(169 days)
The uMR 780 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 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 modification performed on the uMR 780 (K191157) in this submission is due to the following changes that include:
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- Addition and modification of pulse sequences
- New pulse sequences: gre_quick_wfi, hise, gre_quick_4dcemra, gre_ute, a) gre_maps.
- Broadened application scope of contrast characteristic for certain sequences: b) T1, T2, Pd.
- Added associated options for certain sequences: dark blood, navigator, multic) echo, reduced-FOV, computed DWI.
- d) Added reconstruction methods for certain sequences: compressed sensing, AI-assisted compressed sensing.
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- Addition of imaging processing methods: FACT (Fat Analysis and Calculation Technique), PSIR (Phase Sensitive Inversion Recovery), cDWI (Computed DWI), Inline T1/T2* Map, SWI+ (Susceptibility Weighted Imaging Plus).
The provided text is a 510(k) summary for the uMR 780 device, a magnetic resonance diagnostic device. Based on the content, this document primarily focuses on demonstrating substantial equivalence to a previously cleared predicate device due to software modifications (new pulse sequences and imaging processing methods).
Crucially, the document explicitly states: "No clinical testing was conducted on the proposed devices." This means that the information requested regarding acceptance criteria, performance studies, sample sizes, expert involvement, and ground truth establishment cannot be provided from this document.
The 510(k) summary asserts that the modifications "don't affect the intended use or alter the fundamental scientific technology of the device" and that "the test results demonstrated that the device performs as expected." However, it does not elaborate on the specific acceptance criteria or the study design/results for these non-clinical tests.
Therefore, for the information requested in your prompt, the answer is:
Based on the provided 510(k) summary, clinical testing was explicitly stated as "No clinical testing was conducted on the proposed devices." Therefore, the document does not contain the information required to answer the following questions regarding acceptance criteria and performance studies for the device:
- A table of acceptance criteria and the reported device performance: Not provided.
- Sample sizes used for the test set and the data provenance: Not provided.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as no clinical ground truth established.
- Adjudication method for the test set: Not applicable.
- 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: Not applicable as no clinical study or AI assistance comparison was detailed.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable as "AI-assisted compressed sensing" is mentioned but no performance data for it is provided, and no standalone algorithm was described as being evaluated clinically.
- The type of ground truth used: Not applicable as no clinical ground truth established.
- The sample size for the training set: Not provided.
- How the ground truth for the training set was established: Not provided.
The document discusses "Performance evaluation report for Spectroscopy, Computed DWI, AI-assisted compressed sensing" under "Non-Clinical Tests," but it only states that "The test results demonstrated that the device performs as expected" without detailing the specific criteria, methods, or results of these non-clinical performance evaluations.
§ 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.