(14 days)
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:
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
§ 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.