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The intended use of the iLoop Interventional Coil 0.55T is, in conjunction with a Magnetic Resonance Scanner, the MR examination of the human body. Used in a magnetic resonance tomograph, the iLoop Interventional Coil 0.55T is intended to produce transversal, sagittal, coronal and oblique images of the internal structures of the body. This device may be used for interventional procedures.

The iLoop Interventional Coil 0.55T is a 1-channel receiver coil that can be used for MR imaging before, during and after MR-guided interventions with a Siemens MRI System with field strength 0.55T. The iLoop Interventional Coil 0.55T can also be used as a standard diagnostic coil for diagnostic examination of the human body. The iLoop Interventional Coil 0.55T is a coil that can be used on many different regions of the body. Used in conjunction with a sterile, self-adhesive OP-drape, the coil enables the workflow for MR-guided interventions

The provided text is a 510(k) summary for the iLoop Interventional Coil 0.55T, a medical device. It does not describe a study involving an AI or algorithm for medical imaging analysis, nor does it detail acceptance criteria and performance of such a device in the context of diagnostic accuracy (e.g., sensitivity, specificity, AUC).

Instead, this document focuses on the substantial equivalence of a new MR coil to a legally marketed predicate device. The performance testing mentioned (e.g., Image Signal to Noise (SNR), Image Uniformity, Surface heating) is related to the physical and electrical characteristics of the coil itself, rather than the diagnostic interpretive performance of an AI system.

Therefore, I cannot extract the information required for the requested table and study description (e.g., sample size for test/training sets, expert qualifications, MRMC studies, standalone performance, ground truth methods) as they pertain to AI/algorithm-based diagnostic devices, because this document is about a different type of medical device (an MR coil).

The "SUMMARY OF PERFORMANCE TESTING" section (page 5 of the PDF, marked with {5} in your input) outlines engineering and safety tests for the physical coil, not a clinical study to evaluate an AI's diagnostic performance. It states: "J) CLINICAL TESTING: Not required." This explicitly confirms that clinical studies to evaluate diagnostic accuracy were not performed or required for this device's clearance.

Thus, I cannot fill out the requested table or describe such a study based on the provided text.

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