(133 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 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 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 provided text does not contain detailed acceptance criteria for a medical device's performance, nor does it describe a study specifically designed to "prove the device meets the acceptance criteria" in terms of clinical efficacy or diagnostic accuracy. Instead, it focuses on demonstrating substantial equivalence to a predicate device for regulatory clearance.
Here's an analysis of the provided information based on your requested points:
1. A table of acceptance criteria and the reported device performance
The document lists several NEMA MS standards that the uMR 780 conforms to, which implicitly define performance criteria. However, it does not explicitly state acceptance criteria in a quantitative form (e.g., "SNR must be > X dB") nor does it present the specific numerical results obtained for each of these performance metrics. It only 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."
Therefore, a table cannot be constructed with the provided information.
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 mentions:
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"A volunteer study was used to determine the safety limits associated with gradient-induced nerve stimulation."
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"Sample clinical images were provided to support the ability of uMR 780 to A generate diagnostic quality images in accordance with the MR guidance on premarket notification submissions."
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Sample size for gradient-induced nerve stimulation study: Not specified.
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Sample size for diagnostic image quality study: Not specified (referred to as "Sample clinical images").
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Data provenance: Not specified (e.g., country of origin, retrospective or prospective nature).
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. The diagnostic images were "interpreted by a trained physician," but the number of physicians, their qualifications, or the process for establishing ground truth from these images is not detailed.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided.
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 MRMC comparative effectiveness study is mentioned.
- The device is a Magnetic Resonance Diagnostic Device (uMR 780), which is an imaging scanner, not an AI-assisted diagnostic tool for interpretation. Therefore, the question about human reader improvement with AI assistance is not applicable in this context.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- A "standalone" study in the context of an algorithm's performance is not applicable to a physical imaging device like the uMR 780.
- The document implies that the device itself (uMR 780) was tested for its performance metrics (NEMA standards, SNR, uniformity, geometric distortion, etc.) and for its ability to produce diagnostic quality images, which can be seen as standalone performance for the device's image acquisition capabilities.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- For the "sample clinical images" used to support diagnostic quality, the ground truth is implicitly understood to be the interpretation by "a trained physician." However, the method for establishing a definitive "ground truth" (e.g., expert consensus, comparison to another gold standard like pathology, or follow-up outcomes) is not explicitly described.
- For the NEMA standards testing, the "ground truth" is the established reference values or methods defined by those standards.
8. The sample size for the training set
The document does not describe any "training set" as it pertains to AI/machine learning algorithms. The uMR 780 is a hardware device for acquiring images.
9. How the ground truth for the training set was established
Not applicable, as there is no mention of a training set for an AI/machine learning algorithm.
In summary:
This document is a 510(k) summary focused on demonstrating substantial equivalence for a new MRI scanner (uMR 780) to a predicate device (SIEMENS MAGNETOM SKYRA). It primarily relies on engineering and performance testing against industry standards (NEMA, IEC, ISO) and a volunteer safety study, along with providing "sample clinical images" to show diagnostic quality. It does not provide the detailed diagnostic performance studies (like sensitivity, specificity, accuracy against a clinical ground truth, or reader studies) that would typically be described for a diagnostic AI algorithm.
§ 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.