The Superopen 0.23T(Modified) is intended to produce images that 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 (T), 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.

The Superopen 0.23T(Modified) is an imaging device, and is intended to provide the physician with indications for use. The system obtains images non-invasively and without the use of ionizing radiation. The MRI system produces transverse, coronal, sagittal, oblique, and curved cross-sectional images that display the internal structure of the head, body, or extremities. The images produced by 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 diagnosis determination.

Device Description

The Superopen 0.23T(Modified) is a 0.35T permanent magnet MRI system. The magnet is mainly made of NdFeB material. The system software based on Windows (TM) is an interactive program with user-friendly interface. Its functions cover scanning control, image reconstruction and image/archive management and maintenance.

AI/ML Overview

This document is a 510(k) summary for the Superopen 0.23T (Modified) Magnetic Resonance Diagnostic Device. It outlines the general information, intended uses, device description, and its substantial equivalence to a predicate device.

It's important to note that this 510(k) pertains to a magnetic resonance imaging (MRI) system, which is a diagnostic imaging device that produces images based on physical properties (proton distribution, relaxation times, flow). The context of this document is a regulatory submission for a medical device that generates images, not an AI or software device that analyzes images to provide a diagnosis or finding.

Therefore, the requested information about "acceptance criteria and the study that proves the device meets the acceptance criteria" in the context of an AI/software device performance (e.g., sensitivity, specificity, FROC, reader studies) is not directly applicable to this 510(k) submission for an MRI hardware system.

This 510(k) submission focuses on demonstrating the substantial equivalence of the modified MRI system to its predicate device, primarily through technical specifications, safety standards, and performance that is comparable to the predicate. It does not present clinical studies with specific performance metrics like sensitivity or specificity against a ground truth for diagnostic accuracy, as those are typically assessed for AI algorithms that interpret images.

However, I can extract information related to the device's technical specifications and how its performance is established to meet regulatory requirements through compliance with recognized standards.

No. 1 & No. 6: Table of Acceptance Criteria and Reported Device Performance / Standalone Performance

Since this is an MRI hardware system and not an AI algorithm, the concept of "acceptance criteria" and "reported device performance" are primarily related to its technical specifications, safety, and image quality for general diagnostic use, rather than specific disease detection metrics. The document asserts substantial equivalence to the predicate device (K033315: Superopen 0.23T).

The "performance" of an MRI system is typically demonstrated through:

Compliance with recognized standards: This ensures safety and fundamental operational characteristics.
Image quality assessment: This is typically done through phantom studies and clinical examples to show the system can produce diagnostically acceptable images.
Demonstration of intended capabilities: Showing it can perform various imaging sequences and image different anatomical regions.

Therefore, a direct table of "acceptance criteria" with numerical performance metrics like sensitivity/specificity for a specific diagnostic task is not present in this document because it's not a diagnostic AI/software. Instead, the document implies that the device performs equivalently to the predicate by meeting safety standards and having comparable technical capabilities.

Implied "Acceptance Criteria" (based on the document's content):

Acceptance Criteria Category	Description	Reported Device Performance/Evidence in Document
Intended Use	Ability to produce images reflecting spatial distribution of protons, useful for diagnosis by a trained physician.	"The Superopen 0.23T(Modified) is intended to produce images that reflect the spatial distribution of protons (hydrogen nuclei) exhibiting magnetic resonance." "When interpreted by a trained physician, these images provide information that can be useful in determining a diagnosis."
Substantial Equivalence	Device is comparable in type and substantially equivalent to predicate device (Superopen 0.23T, K033315) in technology and intended uses.	"The Superopen 0.23T(Modified) is of comparable type and substantially equivalent to the Superopen 0.23T (K033315) in that they are similar in technology and intended uses."
Safety Standards	Compliance with relevant electrical and medical device safety standards.	Listed Applicable Standards: IEC60601-1, IEC60601-2-33, 21 CFR Subchapter J, IEC60825-1, DICOM 3.0, NEMA MS Series (MS1-MS8).
Technical Specifications	Open-permanent-magnet system, 0.35T magnet, Gradient Subsystem, RF Subsystem, Windows-based software, 2D/3D image production, various imaging capabilities (e.g., SE, STIR, FLAIR, FE, FSE, MRA, EPI, Diffusion).	Device Description and Imaging Capabilities section details these features, confirming that the modified device has these core technical capabilities, similar to the predicate.
Anatomical Regions	Capable of imaging Head, Body, Spine, Extremities.	Explicitly stated in "Indications for use" table.
Diagnostic Uses	Capable of T1, T2, proton density weighted imaging, Diffusion weighted imaging, MR Angiography, and imaging processing.	Explicitly stated in "Indications for use" table.

