The Superopen 0.23T 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.

The indications for use are as follows:

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

Device Description

The Superopen 0.23T is a 0.23T 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 MRI System, not a study report. Therefore, it does not contain the detailed information requested regarding acceptance criteria and a specific study proving the device meets them.

The document states that the device is "substantially equivalent" to a predicate device (NEUSOFT Superopen 0.35T, K030918) based on similarities in technology and intended uses. This means the FDA cleared the device not by requiring a study demonstrating it meets specific performance acceptance criteria, but by determining it is as safe and effective as a device already on the market.

Therefore, for each of your requested points, the answer is that the information is not provided in this 510(k) summary.

Here's a breakdown based on the provided document:

A table of acceptance criteria and the reported device performance
- Not provided. This document is a 510(k) summary demonstrating substantial equivalence, not a performance study report with specific acceptance criteria and detailed performance metrics.
Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not provided. The 510(k) process for this type of device often relies on demonstrating technical equivalence and similarity to a predicate, rather than new clinical trials with a test set of patient data.
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)
- Not provided. Ground truth establishment for a test set is part of a clinical performance study, which is not detailed here.
Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not provided. Adjudication methods are relevant for studies involving human interpretation of results, which is not described.
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 provided. This document describes an MRI system, not an AI-assisted diagnostic tool. Therefore, an MRMC study related to AI assistance would not be relevant or expected.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not provided. This is an MRI system, not a standalone algorithm. Its performance is inherent to its scanning capabilities, which are deemed substantially equivalent to a predicate.
The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- Not provided. As no specific performance study against a ground truth is described, this information is absent.
The sample size for the training set
- Not provided. Training set information is relevant for AI/machine learning models. This document describes an MRI system, which doesn't typically have a "training set" in that context. Its "training" would be its design, calibration, and engineering to meet technical specifications.
How the ground truth for the training set was established
- Not provided. Similar to the point above, this is not applicable or detailed for an MRI system's substantial equivalence submission.

Summary

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Attachment 1

KO 33315

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 0.23T
Model:	NAM-P023A (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 classification,requirement 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, P.R.ChinaPost Code : 110004
Submitter:	Contact : Wang ZhiqiangTitle : Manager of Quality Management DepartmentTel : 86-24-83665003Fax : 86-24-23782711E-Mail : wangzq@neusoft.comSummary prepared : July 16th, 2003

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510(k)

Page 2 of 2

Safety and Effectiveness information

Intended Uses:

The Superopen 0.23T 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.

Device Description:

Predicated Device:

K030918 : Superopen 0.35T (MRI System)

Statement of Substantial Equivalence:

The Superopen 0.23T is of comparable type and substantially equivalent to the NEUSOFT Superopen 0.35T (K030918) 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

OCT 2 9 2003

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

Re: K033315

Trade/Device Name: Superopen 0.23T Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: 90 LNH Dated: October 13, 2003

Received: October 15, 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 (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (sections 531-542 of the Act); 21 CFR 1000-1050.

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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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NEUSOFT

510(k)

Attachment 2 Page 2 of 2

KO333315 510(k) Number (if Known) Device Name: Superopen 0.23T Indications for use:

The indications for use are as follows:

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use

David A. Seaman

(Division Sign-Off) Division of Reproductive and Radiological Devices 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.