(8 days)
The Superopen 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.
The Superopen 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.
Diffusion weighted imaging
MR Angiography
The indications for use are as follows:
Anatomical Region: Head, Body, Spine, Extremities Nucleus excited: Proton T1,T2, proton density weighted imaging Diagnostic uses:
Imaging capabilities:
Imaging processing 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 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.
The provided text does not contain information about specific acceptance criteria, a study proving device performance against those criteria, or the details about sample sizes, expert involvement, and ground truth establishment typically found in a clinical performance study summary.
Instead, the document is a 510(k) summary for a Magnetic Resonance Imaging (MRI) system (Superopen 0.35T) seeking substantial equivalence to a predicate device (Hitachi AIRIS II and its software).
Here's a breakdown of what the document does provide, and what it lacks in relation to the prompt's request:
Information Present in the Document:
- Device Description and Intended Use: The document clearly outlines the Superopen 0.35T as a 0.35T permanent magnet MRI system intended to produce images for diagnostic purposes by trained physicians. It lists various imaging capabilities and anatomical regions.
- Predicate Device: It identifies the Hitachi AIRIS II (K974212) and AIRIS II Version 4.1 Software (K001334) as the predicate devices for substantial equivalence.
- Substantial Equivalence Statement: The Superopen 0.35T is deemed substantially equivalent based on similar technology, intended uses, and functional components (magnet system, gradient subsystem, RF subsystem, image reconstruction, etc.).
- Regulatory Information: It includes CFR sections, classification name, product code, device class, applicable standards (IEC, DICOM, NEMA), and manufacturer details.
Information Not Present in the Document (and therefore, cannot be provided in response to the prompt):
- Acceptance Criteria Table and Reported Device Performance: There is no specific table defining performance metrics (e.g., sensitivity, specificity, accuracy, image quality scores) or acceptance thresholds. The document asserts substantial equivalence based on technical and functional similarity, not on a detailed performance study with defined criteria.
- Sample Sizes and Data Provenance for Test Set: No information is provided about a specific "test set" of images or patients used for performance evaluation. The substantial equivalence argument relies on the predicate device's established performance rather than a new clinical study.
- Number of Experts and Qualifications for Ground Truth: Since no independent performance study is detailed, there's no mention of experts establishing ground truth for a test set.
- Adjudication Method: Not applicable as there's no described performance study or ground truth establishment process involving multiple readers.
- Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: No MRMC study is mentioned. The submission is for a standalone imaging device, not an AI-assisted diagnostic tool.
- Standalone Performance (Algorithm Only): The device itself is a standalone MRI system, but the prompt's context usually refers to an algorithm's performance. There is no algorithm performance discussed in the AI sense.
- Type of Ground Truth Used: Not applicable in the context of a new performance study.
- Sample Size for Training Set: No information on a training set as this is a medical device submission based on substantial equivalence, not an AI algorithm development and validation.
- How Ground Truth for Training Set Was Established: Not applicable.
Conclusion:
The provided 510(k) summary focuses on demonstrating substantial equivalence of the Superopen 0.35T MRI system to existing legally marketed devices based on technological similarities and intended use. It does not present a clinical study with detailed acceptance criteria or performance metrics for the device itself. Therefore, I cannot construct the requested table or offer the detailed study information as it is not present in the provided text.
§ 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.