(28 days)
The uMR 780/uMR790 system is indicated for use as a magnetic 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 images when interpreted by a trained physician yield information that may assist the diagnosis. Contrast agents may be used depending on the region of the scan.
The uMR 780 is a 3.0T superconducting magnetic resonance diagnostic device with a 65cm 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 780 Magnetic Resonance Diagnostic Device is designed to conform to NEMA and DICOM standards.
The uMR 790 is a 3.0T 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 790 Magnetic Resonance Diagnostic Device is designed to conform to NEMA and DICOM standards.
The modification performed on the previously cleared devices (K181370 for uMR 780 and K181371 for uMR 790) is due to the modification of magnet. The modification, which do not affect the intended use or alter the fundamental scientific technology of the device, is following:
A modify magnet with a new model number;
In addition, seven coils which have been previously cleared by FDA via K183186 (Head Coil - 12, Head Coil - 32, Carotid Coil - 8, Temporomandibular Joint Coil - 4, Infant Coil - 24, Cardiac Coil - 24, Foot & Ankle Coil - 24) are added in this submission.
This document is a 510(k) Summary for medical device clearance, specifically for the uMR 780 and uMR 790 Magnetic Resonance Diagnostic Devices. It describes modifications to previously cleared devices (K181370 for uMR 780 and K181371 for uMR 790) and the addition of previously cleared coils.
It explicitly states that no clinical testing was conducted on the proposed devices. Therefore, the information requested regarding acceptance criteria based on clinical performance, sample sizes for test sets, expert-established ground truth, adjudication methods, multi-reader multi-case studies, standalone performance, training set sample sizes, and ground truth establishment for training sets is not available within this document. The provided text indicates a reliance on non-clinical testing and substantial equivalence to predicate devices rather than new clinical effectiveness studies.
The acceptance criteria described in the document relate to engineering and safety standards, not clinical performance.
Here's a breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Non-Clinical Tests) | Reported Device Performance (as stated in the document) |
|---|---|
| Signal to Noise Ratio | Test results demonstrated that the device performs as expected. |
| Geometric Distortion | Test results demonstrated that the device performs as expected. |
| Image Uniformity | Test results demonstrated that the device performs as expected. |
| Magnetic Field Homogeneity | Test results demonstrated that the device performs as expected. |
| Magnetic Field Decay | Test results demonstrated that the device performs as expected. |
| IEC 60601-2-33 Ed. 3.2 B:2015 Compliance | Test results demonstrated that the device performs as expected. |
2. Sample size used for the test set and the data provenance:
- Not Applicable. The document states, "No clinical testing was conducted on the proposed devices." The non-clinical tests would have involved physical measurements of the devices themselves, not patient data sets.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. No clinical test set or ground truth established by experts is mentioned in this document.
4. Adjudication method for the test set:
- Not Applicable. No clinical test set or adjudication process 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:
- No. The document explicitly states "No clinical testing was conducted on the proposed devices." This type of study would fall under clinical effectiveness.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- No. As a Magnetic Resonance Diagnostic Device (MRDD), it is a hardware system that produces images for interpretation by a physician. There is no mention of an "algorithm only" component with standalone performance in this document. The device is not an AI-driven image analysis tool, but an imaging system.
7. The type of ground truth used:
- Not Applicable. For the non-clinical tests described, the "ground truth" would be established engineering specifications and measurement standards, not medical ground truth like pathology or outcomes data.
8. The sample size for the training set:
- Not Applicable. No training set is mentioned as no machine learning or AI algorithm development is described in this document.
9. How the ground truth for the training set was established:
- Not Applicable. No training set is mentioned.
§ 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.