The 1.5T Signa HDx family and 3.0T Signa HDx family are 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 the 1.5T Signa HDx family and 3.0T Signa HDx family 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

The 1.5T Signa HDx family and 3.0T Signa HDx family systems are a whole body magnetic resonance system designed to support high resolution, high signal-to-noise ratio, and short scan times. The Signa HDx family of scanners is available in two different field strengths of 1.5T and 3.0T. The 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. The data acquisition system accommodates up to 32 independent receive channels in various increments and multiple independent coil elements per channel during a single acquisition series. The System can image axial, sagittal, coronal, and oblique anatomical images, spectroscopic data, parametric maps, or dynamic images of the structures or functions of the entire body.

AI/ML Overview

The provided text describes a 510(k) summary for the GE Healthcare 1.5T Signa HDx family and 3.0T Signa HDx family Magnetic Resonance Imaging System.

Here's an analysis of the acceptance criteria and study information as requested:

1. Table of Acceptance Criteria and Reported Device Performance

The submission is for a Magnetic Resonance Imaging System, and the document focuses on regulatory compliance and substantial equivalence to predicate devices, rather than specific performance metrics directly comparable to a typical AI/CADe device. The acceptance criteria in this context are related to meeting established medical device standards and demonstrating similar functionality to previously cleared devices.

Acceptance Criterion (Implicit)	Reported Device Performance (Summary)
Compliance with Voluntary Standards (e.g., electrical safety, risk management, software)	Complies with:
	- IEC60601-1 (Medical electrical equipment - Part 1: General requirements for basic safety and essential performance)
	- IEC60601-2-33 (Particular requirements for the basic safety and essential performance of medical electrical equipment in the magnetic resonance environment)
	- IEC60601-1-1 (General requirements for safety - Collateral standard: Safety requirements for medical electrical systems)
	- IEC60601-1-2 (Electromagnetic compatibility - Requirements and tests)
	- IEC60601-1-4 (Programmable electrical medical systems)
	- IEC60601-1-6 (Usability)
	- ISO14971 (Medical devices - Application of risk management to medical devices)
	- ISO10993-1 (Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process)
	- IEC62304 (Medical device software - Software life cycle processes)
Quality Assurance Measures applied during development	Applied:
	- 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)
Substantial Equivalence to Predicate Devices (K052293 and K103327)	Determined to be substantially equivalent in terms of safety, effectiveness, and performance.

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

The document explicitly states: "The subject of this premarket submission, 1.5T Signa HDx family and 3.0T Signa HDx family did not require clinical studies to support substantial external equivalence. Internal scans were conducted as part of validation for workflow and image quality and that sample clinical images are included in the submission."

Sample Size for Test Set: Not specified quantitatively. It mentions "sample clinical images" and "internal scans," implying a limited, internal dataset, not a formal statistically powered test set for clinical performance.
Data Provenance: Not explicitly stated (e.g., country of origin). The nature of "internal scans" suggests they were likely acquired at GE Healthcare facilities or partner sites. The data is retrospective in the sense that it was used for internal validation, not a prospective clinical trial.

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

Given that formal clinical studies were not required and only "internal scans" were used for validation of workflow and image quality, the document does not specify the number or qualifications of experts involved in establishing ground truth for a test set. Interpretation of the "sample clinical images" would implicitly be by qualified personnel, but this is not detailed for the purpose of ground truth for a device performance study.

4. Adjudication Method for the Test Set

No formal adjudication method is mentioned as there was no formal clinical study with a distinct "test set" and ground truth establishment explicitly described.

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

No, an MRMC comparative effectiveness study was not done. The submission explicitly states no clinical studies were required to support substantial equivalence. This type of study would be relevant for AI-assisted diagnostic devices, which this MRI system is not described as.

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

This question is not applicable in the typical sense for an MRI scanner. An MRI system is a diagnostic imaging device that produces images for a physician to interpret. It's not an "algorithm only" device where performance is measured in isolation from human interpretation. The system's performance is inherently tied to the quality of images it produces, which are then used by human readers.

7. The Type of Ground Truth Used

For the internal validation mentioned ("workflow and image quality"), the ground truth would implicitly be based on the established technical specifications for image quality (e.g., signal-to-noise ratio, resolution, artifact levels) and visual assessment by experts against known anatomical structures shown in the "sample clinical images." There is no mention of pathology, outcomes data, or expert consensus in the context of a "test set" for performance metrics.

8. The Sample Size for the Training Set

The document does not mention a training set in the context of AI/machine learning. This submission is for a conventional MRI system, not an AI-driven diagnostic algorithm. Therefore, the concept of a "training set" as it applies to machine learning models is not relevant here.

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

As there is no mention of a training set for an AI/machine learning algorithm, this question is not applicable.

