The MR Radiation Oncology Options are a patient positioning package intended for use with the GE wide bore MR scanners. The MR Radiation Oncology Options when used with a GE wide bore MR scanner is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio and short scan times. The GE wide bore MR scanners with MR Radiation Oncology Options are indicated for use as a diagnostic imaging device to provide axial, sagittal, coronal, and oblique images, spectroscopic images, and/or spectra, dynamic images of the internal structures and organs 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. The images produced by the GE wide bore scanners with MR Radiation Oncology Options reflect the spatial distribution of protons (hydrogen nuclei) exhibiting magnetic resonance. These images and/or spectra when interpreted by a trained physician yield information that may assist in diagnosis.

The MR Radiation Oncology Options include a removable patient table insert for GE wide bore MR scanners that allow patients to be imaged on a flat surface. The flat patient surface allows image acquisition in patient positions similar to other modalities that also use a flat patient surface such as X-Ray, CT, PET, and radiation therapy. The GE wide bore MR scanners with the MR Radiation Oncology Options may also be used with MRcompatible patient positioning and immobilization accessories to assist in obtaining consistent patient positions throughout multiple imaging sessions.

Device Description

The MR Radiation Oncology Options includes a radiation therapy insert that can be used with wide bore (70cm) GE MR scanners for radiation therapy planning. The MR Radiation Oncology Options is similar to the existing GE Signa®MR Oncology Package offered with GE Signa®MR Systems. MR Radiation Oncology Options utilizes a radiation therapy table insert that allows patients to be imaged on a flat surface that matches the imaging patient position. The MR Radiation Oncology Options may be used with MR compatible patient positioning accessories and a 3 pin Lok-Bar.

AI/ML Overview

The provided text is a 510(k) Premarket Notification Submission for a medical device called "MR Radiation Oncology Options" by GE Healthcare. This submission focuses on demonstrating substantial equivalence to a predicate device rather than presenting a performance study with detailed acceptance criteria and quantitative results for a new clinical indication.

Therefore, many of the requested details about acceptance criteria, specific performance metrics, sample sizes for test sets, expert qualifications, and ground truth establishment are not present in this type of submission document.

Here's an analysis based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance:

No specific quantitative acceptance criteria or reported device performance metrics are provided in the document in the format requested, as this is a substantial equivalence submission. The primary "acceptance criterion" for this type of submission is demonstrating that the new device is as safe and effective as the predicate device.

The document states:

"The non-clinical tests outlined above have been executed with acceptable results." (Referring to Risk Analysis, Requirements Reviews, Design Reviews, Subsystem Level Testing, Safety testing).
"Clinical image comparisons demonstrate that the Radiation Oncology Options maintains the same imaging performance results as the GE Signa® MR Oncology Package with existing patient table."
"GE Healthcare considers the MR Radiation Oncology Options 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 the data provenance:

Sample size: Not explicitly stated. The document mentions "Simulated use testing" and "Clinical image comparisons" but does not quantify the number of cases or subjects used for these tests.
Data provenance: Not specified (e.g., country of origin, retrospective or prospective).

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

Not specified. There's no mention of a formal ground truth establishment process involving experts in the context of this submission. The "clinical image comparisons" likely refer to comparing images from the new device with those from the predicate device.

4. Adjudication method for the test set:

Not specified.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, What was the effect size of how much human readers improve with AI vs without AI assistance:

No MRMC comparative effectiveness study is mentioned. This device is an accessory for patient positioning in MR imaging, not an AI-powered diagnostic tool. The focus is on maintaining imaging performance while offering improved patient positioning features for radiation oncology planning.

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

Not applicable. This device is a physical accessory (patient positioning package, table insert) for an MR scanner, not an algorithm.

7. The type of ground truth used:

The implicit "ground truth" for demonstrating substantial equivalence is the imaging performance and safety of the predicate device (GE Signa® MR Oncology Package, K081916). The comparison is made to show that the new device's images are comparable ("maintains the same imaging performance results") to those of the predicate. This is based on "Clinical image comparisons," but the specific details of how this comparison was qualified are not provided.

8. The sample size for the training set:

Not applicable. This is a hardware accessory, not a machine learning algorithm that requires a training set.

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

Not applicable, as there is no training set for this device.

Summary

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K102155

Image /page/0/Picture/1 description: The image shows a logo for General Electric (GE). The logo is a circular design with the letters "GE" intertwined in the center. The letters are stylized and have a vintage look. The logo is black and white.

