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The intended use of Paramed's MRJ_Extended product is for diagnostic nuclear magnetic resonance imaging of hip, knee, ankle, foot, shoulder, elbow, wrist, hand, call, thigh, arm, forearm, Temporo Mandibular Joint (TMJ), C- spine and L-Spine with limitation to joint pathologies (no tumors, no anglography). The device produces transverse, sagittal, coronal and oblique cross-sectional images, displaying the internal structure of the limbs and joint being imaged. The images that are produced correspond to the spatial distribution of protons (hydrogen nuclei) that check the magnetic resonance properties and depend upon the MR parameters (spin-lattice relaxation time (T1), spin-spin relaxation fime (T2), nuclei density, flow velocity and chemical shift). If interpreted by a medical expert, these images can provide diagnostically useful information.

The MRJ Extended MRI system is substantially equivalent to the currently available Paramed MrJ cleared via K033507 for all items excluded the spine coils for which the and Esaote S-Scan system cleared via K063207 is addressed.

The provided text is a 510(k) summary for the MRJ_Extended Magnetic Resonance Diagnostic Device. It states that the device is substantially equivalent to legally marketed predicate devices (Paramed MrJ K033507 and Esaote S-Scan K063207).

However, the document does not contain information regarding:

• Specific acceptance criteria metrics (e.g., sensitivity, specificity, accuracy targets).
• Any formal study designed to demonstrate device performance against such criteria.
• Data provenance, sample sizes for test sets, or training sets.
• The number or qualifications of experts used for ground truth establishment or adjudication methods.
• Whether MRMC or standalone performance studies were conducted.
• The type of ground truth used.

The document primarily focuses on establishing substantial equivalence based on technological characteristics and intended use, rather than presenting a performance study with detailed acceptance criteria and results. The "study" mentioned refers implicitly to the comparison with predicate devices, which is the basis of a 510(k) submission, but it doesn't provide the type of detailed performance study sought by this request.

Therefore, I cannot populate the table or answer the specific questions about acceptance criteria and study details. The included text is a regulatory submission for device clearance, not a performance study report.

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