Since this is an MRI system, a "standalone performance" (like for an AI algorithm) is not applicable in the same way. The device itself is "standalone" in its function as an imaging system, and its performance is assessed by its ability to generate images that meet quality and safety standards, comparable to the predicate.

No. 2, 3, 4, 5, 7, 8, 9:

These questions are geared towards the evaluation of an AI/software diagnostic device's clinical performance, typically involving a test set of cases, ground truth established by experts, and statistical analysis (e.g., sensitivity, specificity, FROC, reader studies).

As this 510(k) is for an MRI hardware system and does not include a clinical performance study demonstrating diagnostic accuracy for specific findings, the document does not provide information for the following points:

Sample size used for the test set and data provenance: No clinical test set for diagnostic accuracy is described.
Number of experts used to establish the ground truth: Not applicable, as there's no clinical ground truth for diagnostic performance analysis mentioned.
Adjudication method: Not applicable.
Multi-reader multi-case (MRMC) comparative effectiveness study: No such study is mentioned or required for this type of hardware submission.
Type of ground truth used: Not applicable for a hardware submission focused on substantial equivalence.
Sample size for the training set: Not applicable, as this is not an AI/ML device that requires a training set for diagnostic classification.
How the ground truth for the training set was established: Not applicable.

In summary: The provided 510(k) document is for an MRI hardware system (Superopen 0.23T Modified), demonstrating its substantial equivalence to a predicate device (Superopen 0.23T) based on technical features, safety standards compliance, and stated intended uses and capabilities. It does not contain information on clinical performance studies or acceptance criteria typically associated with AI/software diagnostic devices.

Summary

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Kobas60

Attachment 1

OCT 2 7 2006

Summary of Safety and Effectiveness

Page 1 of 2

This 510(k) summary of Safety and Effectiveness information is submitted in accordance with the requirements of 21 CFR Part 807.87(h)

General Information:

Product Name:	Superopen 0.23T
Product Model:	NAM-P023 A
CFR Section:	21 CFR Part 892.1000Magnetic resonance diagnostic device
Classification Name:	System, Magnetic Resonance Imaging
Product Code:	LNH
Device Class:	Class II
Applicable Standard:	IEC60601-1, Medical electrical equipment - Part 1: GeneralRequirements for SafetyIEC60601-2-33, Medical electrical equipment - Part 2-33: Particularrequirements for the safety of magnetic resonance equipment formedical diagnosis21 CFR Subchapter J, Radiological HealthIEC60825-1, Safety of laser products-Part1:Equipment classification,requirement and user's guideDICOM 3.0NEMA MS Series (MS1 - MS8)
Manufacture andDistributor:	Neusoft Medical Systems Co., Ltd.No.3-11, Wenhua Road, Heping District,Shenyang, ChinaPost Code : 110004
Submitter:	Contact : TianyanfangTitle : Manager of Q&R DepartmentTel : 86-24-83660649Fax : 86-24-83780480E-Mail : Tianyanfang@neusoft.comSummary prepared : August 15th, 2006

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Safety and Effectiveness information

Intended Uses:

Device Description:

Predicated Device:

K033315 : Superopen 0.23T

Statement of Substantial Equivalence:

The Superopen 0.23T(Modified) is of comparable type and substantially equivalent to the Superopen 0.23T (K033315) in that they are similar in technology and intended uses. It is a modified product based on the Superopen 0.23T. Both of these systems are open-permanent-magnet MR Imaging System, use Gradient Subsystem to provide controlled and uniform gradient magnet fields in the X, Y and Z planes, and use RF Subsystem to complete the function of RF signal transmitting/receiving and processing. Image reconstruction is controlled by console's computer that has an interactive user interface, and the system produces 2D and 3D image that can be filmed or electronically stored for future review. Both of these systems have the traditional MRI unit.

