The Superopen 0.35T 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 (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.

The Superopen 0.35T is an imaging device, and is intended to provide the physician with physiological and clinical information obtained 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.

Diffusion weighted imaging

MR Angiography

The indications for use are as follows:

Anatomical Region: Head, Body, Spine, Extremities Nucleus excited: Proton T1,T2, proton density weighted imaging Diagnostic uses:

Imaging capabilities:

Imaging processing 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

Device Description

The Superopen 0.35T 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

The provided text does not contain information about specific acceptance criteria, a study proving device performance against those criteria, or the details about sample sizes, expert involvement, and ground truth establishment typically found in a clinical performance study summary.

Instead, the document is a 510(k) summary for a Magnetic Resonance Imaging (MRI) system (Superopen 0.35T) seeking substantial equivalence to a predicate device (Hitachi AIRIS II and its software).

Here's a breakdown of what the document does provide, and what it lacks in relation to the prompt's request:

Information Present in the Document:

Device Description and Intended Use: The document clearly outlines the Superopen 0.35T as a 0.35T permanent magnet MRI system intended to produce images for diagnostic purposes by trained physicians. It lists various imaging capabilities and anatomical regions.
Predicate Device: It identifies the Hitachi AIRIS II (K974212) and AIRIS II Version 4.1 Software (K001334) as the predicate devices for substantial equivalence.
Substantial Equivalence Statement: The Superopen 0.35T is deemed substantially equivalent based on similar technology, intended uses, and functional components (magnet system, gradient subsystem, RF subsystem, image reconstruction, etc.).
Regulatory Information: It includes CFR sections, classification name, product code, device class, applicable standards (IEC, DICOM, NEMA), and manufacturer details.

Information Not Present in the Document (and therefore, cannot be provided in response to the prompt):

Acceptance Criteria Table and Reported Device Performance: There is no specific table defining performance metrics (e.g., sensitivity, specificity, accuracy, image quality scores) or acceptance thresholds. The document asserts substantial equivalence based on technical and functional similarity, not on a detailed performance study with defined criteria.
Sample Sizes and Data Provenance for Test Set: No information is provided about a specific "test set" of images or patients used for performance evaluation. The substantial equivalence argument relies on the predicate device's established performance rather than a new clinical study.
Number of Experts and Qualifications for Ground Truth: Since no independent performance study is detailed, there's no mention of experts establishing ground truth for a test set.
Adjudication Method: Not applicable as there's no described performance study or ground truth establishment process involving multiple readers.
Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: No MRMC study is mentioned. The submission is for a standalone imaging device, not an AI-assisted diagnostic tool.
Standalone Performance (Algorithm Only): The device itself is a standalone MRI system, but the prompt's context usually refers to an algorithm's performance. There is no algorithm performance discussed in the AI sense.
Type of Ground Truth Used: Not applicable in the context of a new performance study.
Sample Size for Training Set: No information on a training set as this is a medical device submission based on substantial equivalence, not an AI algorithm development and validation.
How Ground Truth for Training Set Was Established: Not applicable.

Conclusion:

The provided 510(k) summary focuses on demonstrating substantial equivalence of the Superopen 0.35T MRI system to existing legally marketed devices based on technological similarities and intended use. It does not present a clinical study with detailed acceptance criteria or performance metrics for the device itself. Therefore, I cannot construct the requested table or offer the detailed study information as it is not present in the provided text.

Summary

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Attachment 1

APR 0 1 2003

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:

Trade Name:	Superopen 0.35T
Model:	NSM-P035 (MRI System)
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 classificationrequirement and user's guideDICOM 3.0NEMA MS Series (MS1 - MS8)
Manufacture andDistributor:	NEUSOFT Digital Medical Systems Co., Ltd.No.3-11, Wenhua Road, Heping District,Shenyang, ChinaPost Code : 110004
Submitter:	Contact : Wang ZhiqiangTitle : Manager of Quality Management DepartmentTel : 86-24-83665003Fax : 86-24-23782711E-Mail : wangzq@neusoft.com
	Summary prepared : Mar. 14th, 2003

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510(k)

Page 2 of 2

Safety and Effectiveness information

Intended Uses:

Device Description:

Predicated Device:

K974212 : AIRIS II (MRI System) K001334: AIRIS II Version 4.1 Software

Statement of Substantial Equivalence:

The Superopen 0.35T is of comparable type and substantially equivalent to the Hitachi AIRIS II (K974212) and the AIRIS II Version 4.1 Software(K001334) in that they are similar in technology and intended uses. 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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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 0 1 2003

Neusoft Digital Medical Systems, Co. Ltd. % Mr. Heinz Joerg Steneberg TUV Rheinland of North America 12 Commerce Road NEWTOWN CT 06470

Re: K030918

Trade/Device Name: Superopen 0.35T Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: 90 LNH Dated: March 20, 2003 Received: March 24, 2003

Dear Mr. Steneberg:

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); 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.

Image /page/2/Picture/11 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 healthcare, featuring a staff with a serpent entwined around it.

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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 Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of the letter:

8xx. 1xxx	(301) 594-4591
876.2xxx, 3xxx, 4xxx, 5xxx	(301) 594-4616
884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx	(301) 594-4616
892.2xxx, 3xxx, 4xxx, 5xxx	(301) 594-4654
Other	(301) 594-4692

Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Nancy C. Brogdon

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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Attachment 2 Page 2 of 2

Ko30 918 510(k) Number (if Known) Device Name: Superopen 0.35T Indications for use:

Diffusion weighted imaging

MR Angiography

The indications for use are as follows:

Anatomical Region: Head, Body, Spine, Extremities Nucleus excited: Proton T1,T2, proton density weighted imaging Diagnostic uses:

Imaging capabilities:

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

David A. Lessem

(Division Sign-Off) Division of Reproductive. A 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.