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 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 the SIGNA Pioneer 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.

Device Description

The SIGNA Pioneer features a 3.0T superconducting magnet with a 70cm bore size. The RF receiver is equipped with 97 RF channels. The data acquisition system accommodates 32 channels for image reconstruction simultaneously. 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 system can image in the sagittal, coronal, axial, oblique, and double oblique planes, using various pulse sequences and reconstruction algorithms. The SIGNA Pioneer uses multi-drive RF transmit for imaging of the head and body regions. The SIGNA Pioneer is designed to conform to NEMA DICOM standards.

AI/ML Overview

The provided document is a 510(k) summary for the GE Healthcare SIGNA Pioneer Magnetic Resonance Diagnostic Device. It states that the device has been found substantially equivalent to a predicate device (Discovery MR750w 3.0T, K142085). The summary primarily focuses on affirming that the SIGNA Pioneer performs equivalently to the predicate device and meets established safety standards rather than establishing new acceptance criteria for an AI/algorithm-driven device.

Therefore, the information requested in the prompt, which is typically relevant for studies evaluating the performance of AI/algorithm-driven devices against specific acceptance criteria, is largely not present in this document. This document describes a traditional medical device (an MRI scanner) and its substantial equivalence to another MRI scanner, not a standalone AI diagnostic software.

However, I can extract the relevant information that is present and identify what is missing based on your questions.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not present specific "acceptance criteria" in the format of a table with numerical thresholds for performance metrics for an AI/algorithm. Instead, it states that the device was verified to meet safety criteria and demonstrated acceptable diagnostic imaging performance, which is "substantially equivalent" to the predicate device.

Acceptance Criterion (Implicit)	Reported Device Performance (Summary)
Safety Compliance	Complies with IEC 60601-1, IEC 60601-1-2, IEC 60601-2-33, ISO 10993-1, NEMA MS, and NEMA PS3 standards for MRI and DICOM. Verified to meet the same local SAR safety criteria as the predicate device via human modeling simulations for RF multi-drive transmit.
Diagnostic Imaging Performance	Clinical images and clinical results summary demonstrate acceptable diagnostic imaging performance. Image quality is substantially equivalent to that of the predicate device.
Intended Use	Indications for Use are identical to the predicate device.

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

Test Set Sample Size: Not specified. The document only mentions "clinical images and clinical results summary" were used, but no numbers are provided for cases or subjects.
Data Provenance: Not specified (e.g., country of origin, retrospective/prospective).

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

Number of Experts: Not specified.
Qualifications: The document states that "images and/or spectra when interpreted by a trained physician yield information that may assist in diagnosis." This implies physicians were involved in interpreting clinical data, but their number and specific qualifications (e.g., years of experience, subspecialty) are not detailed.

4. Adjudication Method for the Test Set

Not specified.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Was it done?: No, a traditional MRMC comparative effectiveness study as typically understood for AI-assisted reading was not performed or described. The comparison is between the SIGNA Pioneer MRI device and a predicate MRI device, focusing on substantial equivalence in overall performance and safety, not on how an AI improves human reader performance.
Effect size of AI improvement: Not applicable, as this was not an AI assistance study.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Was it done?: No. This document describes an MRI scanning device, which produces images for physician interpretation. It is not an algorithm that performs a diagnosis in a standalone manner. The device's "performance" refers to the quality of the images it produces and its adherence to safety standards.

7. Type of Ground Truth Used

The document implies that "clinical images and clinical results" were evaluated, likely against the interpretations of "trained physicians" (expert consensus based on clinical findings) for diagnostic imaging performance. However, specific methodologies for establishing ground truth (e.g., pathology, long-term outcomes) are not detailed.

8. Sample Size for the Training Set

Not applicable/Not specified. This device is a hardware scanner, not a machine learning algorithm that requires a training set in the conventional sense for its primary function. While some integrated software features might have been developed using data, the document does not distinguish or describe a "training set" for the fundamental device performance.

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

Not applicable/Not specified for the reasons stated above.

Summary

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

August 20, 2015

GE Healthcare Japan Corporation % Toru Shimizu Regulatory Affairs Specialist 7-127, Asahigaoka 4-chome Hino-shi, Tokyo 191-8503 JAPAN

Re: K143345

Trade/Device Name: SIGNA Pioneer Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: Class II Product Code: LNH, MOS Dated: June 19, 2015 Received: June 22, 2015

Dear Toru Shimizu:

This letter corrects our substantially equivalent letter of July 10, 2015.

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

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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.

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/ResourcesforYou/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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Section 4: Indications for Use Statement

SIGNA Pioneer

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Indications for Use

510(k) Number (if known)

Device Name SIGNA Pioneer

Indications for Use (Describe)

The SIGNA Pioneer is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and short scan times.

