(77 days)
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:
- A table of acceptance criteria and reported device performance.
- Sample size used for a test set or data provenance.
- Number of experts or their qualifications used to establish ground truth.
- Adjudication method for a test set.
- Information about a multi-reader multi-case (MRMC) comparative effectiveness study or effect size.
- Information about a standalone performance study.
- The type of ground truth used.
- Sample size for a training set.
- How ground truth for the training set was established.
§ 892.1200 Emission computed tomography system.
(a)
Identification. An emission computed tomography system is a device intended to detect the location and distribution of gamma ray- and positron-emitting radionuclides in the body and produce cross-sectional images through computer reconstruction of the data. This generic type of device may include signal analysis and display equipment, patient and equipment supports, radionuclide anatomical markers, component parts, and accessories.(b)
Classification. Class II.