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The MR system is an imaging device, and is intended to provide the physician with physiological and clinical information, obtained non-invasively and without the use of ionizing radiation. The MR system produces transverse, coronal, sagittal, oblique, and curved cross-sectional images that display the internal structure of the head, body, or extremities. The images produced by the MR system reflect the spatial 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 diagnosis determination.

The AIRIS MRI Magnetic Resonance Diagnostic Device is being enhanced by two additional RF Coils (QD HP [High Performance] Wrist Coil, and Shaped Shoulder Coil) to increase the clinical utility of the AIRIS in the stationary configuration.

The QD HP [High Performance] Wrist Coil P/N MR-QWC-51 is a new addition to the complement of coils intended for use with AIRIS. The coil utilizes a proprietary multiple receiver quadrature coil design for improved S/N Ratio.

The Shaped Shoulder coil P/N MR-SC-51 is identical to the Latchable Large Extremity coil, which was documented in a Memo-to-File document as identical to the original Large Extremity Coil for AIRIS, with the exception that the coil geometry has been curved for easier coil positioning over the anatomy of interest. Safety and effectiveness of the coil are unchanged from the original, and this coil will replace the original coil.

AIRIS software did not need to be revised in order to support full functionality of these coils.

This document describes the submission K980691 for Additional RF Coils for AIRIS (QD HP Wrist, Shaped Shoulder) by Hitachi Medical Systems America. However, this submission focuses on establishing substantial equivalence for the coils as medical devices, not on a new AI/algorithm device that would typically have the detailed performance metrics requested in your prompt.

Therefore, many of the fields for acceptance criteria and study design are not applicable or cannot be determined from the provided text, as the submission is not for an AI diagnostic device. The provided text is a 510(k) summary for a Magnetic Resonance Diagnostic Device (AIRIS MRI) and associated RF coils, not an AI/ML product.

Here’s what can be extracted and what cannot:

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

• Acceptance Criteria: Not explicitly stated as performance metrics in the way an AI/ML product would have (e.g., sensitivity, specificity). The acceptance criterion is "substantial equivalence" to the predicate device (Hitachi AIRIS).
• Reported Device Performance:
  • QD HP Wrist Coil: "New addition to the complement of coils intended for use with AIRIS. The coil utilizes a proprietary multiple receiver quadrature coil design for improved S/N Ratio." (No quantitative S/N ratio improvement stated, but "improved" implies enhanced performance).
  • Shaped Shoulder Coil: "identical to the Latchable Large Extremity coil... Safety and effectiveness of the coil are unchanged from the original, and this coil will replace the original coil." (This implies performance is at least equivalent to the original coil).

2. Sample size used for the test set and the data provenance

• Not Applicable / Not Provided: This submission is for hardware components (RF coils) of an MRI system, not an AI diagnostic algorithm. There is no "test set" in the context of diagnostic performance metrics like those for AI. The evaluation would typically involve engineering tests, phantom studies, and possibly limited clinical imaging to confirm image quality and safety, but these details are not provided in this 510(k) summary.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Not Applicable / Not Provided: As this is not an AI diagnostic algorithm, there is no "ground truth" establishment by experts in the context of assessing diagnostic accuracy. The "trained physician" mentioned in the "Indications for Use" section refers to the end-user of the MRI system, not an expert panel for performance evaluation of the coils themselves for a 510(k) submission.

4. Adjudication method for the test set

• Not Applicable / Not Provided: There is no "test set" or adjudication method described for performance evaluation in the context of diagnostic accuracy.

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 submission is not for an AI-assisted device. Therefore, no MRMC study or effect size related to AI assistance would be conducted or reported.

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

• Not Applicable: This submission is for MRI hardware (coils), not an algorithm.

7. The type of ground truth used

• Not Applicable / Not Provided: No "ground truth" as typically defined for diagnostic accuracy studies. The safety and effectiveness would be demonstrated through engineering specifications, comparison to the predicate, and possibly phantom studies or limited human subject imaging to confirm image quality.

8. The sample size for the training set

• Not Applicable / Not Provided: This is not an AI/ML device, so there is no training set.

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

• Not Applicable / Not Provided: No training set or associated ground truth.

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