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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.

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.

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):

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.

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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

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.

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:

1. 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.

2. 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.

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)

   • Not provided. Ground truth establishment for a test set is part of a clinical performance study, which is not detailed here.

4. 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.

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

   • 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.

6. 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.

7. 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.

8. 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.

9. 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.

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