HyperBand is a software option intended for use on GE MR 1.5T and 3T Systems. HyperBand consists of an acquisition and reconstruction technique allowing simultaneous excitation of multiple slices at multiple locations to accelerate imaging acquisition times or increase slice coverage without increasing scan time. HyperBand is indicated for echo-planar imaging (EPI) of the head and breast. HyperBand is indicated for imaging all patients not otherwise contraindicated for MRI examination.

Device Description

HyperBand is a clinical software application which is offered as an optional feature for GE Healthcare's 1.5T and 3T MR systems. It provides a reduction in scan time by simultaneously exciting multiple slices at multiple locations. It can lead to higher acceleration reduction factors when combined to other methods of parallel imaging. The benefits of HyperBand acceleration include enhancements on productivity and patient experience by shortened breath holds, increased anatomy coverage and higher resolution image acquisition.

AI/ML Overview

The provided document is a 510(k) Premarket Notification Submission for a device called "HyperBand" by GE Medical Systems. This device is a software option for GE MR 1.5T and 3T Systems, intended to accelerate imaging acquisition times or increase slice coverage.

The document discusses the substantial equivalence of HyperBand to a predicate device (ASSET, K012970) and presents performance data to support this claim. However, it does not provide a table of acceptance criteria with reported device performance in terms of specific metrics like sensitivity, specificity, or accuracy. It also does not detail a study that defines explicit acceptance criteria with numerical targets.

Based on the information available, here's a breakdown of what can be extracted and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Metric (Implicit)	Acceptance Target (Implicit)	Reported Device Performance
Image Quality	Image Quality Performance	Maintain same imaging performance as predicate	"demonstrated that HyperBand maintain the same imaging performance results as its predicate devices (K012970)."
Safety and Effectiveness	Overall Safety and Effectiveness	As safe and effective as predicate	"demonstrating that HyperBand is as safe and effective as the predicate, and does not raise different questions of safety and effectiveness."
Workflow	Workflow performance	Not explicitly stated	"Internal scans were conducted as part of validation for workflow..."
Signal-to-Noise Ratio (SNR)	SNR (with and without HyperBand)	To support substantial equivalence	"Signal to Noise Ratio (SNR) testing was performed with and without the HyperBand feature, and provided to support substantial equivalence."

Critique: The provided document uses qualitative statements like "maintain the same imaging performance" and "as safe and effective as the predicate" rather than specific, quantitative acceptance criteria with numerical targets (e.g., "SNR must be within X% of predicate," "image quality rated as diagnostic by Y% of radiologists"). This is typical for a 510(k) submission where "substantial equivalence" is the goal, often relying on comparison to an already cleared device.

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

Test Set Sample Size: Not explicitly stated. The document mentions "Internal scans were conducted as part of validation for workflow and image quality for the addition of the new features." It does not specify the number of scans or patients included in this validation.
Data Provenance: "Internal scans were conducted." This implies the data was generated within GE Healthcare, possibly at their facilities or in collaboration with internal sites. It is prospective in the sense that these scans were conducted for the purpose of validating the new features. The country of origin is not specified, but given GE Healthcare's operations, it could be the US or international.

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

Number of Experts: Not specified.
Qualifications of Experts: Not specified. The document mentions "clinical results" and "image quality," implying assessment by medical professionals, but their specific roles, experience, or specialty (e.g., radiologist) are not detailed.

4. Adjudication method for the test set

Adjudication Method: Not specified. Since the number of experts is not stated, it's impossible to determine if a method like 2+1, 3+1, or any other consensus-based adjudication was used.

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: No, an MRMC comparative effectiveness study involving human readers with and without AI assistance was not explicitly mentioned or performed. HyperBand is described as an acquisition and reconstruction technique to accelerate imaging, not an AI-assisted diagnostic tool that helps human readers improve their diagnostic performance. The focus is on maintaining image quality while improving scan efficiency.

