The Superstar 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.

The indications for use are as follows:

Anatomical Region: Head, Neck, Shoulder, Breast, Wrist, Ankle 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 )

Turbo spin echo (TSE)

Short time inversion recovery (STIR); Fast STIR, IRFFE, IRSE, Fast IR, IR TSE

Fluid attenuated inversion recovery (FLAIR); Fast FLAIR

2D,3D Fast Field Echo (FFE)

T1/T2/N-Fast field echo (FFE);

B-Fast filed echo (B-FFE);N/B-Fast filed echo 3D; T1-Fast field echo 3D; Dual echo (DE);DTSE; DSE;

MR angiography FE, FFE 3D;

Echo Planar Imaging (EPI)

-SE-EPI

-Diffusion DW-EPI

Device Description

The Superstar 0.35T is a 0.35T permanent magnet MRJ 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 is a 510(k) summary for the Neusoft Superstar 0.35T MRI system. This document primarily focuses on demonstrating substantial equivalence to predicate devices based on technical similarity and intended use, rather than conducting a detailed performance study with specific acceptance criteria as you might see for a novel AI/CAD device.

Therefore, much of the requested information (acceptance criteria, specific study details, sample sizes, expert involvement, and ground truth methodologies) is not present in this type of regulatory submission for a conventional MRI system. The document does not describe a performance study with acceptance criteria in the manner you've outlined.

However, I can extract information related to the device's technical specifications and how its equivalence is established.

Here's an attempt to answer your questions based on the available text, keeping in mind that many fields will be "Not Applicable" or "Not Provided" due to the nature of the submission:

1. A table of acceptance criteria and the reported device performance

This information is Not Provided in the document. For a traditional MRI system 510(k), acceptance criteria would typically refer to technical specifications and safety standards (e.g., magnetic field strength, RF power limits, image resolution capabilities, compliance with IEC standards), not performance metrics in the context of diagnostic accuracy or reader improvement studies. The document states compliance with standards like IEC60601-1, IEC60601-2-33, and DICOM 3.0, which are the "acceptance criteria" for safe and functional operation.

2. Sample sized 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. The document does not describe a performance study with a test set of patient data. The substantial equivalence is based on the device's technological similarity and intended use compared to legally marketed predicate devices.

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. No test set with ground truth established by experts is described in this submission.

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

This information is Not Provided. No test set or 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. The device is a conventional MRI system, not an AI/CAD system, so an MRMC comparative effectiveness study involving AI assistance would not be applicable or expected.

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

This information is Not Provided. The device is an MRI system, not a standalone algorithm. Its intended use specifies interpretation "by a trained physician."

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

This information is Not Provided. No ground truth for a performance study is mentioned.

8. The sample size for the training set

This information is Not Provided. The device is a hardware and software system, not a machine learning algorithm that requires a "training set" in the context of AI/ML.

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

This information is Not Provided. As above, there is no mention of a training set or its ground truth.

Summary based on available information for a conventional MRI system:

The Neusoft Superstar 0.35T is a conventional 0.35T permanent magnet MRI system. Its acceptance criteria for regulatory clearance are based on compliance with general and particular safety and performance standards for medical electrical equipment (e.g., IEC60601-1, IEC60601-2-33), as well as conformity to DICOM 3.0 and NEMA MS Series standards. The "study" proving it meets these criteria would typically involve engineering tests, safety evaluations, and bench testing to demonstrate compliance with these technical standards, rather than clinical performance studies involving patient data and diagnostic accuracy metrics.

The submission focuses entirely on demonstrating substantial equivalence to existing predicate devices (K030918: Superopen 0.35T and K024042: Panorama Enhancement) based on similar technology, intended use, and functioning principles (open-magnet system, gradient subsystem, RF subsystem, image reconstruction, 2D/3D imaging, etc.). The 510(k) process for such devices relies on this equivalence to infer safety and effectiveness.

Summary

{0}------------------------------------------------

K071154

Neusoft

510(k)

MAY 1 0 2007

Attachment 1

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:	Superstar 0.35T
Product Model:	Superstar 0.35T
Common Name of Device	MRI System
CFR Section:	21 CFR Part 892.1000Magnetic resonance diagnostic device
Classification Name:	System, Nuclear 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 : Tian YanfangTitle : Manager of Quality Management DepartmentTel : 86-24-83660649Fax : 86-24-83780480E-Mail : Tianyanfang@neusoft.com

{1}------------------------------------------------

Safety and Effectiveness information

Intended Uses:

The Superstar 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.

Device Description:

Predicated Device:

K030918 : Superopen 0.35T K024042 : Panorama Enhancement

Statement of Substantial Equivalence:

The Superstar 0.35T system is comparable and substantially equivalent to the Superopen 0.35T MRI system (K030918, another product of Neusoft ) and Panorama Enhancements (K024042) in that they are similar in technology and intended uses. Both of these systems are open-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.

{2}------------------------------------------------

Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the department's name around the perimeter. In the center of the circle is an abstract symbol that resembles a stylized caduceus or a representation of human services.

Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850

Neusoft Medical Systems Co., Ltd. % Mr. Tamas Borsai Division Manager, Medical Division TUV Rheinland of North America 12 Commerce Road NEWTOWN CT 06470

MAY 1 0 2007

Re: K071154 Trade/Device Name: Superstar 0.35T

Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: LNH Dated: April 16, 2007 Received: April 25, 2007

Dear Mr. Borsai:

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 black and white circular logo. The logo has the letters "PA" in a bold, sans-serif font in the center. Above the letters "PA" is the text "1906-1986". Below the letters "PA" is the word "Centennial" in a cursive font. Below the word "Centennial" are three stars. The logo is surrounded by a dotted border.

Protecting and Promoting Public Health

{3}------------------------------------------------

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.

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 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

{4}------------------------------------------------

K071154

510(k)

Attachment 2

Indications for Use

The indications for use are as follows:

Anatomical Region: Head, Neck, Shoulder, Breast, Wrist, Ankle 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 )

Turbo spin echo (TSE)

Short time inversion recovery (STIR); Fast STIR, IRFFE, IRSE, Fast IR, IR TSE

Fluid attenuated inversion recovery (FLAIR); Fast FLAIR

2D,3D Fast Field Echo (FFE)

T1/T2/N-Fast field echo (FFE);

B-Fast filed echo (B-FFE);N/B-Fast filed echo 3D; T1-Fast field echo 3D; Dual echo (DE);DTSE; DSE;

MR angiography FE, FFE 3D;

Echo Planar Imaging (EPI)

-SE-EPI

-Diffusion DW-EPI

Nancy C Brogdon

(Division Sign-O Division of Reproductive, Ab and Radiological Devi 510(k) Number

cription Use (Per 21 CFR 801.109)

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.