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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 Transmission Kit, Trans-CT for E.CAM, Model NSTR-050A is a software option for the ECAM gamma camera system that will be used to process and reconstruct acquired transmission and emission data. This software will be installed into the GMS-5500A/UI image processor which is part of the ECAM system. 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, K983516, is a 510(k) Summary for a medical device called "Transmission Kit, Trans-CT, Model NSTR-050A." This document describes the device, its intended use, and its technological characteristics, and importantly, declares substantial equivalence to a predicate device. However, it does not contain information about acceptance criteria or a study proving that the device meets those criteria.

The summary instead focuses on demonstrating that the device is substantially equivalent to a previously cleared device (Siemens E.CAM Profile Attenuation Correction, K963983) based on its intended use and technological characteristics. This type of submission generally relies on demonstrating similarity to a predicate, rather than presenting a novel clinical study with explicit acceptance criteria and performance data for the new device.

Therefore, I cannot provide the requested information from the given text. The K983516 document does not include:

1. A table of acceptance criteria and reported device performance.
2. Sample size used for a test set or data provenance.
3. Number of experts or their qualifications used to establish ground truth.
4. Adjudication method for a test set.
5. Information about a multi-reader multi-case (MRMC) comparative effectiveness study or effect size.
6. Information about a standalone performance study.
7. The type of ground truth used.
8. Sample size for a training set.
9. How ground truth for the training set was established.

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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.

Ask a specific question about this device