Depending on the region of interest being imaged, contrast agents may be used.

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.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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Image /page/4/Picture/1 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 is surrounded by swirling, wave-like shapes, also in blue, giving the logo a dynamic and recognizable appearance. The background is plain white.

Section 5: 510(k) Summary

SIGNA Pioneer

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510(k) Summary

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

Date:	August 7, 2015
Submitter:	GE Healthcare, (GE Healthcare Japan Corporation)7-127, Asahigaoka 4-chome, Hino-shi,Tokyo 191-8503 JAPAN
Primary Contact Person:	Toru ShimizuRegulatory Affairs Specialist - ProductGE Healthcare, (GE Healthcare Japan Corporation)Phone: +81-42-585-5344Fax: +81-42-585-5911
Secondary Contact Person:	Glen SabinRegulatory Affairs Director - MRGE Healthcare, (GE Medical Systems, LLC)Phone: 262-521-6848
Device Trade Name:	SIGNA Pioneer
Common/Usual Name:	Magnetic Resonance Diagnostic Device
Classification Names:	Magnetic Resonance Diagnostic Device per 21 CFR 892.1000
Product Code:	LNH, MOS
Predicate Device:	Discovery MR750w 3.0T (K142085)
Device Description:	The SIGNA Pioneer features a 3.0T superconducting magnet witha 70cm bore size.The RF receiver is equipped with 97 RF channels. The dataacquisition system accommodates 32 channels for imagereconstruction simultaneously.The system uses a combination of time-varying magnetic fields(gradients) and RF transmissions to obtain information regardingthe density and position of nuclei exhibiting magnetic resonance.The system can image in the sagittal, coronal, axial, oblique, anddouble oblique planes, using various pulse sequences andreconstruction algorithms.The SIGNA Pioneer uses multi-drive RF transmit for imaging ofthe head and body regions.The SIGNA Pioneer is designed to conform to NEMA DICOMstandards.
Intended Use:	The SIGNA Pioneer is a whole body magnetic resonance scannerdesigned to support high resolution, high signal-to-noise ratio, andshort scan times.
	It is indicated for use as a diagnostic imaging device to produceaxial, sagittal, coronal, and oblique images, spectroscopic images,parametric maps, and/or spectra, dynamic images of the structuresand/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 agentsmay be used.The images produced by the SIGNA Pioneer reflect the spatialdistribution or molecular environment of nuclei exhibitingmagnetic resonance. These images and/or spectra when interpretedby a trained physician yield information that may assist indiagnosis.
Technology:	The SIGNA Pioneer employs the same fundamental scientifictechnology as its predicate device.
	The following is a summary of the different technologycharacteristics from the predicate device:Newly designed gradient system and RF receive chain including DDI and DST Addition of new software features including Auto Navigator tracker placement, Auto Protocol Optimization and enhanced Image filter TDI Coil Suite including DMS
Determination ofSubstantial Equivalence:	Summary of Non-Clinical Tests:Like the predicate device, the SIGNA Pioneer complies with thefollowing voluntary standards:IEC 60601-1 IEC 60601-1-2 IEC 60601-2-33 ISO 10993-1
	In addition, the SIGNA Pioneer complies with the applicableNEMA MS standards for MRI and NEMA PS3 standard forDICOM, as does the predicate device.
	The SIGNA Pioneer has been verified to meet the same safetycriteria as the predicate device for local SAR for variousanatomies. This verification was done by using local SAR humanmodeling simulations for RF multi drive transmit, as was done forthe predicate device.
	The following quality assurance measures were applied to thedevelopment of the system, as they were for the predicate: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 clinical images and clinical results summary demonstrate theacceptable diagnostic imaging performance of the SIGNA Pioneerincluding the additional new software features and TDI coil suite.The image quality of SIGNA Pioneer is substantially equivalent tothat of the predicate device.
	Substantial Equivalence Conclusion:The Indications for Use of the SIGNA Pioneer are identical to thepredicate device. The results from the above Non-Clinical andClinical Tests demonstrate that the SIGNA Pioneer is substantiallyequivalent to the predicate with regards to safety and efficacy.
Conclusion:	GE Healthcare considers the SIGNA Pioneer to be as safe, aseffective, and performance is substantially equivalent to thepredicate device.

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Image /page/6/Picture/1 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'GE' intertwined within a blue circle. The circle has a stylized design with swirling elements around the letters, giving it a dynamic and recognizable appearance.

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Image /page/7/Picture/1 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'GE' in a stylized, cursive font, enclosed within a circular shape. The circle has wave-like designs around it, giving it a dynamic and fluid appearance. The logo is presented in a blue color, which is consistent with GE's branding.

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.