1.5T SIGNA Creator and 1.5T SIGNA Explorer 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 regions of the body. Depending on the region of interest being imaged, contrast agents may be used.
The images produced by 1.5T SIGNA Creator and 1.5T SIGNA Explorer 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.

Device Description

1.5T SIGNA Creator and 1.5T SIGNA Explorer is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and short scan times. The 1.5T SIGNA Creator and 1.5T SIGNA Explorer features a superconducting magnet operating at 1.5 Tesla. The system uses a combination of time-varying magnetic fields (gradients) and RF transmissions to obtain information regarding the density and position of nuclei exhibiting magnetic resonance. The data acquisition system accommodates 16 independent receive channels and multiple independent coil elements per channel during a single acquisition series.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the 1.5T SIGNA Creator and 1.5T SIGNA Explorer:

The provided document is a 510(k) Premarket Notification Summary from the FDA for GE Healthcare's 1.5T SIGNA Creator and 1.5T SIGNA Explorer Magnetic Resonance Imaging (MRI) systems. The primary purpose of a 510(k) submission is to demonstrate substantial equivalence to a legally marketed predicate device, rather than proving performance against specific acceptance criteria in a detailed clinical study for a novel device.

Therefore, the information you're requesting regarding explicit acceptance criteria and a dedicated study to prove precise performance metrics is largely not present in this type of regulatory document. Instead, the document focuses on demonstrating that the new device meets the same safety and effectiveness standards as its predicate.

Here's a breakdown of the information that can be extracted and what is not available based on your request:

1. Table of Acceptance Criteria and Reported Device Performance

Not explicitly provided in this document.

This 510(k) submission does not include a table of quantitative acceptance criteria (e.g., specific sensitivity, specificity, accuracy thresholds for a diagnostic task) and corresponding performance metrics for the 1.5T SIGNA Creator and 1.5T SIGNA Explorer. The acceptance criteria for a 510(k) are generally around demonstrating that the new device is as safe and effective as the predicate device(s).

The document states:

"The subject of this premarket submission, 1.5T SIGNA Creator and 1.5T SIGNA Explorer did not require clinical studies to support substantial equivalence."
"Internal scans were conducted as part of validation for workflow and image quality, and sample clinical images are included in the submission."
"Additionally, the result of the above described testing demonstrates that the device performs as intended."
"GE Healthcare considers the 1.5T SIGNA Creator and 1.5T SIGNA Explorer to be as safe, as effective, and performance is substantially equivalent to the predicate device(s)."

These statements highlight that the absence of significant differences and the compliance with established standards are the "acceptance criteria" for substantial equivalence.

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

Not applicable/available as a formal "test set" for performance evaluation.

Since no dedicated clinical study was performed to assess diagnostic performance against specific acceptance criteria, there is no "test set" in the traditional sense for diagnostic accuracy. The document mentions "internal scans" as part of validation, but does not specify sample size or data provenance for these (e.g., country of origin, retrospective/prospective). These internal scans would likely be used to evaluate image quality and workflow, not necessarily diagnostic performance against a ground truth.

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

Not applicable.

Because there was no diagnostic performance study with a formal "test set," there's no mention of experts establishing ground truth for such a study.

4. Adjudication Method for the Test Set

Not applicable.

No formal test set or diagnostic performance study means no adjudication method is mentioned.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a MRMC comparative effectiveness study was not done.

The document explicitly states: "The subject of this premarket submission, 1.5T SIGNA Creator and 1.5T SIGNA Explorer did not require clinical studies to support substantial equivalence." This implies that no MRMC study or any other clinical study was deemed necessary to demonstrate the device's functionality beyond substantial equivalence to the predicate. Therefore, no effect size of human reader improvement with/without AI assistance is applicable, as this device is an MRI scanner, not an AI-assisted diagnostic tool.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable.

This is an MRI hardware device, not a diagnostic algorithm. Therefore, "standalone" algorithm performance is not relevant.

7. The Type of Ground Truth Used

Not applicable.

Without a diagnostic performance study, the concept of "ground truth" for diagnostic accuracy is not discussed in this document. The "ground truth" underpinning this submission is fundamentally that the new device is technologically equivalent and operates within the same safety and performance parameters as already-approved predicate devices.

8. The Sample Size for the Training Set

Not applicable.

This is not an AI/algorithm-driven device requiring a training set in the machine learning sense.

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

Not applicable.

As it's not an AI/algorithm-driven device, there is no training set or associated ground truth establishment process.

Summary of what the document does provide regarding "performance" and "acceptance criteria":

Reliance on Substantial Equivalence: The core "acceptance criterion" for this 510(k) approval is demonstrating substantial equivalence to predicate devices (1.5T Brivo MR355 and 1.5T Optima MR360, K123417; and 1.5T Optima MR450w, K142085).
Technological Equivalence: The document states, "Proposed 1.5T SIGNA Creator and 1.5T SIGNA Explorer Technology employs the same fundamental scientific technology as its predicate device..."
Compliance with Voluntary and Recognized Standards: The device underwent testing to comply with various standards, which serve as performance benchmarks in lieu of specific clinical performance criteria:
- IEC60601-1, IEC60601-2-33, IEC60601-1-1, IEC60601-1-2 (Electrical safety and performance for medical devices, specifically MRI)
- NEMA MS1, MS2, MS3, MS4, MS5, MS8 (Performance standards for MRI systems, defining terms, measurements, and reporting for aspects like image quality, S/N, geometric distortion, etc.)
- NEMA PS PS3.1-3.20 (DICOM standard for communication interface)
Quality Assurance Measures: The device applied standard quality assurance measures, including Risk Analysis, Requirements Reviews, Design Reviews, Testing on unit level (Module verification), Integration testing (System verification), Performance testing (Verification), Safety testing (Verification), and Simulated use testing (Validation). These indicate that the device meets internal design and quality standards.
Internal Scans for Validation: "Internal scans were conducted as part of validation for workflow and image quality." While not a formal clinical study, these would demonstrate that the system produces images and operates as expected.

