(25 days)
The uMR Omega system is indicated for use as a magnetic resonance diagnostic device (MRDD) that produces sagittal, transverse, coronal, and obligue cross sectional images, and spectroscopic 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 vield information that may assist the diagnosis. Contrast agents may be used depending on the region of interest of the scan.
The uMR Omega is a 3.0T superconducting magnetic resonance diagnostic device with a 75cm 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 Omega Magnetic Resonance Diagnostic Device is designed to conform to NEMA and DICOM standards.
uMR Omega has been previously cleared by FDA via K230152. The modification performed on uMR Omega (K230152) in this submission is due to the addition of Breast Coil -24.
The modification does not affect the intended use or alter the fundamental scientific technology of the device.
The provided text describes the regulatory clearance of the uMR Omega magnetic resonance diagnostic device, specifically focusing on the addition of a new Breast Coil - 24. The submission demonstrates substantial equivalence to a previously cleared predicate device (uMR Omega, K230152).
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based only on the provided text:
1. A table of acceptance criteria and the reported device performance
| Item | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Surface heating | The maximum temperature of all temperature probes shall not exceed 41℃. | Pass |
| General electrical/mechanical safety | Conform with ANSI/AAMI ES60601-1 | Pass |
| SNR and Uniformity | SNR and Uniformity shall fulfill the design specification. | Pass |
| Biocompatibility | Materials of construction and manufacturing materials exempt from testing according to the Biocompatibility guidance..., the 510(k) numbers for devices where these materials have been previously approved, or full biocompatibility report... for components that have direct contact with the patient. | All the materials of patient-contacting components for the Breast Coil - 24 are identical to uMR Omega which was cleared in K230152 in formulation, processing, sterilization, and geometry, and no other chemicals have been added. |
| EMC-immunity, electrostatic discharge | Conform with IEC 60601-1-2 and IEC 60601-4-2 | Pass |
| Clinical image quality | Image quality is sufficient for diagnostic use. | The U.S. Board Certified radiologist approves that image quality is sufficient for diagnostic use. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not provide explicit details on the sample size for any of the tests, nor does it specify the data provenance (e.g., country of origin, retrospective or prospective) for the clinical image quality evaluation or any other performance tests.
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)
For the "Clinical image quality" test, the document states: "The U.S. Board Certified radiologist approves that image quality is sufficient for diagnostic use."
- Number of experts: Singular ("The U.S. Board Certified radiologist"), implying one expert.
- Qualifications of experts: "U.S. Board Certified radiologist." No information on years of experience is provided.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Based on the mention of "The U.S. Board Certified radiologist approves," the adjudication method for clinical image quality appears to be none, as a single expert's approval is noted. There is no indication of multiple reviewers or an adjudication process for disagreement.
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
There is no mention of a multi-reader multi-case (MRMC) comparative effectiveness study being done. This submission focuses on the performance of a medical device (uMR Omega with a new coil) rather than an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This document refers to a Magnetic Resonance Diagnostic Device (MRDD), which produces images for interpretation by a trained physician. It does not describe an algorithm with standalone performance, but rather a hardware component (MRI system with a new coil). Therefore, a standalone (algorithm only) performance study is not applicable and was not done in the context described.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the "Clinical image quality" test, the ground truth is established by expert opinion/approval ("The U.S. Board Certified radiologist approves that image quality is sufficient for diagnostic use."). Other tests (Surface heating, electrical/mechanical safety, SNR and Uniformity, EMC) rely on defined physical and engineering standards/specifications. Biocompatibility refers to material identity with a previously approved device.
8. The sample size for the training set
This document does not mention a training set. The device is a Magnetic Resonance Diagnostic Device (hardware), not an algorithm that requires a training set in the conventional sense. The "training set" concept is typically relevant for machine learning or AI algorithms.
9. How the ground truth for the training set was established
As no training set is mentioned (see point 8), this information is not provided and is not applicable to the context of this device submission.
§ 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.