Summary

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SEP 20 2012

510(k) Summary

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

Date:	25-May-2012
Submitter:	GE Healthcare. (GE Medical Systems LLC)3200 N Grandview Blvd.Waukesha, WI 53188 USA
Primary Contact Person:	Shashidhar C SRegulatory Affairs Leader - MRGE Healthcare,Phone: +91-80-40883613
Secondary Contact Person:	Glen SabinRegulatory Affairs Director - MRGE Healthcare,Phone: (262) 521-6848Fax: (262) 364-2785
Device /Trade Name:	1.5T Signa HDx family and 3.0T Signa HDx family
Common /Usual Name:	Magnetic Resonance Imaging System
Classification Names:	Magnetic resonance diagnostic device
Product Code:	LNH
Predicate Device(s):	1.5T and 3.0T Signa HDx MR System (K052293)
	Discovery MR750w 3.0T (K103327)
Device Description:	The 1.5T Signa HDx family and 3.0T Signa HDx familysystems are a whole body magnetic resonance systemdesigned to support high resolution, high signal-to-noiseratio, and short scan times. The Signa HDx family ofscanners is available in two different field strengths of1.5T and 3.0T. The system uses a combination of time-varying magnetic fields (gradients) and RF transmissionsto obtain information regarding the density and position ofelements exhibiting magnetic resonance. The dataacquisition system accommodates up to 32 independentreceive channels in various increments and multiple

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K121676
page 2 of 3

independent coil elements per channel during a single acquisition series. The System can image axial, sagittal, coronal, and oblique anatomical images, spectroscopic data, parametric maps, or dynamic images of the structures or functions of the entire body.

Intended Use: The 1.5T Signa HDx family and 3.0T Signa HDx family are 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 the 1.5T Signa HDx family and 3.0T Signa HDx family 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.
- Technology: The 1.5T Signa HDx family and 3.0T Signa HDx family employs the same fundamental scientific technology as its predicate devices.

Determination of Substantial Equivalence:

Summary of Non-Clinical Tests:

The 1.5T Signa HDx family and 3.0T Signa HDx family and its applications comply with voluntary standards, including IEC60601-1, IEC60601-2-33, IEC60601-1-1, IEC60601-1-2, IEC60601-1-4, IEC60601-1-6, ISO14971, ISO10993-1 and IEC62304.

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

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. 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 Signa HDx family and 3.0T Signa HDx family did not require clinical studies to support substantial external equivalence. Internal scans were conducted as part of validation for workflow and image quality and that sample clinical images are included in the submission.

Conclusion:

GE Healthcare considers the 1.5T Signa HDx family and 3.0T Signa HDx family to be as safe; as effective, and performance is substantially equivalent to the predicate device(s).

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Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its body and wing. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

SEP 20 2012

Mr. C.S. Shashidhar Regulatory Affairs Leader GE Medical Systems LLC 3200 N. Grandview Blvd WAUKESHA WI 53188

Re: K121676

Trade/Device Name: 1.5T Signa HDx family and 3.0T Signa HDx family Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: LNH, MOS, and LNI Dated: September 7, 2012 Received: September 11, 2012

Dear Mr. Shashidhar:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your Scellon 910(t) promised is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the Citilosure) to regarry management date of the Medical Device American County commerce phor to May 26, 1976, the encordance 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 You may, therefore, market the device, sourcements for annual registration, listing of general controls provisions of the rist labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into class II (Special Controls), it may be subject to such II your device is Classified (see above) into in affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Please oe auvised that I Dri s issuance of a read on a complies with other requirements of the Act
that FDA has made a determination that your device complies with other requ that IDA has made a dolorimmentin as administered by other Federal agencies. You must or any Federal Statutes and regulations and limited to: registration and listing (21)
comply with all the Act's requirements, including, but not limited to: researching of comply with an the Act 3 requirements, and 809); medical device reporting (reporting of

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medical device-related adverse events) (21 CFR 803); and good manufacturing practice medical device related adverse ovality systems (QS) regulation (21 CFR Part 820). This letter requirements as set form in the quality -Jevice as described in your Section 510(k) premarket with anow you to begal mading of your device of your device to a legally marketed noticate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Parts 601) 70 11 you desire specific ad rice for your estic Device Evaluation and Safety at (301) 796-5450. 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 under the MDK regulation (27 Of RP Latv 900), Portal Problem/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 Tou thay obtain of Scherers, International 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,

Janine M. Morris

Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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K121676 510(k) Number (if known):

Device Name: 1.5T Signa HDx family and 3.0T Signa HDx family

Indications for Use:

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

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

AND/OR

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Mashad D. Othman
Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) Kia1676

Section 4

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.