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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

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.

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.

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