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Image /page/2/Picture/1 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 entwined around it, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged in a circular fashion around the symbol. The text is in all caps and appears to be in a sans-serif font. The logo is black and white.

Food and Drug Administration 9200 Cornorate Blvd. Rockville MD 20850

Mr. Tian Yanfang Manager of Quality Management Department Neusoft Medical System Co., Ltd No.3-11, Wenhua Road, Heping District Shenvang, Liaoning, 110004 R.P. CHINA

OCT 2 7 2006

Re: K062860

Trade/Device Name: Superopen 0.23T Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: LNH Dated: September 20, 2006 Received: September 25, 2006

Dear Mr. Yanfang:

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 (Premarket Approval), it may be subject to such 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.

Image /page/2/Picture/10 description: The image is a circular logo or emblem. The text "1886-1986" is at the top of the circle. The letters "FDA" are in the center of the circle. The word "Centennial" is at the bottom of the circle. There are stars around the circle.

Protecting and Promoting Public Health

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Please be advised that FDA's issuance of a substantial equivalence determination does not mean i tease be actised a determination that your device complies with other requirements of the Act that I Dr. Head statutes and regulations administered by other Federal agencies. You must of any I vith all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic fordinal in the quant) byeveline (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 510(k) I mis letter will and in Jours substantial equivalence of your device of your device to a legally premailer nodicate 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 Part 801), please if you desire specifice at one of the following numbers, based on the regulation number at the top of this letter:

21 CFR 876.xxx	(Gastroenterology/Renal/Urology)	240-276-0115
21 CFR 884.xxx	(Obstetrics/Gynecology)	240-276-0115
21 CFR 894.xxx	(Radiology)	240-276-0120
Other		240-276-0100

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (240) 276-3150

or at its Internet address http://www.fda.gov/cdrl/industry/support/index.html.

Sincerely yours,

Nancy C. Hogdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Neusoft

510(k)

Page 2 of 2 Attachment 2

510(k) Number (if Known)

Device Name: Superopen 0.23T Indications for use:

indications for use.

The Superopen 0.23T(Modified) is an imaging device, and is intended to provide the physician with The bapt open olds it (1/2 and invasively and without the use of ionizing radiation. The MRI system produces transverse, coronal, sagittal, oblique, and curved cross-sectional images that display the internal structure of the head, body, or extremities. The images produced by 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 diagnosis determination.

KOL2860

The indications for use are as follows:

Anatomical Region:	Head, Body, Spine, Extremities
Nucleus excited:	Proton
Diagnostic uses:	T1, T2, proton density weighted imaging
	Diffusion weighted imaging
	MR Angiography
	Imaging processing
Imaging capabilities:	2D, 3D Spin Echo( SE )
	Short time inversion recovery (STIR)
	Fluid attenuated inversion recovery (FLAIR)
	2D,3D Field Echo (FE)
	2D, 3D Field Echo with Spoiler (FESP)
	2D FESP Multi-Slice (FESP-MS)
	2D and 3D Field Echo Steady State FID with rephasing
	gradient (FESS-FID)
	2D, 3D Fast Spin Echo (FSE)
	2D, 3D MRCP
	MR Angiography
	2D, 3D TOF
	MTC
	Echo Planar Imaging (EPI)
	Multi-shot SE / FE
	Diffusion

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

David h. Leyman

(Division Sign-Off) Division of Reproductive, Abdo and Radiological Devices 510(k) Number

Prescription Use

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.