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The MR Open is indicated for use as a diagnostic total body imaging device with the following limitation: no angiography, no cardiac imaging, no breast imaging.

MR Open tomograph produces transverse, sagittal, coronal and oblique crosssectional images that display the internal structure of the body.

The images produced reflect the spatial distribution of protons (hydrogen nuclei) exhibiting magnetic resonance.

The MR parameters that determine image appearance are proton density, spinlattice 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 MrOpen 05 MRI system is substantially equivalent to Paramed MrOpen K073362 as a total body open structure superconducting MRI Scanner.

The provided text does not contain any information about acceptance criteria or a study proving device performance in the context of specific performance metrics.

This document is a 510(k) summary for a medical device (MrOpen 05 MRI system). 510(k) submissions typically focus on demonstrating substantial equivalence to a predicate device, rather than providing detailed acceptance criteria and performance studies with statistical analysis as might be done for a novel device or a device with new performance claims.

Here's a breakdown of why the requested information cannot be extracted from this document:

• Acceptance Criteria and Reported Device Performance: The document lists IEC, UL, and FDA standards as compliance targets, but these are general safety and performance standards for MRI devices, not specific diagnostic performance metrics (e.g., sensitivity, specificity, accuracy for a particular condition). There is no table of acceptance criteria and reported device performance related to diagnostic accuracy.
• Sample Size and Data Provenance (Test Set): No information about a test set, its sample size, or data provenance is provided.
• Number of Experts and Qualifications (Ground Truth): No information about experts used to establish ground truth is mentioned.
• Adjudication Method: No adjudication method is described.
• Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: There is no mention of an MRMC study or any comparison of human readers with vs. without AI assistance. This device is an MRI scanner, not an AI-assisted diagnostic tool.
• Standalone Performance: As this is an MRI scanner, its "standalone performance" would relate to image quality parameters, signal-to-noise ratio, spatial resolution, etc., which are often demonstrated through technical evaluations and phantom studies rather than diagnostic performance studies in a 510(k) summary. However, these specific details are not provided here.
• Type of Ground Truth: No specific ground truth type (e.g., pathology, outcomes data, expert consensus) is discussed for any performance evaluation.
• Sample Size for Training Set: There is no mention of a training set, as this is a hardware device, not a machine learning algorithm.
• How Ground Truth for Training Set was Established: Not applicable, as there's no training set mentioned.

In summary, the provided document focuses on regulatory compliance (510(k) process) and establishing substantial equivalence to a predicate MRI device. It does not contain the detailed performance study information requested, which would typically be found in clinical study reports for devices making specific diagnostic claims or incorporating AI/algorithmic components.

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