(50 days)
The OPER Series Open Type Permanent-Magnet MRI System is an open, whole body scanner. It is indicated for use as a diagnostic imaging device to produce transverse, sagittal, coronal and oblique images of the internal structures and organs of the head, body, or extremities. The images produced by the OPER Series Open Type Permanent-Magnet 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 determining a diagnosis.
The OPER Series Open Type Permanent-Magnet MRI System (OPER MRI) is a series of open permanent magnet MRI system, with magnetic field strength of 0.3T, and 0.4T, respectively. The model number for each of the corresponding system is OPER-0.3, OPER-0.35, and OPER-0.4, respectively. The OPER MRI system utilizes a permanent magnet to acquire 2D single-slice and multislice and 3D volume images. A wide range of pulse sequences are provided to the operator, including spin echo, fast spin echo, 2D and 3D gradient echo acquisitions. Imaging options such as inversion recovery and flow compensation are provided to suppress artifacts due to physiological motion and improve image quality.
This document describes the safety and effectiveness of the OPER Series Open Type Permanent-Magnet MRI System, but it does not contain a study that proves the device meets specific acceptance criteria with quantifiable results.
Instead, it presents a statement of substantial equivalence to predicate devices. This means the manufacturer is asserting their device is as safe and effective as other legally marketed devices, rather than providing independent clinical trial data with acceptance criteria.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" with numerical thresholds that the device was tested against in a study and then reported its performance.
Instead, it lists "safety parameters with action levels" and "performance levels" that were evaluated against NEMA performance standards and IEC safety standards. The document concludes that the device "was evaluated to the appropriate NEMA performance standards as well as the IEC 60601-1 international medical equipment safety standards and the IEC 60601-2-33 Particular requirements for the safety of magnetic resonance equipment for medical diagnosis."
Therefore, I cannot create a table with specific acceptance criteria and reported device performance from the provided text.
2. Sample size 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 in the document. The document describes the technical specifications and intended use of the MRI system but does not detail any specific test sets, patient data, or study designs (retrospective/prospective).
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 in the document. Since there is no mention of a specific test set or clinical study to validate performance, the concept of establishing ground truth by experts for such a test set is not discussed. The "Indications for Use" section mentions that images are "interpreted by a trained physician," implying the need for medical expertise in the clinical use of the device, but not for a performance study.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
This information is not provided in the document. As no specific test set or clinical study is described, no 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 in the document. The OPER Series MRI System is a diagnostic imaging device, not an AI-powered image interpretation tool. Therefore, an MRMC study comparing human readers with and without AI assistance is irrelevant and not mentioned.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This information is not provided in the document. The OPER Series MRI System is an imaging device, not an algorithm, so a standalone algorithm performance study is not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
This information is not provided in the document. Given the absence of a described performance study or test set, there is no mention of the type of ground truth used.
8. The sample size for the training set
This information is not provided in the document. The OPER Series MRI System is a hardware device for image acquisition, not a machine learning algorithm that requires a training set.
9. How the ground truth for the training set was established
This information is not provided in the document. As above, the device is hardware, not an AI model, so the concept of a "training set" and its "ground truth" is not applicable.
§ 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.