(38 days)
MRopen EVO is a diagnostic total body imaging device with the following limitation: no cardiac imaging, no breast imaging. MRopen EVO tomograph produces transverse, sagittal, coronal and oblique cross-sectional images that display the internal structure of the examinations may be performed both in weight free (supine or seated position) and weight bearing position. The images produced reflect the spatial distribution of protons (hydrogen nuclei) exhibiting magnetic resonance. The MR parameters that determine image appearance are proton density, spin-lattice relaxation time (TI), spin-spin relaxation time (T2), chemical shift and flow velocity. When interpreted by a trained physician, these images can yield information that can be useful in the determination of a diagnosis.
Like the previously cleared device K190524, the actual MRopen EVO is a total body magnetic resonance imaging device characterized by high homogeneity Open-sky Magnet, based on high temperature cryogenless superconductive proprietary technology. The magnet is "U" shaped with the opening upwards to host the patient preventing claustrophobic reactions. The pole plates limit laterally the FOV.
Modification of K190524 cleared device.
- . New commercial name (hence labeling is amended)
- . Different cover colours from light blue to grey
- . Changes in labelling due to above changes
MRopen EVO is a diagnostic total body imaging device with the following limitation: no cardiac imaging, no breast imaging. MRopen EVO tomograph produces transverse, sagittal, coronal and oblique cross-sectional images that display the internal structure of the body. The examinations may be performed both in weight free (supine or seated position) and weight bearing position. The images produced reflect the spatial distribution of protons (hydrogen nuclei) exhibiting magnetic resonance. The MR parameters that determine image appearance are proton density, spin-lattice relaxation time (TI), spin-spin relaxation time (T2), chemical shift and flow velocity. When interpreted by a trained physician, these images can yield information that can be useful in the determination of a diagnosis.
This FDA 510(k) summary for the MRopen EVO device states that no new testing was performed to establish acceptance criteria or device performance, as the changes from the predicate device (MRopen 0.5 T, K190524) were limited to a new commercial name and different cover colors. The submission relies entirely on the safety and effectiveness data provided for the predicate device.
Therefore, many of the requested details cannot be extracted directly from this document regarding the MRopen EVO. However, based on the information provided, we can infer the following about the approach taken for the MRopen EVO and, by extension, the predicate device it references:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state acceptance criteria in a quantitative table format for the MRopen EVO. Instead, it asserts substantial equivalence to the predicate device (MRopen 0.5 T, K190524) because the changes are only cosmetic (name and color). The performance is therefore assumed to be identical to the predicate device.
2. Sample size 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 for the MRopen EVO or explicitly detailed for the predicate device within this summary. The summary states that "non clinical (bench) and clinical (healthy volunteers) data supplied within K190524 file" were used.
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.
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
The MRopen EVO is a magnetic resonance diagnostic device, not an AI-powered diagnostic tool. Therefore, an MRMC comparative effectiveness study involving AI-assisted reading would not be applicable or expected for this device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
The MRopen EVO is a medical imaging device, not an algorithm. Standalone algorithm performance is not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This information is not explicitly provided. The summary mentions that images produced by the device "can yield information that can be useful in the determination of a diagnosis" when interpreted by a "trained physician," implying that clinical diagnosis by qualified medical professionals would establish ground truth for the predicate device's performance.
8. The sample size for the training set
This information is not applicable as the MRopen EVO is an imaging device, not an AI algorithm that requires a training set.
9. How the ground truth for the training set was established
This information is not applicable.
Summary of the Acceptance Criteria and Study for MRopen EVO based on the provided document:
| Feature | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Device Performance (Overall) | To be as safe, as effective, and to perform as well as or better than the legally marketed predicate device (MRopen 0.5 T, K190524). | The MRopen EVO, with only cosmetic changes (commercial name and cover colors) from the predicate device, is asserted to be as safe, as effective, and to perform as well as the predicate device (MRopen 0.5 T, K190524). No new performance data was presented for MRopen EVO. Performance is functionally identical to the predicate. |
| Test Set Sample Size & Provenance | Not explicitly stated for specific tests for either MRopen EVO or its predicate. Clinical data for the predicate (K190524) referred to as "healthy volunteers" and "non clinical (bench)" data. | Not applicable for MRopen EVO as no new testing was performed. Information for the predicate device's clinical and non-clinical data is not detailed in this summary. |
| Ground Truth Experts/Qualifications | Not applicable, as no new testing was conducted for MRopen EVO, and details for the predicate are not included. Interpretation by "trained physician" for diagnosis is mentioned for the predicate. | Not applicable for MRopen EVO. |
| Adjudication Method | Not applicable. | Not applicable. |
| MRMC Comparative Effectiveness Study | Not applicable. The device is a diagnostic imaging system, not an AI-assisted reading tool. | Not applicable. |
| Standalone Performance (Algorithm) | Not applicable. The device is a medical imaging system, not an algorithm. | Not applicable. |
| Type of Ground Truth | For the predicate device, implied to be clinical diagnosis based on images interpreted by trained physicians. | Not applicable for MRopen EVO. For the predicate, presumed clinical diagnosis by trained physicians. |
| Training Set Size | Not applicable. The device is an imaging system, not an AI algorithm. | Not applicable. |
| Training Set Ground Truth Method | Not applicable. The device is an imaging system, not an AI algorithm. | Not applicable. |
Conclusion:
This 510(k) submission for the MRopen EVO is a Special 510(k) primarily focused on demonstrating substantial equivalence to its predicate (MRopen 0.5 T, K190524) based on the limited nature of the proposed changes (commercial name and cover colors). Consequently, the document explicitly states that no new non-clinical or clinical testing was deemed necessary. All safety and effectiveness claims for the MRopen EVO rely on the data previously submitted and reviewed for the predicate device. Therefore, this document does not contain the detailed study information (sample sizes, expert qualifications, ground truth methods, etc.) that would typically be found for a device undergoing de novo testing or significant modifications.
§ 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.