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The Magnetic Resonance Imaging System produces transversal, sagittal and oblique cross-section images of the limbs and joints. It's intended for imaging portions of the arm, including the hand, wrist, forearm, elbow, and imaging portion of the leg, including the foot, ankle, calf and knee, but excluding the thigh.

Magspin's magnetic resonance imaging system is a fixed system, it produces images correspond to the spatial distribution of protons (hydrogen nuclei) that embodies magnetic resonance properties of human body and is weighted by the MR parameters such as spinlattice relaxation time (T1), spin-spin relaxation time (T2), nuclei density and "chemical shif". When interpreted by a medical expert trained in the use of MR equipment, the images can provide diagnostically useful information.

Magnetic Resonance Imaging System produces images of the internal structures of the patient's limbs and joints.

The MRI system consists of the following components:

• Permanent Magnetic
• Magnetic Gradient system
• Dedicated RF coils
• Spectrometer
• Radiofrequency Transmitter
• Receiver coil
• Computer equipped with imaging software
• Patient chair

The provided text describes a 510(k) premarket notification for a Magnetic Resonance Imaging System, focusing on non-clinical testing and benchmarking against predicate devices. However, it does not contain information about specific acceptance criteria related to diagnostic performance or a study proving the device meets acceptance criteria in a clinical context (e.g., sensitivity, specificity, accuracy). Instead, it focuses on demonstrating safety and technical equivalence to predicate devices through engineering evaluations.

Here’s a breakdown of the information as requested, identifying what is present and what is absent:

1. Table of acceptance criteria and the reported device performance

The document does not specify diagnostic performance acceptance criteria (e.g., sensitivity, specificity thresholds) nor does it report such performance for the device. The "performance data" provided relates to adherence to recognized electrical, mechanical, and imaging quality standards for an MRI system.

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. The document explicitly states: "The subject of this premarket submission, Magnetic Resonance Imaging System, does not require animal or clinical studies to support substantial equivalence." The testing described is "bench testing" of the device itself against engineering standards.

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 applicable/not provided. There was no clinical ground truth established for a test set as no clinical studies were performed. The "ground truth" for the engineering tests would be the specifications of the standards (e.g., NEMA, IEC).

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

This information is not applicable/not provided. No clinical test set or adjudication for diagnostic performance was conducted.

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

This information is not applicable. No MRMC study was conducted, and the device (a basic MRI system) is not described as having an AI component that would assist human readers in interpretation.

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

This information is not applicable. This is a hardware MRI system; there is no mention of a standalone algorithm for diagnostic purposes.

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

The "ground truth" for the non-clinical testing described is the engineering specifications and measurement methodologies defined by international and national standards (e.g., IEC 60601 series, NEMA MS series). There is no clinical ground truth (like expert consensus, pathology, or outcomes data) mentioned.

8. The sample size for the training set

This information is not applicable/not provided. There is no mention of an algorithm requiring a training set in this submission.

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

This information is not applicable/not provided as no training set or clinical ground truth for and AI/algorithm-based component was mentioned.

Summary Takeaway:

This 510(k) submission relies on demonstrating technical and safety equivalence to predicate devices through bench testing against recognized engineering and safety standards. It explicitly states that animal or clinical studies were not required to support substantial equivalence. Therefore, the typical elements of clinical performance evaluation (like acceptance criteria for diagnostic metrics, sample sizes for medical image datasets, expert ground truth, or MRMC studies) are absent from this document.

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