The Optima MR430s MR Scanner is indicated to use as a magnetic resonance imaging device of the leg (excluding the thigh), knec, ankle, foot, elbow, forearm, wrist, and hand. The device produces transverse, sagittal, coronal, and oblique cross-sectional images, displaying the internal structure of the limbs and joints being imaged. If interpreted by a medical expert, these images can provide diagnostically useful information.

Device Description

The Optima MR430s MRI Scanner utilizes a superconducting magnet to acquire 2D single-slice and multi-slice and 3D volume images. A wide variety of pulse sequences are provided to the operator, including spin echo, fast spin echo, 2D and 3D gradient echo acquisitions. Imaging options such as inversion recovery, flow compensation and fat/water suppression are provided to suppress artifacts due to physiological motion and improve image quality. The system is used as a stationary system.

AI/ML Overview

The provided text describes the regulatory filing for the Optima MR430s MRI Scanner. It highlights that the device is substantially equivalent to a predicate device (MSK Extreme, K080048) and that non-clinical and clinical tests were performed to demonstrate its safety and effectiveness. However, the document does not contain specific quantitative acceptance criteria or detailed results of a study designed to prove the device meets such criteria in the way a clinical performance study for an AI algorithm would.

Instead, the document focuses on the substantial equivalence of the Optima MR430s to a predicate device, as per FDA 510(k) requirements. This means the primary "acceptance criteria" here relate to demonstrating that the new device is as safe and effective as the previously cleared predicate device, rather than achieving specific performance metrics against a defined ground truth.

Therefore, many of the requested sections below cannot be fully answered as they pertain to a type of study not detailed in this submission for this specific medical device (an MRI scanner, not an AI diagnostic algorithm).

Here's an attempt to extract and infer information based on the provided text, with significant caveats for the sections not directly addressed:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Inferred from Substantial Equivalence to Predicate)	Reported Device Performance
Non-Clinical:
Compliance with voluntary standards (e.g., IEC 60601-2-33)	The Optima MR430s complies with voluntary standards.
Risk analysis completed	Applied
Requirements reviews completed	Applied
Design reviews completed	Applied
Design verification testing completed	Applied
System verification testing completed	Applied
Performance testing (Verification) completed	Applied
Safety testing (Verification) completed	Applied
Clinical:
No nerve sensation reported during PNS characterization study	No nerve sensation was reported.
System operates within Normal Operating Mode concerning PNS	The system is not capable of operating outside of the Normal Operating Mode (with respect to PNS).
Images provide diagnostically useful information (when interpreted by a medical expert)	Implied as part of substantial equivalence to predicate device.
Device is as safe and effective as predicate device (MSK Extreme, K080048)	Conclusion: "GE Healthcare considers the Optima MR430s to be as safe, as effective, and performance is substantially equivalent to the predicate device(s)."

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

Sample Size (Clinical): "A non-significant risk study was performed to characterize onset levels for Peripheral Nerve Stimulation (PNS)..." and "The sample DICOM images included in this submission were also collected as part of a non-significant risk study." The exact number of subjects or images collected for these studies is not specified in the provided text.
Data Provenance: Not explicitly stated (e.g., country of origin). The studies appear to be prospective as they were specifically performed for verification testing.

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

This information is not detailed in the provided text. The document refers to images providing "diagnostically useful information" if "interpreted by a medical expert," but does not describe the specific process of establishing ground truth for the verification studies or the number/qualifications of experts involved. Given the nature of a 510(k) for an MRI scanner (not an AI diagnostic tool), this type of ground truth establishment is typically not a primary focus of the regulatory submission in the way it would be for an AI device.

4. Adjudication Method for the Test Set

Not specified.

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, an MRMC comparative effectiveness study was not done as described for an AI device. This submission is for an MRI scanner, not an AI diagnostic algorithm or an AI-assisted reading system. Therefore, the concept of human readers improving with AI assistance is not applicable here.

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

Not applicable. This device is an MRI scanner which produces images for interpretation by a human expert. It is not a standalone algorithm.

7. The Type of Ground Truth Used

For the PNS study, the "ground truth" was the subject's reported sensation (or lack thereof) in response to the gradient slew rate changes.
For the image quality assessment, the "ground truth" is implicitly tied to the established diagnostic utility of images from the predicate device and the ability of "medical experts" to interpret the images effectively. No specific pathology or outcomes data as "ground truth" is mentioned in the context of a formal validation study in this summary.

8. The Sample Size for the Training Set

Not applicable. There is no mention of a "training set" in the context of an AI algorithm within this submission for an MRI scanner. The device is hardware-based.

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

Not applicable. (See point 8.)

