The Optima™ MR450w 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 the Optima™ MR450w 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 1.5 GE Optima MR450w features a superconducting magnet operating at 1.5 Tesla. 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 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 system can image in the sagittal, coronal, axial, oblique and double oblique planes, using various pulse sequences and reconstruction algorithms. The Silenz Imaging Application using the 3D Radial Pulse sequence reduces the acoustic noise that is generated during an MR examination. This application is compatible on the Optima MR450w system with GEM configuration. The 1.5T GE Optima MR450w is designed to conform to NEMA DICOM standards (Digital Imaging and Communications in Medicine).

AI/ML Overview

Here's an analysis of the provided text regarding the Optima MR450w, focusing on acceptance criteria and supporting studies:

It is important to note that the provided text is a 510(k) Summary for a modification to an existing MRI device (addition of the Silenz Imaging Application to the Optima MR450w). As such, it primarily focuses on demonstrating substantial equivalence to the predicate device, rather than proving novel clinical efficacy or establishing new clinical performance targets as would be the case for an entirely new device.

Acceptance Criteria and Reported Device Performance

The document does not explicitly state specific quantitative acceptance criteria or a table of performance metrics for the Optima MR450w with the Silenz application in the traditional sense of a clinical performance study (e.g., sensitivity, specificity, accuracy against a gold standard).

Instead, the acceptance criteria are implicitly met by demonstrating compliance with recognized standards and by verification and validation activities ensuring the device performs as intended and is equivalent to the predicate.

The reported device performance is qualitative, focused on maintaining existing standards and functionality:

Acceptance Criterion (Implicit)	Reported Device Performance
Compliance with IEC 60601-1 Series (Medical Electrical Equipment)	Device is in compliance.
Compliance with IEC 62304 (Medical Device Software)	Device is in compliance.
Compliance with ISO 14971 (Risk Management)	Device is in compliance.
Compliance with NEMA DICOM Standards	Device is in compliance (PS3.1-3.18).
Maintenance of high resolution	The device is still "designed to support high resolution."
Maintenance of high signal-to-noise ratio	The device is still "designed to support high signal-to-noise ratio."
Maintenance of short scan times	The device is still "designed to support... short scan times."
Silenz Imaging Application functions as intended (reduces acoustic noise)	"The Silenz Imaging Application using the 3D Radial Pulse sequence reduces the acoustic noise that is generated during an MR examination."
No alteration of overall technology of the Optima MR450w System	"The addition of the Silenz feature does not alter the overall technology of the Optima MR450w System."
Safety and Effectiveness substantially equivalent to predicate	"GE Healthcare considers the Optima MR450w to be as safe, as effective, and performance is substantially equivalent to the predicate device."

Study Details

The document explicitly states that no external clinical studies were required to support substantial equivalence. The "studies" mentioned are internal verification and validation activities.

1. Sample size used for the test set and the data provenance:
* Test Set Sample Size: Not specified. The document mentions "Internal scans were conducted as part of validation for workflow and image quality." It does not provide a number of scans or distinct subjects/patients used for these internal tests.
* Data Provenance: "Internal scans" implies the data was generated within GE Healthcare, likely on their own systems for testing purposes. The country of origin and whether it was retrospective or prospective is not specified, but typically, internal validation scans are prospective as they are specifically generated for testing.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
* Not specified. The document highlights "Testing on unit level," "Integration testing," and "Performance testing" with "passing results per the pass/fail criteria defined in the test cases." It also mentions "Simulated use testing."
* The interpretation of images is for "a trained physician" to yield information for diagnosis, but this refers to the intended use of the device, not the ground truth establishment for the internal validation studies.

3. Adjudication method for the test set:
* Not applicable/Not specified. The internal validation focused on technical performance rather than clinical diagnostic accuracy requiring adjudicated ground truth for a test set. The validation used "pass/fail criteria defined in the test cases."

4. 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 MRMC comparative effectiveness study was done.
* This device is an MRI scanner, and the "Silenz Imaging Application" is a feature to reduce acoustic noise, not an AI or CAD system intended to assist human readers in diagnosis. Therefore, the concept of improving human readers with AI assistance does not apply here.

5. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
* Not applicable in the context of an "algorithm only" performance study for diagnostic AI. The device is a whole-body MRI scanner. Its performance is inherent in the image acquisition and reconstruction, not a standalone diagnostic algorithm.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
* For the internal validation "workflow and image quality" scans, the ground truth would likely be based on technical specifications, industry standards for image quality, and expert review (though not explicitly detailed) of the acquired images to confirm they met predefined quality metrics (e.g., signal-to-noise ratio, spatial resolution, artifact levels, and successful noise reduction). It would not be clinical ground truth like pathology or outcomes data.

