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The i Open 0.5T system is an open, whole body scanner. It is indicated for use as a diagnostic imaging device to produce transverse, sagittal, coronal and oblique images of the internal structures and organs of the head, body, or extremities. The images produced by the i Open 0.5T system reflect the special distribution of protons (hydrogen nuclei) exhibiting magnetic resonance. The NMR properties that determine the image appearance are proton density, spin-lattice relaxation time (T1), spin-spin relaxation time (T2) and flow. When interpreted by a trained physician, these images provide information that can be useful in determining a diagnosis.

The i_Open 0.5T is a 0.5 Tesla permanent MRI system. The magnet is mainly made of Nd-B-Fe material. The system software based on Windows XP is an interactive program integrated with scanning control, image reconstruction, reviewing, post-processing, DICOM printing.

The provided text describes a 510(k) submission for the i_Open 0.5T MRI system, focusing on its substantial equivalence to predicate devices rather than a study demonstrating its performance against specific acceptance criteria. This type of submission, common for medical devices, often relies on demonstrating that the new device has the same intended use, technological characteristics, and safety/effectiveness principles as a legally marketed predicate device, rather than conducting a de novo performance study against defined acceptance criteria.

Therefore, much of the requested information regarding specific acceptance criteria, performance studies, sample sizes, expert involvement, and ground truth establishment is not available in the provided document, as it describes a substantial equivalence determination rather than a performance study.

Here's what can be inferred from the document:

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

The document lists performance levels that will be evaluated according to FDA guidance and NEMA/IEC standards. It does not state specific quantitative acceptance criteria or provide the device's measured performance against these criteria. Instead, it states the device will conform to these standards.

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

Not applicable. The document describes a comparison to predicate devices based on technological characteristics and safety parameters, not a clinical trial with a test set of patient data.

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)

Not applicable. No ground truth establishment for a test set is described.

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

Not applicable. No test set or adjudication method is described.

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

Not applicable. This device is an MRI scanner, not an AI-assisted diagnostic tool for human readers. No MRMC study is mentioned.

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

Not applicable. This is an MRI scanner, not an algorithm, and its performance is described in terms of hardware/software specifications and conformance to standards, not as a standalone algorithm performance.

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

Not applicable. No ground truth is mentioned in the context of a performance study. The "ground truth" implicitly referred to is the established safety and performance of the predicate devices and the relevant industry standards.

8. The sample size for the training set

Not applicable. No training set is mentioned as this is a medical imaging device, not an AI model.

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

Not applicable.

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