The GEM RT Open Array Coil that is a part of the Oncology Suite is a receive-only RF coil designed for use with 1.5T MRI systems manufactured by GE Healthcare. The indications for use include the head, neck, and brachial plexus anatomies and vasculature imaging. The nucleus excited is hydrogen.

Device Description

The 1.5T GEM RT Open Array is a receive only 8-Channel 8-element Posterior Phased Array, for use as an option to the Optima MR450w MR Systems with GEM suites. It is a posterior array which can be inserted into the GEM Table cradle (K103335) at either the head or foot end.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the GE Healthcare 1.5T GEM RT Open Array:

The provided text does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria related to diagnostic accuracy or clinical effectiveness. The submission is for a medical device that appears to be an RF coil for an MRI system, not an AI/ML powered device, hence most of the questions posed (e.g., effect size of human readers improving with AI, standalone performance, training set details) are not applicable.

The document primarily focuses on demonstrating substantial equivalence to a predicate device based on non-clinical tests related to safety and performance standards of the coil itself, rather than its diagnostic output.

However, based on the non-clinical tests described, we can infer some "acceptance criteria" related to the device's technical specifications and safety compliance.

Here's a breakdown of the requested information, adapted to what is actually available in the document:

Analysis of Acceptance Criteria and Proving Study for GE Healthcare 1.5T GEM RT Open Array

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

Since this is a submission for an MRI RF coil, not an AI/ML diagnostic device, the acceptance criteria are focused on safety, electromagnetic compatibility, and technical performance related to signal quality. The document states compliance with established standards.

Acceptance Criteria Category	Specific Standard/Requirement	Reported Device Performance
Electrical Safety	IEC 60601-1 (all applicable sections)	Compliant
Electromagnetic Compatibility (EMC)	IEC 60601-1-2 (all applicable sections, e.g., electrostatic discharge)	Compliant
Electrical Safety (MRI Specific)	IEC 60601-2-33 (all applicable sections)	Compliant
Image Quality (SNR & Uniformity)	NEMA MS-9: SNR and Uniformity of Phased Array Coils (all applicable sections)	Compliant
Risk Management	Application of Risk Analysis	Applied (mentioned as a quality assurance measure)
Design Control	Requirements Reviews, Design Reviews	Applied (mentioned as quality assurance measures)
Verification & Validation	Unit/Module, Integration, Performance, Safety, Simulated Use Testing	Applied (mentioned as quality assurance measures)

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

Sample Size: The document explicitly states: "The subject of this premarket submission, 1.5T GEM RT Open Array, did not require clinical studies to support substantial equivalence." Therefore, there is no formal "test set" in the context of clinical images or patient data for evaluating diagnostic performance. "Sample clinical images have been included in this submission," but these are not described as part of a formal test set with defined sample size for performance evaluation.
Data Provenance: Not applicable as a formal clinical test set was not used.

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

Not applicable as a formal clinical test set requiring expert ground truth for diagnostic accuracy was not established. The evaluation focused on technical and safety compliance.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Not applicable as there was no formal clinical test set requiring adjudication.

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:

No. This device is an MRI RF coil, not an AI/ML driven diagnostic tool. Therefore, an MRMC study related to AI assistance is not relevant or applicable.

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

No. This device is a hardware component (an RF coil) for an MRI system, not an algorithm or AI. Standalone algorithm performance is not applicable.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

For the non-clinical tests, the "ground truth" was compliance with established technical and safety standards (e.g., IEC, NEMA). This involves engineering measurements and evaluations against predefined specifications rather than clinical pathology or expert consensus on diagnostic findings.

8. The sample size for the training set:

Not applicable. This is a hardware device submission, not a machine learning model. There is no concept of a "training set" in the context of this submission.

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

Not applicable, as there is no training set.

Summary of Conclusions from the Document:

The GE Healthcare 1.5T GEM RT Open Array coil achieved FDA clearance (K123327) by demonstrating substantial equivalence to a predicate device (K103335, GEM Option for 1.5T MRI Systems) based on:

Non-clinical testing: Compliance with established international and industry standards for electrical safety (IEC 60601-1, IEC 60601-2-33), electromagnetic compatibility (IEC 60601-1-2), and MRI image quality characteristics like Signal-to-Noise Ratio (SNR) and Uniformity for phased array coils (NEMA MS-9).
Quality assurance measures: The development process included risk analysis, requirements reviews, design reviews, and various levels of testing (unit, integration, performance, safety, simulated use).
No clinical studies were required to support substantial equivalence for this specific device.

