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MrOpen 05 is indicated for use as a diagnostic total body imaging device with the following limitation: no cardiac imaging, no breast imaging, MrOpen 05 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 (72), chemical shift and flow velocity. When interpreted by a trained physician, these images en yield information that can be useful in the determination of a diagnosis,

Like the previously cleared device K101295, the actual MROpen 05 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 K101295 cleared device.

• . Remove the angiography limitation,
• . update software by adding a new angiography sequence and 3D viewer tool,
• update the receiving coils' set including some new coils. .

MROpen 05 is indicated for use as a diagnostic total body imaging device with the following limitation: no cardiac imaging, no breast imaging. MrOpen 05 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 provided text describes a 510(k) premarket notification for the MrOpen 05, a Magnetic Resonance Diagnostic Device. The submission is focused on demonstrating substantial equivalence to a predicate device, rather than proving the device meets specific acceptance criteria through a comprehensive clinical study with predefined endpoints.

Therefore, much of the requested information regarding acceptance criteria, specific study design (sample size, data provenance, ground truth, adjudication, MRMC study), and training set details are not explicitly present in the provided text, as these are typically part of a more extensive clinical trial report.

However, based on the available information, here's what can be extracted:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state quantitative "acceptance criteria" but focuses on demonstrating that the new angiography sequence and coils provide expected image quality and performance equivalent to or better than the predicate devices. The "reported device performance" is qualitative.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size for Test Set: "healthy volunteers" (number not specified, but plural indicates more than one).
• Data Provenance: The healthy volunteers were "available in our firm," suggesting prospective data collection at the company's location (likely Italy, given the submitter's address).

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)

• Number of Experts: Not specified.
• Qualifications of Experts: The document states that the images are "interpreted by a trained physician," but no specific details about the number or qualifications of physicians involved in establishing ground truth for this particular demonstration are provided.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Adjudication Method: Not specified.

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

• MRMC Comparative Effectiveness Study: No, an MRMC comparative effectiveness study was not done. The submission focuses on device equivalence, not reader improvement with AI assistance.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Standalone Performance: Not applicable, as this is a medical imaging device (MRI scanner), not an algorithm-only device. The device produces images that are then interpreted by a trained physician.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

• For the non-clinical tests (bench testing for standards) and healthy volunteer imaging: The "ground truth" for the new angiography sequence was qualitative, based on whether the images conformed to "expected image quality." For the new coils, it was assessed as "equivalent or better quality image, or patient comfort" compared to previous models. This suggests a form of expert visual assessment or comparison rather than a strict pathologist-confirmed or outcomes-based ground truth.

8. The sample size for the training set

• The document describes testing and comparison against predicate devices, not the training of an AI algorithm. Therefore, "training set" is not applicable in this context. The device's performance relies on its inherent hardware and software design, which would have been developed and refined (analogous to 'training') during its engineering phase, but not in the sense of an algorithmic training set with ground-truth labels.

9. How the ground truth for the training set was established

• Not applicable, as explained above.

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