The OPER Series Open Type Permanent-Magnet MRI System is an open, whole body scanner. It is indicated for use as a diagnostic imaging device to produce transverse, sagittal, coronal and oblique images of the internal structures and organs of the head, body, or extremities. The images produced by the OPER Series Open Type Permanent-Magnet MRI System reflect the spatial distribution of protons (hydrogen nuclei) exhibiting magnetic resonance. The NMR properties that determine the image appearance are proton density, spin-lattice relaxation time (T1), spin-spin relaxation time (T2) and flow. When interpreted by a trained physician, these images provide information that can be useful in determining a diagnosis.

Device Description

The OPER Series Open Type Permanent-Magnet MRI System (OPER MRI) is a series of open permanent magnet MRI system, with magnetic field strength of 0.3T, and 0.4T, respectively. The model number for each of the corresponding system is OPER-0.3, OPER-0.35, and OPER-0.4, respectively. The OPER MRI system utilizes a permanent magnet to acquire 2D single-slice and multislice and 3D volume images. A wide range 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 and flow compensation are provided to suppress artifacts due to physiological motion and improve image quality.

AI/ML Overview

This document describes the safety and effectiveness of the OPER Series Open Type Permanent-Magnet MRI System, but it does not contain a study that proves the device meets specific acceptance criteria with quantifiable results.

Instead, it presents a statement of substantial equivalence to predicate devices. This means the manufacturer is asserting their device is as safe and effective as other legally marketed devices, rather than providing independent clinical trial data with acceptance criteria.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" with numerical thresholds that the device was tested against in a study and then reported its performance.

Instead, it lists "safety parameters with action levels" and "performance levels" that were evaluated against NEMA performance standards and IEC safety standards. The document concludes that the device "was evaluated to the appropriate NEMA performance standards as well as the IEC 60601-1 international medical equipment safety standards and the IEC 60601-2-33 Particular requirements for the safety of magnetic resonance equipment for medical diagnosis."

Therefore, I cannot create a table with specific acceptance criteria and reported device performance from the provided text.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

This information is not provided in the document. The document describes the technical specifications and intended use of the MRI system but does not detail any specific test sets, patient data, or study designs (retrospective/prospective).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

This information is not provided in the document. Since there is no mention of a specific test set or clinical study to validate performance, the concept of establishing ground truth by experts for such a test set is not discussed. The "Indications for Use" section mentions that images are "interpreted by a trained physician," implying the need for medical expertise in the clinical use of the device, but not for a performance study.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

This information is not provided in the document. As no specific test set or clinical study is described, no adjudication method is mentioned.

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

This information is not provided in the document. The OPER Series MRI System is a diagnostic imaging device, not an AI-powered image interpretation tool. Therefore, an MRMC study comparing human readers with and without AI assistance is irrelevant and not mentioned.

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

This information is not provided in the document. The OPER Series MRI System is an imaging device, not an algorithm, so a standalone algorithm performance study is not applicable.

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

This information is not provided in the document. Given the absence of a described performance study or test set, there is no mention of the type of ground truth used.

8. The sample size for the training set

This information is not provided in the document. The OPER Series MRI System is a hardware device for image acquisition, not a machine learning algorithm that requires a training set.

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

This information is not provided in the document. As above, the device is hardware, not an AI model, so the concept of a "training set" and its "ground truth" is not applicable.

Summary

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Document No.		XGY/JW JS-20-003	Page 8 of 25
Ningbo Xingaoyi Magnetism Co., Ltd.	Editor	Technical Dept.	Date	2009-10-15
Response to FDA Reviewer QuestionsTitle OPER Series Open Type Permanent-MagnetMRI System - Supplement 1	Revision	A0	Implementation Date	2009-10-15

NOV 1.0 2009

Appendix S1-2 Revised 510(k) Summary

1. 510(k) Summary

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 ad 21CFR 807.92.

