(14 days)
The GE Discovery ST system is intended for head and whole body attenuation corrected Positron Emission Tomography (PET) imaging and localization of emission activity in patient anatomy by means of integrated PET and CT images.
The Discovery ST is to be used by trained health care professionals for imaging the distribution of radiopharmaceuticals in the body for the assessment of metabolic (molecular) and physiologic functions. This can assist in the evaluation, diagnosis, staging, restaging, and follow up of lesions, disease and organ function such as (but not limited to) cancer, cardiovascular disease, and brain dysfunction. This device can also assist in radiotherapy planning.
The Discovery ST system can also be used as a stand-alone head and whole body multi-slice computed tomography (CT) diagnostic imaging system.
The Discovery ST is an integrated multi-slice Computed Tomography and Positron Emission Tomography scanner. In addition to providing CT and PET stand-alone capabilities, it uses the CT images to correct for non-uniform attenuation of the PET images and it uses integrated CT and PET images to localize emission activity in the patient anatomy. Discovery ST has capabilities for imaging all available PET tracers and CT contrast agents and can provide inherently registered anatomical and functional information via an integrated user interface. It can also be used as a standalone head and whole body multi-slice computed tomography diagnostic imaging system.
I am sorry, but based on the provided text, I cannot describe the acceptance criteria and the study that proves the device meets them. The document is a 510(k) Summary of Safety and Effectiveness for the GE Discovery ST PET/CT scanner. It describes the device, its intended use, and states that it is substantially equivalent to previously marketed devices. However, it does not include specific acceptance criteria (e.g., performance metrics, thresholds) or details of a study designed to demonstrate that the device meets such criteria.
The 510(k) summary format typically focuses on demonstrating substantial equivalence to a predicate device rather than presenting detailed performance study results against predefined acceptance criteria for a novel device.
Therefore, I cannot provide the requested information, including the table of acceptance criteria, sample sizes, expert details, adjudication methods, MRMC study information, standalone performance, ground truth types, or training set details as they are not present in the given text.
§ 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.