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To detect or image the distribution of radionuclides in the body or organ, using the following technique(s).
Tomographic imaging (SPECT) for non Positron emitter

The TRANSVIEW (Transmission system), model NDTR-701A is an option designed to be used with Toshiba's GCA-7200 gamma camera systems to acquire transmission CT data (TCT). When the external flood source of this system is combined with a parallel-hole collimator, this system can generate anatomic frame attenuation maps and perform attenuation corrections on SPECT images.

The provided text is a 510(k) Summary for the Toshiba TRANSVIEW (Transmission System), Model NDTR-701A. The document describes the device, its intended use, and its technological characteristics. However, it does not contain any information regarding acceptance criteria, device performance studies, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment relevant to the device's accuracy or efficacy.

The 510(k) summary explicitly 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 device employs the same technological characteristics as the predicate devices, differing only in the specifics of subassembly component composition and algorithms used. All systems employ the use of a transmission source to provide the attenuation map. This attenuation map is then used to perform attenuation corrections on SPECT images along with scatter correction. Non uniform attenuation correction using transmission systems is well understood and is documented in peer reviewed scientific publications."

These statements indicate that the submission likely relied on the substantial equivalence to predicate devices, and the well-established nature of the technology, rather than presenting a new study with specific performance metrics and acceptance criteria for this particular device's functionality.

Therefore, I cannot provide the requested table and study details based on the given input, as this information is not present in the provided document.

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