Summary

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K103238

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Image /page/0/Picture/1 description: The image shows a black and white logo of General Electric (GE). The logo consists of the letters 'G' and 'E' intertwined within a circular border. The design has a vintage or classic appearance, with slightly rough or textured lines, suggesting it may be an older version of the logo.

FEB 1 1 2011 、、・・・・・ .

•

GE Healthcare
301 Ballardvale Street
Wilmington, MA 01887

510(k) Summary

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

Date: October 29, 2010

ﺎ

Submitter:	GE Medical Systems, LLC (GE Healthcare)301 Ballardvale Street, Suite 4Wilmington, MA 01887
Primary Contact Person:	Norma LeMayRegulatory Affairs Leader, Specialty MRGE Medical Systems, LLC (GE Healthcare)Tel: (781) 262-5581Fax: (978) 658-0898
Secondary Contact Person:	Glen SabinDirector of Regulatory Affairs, MRGE Medical Systems, LLC (GE Healthcare)3200 N Grandview BoulevardWaukesha, WI 53188Tel: (262) 521-6848Fax: (262 521-6439
Device:Trade Name:	Optima MR430s MRI Scanner
Common/Usual Name:	Magnetic Resonance Diagnostic Device
Classification Names:	Magnetic Resonance Diagnostic Device
Product Code:Predicate Device(s):	LNHK080048, MSK Extreme MRI Scanner

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Device Description: The Optima MR430s MRI Scanner utilizes a superconducting magnet to acquire 2D single-slice and multi-slice and 3D volume images. A wide variety of pulse sequences are provided to the operator, including spin echo, fast spin echo, 2D and 3D gradient echo acquisitions. Imaging options such as inversion recovery, flow compensation and fat/water suppression are provided to suppress artifacts due to physiological motion and improve image quality. The system is used as a stationary system.

Indications for Use: The Optima MR430s MRI Scanner is indicated to use as a magnetic resonance imaging device of the leg (excluding the thigh), knee, ankle, foot, elbow, forearm, wrist, and hand. The device produces transverse, sagittal, coronal, and oblique crosssectional images, displaying the internal structure of the limbs and joints being imaged. If interpreted by a medical expert, these images can provide diagnostically useful information.

Technology: The Optima MR430s employs the same fundamental scientific technology as its predicate device (MSK Extreme, K080048).

Determination of Summary of Non-Clinical Tests: Substantial Equivalence:

The Optima MR430s complies with voluntary standards as detailed in Sections 9 and 17 of this premarket submission. The following quality assurance measures were applied to the development of the system:

· Risk Analysis
Requirements Reviews .
Design Reviews ●
Design Verification Testing
System Verification Testing .
Performance testing (Verification) ●
. Safety testing (Verification)

The results of all testing performed indicate that the Optima MR430s meets the acceptance criteria and is substantially equivalent to the currently cleared 1.5T MSK Extreme (predicate device, cleared through K080048).

Summary of Clinical Tests:

As part of Verification testing, a non-significant risk study was performed to characterize onset levels for Peripheral Nerve Stimulation (PNS) in accordance with IEC 60601-2-33 for the

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K 103 238 p3/3

change in the gradient slew rate (300 T/m/s). No nerve sensation was reported. As a result, with respect to PNS, the system is not capable of operating outside of the Normal Operating Mode. The sample DICOM images included in this submission were also collected as part of a non-significant risk study. See Section 20 for more details of the studies performed.

GE Healthcare considers the Optima MR430s to be as safe, as Conclusion: effective, and performance is substantially equivalent to the predicate device(s).

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of a caduceus, a symbol often associated with medicine and healthcare, featuring a staff with a serpent entwined around it.

Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993

Ms. Norma J. LeMay Regulatory Affairs Leader GE Healthcare 301 Ballard Street, Suite 4 WILMINGTON MA 01887

FEB 25 2011

Re: K103238

Trade/Device Name: Optima MR430s 1.5T MR Scanner Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic Resonance diagnostic device Regulatory Class: II Product Code: LNH Dated: January 31, 2011 Received: February 1, 2011

Dear Ms. LeMay:

This letter corrects our substantially equivalent letter of February 11, 2011.

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 (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

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Page 2 - Ms. LeMay

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 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/Resourcesfor You/Industry/default.htm.

Sincerely yours,

ull D'Othen for

Mary Pastel, ScD. Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

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KID3238

510(k) Number (if known):

Device Name: Optima MR430s 1.5T MR Scanner

Indications for Use:

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (Part 21 CFR 801 Subpart C)

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

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

Vinny Spattt

Division Sign-off Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K163238

Page I 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.