AUG 3 1 2010

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:	July 28, 2010
Submitter:	GE Healthcare (GE Medical Systems, LLC)
	3200 N. Grandview Blvd.
	Waukesha, WI 53188
	USA
Primary Contact Person:	Tracey Fox
	Regulatory Affairs Manager
	GE Healthcare (GE Medical Systems, LLC)
	(262) 521-6079
	(262) 521-6439
Secondary Contact Person:	Ayesha Pergadia
	RA Leader
	GE Healthcare (GE Medical Systems, LLC)
	(262) 521-6424
	(262) 521-6439
Device: Trade Name:	MR Radiation Oncology Options
Common/Usual Name:	Patient Positioning Accessory for Magnetic Resonance ImagingSystem
Classification Names:	21 C.F.R. 892.1000Magnetic Resonance Diagnostic Device
Product Code:	LNH

Predicate Device(s): Device Description:

ﺎﺕ ﺍﻟﻤﺴﺘﻮﻯ

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GE Signa® MR Oncology Package, K081916 The MR Radiation Oncology Options includes a radiation therapy insert that can be used with wide bore (70cm) GE MR scanners for radiation therapy planning. The MR Radiation Oncology Options is similar to the existing GE Signa®MR Oncology Package offered with GE Signa®MR Systems. MR Radiation Oncology Options utilizes a radiation therapy table insert that allows patients to be imaged on a flat surface that matches the imaging patient position. The MR Radiation Oncology Options may be used with MR compatible patient positioning accessories and a 3 pin Lok-Bar. . .

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Image /page/1/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'G' and 'E' intertwined in a stylized script. The letters are enclosed within a circular border. The logo is black and white.

GE Healthcare

Intended Use:

510(k) Premarket Notification Submission

Technology:

The MR Radiation Oncology Options employs the same fundamental scientific technology as its predicate device. .. . Summary of Non-Clinical Tests:

The MR Radiation Oncology Options and its applications comply with voluntary standards as detailed in Section 9, 11 and 18 of this premarket submission. The following quality assurance measures were applied to the development of the system:

. Risk Analysis
. Requirements Reviews
. Design Reviews
Subsystem Level Testing (Verification)
Safety testing (Verification)

Determination of Substantial Equivalence:

Page 3 of 4

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Image /page/2/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'G' and 'E' intertwined within a circular border. The logo is black and white.

GE Healthcare

510(k) Premarket Notification Submission

The non-clinical tests outlined above have been executed with acceptable results. Refer to Section 9.1 of this submission for safety testing and section 18 for verification testing.

Summary of Clinical Tests:

Simulated use testing was performed as part of the MR Radiation Package Design Validation. Oncology Clinical image comparisons demonstrate that the Radiation Oncology Options maintains the same imaging performance results as the GE Signa® MR Oncology Package with existing patient table.

GE Healthcare considers the MR Radiation Oncology Options to be as safe, as effective, and performance is substantially equivalent to the predicate device(s).

Conclusion:

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Image /page/3/Picture/0 description: The image shows the logo for the Department of Health & Human Services USA. The logo features a stylized eagle with three wavy lines representing its body and wings. The eagle is facing right. 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

AUG 31 2010

GE Medical System, LLC 3200 N. Grandview Blvd. Waukesha, WI 53188 Attn: Tracey Fox

Re: K102155

Trade/Device Name: MR Radiation Oncology Options Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic Resonance Diagnostic Device Regulatory Class: II Product Code: LNH Dated: July 28, 2010 Received: July 30, 2010

Dear Ms. Fox:

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 class II (Special Controls), it may be subject to such additional controls. Existing major regulations 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 I lease of actives that I Drivers and over device complies with other requirements of the Act that I Dri has made a avon regulations administered by other Federal agencies. You must or any I cocial statuted and registements, including, but not limited to: registration and listing (21 Colliply with an the Act 31equirements, increases, as a so

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medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate 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 801 and 809), please contact the Office of In Vitro Diagnostic 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

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.

Donald J. Trump

Donald J. St.Pierre Acting 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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Kl02/55

GE Healthcare 510(k) Premarket Notification Submission

510(k) Number (if known): |(02155 Device Name: MR Radiation Oncology Options

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 CPRH, Qffice of In Vitro Diagnostic Devices (OIVD)

Dmal

Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety 510(k) K182155

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.