconstruction algorithms.This 510(k) submission is for the SIGNA 7.0T MR System, andhas been triggered by the addition of the AIR Recon DLsoftware feature and inclusion of installed base magnetsystem upgrades.
Indications for Use	The addition of the AIR Recon DL feature and installed basemagnet system upgrades does not impact the intended useof the SIGNA 7.0T system. The Indications for Use remainidentical:
	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 informationthat may assist in diagnosis.
	The device is intended for patients > 20 kg / 44 lb.
Technology:	The SIGNA 7.0T employs the same fundamental scientifictechnology as its predicate device.
	The software used on the proposed SIGNA 7.0T system hasbeen modified to include the AIR Recon DL feature. The userinterface provides operators of the system with new options
	for selecting AIR Recon DL and adjusting the associated levelof image noise reduction. The resulting images can havehigher SNR and improved sharpness compared to imagesreconstructed without AIR Recon DL.AIR Recon DL has been previously cleared for use with GEHealthcare's 3T SIGNA Premier system through K193282.Due to the technical similarities, SIGNA Premier (K193282) isused as a reference device for this submission.Upgrades to SIGNA 7.0T are also being expanded to becompatible with additional 7.0T magnets in the installed
	base.
Determination ofSubstantial Equivalence:	Summary of Non-Clinical Tests:
	The AIR Recon DL feature has undergone performancetesting. These tests were designed to evaluate the AIR ReconDL feature and its impact on image quality, including SNR,sharpness, and low contrast detectability.
	The nonclinical testing demonstrated that AIR Recon DL doesimprove SNR and image sharpness while maintaining lowcontrast detectability. AIR Recon DL was also able tomaintain image SNR and did not sacrifice sharpness forimages acquired with a reduced scan time. The nonclinicaltesting passed the defined acceptance criteria, and did notidentify any adverse impacts to image quality or otherconcerns related to safety and performance.
	Simulations and analyses were performed for the differentinstalled base magnet types to ensure equivalence.
	Summary of Clinical Tests:
	Objective measures of in vivo images were analyzed toconfirm that AIR Recon DL improves SNR and imagesharpness for typical clinical use cases.
	A reader study was performed on images with and withoutAIR Recon DL feature. Radiologists were asked to rate theimages, and to comment on any notable aspects related toimage quality. This study showed that AIR Recon DL featureprovides images with better SNR and equivalent or bettersharpness. The radiologists uniformly preferred the AIRRecon DL images for clinical evaluation.
Conclusion:	The Indications for Use of the SIGNA 7.0T are identical to thepredicate device. The modifications to the SIGNA 7.0Tsystem do not change the fundamental scientific technologyof the device. The results of design controls activitiesdemonstrate that the SIGNA 7.0T is substantially equivalentto the predicate with regards to safety and efficacy.
	GE Healthcare considers the SIGNA 7.0T to be as safe, aseffective, and performance is substantially equivalent to thepredicate device.
	In conclusion, GE Healthcare believes that SIGNA 7.0T withAIR Recon DL and installed base magnet system upgrades issubstantially equivalent to the predicate device, and is safeand 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.