The SIGNA Architect system 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, TMJ, spine, breat, abdomen, pelvis, joints, prostate, blood vessels, and musculoskelatal regions of the region of interest being imaged, contrast agents may be used.

The images produced by the SIGNA Architect system reflect the spatial distribution or molecular environment of nuclei exhibiting magnetic resonance. These images and/or spectra when interpreted by a trained physician vield information that may assist in diagnosis.

Device Description

SIGNA Architect is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and short scan times. The system features a superconducting magnet. The data acquisition system accommodates up to 128 independent receive channels in various increments and multiple independent coil elements per channel during a single acquisition series. Each system uses a combination of time varying magnetic fields (gradients) and RF transmissions to obtain information regarding the density and position of elements exhibiting magnetic resonance. Each system can imaqe in the saqittal, coronal, axial, oblique, and double oblique planes, using various pulse sequences and reconstruction algorithms.

This submission is prompted by the introduction of two new software features called HyperSense 2.0 and Star onto SIGNA Architect. HyperSense 2.0 is an acceleration technique based on sparse data compressibility allowing scan time reduction while maintaining SNR efficiency. Star is a motion-robust, free-breathing imaging technique. HyperSense 2.0 is a modification to the previously cleared HyperSense, while Star is a technique that can be used with the previously cleared DISCO feature. Both HyperSense and DISCO are listed above as reference devices along with their associated 510(k) submission numbers.

The addition of both the HyperSense 2.0 and Star features involved modifications to the SIGNA Architect system software. There were no changes from either of these features that were related to the system's hardware components.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a medical device, the SIGNA Architect, a Magnetic Resonance (MR) system with new software features (HyperSense 2.0 and Star). Here's a breakdown of the acceptance criteria and study proving the device meets them, based on the information provided:

Disclaimer: The provided document is a 510(k) summary, which is a high-level overview. It does not contain detailed information about the specific acceptance criteria, statistical methodologies, or all aspects of the studies that would be present in the full submission. Therefore, some sections below will indicate "Not explicitly stated in the provided document."

Acceptance Criteria and Device Performance

The core acceptance criterion for a 510(k) submission is Substantial Equivalence (SE) to a legally marketed predicate device. This means the new device is as safe and effective as the predicate, and does not raise new questions of safety and effectiveness.

The document indicates that studies were performed to demonstrate that the new features (HyperSense 2.0 and Star) do not negatively impact image quality or diagnostic utility compared to the predicate/existing techniques.

Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria (Inferred from 510(k) Context)	Reported Device Performance (Summary from Document)
HyperSense 2.0: Maintain or improve image quality (e.g., overall image quality, uniformity, SNR efficiency) while allowing scan time reduction.	"Overall image quality and uniformity was acceptable."
Star: Produce images of sufficient quality for diagnostic use, particularly for motion robustness and free-breathing imaging.	"Images produced by Star were judged to be of sufficient quality for diagnostic use by a U.S. Board Certified radiologist."
No new hazards, adverse effects, or safety/performance concerns compared to predicate MR imaging.	"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."
Device is safe and effective for its intended use.	"Clinical testing confirms that both HyperSense 2.0 and Star can be used safely and effectively in a clinical setting.""GE Healthcare believes that the proposed SIGNA Architect with HyperSense 2.0 and Star is substantially equivalent to the predicate device, and is safe and effective for its intended use."

Study Details

The document mentions two main types of studies: non-clinical and clinical. The clinical evaluation focuses on the new features: HyperSense 2.0 and Star.

1. Sample Size Used for the Test Set and Data Provenance:

HyperSense 2.0: "The images involved were generated using 3 different reconstruction techniques across different anatomies."
- Sample Size: Not explicitly stated (e.g., number of patients/cases, number of images).
- Data Provenance: Not explicitly stated (e.g., country of origin, retrospective or prospective).
Star: "Images from the assessment are provided."
- Sample Size: Not explicitly stated (e.g., number of patients/cases, number of images).
- Data Provenance: Not explicitly stated (e.g., country of origin, retrospective or prospective).

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

HyperSense 2.0: "Radiologists were asked to evaluate side-by-side image quality of the HyperSense 2.0 images compared to the predicate."
- Number of Experts: "Radiologists" (plural), but specific number not stated.
- Qualifications: Not explicitly stated (e.g., years of experience, subspecialty).
Star: "Images produced by Star were judged to be of sufficient quality for diagnostic use by a a U.S. Board Certified radiologist."
- Number of Experts: "a U.S. Board Certified radiologist" (singular).
- Qualifications: "U.S. Board Certified radiologist." (Years of experience or subspecialty not stated).

3. Adjudication Method (for the test set):

HyperSense 2.0: "Radiologists were asked to evaluate side-by-side image quality of the HyperSense 2.0 images compared to the predicate." This suggests individual evaluation rather than a formal adjudication process between multiple readers.
- Method: Not explicitly stated beyond individual reader evaluation of side-by-side images. No mention of 2+1, 3+1, or consensus.
Star: "Images produced by Star were judged to be of sufficient quality for diagnostic use by a U.S. Board Certified radiologist."
- Method: Single reader evaluation. No adjudication described.

4. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

HyperSense 2.0: The description "An external reader evaluation study was performed" and "Radiologists were asked to evaluate side-by-side image quality" suggests a multi-reader study, but it's not explicitly labeled as a formal MRMC study. The details provided are insufficient to confirm the rigor of a full MRMC design (e.g., statistical analysis of reader performance differences).
- Effect Size of Human Readers Improve with AI vs. without AI assistance: This specific metric is not applicable here as the described studies focus on image quality assessment of a new image acquisition/reconstruction technique, not directly on AI assisting human readers in a diagnostic task for a specific condition. The "AI" implied (HyperSense 2.0 and Star) are image processing algorithms, not diagnostic AI systems assisting in interpretations.