7. The sample size for the training set:
* Not applicable. This device is an MRI scanner, not a machine learning algorithm that requires a "training set" in the typical sense for diagnostic AI. While the internal development of the Silenz application (which likely involves signal processing and perhaps some optimization algorithms) would have utilized data, it's not described as a "training set" for a diagnostic AI.

8. How the ground truth for the training set was established:
* Not applicable, as there is no "training set" for a diagnostic AI algorithm in this context.

Summary

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K123522 | Page 1 of 3

510(k) Summary

MAR 1 3 2013

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

Date: December 10, 2012

GE Healthcare, (GE Medical Systems, LLC) Submitter: 3200 N. Grandview Blvd. Waukesha, W153188

Primary Contact Person: Michelle Huettner Regulatory Affairs Leader GE Healthcare, (GE Medical Systems, LLC) Ph: (262) 521-6102 Fax: (262) 546-0902

Secondary Contact Person: Glen Sabin Regulatory Affairs Director GE Healthcare, (GE Medical Systems, LLC) Ph: (262) 521-6848 Fax: (262) 364-2785

Optima MR450w Device: Trade Name:

Common/Usual Name: Magnetic Resonance Diagnostic Device

Classification Names: 892.1000

Product Code: LNH

Optima MR450w (K113490) Predicate Device(s):

The 1.5 GE Optima MR450w features a superconducting Device Description: magnet operating at 1.5 Tesla. 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 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 system can image in the sagittal, coronal, axial, oblique and double oblique planes, using various pulse sequences and reconstruction algorithms. The Silenz Imaging Application using the 3D Radial Pulse sequence reduces the acoustic noise that is generated during an MR examination. This application is compatible on the Optima MR450w system with GEM

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K123522) Page 2 of 3

configuration. The 1.5T GE Optima MR450w is designed to conform to NEMA DICOM standards (Digital Imaging and Communications in Medicine).

Intended Use: The Optima™ MR450w 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 the Optima™ MR450w reflect the spatial distribution or molecular environment of nuclei exhibiting magnetic resonance. These images and/or spectra when interpreted by a trained physician vield information that may assist in diagnosis.

Technology: The modified Optima MR450w employs the same fundamental scientific technology as its predicate device, the Optima MR450w. It is still a whole body magnetic resonance scanner designed to support high resolution. high signal-to-noise ratio, and short scan times. The images produced with the Optima MR450w reflect the spatial distribution or molecular environment of the nuclei which exhibit magnetic resonance. The addition of the Silenz feature does not alter the overall technology of the Optima MR450w System.

Determination of Summary of Non-Clinical Tests:

Substantial Equivalence: The Optima MR450w scanner with the GEM configuration and addition of the Silenz Imaging Application complies with the following voluntary standards:

. IEC 60601-1
� IEC 60601-1-1
IEC 60601-1-2 .
IEC 60601-1-4 .
IEC 60601-1-6 ●
IEC 60601-2-33 .

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KI23522
Page 3 of 3
IEC 62304 .
ISO 14971 ●

In addition, this MR scanner is in compliance with the applicable NEMA standards. including NEMA PS3.1-3.18 for DICOM conformance.

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) .

The non-clinical tests have been summarized in the Verification testing that was completed for the Optima MR450w System with the Silenz application. The testing was completed with passing results per the pass/fail criteria defined in the test cases. This supports substantial equivalence to its predicate (Optima MR450w) because it was also developed under quality assurance Design Controls. In addition, it is in compliance to the same Standards.

Summary of Clinical Tests:

The subject of this premarket submission, Optima MR450w, did not require external clinical studies to support substantial equivalence. Internal scans were conducted as part of validation for workflow and image quality for the addition of the Silenz Imaging Application. Sample clinical images are included in this submission.

GE Healthcare considers the Optima MR450w to be as Conclusion: safe, as effective, and performance is substantially equivalent to the predicate device.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol resembling a caduceus, which is a traditional symbol associated with medicine and healthcare. The symbol features a staff with two snakes coiled around it, topped with a pair of wings.

Public Health Service

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

March 13, 2013

Michelle Huettner Regulatory Affairs Leader GE Healthcare (GE Medical Systems, LLC) 3200 N. Grandview Blvd WAUKESHA. WI 53188

Re: K123522

Trade/Device Name: Optima MR450w Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: LNH, MOS Dated: February 11, 2013 Received: February 12, 2013

Dear Michelle Huettner:

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. Drue, 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 (OS) 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— Huettner

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers. 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/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Medhat D. DiHasa for

Janine M. Morris 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): K123522

Device Name: Optima MR450w

Indications for Use: The Optima™ MR450w 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.

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 D. O'Hara

(Division Sign Off) Division of Radiological Health Office of In Vitro Diagnostic and Radiological Health

510(k) K123522

Page 1 of

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.