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PICA is indicated for use as magnetic resonance diagnostic devices (MRDD) that produce transverse, sagittal, coronal and oblique cross sectional images, and that display the internal structure and/or function of the head, body, or extremities. Depending on the region of interest, contrast agents may be used. These images when interpreted by a trained physician yield information that may assist in diagnosis. Pica may also be used for imaging during interventional procedures when performed with MR compatible devices such as, in room display and MR safe biopsy needles.

Pica Whole Body MRI System is a 0.3T permanent magnet MRI system. It is composed of Magnet, Magnet Enclosure, Patient Table, Gradient Coil, RF Transmission Coil, RF Receiver Coil, Client PC, and Imaging Cabinet. The system software, PRODIVA, based on Windows XP® Professional is an interactive program with user friendly interface.

The provided text is a 510(k) Summary for the Pica Whole Body MRI System. It details the device's technical specifications and claims of substantial equivalence to a predicate device. However, it does not include information about specific acceptance criteria for device performance, nor does it describe a study proving the device meets particular performance metrics with reported results like sensitivity, specificity, or accuracy.

The document focuses on the regulatory submission process, device description, intended use, and a statement of substantial equivalence. It mentions "Performance testing including clinical and laboratory testing was conducted to validate and verify that the proposed device... met all design specifications," but it does not provide the acceptance criteria or the study results in this summary.

Therefore, I cannot provide the requested information in the format of a table of acceptance criteria and reported device performance or details about sample sizes, expert qualifications, ground truth, or MRMC studies, as this information is not present in the provided text.

The text does state:

• Test Conclusion: "Performance testing including clinical and laboratory testing was conducted to validate and verify that the proposed device, Pica Whole Body MRI System met all design specifications and was substantially equivalent to the predicate device."
• SE Conclusion: "Pica Whole Body MRI System, is claimed to be Substantially Equivalent (SE) to the predicate device, mStar MPF4500 (K073457)."

This indicates that some performance testing was done, but the specifics are not detailed in this summary. The summary is primarily a regulatory document asserting substantial equivalence.

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