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To be used in conjunction with a Magnetic Resonance Scanner to produce diagnostic images of the shoulder that can be interpreted by a trained physician.

Model OSC-63-INT Shoulder Array Coil

This document is a 510(k) clearance letter for the "Model OSC-63-INT Shoulder Array Coil" from MRI Devices Corporation. It confirms that the FDA has found the device to be substantially equivalent to legally marketed predicate devices.

The letter primarily focuses on the regulatory clearance process and does not contain detailed information about specific acceptance criteria or a study proving the device meets those criteria in the way described in the prompt. The device in question is a magnetic resonance diagnostic device (a coil used with an MRI scanner), not an AI or algorithm-based diagnostic tool that would typically undergo performance studies with the detailed metrics requested.

Therefore, most of the requested information regarding acceptance criteria, performance metrics, sample sizes, expert ground truth, adjudication methods, multi-reader multi-case studies, or standalone algorithm performance is not available in this document.

The only relevant information regarding performance and intended use is:

• Indications for use: "To be used in conjunction with a Magnetic Resonance Scanner to produce diagnostic images of the shoulder that can be interpreted by a trained physician."
• Regulatory Classification: Class II, Product Code 90 MOS (Magnetic Resonance Diagnostic Device). This implies general controls and potentially special controls, but the specifics of how performance is measured are not in this document.

Summary of unavailable information from the provided text:

1. A table of acceptance criteria and the reported device performance: Not present. The document is about regulatory clearance, not performance metrics.
2. Sample size used for the test set and the data provenance: Not present.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not present.
4. Adjudication method for the test set: Not present.
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 present. This device is hardware, not an AI, so such a study would not apply in this context.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not present. This device is hardware.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not present.
8. The sample size for the training set: Not present.
9. How the ground truth for the training set was established: Not present.

In essence, this document is a regulatory approval notice, not a clinical study report.

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