Summary

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GE Healthcare 510(k) Premarket Notification Submission

510(k) Summary

JAN 1 1 2013

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

December 27, 2012 Date:

Submitter: GE Healthcare Coils, (USA Instruments, Inc) Establishment Registration Number: 1529041 l 515 Danner Dr. Aurora, OH 44202-9273 USA

Primary Contact Person:

Andrew Menden Regulatory Affairs Manager GE Healthcare (GE Medical Systems, LLC) Establishment Registration Number: 2183553 3200 N Grandview Blvd., Mail Code - W-827 Waukesha, WI-53188 USA Phone: 262-521-6223 Fax: 414-908-9585

Secondary Contact Person:

Glen Sabin Regulatory Affairs Director GE Healthcare (GE Medical Systems LLC.) Establishment Registration Number: 2183553 3200 N Grandview Blvd., Mail Code - W-827 Waukesha, WI-53188 USA Phone: 262-521-6848 Fax: 262-364-2785

Device: Trade Name: Common/Usual Name: Classification Names:

1.5T GEM RT Open Array Coil, Magnetic Resonance, Specialty 21CFR 892.1000 - Magnetic resonance diagnostic device

Product Code:	90MOS
Predicate Device(s):	K103335, GEM Option for 1.5T MRI Systems
Device Description:	The 1.5T GEM RT Open Array is a receive only 8-Channel 8-element Posterior Phased Array, for use as an

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K123327 Page 2 of 3

GE Healthcare 510(k) Premarket Notification Submission

option to the Optima MR450w MR Systems with GEM suites. It is a posterior array which can be inserted into the GEM Table cradle (K103335) at either the head or foot end.

Intended Use:

Technology:

Comparison with GEM Option for 1.5T MRI Systems

The GE 1.5T GEM RT Open Array is a multi-element phased array RF Receive only coil with integrated preamplifiers. The 1.5T GEM RT Open Array coil operates on the same principles and is an addition to the GEM suite of coils (K103335). The GEM RT Open Array is designed to fit into the GEM table at the head or foot end adjacent to where the existing integrated posterior array in the GEM table resides.

Determination of Substantial Equivalence:

Summary of Non-Clinical Tests:

The GE 1.5T GEM RT Open Array has used the same non-clinical voluntary standards to demonstrate substantial equivalence of safety and performance:

IEC 60601-1: Electrical Safety - compliant with all applicable sections

IEC 60601-1-2: Electromagnetic Compatibility compliant with all applicable sections (i.e. electrostatic discharge)

IEC 60601-2-33: Electrical Safety - compliant with all applicable sections

NEMA MS-9: SNR and Uniformity of Phased Array Coils - compliant with all applicable sections

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Page 3 of 3

GE Healthcare 510(k) Premarket Notification Submission

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

. 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) .

Summary of Clinical Tests:

The subject of this premarket submission, 1.5T GEM RT Open Array, did not require clinical studies to support substantial equivalence. Sample clinical images have been included in this submission.

Conclusion: GE Healthcare considers the 1.5T GEM RT Open Array to be as safe, as effective, and performance is substantially equivalent to the predicate device.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002

January 11, 2013

GE Healthcare Coils (USA Instruments, Inc) % Mr. Andrew Menden 1515 Danner Dr. Aurora, OH 44202-9273

Re: K123327

Trade/Device Name: 1.5T GEM RT Open Array Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: Class II Product Code: MOS Dated: October 25, 2012 Received: October 26, 2012

Dear Mr. Menden:

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 for association 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.

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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Page 2 - Mr. Menden

If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 11: You desire spearle and the Office of In Vitro Diagnostics and Radiological Health at (301) 796-005), please note the regulation entitled, "Misbranding by reference to premarket 5 150. And 1100, productions regarding the reporting the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

under the MDR regulation (27 Of Reacony/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 I ou may obtain oner generar mennersational and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Michael D. O'Hara

Janine M. Morris Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

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GE Healthcare 510(k) Premarket Notification Submission

Indications for Use

510(k) Number (if known): K123327

1.5T GEM RT Open Array Device Name:

Indications for Use:

Prescription Use _ X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)

Michael J. D. O'Hara

(Division Sign Off)

Division of Radiolog

Office of In Vitro

5100a <1.23327

Page 1 of 1 .

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.