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510(k) Data Aggregation
(30 days)
MODIFICATION TO SUPEROPEN 0.35T, MODEL NSM-P035
The Superopen 0.35T(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 (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.
The Superopen 0.35T(Modified) 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 T1.T2, proton density weighted imaging
Diagnostic uses: Diffusion 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 Echo Planar Imaging (EPI) Multi-shot SE / FE Diffusion
The Superopen 0.35T(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 is a 510(k) premarket notification for a Class II medical device, specifically a Magnetic Resonance (MR) diagnostic device. The provided text is mostly administrative and does not contain specific study details or acceptance criteria for device performance in the way a clinical trial or performance study report would.
Therefore, most of the requested information cannot be extracted from this document, except for the "acceptance criteria" which, in this context, refers to the general functional specifications and intended use of the MRI system, and the device's reported performance as a substantially equivalent device.
Here's what can be extracted and what cannot:
1. A table of acceptance criteria and the reported device performance
| Category / Criteria | Acceptance Criteria (Implied by Intended Use) | Reported Device Performance (Summary of Substantial Equivalence) |
|---|---|---|
| Intended Use | Produce images reflecting spatial distribution of protons (hydrogen nuclei). Provide diagnostic information when interpreted by a trained physician. | The Superopen 0.35T (Modified) is intended to produce images that reflect the spatial distribution of protons (hydrogen nuclei) exhibiting magnetic resonance. When interpreted by a trained physician, these images provide information useful in determining a diagnosis. |
| Imaging Capabilities | Image various anatomical regions (Head, Body, Spine, Extremities). Excite Proton nuclei. Perform T1, T2, proton density weighted imaging, Diffusion-weighted imaging, MR Angiography. Incorporate 2D, 3D imaging, Spin Echo (SE), Short time inversion recovery (STIR), Fluid attenuated inversion recovery (FLAIR), Field Echo (FE), Field Echo with Spoiler (FESP), Fast Spin Echo (FSE), MRCP, TOF, MTC Echo Planar Imaging (EPI), Multi-shot SE/FE Diffusion. | Same as the Intended Use; the device performs these imaging capabilities. |
| Technology | Open-permanent-magnet MR Imaging System. Uses Gradient Subsystem. Uses RF Subsystem. Console computer with interactive user interface for image reconstruction and management. Produces 2D and 3D images. | The Superopen 0.35T (Modified) is a 0.35T permanent magnet MRI system. It is of comparable type and substantially equivalent to the predicate device (Superopen 0.35T, K030918), sharing similar technology and intended uses. Both use Gradient and RF Subsystems and a console computer for image reconstruction, producing 2D and 3D images. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not provided. This document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting new clinical study data with specific test sets.
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. No information on specific test sets or ground truth establishment is included. The document notes that "interpreted by a trained physician, these images provide information that can be useful in diagnosis determination," but this refers to the general clinical use of MRI, not a specific ground truth for a performance study.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not provided. No information on test set adjudication.
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 applicable / Not provided. This document describes an MRI hardware system, not an AI-powered diagnostic software or a system requiring human readers to interpret its output for an MRMC study comparing AI-assisted vs. unassisted performance. The device itself is a diagnostic imaging tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable / Not provided. This refers to an MRI hardware system, not an algorithm that would be evaluated in a standalone performance study.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not provided. No information on ground truth for any specific performance study is included. The device's substantial equivalence is based on its similarity to a predicate MRI machine.
8. The sample size for the training set
- Not applicable / Not provided. This document is not describing a machine learning algorithm that would have a training set. It refers to an MRI system.
9. How the ground truth for the training set was established
- Not applicable / Not provided. As above, no training set is relevant to this document.
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