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The PCD Option to the Prism Dual Head system is a modification of a gamma camera system. This device is intended to be used for diagnostic imaging of organs and lesions. There is no change of intended use from that of the predicate device.

The PCD Option to the Prism Dual Head system is a modification of a gamma camera system. This device includes adding hardware and software to a gamma camera system.

The provided text is a 510(k) notice for the PCD Option to the Prism Dual Head System. It describes the device's intended use and claims substantial equivalence to a predicate device. However, it does not contain specific acceptance criteria, detailed study designs, or performance metrics that would allow me to populate the requested table and answer the detailed questions about the study proving the device meets those criteria.

The document states:

• "Laboratory tests have shown that the PCD option has improved image quality and sensitivity compared to a standard gamma camera."
• "The product will perform in accordance with the development specifications."
• "A matrix was enclosed comparing the PCD option to a predicate device and therefore we concluded that it is substantially equivalent to that legally marketed predicate device."

These are general statements, not quantifiable acceptance criteria or detailed study results. Therefore, I cannot extract the specific information requested in your prompt based solely on the provided text.

To answer your questions, I would need a section of the document that outlines:

• Specific, measurable acceptance criteria (e.g., "sensitivity > X%", "spatial resolution

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