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.

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 document is a 510(k) Premarket Notification Submission for the GE Healthcare Optima MR430s MRI Scanner. It details the device's description, intended use, and the basis for its substantial equivalence to a predicate device.

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

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state acceptance criteria in terms of performance metrics (e.g., sensitivity, specificity, accuracy) for diagnosis or detection. The submission is for a magnetic resonance imaging device rather than a software algorithm that provides a diagnostic output.

Instead, the acceptance criteria are implicit in the Substantial Equivalence determination. The core assertion is that the "modified Optima MR430s employs the same fundamental scientific technology as the unmodified predicate device" and that it is "as safe, as effective, and performance is substantially equivalent to the predicate device."

Therefore, the "reported device performance" is essentially that it meets the safety and effectiveness standards of its predicate device (K103238, Optima MR430s MRI Scanner).

Table:

Acceptance Criteria Category	Specific Criteria	Reported Device Performance
Safety	The modified device must be as safe as the predicate device. This is assessed through risk analysis and compliance with voluntary standards.	"GE Healthcare considers the Optima MR430s to be as safe... as the predicate device." Compliance with voluntary standards and risk analysis performed.
Effectiveness	The modified device must be as effective as the predicate device in producing diagnostically useful images of the specified anatomical regions (leg, knee, ankle, foot, elbow, forearm, wrist, and hand). This implies producing high-quality transverse, sagittal, coronal, and oblique cross-sectional images displaying internal structures.	"GE Healthcare considers the Optima MR430s to be as... effective... as the predicate device." The device produces the required image types for medical expert interpretation.
Performance	The device's performance (e.g., image quality, operational characteristics) must be substantially equivalent to the predicate device. This is assessed through non-clinical tests (Performance Testing/Verification, System Validation Testing), design reviews, and requirements reviews. The "fundamental scientific technology" remains the same.	"GE Healthcare considers the Optima MR430s to be... performance is substantially equivalent to the predicate device." "The modified Optima MR430s employs the same fundamental scientific technology as the unmodified predicate device." Non-clinical tests were conducted (Performance Testing, System Validation Testing).

2. Sample size used for the test set and the data provenance

The document explicitly states: "The modification that prompted this submission did not require clinical testing." This indicates that there was no clinical test set of patient data used for this specific 510(k) submission. The evaluation was based on non-clinical tests to demonstrate substantial equivalence to the predicate device, which would have had its own testing data.

Therefore, no information on sample size or data provenance for a clinical test set is provided.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Given that clinical testing was not required for this submission, there were no experts used to establish ground truth for a clinical test set in this context. The "diagnostically useful information" from the images is expected to be interpreted "by a medical expert" in real-world clinical use, but this is not part of the current device's evaluation for this 510(k).

4. Adjudication method for the test set

Not applicable, as no clinical test set was required or used for this submission.

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

Not applicable. This submission is for an MRI imaging device, not an AI-powered diagnostic algorithm or an assistive tool for human readers. No MRMC study or AI assistance is mentioned.

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

Not applicable. This is an imaging device, not a standalone algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not applicable, as no clinical test set evaluating diagnostic performance was conducted for this submission. The ground truth for the device's technical specifications and image quality would have been established through engineering and performance testing against defined standards.

8. The sample size for the training set

Not applicable. This is an MRI imaging device, not a machine learning or AI algorithm that requires a training set of data.

9. How the ground truth for the training set was established

Not applicable. As noted above, this is not an AI/ML device that uses a training set.

Summary

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Image /page/0/Picture/1 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'GE' intertwined and enclosed within a circle. The letters and the circle are black, creating a strong contrast against the white background.

NOV 1 3 2012

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: September 19, 2012

GE Medical Systems, LLC (GE Healthcare) Submitter: 301 Ballardvale Street, Suite 4 Wilmington, MA 01887

Primary Contact Person:

Yuan Ma Regulatory Affairs Manager GE Medical Systems, LLC (GE Healthcare) Tel: (781) 262-5581 Fax: (414) 908-9390 yuan.ma@med.ge.com

Secondary Contact Person:

Glen Sabin Regulatory Affairs Director GE Healthcare (GE Medical Systems, LLC) (262) 521-6848 (262) 364-2785 Glen.Sabin@med.ge.com

Establishment Registration Number:

3008193097

Optima MR430s Device Trade Name:

Common/Usual Name: Magnetic Resonance Imaging System

Classification 21 C.F.R. 892.1000 Magnetic Resonance Diagnostic Device · Names:Product Code: LNH

Predicate Device(s): K103238, Optima MR430s MRI Scanner

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.

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Image /page/1/Picture/19 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 border. The border has decorative swirls or flourishes at regular intervals around the circle.

GE Healthcare

510(k) Premarket Notification Submission

Intended Use:

The modified Optima MR430s employs the same fundamental

scientific technology as the unmodified predicate device.

Technology:

Determination of Substantial Equivalence:

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

. Risk Analysis
Requirements Reviews .

Summary of Non-Clinical Tests:

. Design Reviews
Performance Testing (Verification) ●
System Validation Testing .

Summary of Clinical Tests:

The modification that prompted this submission did not require clinical testing.

Conclusion:

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

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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, topped by a single wing. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002

GE Medical Systems, LLC Speciality MR 301 Ballardvale Street Suite 4 Wilmington, MA 01887

NOV 1 3 2012

Re: K123068

Trade/Device Name: OPTIMA MR430s Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic Resonance Diagnostic Device Regulatory Class: Class II Product Code: LNH Dated: October 01, 2012 Received: October 16, 2012

Dear Dr. Ma: .

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.

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

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Page 2 - Yuan Ma

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 Parts 801 and 809), please contact the Office of In Vitro Diagnostics and Radiological Health 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 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/cdrh/industry/support/index.html.

Sincerely yours,

Michael D. O'hara 2012.11.09 15:33:15-05'00'

Janine 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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K123068

510(k) Number (if known):

Device Name: Optima MR430s

Indications for Use:

The Optima MR430s MR 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 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.

X Prescription Use (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)

Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety 510(k) 123068

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.