(58 days)
The uMR 560 system is indicated for use as a magnetic resonance diagnostic device (MRDD) that produces sagittal, transverse, coronal, and oblique cross sectional images, and that display internal anatomical structure and/or function of the head, body and extremities.
These images and the physical parameters derived from the interpreted by a trained physician yield information that may assist the diagnosis. Contrast agents may be used depending on the region of interest of the scan.
The uMR 560 is a 1.5T superconducting magnetic resonance diagnostic device with a 60cm size patient bore. It consists of components such as magnet, RF power amplifier, RF coils, gradient power amplifier, gradient coils, patient table, spectrometer, computer, equipment cabinets, power distribution system, internal communication system, and vital signal module etc. The uMR 560 Magnetic Resonance Diagnostic Device is designed to conform to NEMA and DICOM standards.
This document is primarily a 510(k) summary for the uMR 560 Magnetic Resonance Diagnostic Device. It outlines its substantial equivalence to a predicate device and lists a series of non-clinical and clinical tests performed. However, it does not contain specific acceptance criteria or detailed study results directly proving the device meets acceptance criteria in the format requested.
The document states that "The test results demonstrated that the device performs as expected and thus, it is substantially equivalent to the predicate devices to which it has been compared." This is a general statement of compliance, not a detailed breakdown of acceptance criteria and performance against them.
Therefore, most of the requested information cannot be directly extracted from the provided text.
Here is a breakdown of what can and cannot be answered from the provided text:
1. A table of acceptance criteria and the reported device performance
- Cannot be provided. The document lists standards that the device was tested against (e.g., NEMA MS standards for SNR, Geometric Distortion, Image Uniformity), but it does not specify the numerical acceptance criteria for each of these tests, nor does it provide the exact reported performance values. It only states that the device "performs as expected."
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Partially available for clinical tests, but limited detail.
- For the "volunteer study" on gradient-induced nerve stimulation: The sample size is not specified. Data provenance is not specified. It's prospective by nature of being a "volunteer study."
- For "sample clinical images" to support diagnostic quality: The sample size is not specified. Data provenance is not specified. It's implied to be prospective clinical images.
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)
- Cannot be provided. The document states that images are "interpreted by a trained physician," but it does not specify the number or qualifications of experts involved in establishing ground truth for the provided clinical images or the volunteer study.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Cannot be provided. The document does not describe any adjudication methods.
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
- Cannot be provided. The uMR 560 is a Magnetic Resonance Diagnostic Device (an MRI scanner), not an AI-powered image interpretation tool. An MRMC study comparing human readers with and without AI assistance is not relevant to this device's regulatory review based on the provided text, and no such study is mentioned. The device generates images; it does not interpret them with AI.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Cannot be provided. As noted above, this device is an MRI scanner which generates images, not an algorithm for image interpretation. Therefore, a standalone algorithm performance study is not applicable or mentioned.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Partially discernible for clinical images: For "sample clinical images," the ground truth implicitly relies on interpretation by "trained physicians" (expert interpretation), but the specific methodology for establishing definitive ground truth (e.g., comparison to pathology, follow-up, etc.) is not detailed. For the volunteer study, the ground truth relates to physiological responses to gradient-induced nerve stimulation.
8. The sample size for the training set
- Not applicable / Cannot be provided. This device is an MRI scanner, not an AI model that would typically have a "training set" in the context of machine learning. The studies mentioned (compliance with standards, volunteer study, sample clinical images) are for verification and validation of the hardware and image quality, not for training an algorithm.
9. How the ground truth for the training set was established
- Not applicable / Cannot be provided. See response to item 8.
Summary of available information from the document:
The provided document details the 510(k) clearance for the uMR 560, an MRI scanner. It lists the non-clinical and clinical tests performed to demonstrate substantial equivalence to a predicate device.
- Non-Clinical Tests: Compliance with various IEC, ISO, and NEMA MS standards related to electrical safety, EMC, basic safety and performance for MR equipment, biological evaluation, and specific MR image quality parameters (SNR, geometric distortion, uniformity, acoustic noise, slice thickness, SAR, phased array coil characterization).
- Clinical Tests:
- A volunteer study to determine safety limits for gradient-induced nerve stimulation.
- Sample clinical images were provided to support the device's ability to generate diagnostic quality images.
The document explicitly states: "The test results demonstrated that the device performs as expected and thus, it is substantially equivalent to the predicate devices to which it has been compared." However, it does not provide the specific numerical acceptance criteria or the measured performance values.
§ 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.