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MRopen 0.5 T is a diagnostic total body imaging device with the following limitation: no cardiac imaging, no breast imaging. MRopen 0.5 T 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 (Tl), 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 K151466, the actual MRopen 0.5 T 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 K151466 cleared device.

• Introduce DWI technique based on HASTE readout sequence 0
• Introduce internally developed User Interface 0
• Introduce changes in hardware such as spectrometer, compressors and cold heads, 0 RFA
• 0 Introduce change in hardware inside the magnet (double current same magnetic field, same superconductive MgB2 wire, less coils)
• Long Spine receiving coil o
• 0 Shoulder coil new model
• Changes to patient support shapes and courtesy cushions o

MRopen 0.5 T is indicated for use as a diagnostic total body imaging device with the following limitation: no cardiac imaging, no breast imaging. MRopen 0.5 T 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.

The modification reflected in this Traditional 510(k) for the MRopen 0.5 T Tomograph are to introduce updates in hardware and software including the DWI technique previously not released. The modifications have not altered the scientific technology of the unmodified version MrOpen K151466 as detailed in below table.

The provided text describes modifications to an existing MRI device (MRopen 0.5 T) and its substantial equivalence to predicate devices, focusing on hardware and software updates, including the introduction of a DWI technique. However, it does not explicitly detail the acceptance criteria for these modifications or a specific study proving the device meets those criteria in the way typically required for a classification of an AI/ML-enabled medical device.

The document states "No clinical tests were performed" for the purpose of demonstrating substantial equivalence in the conventional sense. Instead, it refers to images of healthy volunteers to demonstrate the performance of the device on humans for the new DWI technique and new coils.

Here's an attempt to extract the requested information based on the provided text, acknowledging the limitations for certain points:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not provide a formal table of quantitative acceptance criteria typical for complex AI/ML device performance. Instead, it discusses image quality and performance in a qualitative manner, referencing clinical utility and comparison to predicate devices for specific features.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size for Test Set: "The healthy volunteers were adult male and female aged between 20 and 60 available in our firm." The exact number is not specified, but it implies a small, internal cohort.
• Data Provenance: The healthy volunteers were "available in our firm," suggesting internal, prospective data collection from individuals affiliated with the company. The country of origin is presumably Italy, where ASG Superconductors S.p.A. is located.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts

• Number of Experts: Not specified. The document states, "When interpreted by a trained physician, these images can yield information that can be useful in the determination of a diagnosis." This implies interpretation by a physician but does not detail the number or role of experts in establishing ground truth for the test set explicitly.
• Qualifications of Experts: Assumed to be "trained physician(s)" as stated in the intended use. Specific qualifications (e.g., years of experience, subspecialty) are not provided.

4. Adjudication Method for the Test Set

• Adjudication method: Not specified. Given the qualitative nature of the "results/remarks," it's unlikely a formal adjudication method was employed as would be typical for an AI/ML diagnostic system. The evaluation seems to be based on direct assessment of image quality and clinical utility.

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 MRMC comparative effectiveness study was not performed, nor is it applicable to this submission. The device is a diagnostic imaging system (MRI), not an AI-assisted diagnostic tool for image interpretation. The submission is for hardware and software updates to an existing MRI machine.

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

• A standalone algorithm performance study was not performed, nor is it applicable. This is an MRI system, which produces images for physician interpretation, not an algorithm that provides a standalone interpretation or diagnosis.

7. The Type of Ground Truth Used

• For the performance evaluation of the DWI technique and new coils, the "ground truth" was qualitative assessment of image quality from healthy volunteers compared to expected diagnostic image quality from established techniques and coils. It is not based on pathology, outcomes data, or formal expert consensus in the typical sense of a diagnostic study for a specific condition.

8. The Sample Size for the Training Set

• The document describes the submission as updates to an existing MRI system and the introduction of a DWI technique. It does not refer to an AI/ML model that requires a "training set" in the conventional sense. Therefore, information on a training set size is not applicable/not provided.

9. How the Ground Truth for the Training Set was Established

• As there is no mention of an AI/ML algorithm or training set, this information is not applicable/not provided. The "HASTE readout sequence" mentioned for DWI is a specific MR imaging pulse sequence, not a machine learning algorithm.

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