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

The non-clinical testing for both features would implicitly include standalone performance evaluation of the algorithms (e.g., technical measures of SNR, resolution, artifact reduction), but the document does not elaborate on these specific "standalone" metrics or a formal standalone study results. The clinical evaluations do involve human assessment of the images produced by the algorithms.

6. The Type of Ground Truth Used:

The "ground truth" for these studies appears to be expert consensus/opinion on image quality and diagnostic sufficiency.
- For HyperSense 2.0, the radiologists' evaluation of "overall image quality and uniformity" served as the basis for acceptance.
- For Star, the "U.S. Board Certified radiologist's" judgment of "sufficient quality for diagnostic use" served as the basis for acceptance.
- There is no mention of pathology, long-term outcomes data, or other objective ground truths beyond expert interpretation of the images themselves.

7. The Sample Size for the Training Set:

This information is Not explicitly stated in the provided document. The document details the testing of the software features, but not the development or training set size (if algorithms involved machine learning).

8. How the Ground Truth for the Training Set was Established:

This information is Not explicitly stated in the provided document. As the training set size isn't mentioned, neither is its ground truth establishment.

Summary

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November 13, 2020

GE Healthcare (GE Medical Systems, LLC) % Mr. Joseph Beach Regulatory Affairs Leader, MR 3200 N Grandview Blvd. WAUKESHA WI 53188

Re: K202966

Trade/Device Name: SIGNA Architect Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: Class II Product Code: LNH, LNI, MOS Dated: September 28, 2020 Received: September 30, 2020

Dear Mr. Beach:

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

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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 (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,

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) K202966

Device Name

SIGNA Architect

Indications for Use (Describe)

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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Section 005

510(k) Summary

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GE Healthcare

510(k) Premarket Notification Submission SIGNA Architect

510(k) Summary

K202966

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

Date:	September 29, 2020
Submitter:	GE Medical Systems, LLC3200 N. Grandview Blvd.Waukesha, WI 53188
Primary Contacts:	Joseph BeachRegulatory Affairs LeaderPhone: 262 200-1270Email: joseph.beach@ge.com
	Sandra WestphalRegulatory Affairs LeaderPhone: 262 720-8872Email: sandra.westphal@ge.com
Secondary Contact:	Andrew MendenSenior Regulatory Affairs ManagerPhone: 262 308-5719Email: andrew.menden@ge.com
Device Trade Name:	SIGNA Architect
Common / Usual Name:	MR System
Classification Name:	Magnetic Resonance Diagnostic Device21 CFR 892.1000
Primary Product Code:	LNHLNI, MOS
Predicate Device:	K163331SIGNA ArchitectGE Medical Systems, LLC
Reference Devices:	K162722HyperSenseGE Medical Systems, LLC

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Device Description:

Indications for Use:

The Indications for Use statement for the proposed device is identical to that of the predicate device:

The SIGNA Architect system 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 reqions of the body. Depending on the region of interest being imaged, contrast agents may be used.

The addition of HyperSense 2.0 and Star does not impact the intended use of the SIGNA Architect system.

Comparison of Technological Characteristics:

Many of the technological characteristics of the proposed SIGNA Architect system are unchanged from the predicate device. There are no changes to the maqnet, gradient, and RF subsystems compared to the predicate K163331. Key performance specifications (such as magnet homogeneity and stability, maximum gradient strength, and slew rate, etc.) for the system are also unchanged.

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GE Healthcare 510(k) Premarket Notification Submission SIGNA Architect

The software used on the proposed SIGNA Architect system has been modified to include the HyperSense 2.0 and Star features. The user interface provides operators of the system with new options for selecting these features and adjusting any parameters associated with them. However, the proposed SIGNA Architect system with HyperSense 2.0 and Star employs the same fundamental technology as the predicate device.

Summary of Nonclinical Testing:

The following quality assurance measures were applied to the development of the device:

Risk Analysis .
Requirements Reviews .
. Design Reviews
. Testing on a Unit Level (Module Verification)
Integration Testing (System Verification) .
Performance Testing (Verification) .
. Safety Testing (Verification)
. Simulated Use Testing (Validation)

Exploratory testing was also performed to ensure that the proposed SIGNA Architect is at least as safe and effective as the predicate device. Verification documents, validation documents, and test reports have been provided for more details. No new questions of safety and effectiveness were raised during nonclinical testing.

Summary of Clinical Testing:

Studies were performed for both proposed HyperSense 2.0 and Star features.

An external reader evaluation study was performed for HyperSense 2.0. The images involved were generated using 3 different reconstruction techniques across different anatomies. Radiologists were asked to evaluate side-by-side image quality of the HyperSense 2.0 images compared to the predicate. Overall image quality and uniformity was acceptable.

External clinical testing was performed for the Star feature. Images produced by Star were judged to be of sufficient quality for diagnostic use by a U.S. Board Certified radiologist. Images from the assessment are provided.

Clinical testing confirms that both HyperSense 2.0 and Star can be used safely and effectively in a clinical setting.

Conclusions Drawn from Performance Testing:

Nonclinical and clinical testing demonstrates that the proposed SIGNA Architect with HyperSense 2.0 and Star is at least as safe and effective as the predicate device and does not raise different questions of safety and effectiveness.

The proposed SIGNA Architect system was developed under GE Healthcare's quality system. 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.

Therefore, GE Healthcare believes that the proposed SIGNA Architect with HyperSense 2.0 and Star is substantially equivalent to the predicate device, and is safe and effective for its intended use.

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.