2. General Information

Establishment:		Ningbo Xingaoyi Magnetism Co., Ltd.
Address:		East Tanjialing Road, South Area of Economic Development Zone,Yuyao,Zhejiang, China, 315400
Phone:		+86 574-62730899 - 8011
Fax:		+86 574-62730908
RegistrationNumber:		Xingaoyi will perform establishment registration and device listing before marking the device
Contact Person:		Jiang, MowenTechnology Department Manager, Quality RepresentativePhone:+86 574-62730899 -8011E_Mail: Jiangmowen@163.com or Jiangmowen@gmail.com
Date of SummaryPreparation:		August 31, 2009
Device Name:	Trade Name:	OPER Series Open Type Permanent-Magnet MRISystem, Model: OPER-0.3, OPER-0.35, and OPER-0.4
	Classification Number:	CFR 892.1000 90-LNH
	Classification:	Class II

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Ningbo Xingaoyi Magnetism Co., Ltd.	DocumentNo.	XGY/JW JS-20-003	Page 9 of 25
	Editor	TechnicalDept.	Date	2009-10-15
Response to FDA Reviewer QuestionsTitle OPER Series Open Type Permanent-MagnetMRI System - Supplement 1	Revision	A0	ImplementationDate	2009-10-15

Applicable Standards:

IEC60601-1: Medical electrical equipment-Part 1 General Requirement for safety IEC60601-2-33: Medical electrical equipment-Part 2-33 Particular requirement for the safety of magnetic resonance equipment for medical diagnosis. 21CFR subchapter J, Radiological Health IEC60825-1 Safety of laser products-Part 1: Equipment classification, requirement and user's guide. DICOM 3.0 PS 3.2 NEMA MS Series (MS1-MS6,MS8)

3. Safety and Effectiveness Information.

3.1 Device Description

3.2 Scientific Concepts

Magnetic Resonance (MR) is based on the fact that certain atomic nuclei have electromagnetic properties which cause them to act as small spinning bar magnets. The most ubiquitous of these nuclei is hydrogen, which makes it the primary nucleus used in current imaging experiments in MR. When placed in a magnetic field, there is a slight net orientation or alignment of these atomic nuclei with the magnetic field. The introduction of a short burst of radio frequency (RF) excitation of wavelength specific to the magnetic field strength and to the atomic nuclei under consideration can cause a reorientation of the proton's magnetization vector. When the RF excitation is removed, the proton relaxes and returns to its original orientation. The rate of relaxation is exponential, and varies with the character of the proton and its adjacent molecular environment. This reorientation process is characterized by exponential relaxation times called T1 and T2 which can be measured.

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Image: Logo of Ningbo Xingaoyi Magnetism Co., Ltd.Ningbo Xingaoyi Magnetism Co., Ltd.	Document No.	XGY/JW JS-20-003		Page 10 of 25
	Editor	Technical Dept.	Date	2009-10-15
Title	Response to FDA Reviewer QuestionsOPER Series Open Type Permanent-MagnetMRI System - Supplement 1	Revision	A0	Implementation Date	2009-10-15

These relaxation events are accompanied by an RF emission or echo which can be measured and used to develop a representation of these emission on a three dimensional matrix. Spatial localization is encoded into the echo by varying the RF excitation and by applying magnetic field gradients in x, y, and z directions, and changing the direction and strength of these gradients. Images depicting the spatial distribution of NMR characteristics of the nuclei under consideration can be constructed by using image processing techniques similar to those used in CT

3.3 Physical and Performance Characteristics

MR is capable of producing high quality anatomical images without the associated risks of ionizing radiation. In addition, the biological properties that contribute to MR image contrast are different from those responsible for x-ray image contrast. In x-ray imaging, differences in x-ray attenuation, largely based on differences in electro density are responsible for the contrast observed in x-ray images. In MR imaging, differences in proton density, blood flow, and relaxation time T1 and T2 all may contribute to image contrast. In addition, by varying the pulse sequence characteristics, images may be produced in which the contrast is primarily dependent on T1 relaxation, proton density, or the molecular diffusion of water or other proton containing molecules.

3.4 Intended Use

The OPER Series Open Type Permanent-Magnet MRI System is an open, whole body scanner. It is indicated for use as a diagnostic imaging device to produce transverse, sagittal, coronal and oblique images of the internal structures and organs of the head, body, or extremities. The images produced by the OPER Series Open Type Permanent-Magnet MRI System reflect the spatial distribution of protons (hydrogen nucle) exhibiting magnetic resonance. The NMR properties that determine the image appearance are proton density, spin-lattice relaxation time (T1), spin-spin relaxation time (T2) and flow. When interpreted by a trained physician, these images provide information that can be useful in determining a diagnosis.

