(105 days)
The uMR 570 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 images when 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 570 is a 1.5T superconducting magnetic resonance diagnostic device with a 70cm 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 570 Magnetic Resonance Diagnostic Device is designed to conform to NEMA and DICOM standards.
The provided text describes a 510(k) premarket notification for the uMR 570 Magnetic Resonance Diagnostic Device. It details the device's technical specifications and compares it to a previously cleared predicate device (K180925). The focus of the submission is on modifications to the predicate device, including new RF coils, pulse sequences, and imaging processing methods.
However, the document does not describe, in detail, the acceptance criteria for specific performance metrics or the studies that prove the device meets those criteria with quantitative results. Instead, it generally states that "The test results demonstrated that the device performs as expected and thus, it is substantial equivalent to the predicate devices to which it has been compared." The testing listed is primarily technical and safety performance, as opposed to clinical or diagnostic performance with specific acceptance criteria.
Therefore, much of the requested information cannot be extracted from the provided text. I will populate the table and answer the questions based on the information available.
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Image Signal to Noise Ratio | "Performs as expected" (not quantified) |
| Image Uniformity | "Performs as expected" (not quantified) |
| Performance testing for Spectroscopy | "Performs as expected" (not quantified) |
| Performance testing for Computed DWI | "Performs as expected" (not quantified) |
| Surface Heating of RF Receive | "Performs as expected" (not quantified) |
| ES 60601-1 Medical electrical equipment Part 1: General requirements for basic safety and essential performance | "Comply with ES60601-1" |
| IEC 60601-1-2 Medical electrical equipment Part 1-2: General Requirements for basic safety and essential Performance | "Comply with IEC60601-1-2" |
| IEC 60601-2-33 Medical Electrical Equipment - Part 2-33: Particular Requirements For The Basic Safety And Essential Performance Of Magnetic Resonance Equipment For Medical Diagnostic | "Comply with IEC60601-2-33" |
| Clinical performance evaluation | "Performs as expected" (not quantified) |
| Biocompatibility | Patient Contact Materials were tested and demonstrated no cytotoxicity (ISO 10993-5), no evidence for irritation and sensitization (ISO 10993-10). |
| Performance testing for Inline T1/T2*Map | "Performs as expected" (not quantified) |
| Performance testing for SWI+ | "Performs as expected" (not quantified) |
| Performance testing for Easy-scan | "Performs as expected" (not quantified) |
2. Sample sized 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 mentions "Clinical performance evaluation" but does not detail the nature of this evaluation, the sample size, or data provenance.
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. While it states that images are "interpreted by a trained physician," there is no detail on the number or qualifications of experts for ground truth establishment during testing.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided in the document.
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
A multi-reader multi-case (MRMC) comparative effectiveness study is not mentioned in the document. This device is an MRI system, not explicitly a an AI/CAD device. The new features like Inline T1/T2*Map, PSIR, cDWI, and SWI+ are imaging processing methods, not AI assistance for human readers in the context of comparative effectiveness.
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 device itself is an MRDD that produces images to be interpreted by a trained physician; it does not describe a standalone algorithm for diagnostic output without human interpretation.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The document primarily focuses on technical performance and equivalence to a predicate device. For the "Clinical performance evaluation," the type of ground truth used is not specified. For the general use of the device, images are "interpreted by a trained physician," implying clinical diagnosis as the ultimate ground for interpretation, but not in the context of establishing ground truth for a formal evaluation of the device's diagnostic accuracy.
8. The sample size for the training set
The document describes the device, its modifications, and performance testing for regulatory clearance. It does not mention any training set as this is not a submission for an AI/ML algorithm that typically requires a training set. The "new application software features" are described as "substantially equivalent" to conventional methods, not as machine learning models that require training.
9. How the ground truth for the training set was established
As no training set is mentioned (see point 8), this information 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.