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To detect or image the distribution of radionuclides in the body or organ, using the following technique(s): Positron Imaging by Coincidence and Positron Whole Body Imaging by Coincidence.

The Positron Kit, Model NSCO-050A reconstruction software option will be installed into the GMS-5500A/UI image processor, which is part of the E.CAM dual-detector digital gamma camera system.

The provided text is a 510(k) Summary for a medical device called the "Positron Kit, Model NSCO-050A." It describes the device, its intended use, and its technological characteristics. However, this document does not contain information about acceptance criteria, device performance studies, sample sizes, expert qualifications, adjudication methods, or specific study results (like MRMC or standalone performance).

The 510(k) summary primarily focuses on demonstrating substantial equivalence to a predicate device. It states: "Toshiba America Medical Systems, Inc. believes that this device is safe and effective in that it offers no new intended uses that are not in use on existing marketed devices." This implies that the device's safety and effectiveness are supported by its similarity to already approved devices, rather than through new, independent performance studies with detailed acceptance criteria.

Therefore, I cannot fill in the requested table and answer the specific questions about performance studies from the provided text.

The document explicitly states:

• Reason for Submission: "New option for existing product"
• Technological Characteristics: "This device employs the same technological characteristics as the predicate device. Both systems employ the use of software to allow positron imaging by coincidence. Positron nuclide imaging is well understood and is documented in peer reviewed scientific publications."
• Substantial Equivalence: The FDA's letter (K983514) confirms substantial equivalence, meaning it relies on the predicate device's established safety and effectiveness.

In summary, there is no performance study described in this 510(k) submission that would allow me to populate the requested information.

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