3.5 Predicated Devices

Hitachi AIRIS II, manufactured by Hitachi Medical Systems America, Inc. K974212:
AIRIS II Version 4.1 Software, manufactured by Hitachi Medical Systems America, Inc. K001334:
Superopen 0.35T, Model NSM-P035 MRI System, manufactured by Neusoft Digital Medical K030918: Systems Co., Ltd.

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Image: LogoNingbo Xingaoyl Magnetism Co., Ltd.	DocumentNo.		XGY/JW JS-20-003	Page 11 of 25
	Editor	TechnicalDept.	Date	2009-10-15
Response to FDA Reviewer QuestionsTitle OPER Series Open Type Permanent-MagnetMRI System - Supplement 1	Revision	A0	ImplementationDate	2009-10-15

3.6 Statement of Substantial Equivalence

The OPER Series Open Type Permanent-Magnet MRI System (OPER MRI) is of comparable type and substantially equivalent to Hitachi AIRIS II (K974212) and AIRIS II version 4.1 Software (K001334), and Neusoft NSM-P035 MRI System (K030918) in that they are similar in technology and intended uses. All three of these systems are open-permanent-magnet MRI Imaging System, use Gradient Subsystem to provide controlled and uniform gradient magnetic fields in the X, Y and Z directions, and use RF Subsystem to complete the function of RF signal transmitting/receiving and processing. Image reconstruction is controlled by console that has an interface, and the system produces 2D and 3D image that can be filmed or electronically stored for future review. All three of these systems have the traditional MRI units.

3.7 General Safety and Effectiveness Concerns

Operation of the OPER Series Open Type Permanent-Magnet MRI System (OPER MRI) is substantially equivalent to the commercially available Hitachi AIRIS II and Neusoft NSM-P35. The following are the safety parameter with action levels:

Maximum Static Field
Rate of Change of Magnetic Field(dB/dt)
RF Power Deposition(SAR) .
Acoustic Noise Levels ●

and performance levels:

. Specification Volume
Signal to Noise
. Image Uniformity
. Geometric Distortion
. Slice Profile, Thickness and Gap
High Contrast Spatial Resolution

specified by the FDA guidance document for MR Diagnostic Devices that were evaluated.

Summary of Results:

The OPER Series Open Type Permanent-Magnet MRI System was evaluated to the appropriate NEMA performance standards as well as the IEC 60601-1 international medical equipment safety standards and the IEC 60601-2-33 Particular requirements for the safety of magnetic resonance equipment for medical diagnosis. The OPER Series Open Type Permanent-Magnet MRI System is substantially equivalent to its Predicate Devices in terms of safety and effectiveness.

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Image /page/4/Picture/0 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo features a stylized image of an eagle or bird with three curved lines forming its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the bird image.

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

Ningbo Xingaovi Magnetism Co., Ltd. % Mr. Mark Job Responsible Third Party Official Regulatory Technology Services LLC 1394 25th Street NW BUFFALO MN 55313

NOV 1 0 2009

Re: K092899

Trade/Device Name: OPER Series Open Type Permanent-Magnet MRI System Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device-Regulatory Class: II Product Code: LNH Dated: October 21, 2009 Received: October 22, 2009

Dear Mr. Job:

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 of medical

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Enclosure

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,

Janine M. Morris

Janine M. Morris Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

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Image: [logo]Ningbo Xingaoyi Magnetism Co., Ltd.	DocumentNo.	XGY/JW JS-20-003		Page 7 of 25
	Editor	TechnicalDept.	Date	2009-10-15
Title	Response to FDA Reviewer QuestionsOPER Series Open Type Permanent-MagnetMRI System - Supplement 1	Revision	A0	ImplementationDate	2009-10-15

Appendix S1-1 Revised Indications for Use Statement

Indications For Use

510(k) Number (if known):

Device Name: OPER Series Open Type Permanent-Magnet MRI System

Indications for Use:

CAUTION: Federal (US) law restricts the use of this device to licensed professionals.

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

Arny MWh

Reproductive, Abdominal, and Radiological Dev 510(k) Number

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.