In conclusion, for a 510(k) submission regarding an MRI system like this, the "acceptance criteria" are tied to demonstrating that the device is as safe and effective as a previously approved predicate device, primarily through technological comparison, compliance with recognized performance standards, and internal validation of image quality and workflow, rather than detailed clinical performance metrics from controlled diagnostic studies.

Summary

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

February 4, 2015

GE Healthcare (GE Medical Systems, LLC) % Mr. Glen Sabin Regulatory Affairs Director 3200 N. Grandview Blvd. WAUKESHA WI 53188

Re: K143251

Trade/Device Name: 1.5T SIGNA Creator and 1.5T SIGNA Explorer Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: LNH Dated: November 7, 2014 Received: November 12, 2014

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 A Ochs

Robert Ochs. Ph.D. Acting 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) K143251

Device Name

1.5T SIGNA Creator and 1.5T SIGNA Explorer

Indications for Use (Describe)

The images produced by 1.5T SIGNA Creator and 1.5T SIGNA Explorer 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.

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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Image /page/3/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'GE' intertwined in a stylized script, enclosed within a circular frame. The letters and the frame are colored in a bright blue hue, while the background within the circle is white. The overall design is simple, clean, and recognizable as the brand identity of General Electric.

GE Healthcare 510(k) Premarket Notification Submission

510(k) Summary

In accordance with 21 CFR 807.92 the following summary of information is provided:
Date:	November 7, 2014
Submitter:	GE Healthcare (GE Medical Systems, LLC)3200 N. Grandview Blvd.,Waukesha, WI 53188USA
Primary Contact Person:	Glen SabinRegulatory Affairs DirectorGE HealthcarePhone: 262-521-6848Fax: 262-364-2785
Secondary Contact Person:	Ruoqian LiuRegulatory Affairs DirectorGE HealthcarePhone: 86-10-58068943Fax: 86-10-67803267
Device:	Trade Name: 1.5T SIGNA Creator, 1.5T SIGNA Explorer
Common/Usual Name:	Magnetic Resonance Imaging System
Classification Names:	Magnetic resonance diagnostic device
Product Code:	LNH
Predicate Device(s):	1.5T Brivo MR355 and 1.5T Optima MR360 (K123417)1.5T Optima MR450w (K142085)
Device Description:	1.5T SIGNA Creator and 1.5T SIGNA Explorer is a whole bodymagnetic resonance scanner designed to support high resolution,high signal-to-noise ratio, and short scan times. The 1.5T SIGNACreator and 1.5T SIGNA Explorer features a superconductingmagnet operating at 1.5 Tesla. The system uses a combination oftime-varying magnetic fields (gradients) and RF transmissions toobtain information regarding the density and position of nucleiexhibiting magnetic resonance. The data acquisition systemaccommodates 16 independent receive channels and multipleindependent coil elements per channel during a single acquisitionseries.

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GE Healthcare 510(k) Premarket Notification Submission

1.5T SIGNA Creator and 1.5T SIGNA Explorer is a whole body Intended Use: 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 regions of the body. Depending on the region of interest being imaged, contrast agents may be used.
The images produced by 1.5T SIGNA Creator and 1.5T SIGNA Explorer 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.
Proposed 1.5T SIGNA Creator and 1.5T SIGNA Explorer Technology: employs the same fundamental scientific technology as its predicate device 1.5T Brivo MR355 and 1.5T Optima MR360 (K123417).
Determination of Summary of Non-Clinical Tests:

Substantial Equivalence: 1.5T SIGNA Creator and 1.5T SIGNA Explorer and its applications underwent testing to comply with voluntary standards, including IEC60601-1. IEC60601-2-33, IEC60601-1-1, IEC60601-1-2. In addition, the following FDA-recognized performance standards were used to test the 1.5T SIGNA Creator and 1.5T SIGNA Explorer: NEMA MS1, MS2, MS3, MS4, MS5 and MS8. Additionally, the communication interface for the 1.5T SIGNA Creator and 1.5T SIGNA Explorer is designed to support DICOM format as defined in the NEMA PS PS3.1-3.20 set of standards. The predicate devices also complied with these standards.

As with the predicate devices, 1.5T SIGNA Creator and 1.5T SIGNA Explorer applied the following quality assurance measures:

Risk Analysis ●
Requirements Reviews
Design Reviews
Testing on unit level (Module verification)
Integration testing (System verification)

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Image /page/5/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'GE' in a stylized, cursive font, enclosed within a blue circle. The circle has a swirling design around the letters, giving it a dynamic and recognizable appearance. The logo is simple, yet iconic, representing the brand identity of General Electric.

Performance testing (Verification)
. Safety testing (Verification)
Simulated use testing (Validation)

Summary of Clinical Tests:

The subject of this premarket submission, 1.5T SIGNA Creator and 1.5T SIGNA Explorer did not require clinical studies to support substantial equivalence. Internal scans were conducted as part of validation for workflow and image quality, and sample clinical images are included in the submission.

Substantial Equivalence Conclusion:

The indications for use of the proposed systems and the predicates are nearly identical. The name of the device has changed and minor updates were made to the feature set. 1.5T SIGNA Creator and 1.5T SIGNA Explorer employs equivalent technology to the reference devices. Additionally, the result of the above described testing demonstrates that the device performs as intended.

GE Healthcare considers the 1.5T SIGNA Creator and 1.5T Conclusion: SIGNA Explorer to be as safe, as effective, and performance is substantially equivalent to the predicate device(s).

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.