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

Standalone Performance: Not directly applicable in the terms of a diagnostic algorithm. HyperBand is a software option that modifies the MR acquisition and reconstruction process. Its "performance" is inherent in the generated images. The non-clinical tests (SNR testing) and clinical validation were effectively "standalone" tests of the system's output (image quality) but not in the context of diagnostic accuracy without human interpretation. The system (MR scanner with HyperBand) produces the images, and the validation checks if those images are diagnostically equivalent.

7. The type of ground truth used

Type of Ground Truth: The document implies that the ground truth for image quality and workflow was established through comparative assessment against images acquired using the predicate device (ASSET). The "clinical results demonstrated that HyperBand maintain the same imaging performance results as its predicate devices." This suggests that image quality was judged to be comparable or equivalent, likely by expert review, to images obtained with an already accepted method. It's not pathology, or independent outcomes data, but rather a performance comparison against an established baseline.

8. The sample size for the training set

Training Set Sample Size: Not applicable/not provided. HyperBand is described as an acquisition and reconstruction technique, not a machine learning algorithm that requires a "training set" in the conventional sense (i.e., for learning diagnostic patterns from annotated data). While software development involves testing and iterative refinement, the concept of a distinct 'training set' for an AI model is not mentioned for this device.

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

Ground Truth for Training Set: Not applicable, as no training set (for AI/ML models) is mentioned.

Summary of Study:

The study referenced in the document is an internal validation conducted by GE Healthcare. Its primary goal was to demonstrate substantial equivalence of HyperBand to its predicate device (ASSET) in terms of image quality and overall safety and effectiveness. This was achieved through:

Non-clinical tests: Including Signal to Noise Ratio (SNR) testing (with and without HyperBand) and compliance with voluntary standards (AAMI/ANSI 62304, AAMI/ANSI ES60601-1, IEC 60601-2-33, NEMA PS3.1-3.18 for DICOM conformance).
Clinical tests (internal scans): These were conducted "as part of validation for workflow and image quality" to show that HyperBand maintains "the same imaging performance results as its predicate devices."

The study did not involve formal, external clinical trials with large patient cohorts or multi-reader studies to establish diagnostic performance against a definitive ground truth like pathology for specific conditions. Instead, it focused on demonstrating that the technical performance and resulting image quality of the accelerated acquisition technique were comparable to existing, cleared technology, thereby not raising new questions of safety or effectiveness.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

November 18, 2016

GE Medical Systems, LLC % Mr. Glen Sabin Regulatory Affairs Leader 3200 North Grandview Blvd. WAUKESHA WI 53188

Re: K162403 Trade/Device Name: HyperBand Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: LNH Dated: August 26, 2016 Received: August 29, 2016

Dear Mr. 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. 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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Robert Oolo

Robert Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K162403

Device Name

HyperBand

Indications for Use (Describe)

HyperBand is a software option intended for use on GE MR 1.5T and 3T Systems. HyperBand consistion and reconstruction technique allowing simultaneous excitation of multiple locations to accelerate imaging acquisition times or increase slice coverage without increasing scan time. HyperBand is indicated for echo-planar imaging (EPI) of the head and breast. HyperBand is indicated for imaging all patients not otherwise contraindicated for MRI examination.

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

Prescription Use (Part 21 CFR 801 Subpart D)	☑
Over-The-Counter Use (21 CFR 801 Subpart C)

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GE Healthcare 510(k) Premarket Notification Submission

Section 5: 510(k) Summary HyperBand

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GE Healthcare 510(k) Premarket Notification Submission

In accordance with 21 CFR 807.92 the following summary of information is provided:
Date:	November 16, 2016
Primary Contact Person:	Glen SabinRequlatory Affairs Director, MRGE Healthcare, (GE Medical Systems, LLC)Phone: 262-521-6848Fax: 414-908-9585
Device Trade Name:	HyperBand
Common/Usual Name:	MR Software Application
Classification Names:	Magnetic Resonance Diagnostic Device(21 CFR 892.1000)
Product Code:	LNH
Predicate Devices:	Predicate Device: ASSET (K012970)
Device Description:	HyperBand is a clinical software application which isoffered as an optional feature for GE Healthcare's 1.5Tand 3T MR systems. It provides a reduction in scantime by simultaneously exciting multiple slices atmultiple locations. It can lead to higher accelerationreduction factors when combined to other methods ofparallel imaging. The benefits of HyperBandacceleration include enhancements on productivity andpatient experience by shortened breath holds,increased anatomy coverage and higher resolutionimage acquisition.
Indications for Use:	HyperBand is a software option intended for use on GEMR 1.5T and 3T Systems. HyperBand consists of anacquisition and reconstruction technique allowingsimultaneous excitation of multiple slices at multiplelocations to accelerate imaging acquisition times orincrease slice coverage without increasing scan time.HyperBand is indicated for echo-planar imaging (EPI) ofthe head and breast.HyperBand is indicated for imaging all patients nototherwise contraindicated for MRI examination.
Comparison of IntendedUse	Both HyperBand and the predicate device are magneticresonance imaging devices intended for diagnostic use.
	Both indications for use statements are functional innature, and do not list specific diseases or conditions.HyperBand and the predicate device are indicated forthe same patient population, and for the same clinicalsetting. HyperBand and the predicate device areindicated for similar anatomical regions: HyperBandfor the head and breast, and ASSET for the head orbody.
	Therefore, GE Healthcare believes that HyperBand hasthe same intended use as the predicate device inaccordance with the FDA's guidance document "The510(k) Program: Evaluating Substantial Equivalence inPremarket Notifications [510(k)]", dated 28 July 2014.
Comparison ofTechnologicalCharacteristics:	The most notable technological difference betweenHyperBand and the predicate device is that HyperBandis capable of simultaneously exciting multiple slicesleading to higher acceleration reduction factors whencombined with other methods of parallel imaging. Thepredicate device acquires one slice or one slab at a time.
	However, per bench and clinical data collected tovalidate the indications for use, this technologicaldifference does not raise any different questions ofsafety and effectiveness. Both devices must addressquestions of whether they provide an adequate level ofimage quality appropriate for diagnostic use. Theperformance data described in this submission includeresults of both bench testing and clinical testing thatshow the image quality performance of HyperBandcompared to the predicate device.
Performance Data:	Summary of Non-Clinical Tests:HyperBand is a software only feature and complieswith the following voluntary standards:AAMI/ANSI 62304 AAMI/ANSI ES60601-1 IEC 60601-2-33
	In addition, HyperBand complies with NEMA PS3.1-3.18for DICOM conformance.
	The following quality assurance measures were appliedto the development of the device:Risk Analysis Requirements Reviews Design Reviews Testing on unit level (Module verification) Integration testing (System verification) Performance testing (Verification) Safety testing (Verification) Simulated use testing (Validation)
	Signal to Noise Ratio (SNR) testing was performed withand without the HyperBand feature, and provided tosupport substantial equivalence.
	The non-clinical tests have been summarized in theverification and validation testing for HyperBand. Thetesting was completed with passing results per thepass/fail criteria defined in the test cases. This supportssubstantial equivalence to its predicates because it wasalso developed under quality assurance DesignControls. In addition, the software complies with thesame applicable Standards.
	Summary of Clinical Tests:The subject of this premarket submission, HyperBand,did not require external clinical studies to supportsubstantial equivalence. Internal scans were conductedas part of validation for workflow and image quality forthe addition of the new features. The clinical resultsdemonstrated that HyperBand maintain the sameimaging performance results as its predicate devices(K012970). Sample clinical images are included in thissubmission.
Conclusion:	GE Healthcare believes that the HyperBand softwarefeature has substantially the same intended use as thepredicate ASSET. This 510(k) submission includesinformation on the technological characteristics of theHyperBand feature, as well as performance datademonstrating that HyperBand is as safe and effectiveas the predicate, and does not raise different questionsof safety and effectiveness
	In conclusion, GE Healthcare believes that theHyperBand feature is substantially equivalent to thepredicate device.

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GE Healthcare 510(k) Premarket Notification Submission

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GE Healthcare

510(k) Premarket Notification Submission

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GE Healthcare 510(k) Premarket Notification Submission

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.