(14 days)
The GE Discovery XR and XA Systems are 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 XR and XA are 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. These devices can also assist in radiotherapy planning.
The Discovery XR and XA can also be used as stand-alone head and whole body multislice computed tomography (CT) diagnostic imaging systems.
The Discovery XR and XA are integrated multi-slice Computed Tomography and Positron Emission Tomography scanners. They use CT images to correct for non-uniform attenuation of the PET images and integrated CT and PET images to localize emission activity in the patient anatomy. Discovery XR and XA have capabilities for imaging all available PET tracers and CT contrast agents and can provide inherently registered anatomical and functional information via an integrated graphical user interface. Discovery XR and XA can also be used as a stand-alone head and whole body multislice CT diagnostic imaging system.
The provided text is a 510(k) Summary for the GE Healthcare Discovery XR and XA Diagnostic Imaging Systems. This document is a regulatory submission for a medical device and does not contain a study with acceptance criteria and reported device performance as typically expected for proving the effectiveness of a new or modified device.
Instead, this 510(k) summary focuses on demonstrating "substantial equivalence" to a predicate device (Discovery VCT K020259). This means the device is being presented as safe and effective because it is similar to another device already legally marketed, rather than through a new clinical performance study with specific acceptance criteria.
Therefore, I cannot provide the requested information. The document explicitly states:
- No acceptance criteria or reported device performance for a new study: The document doesn't outline any performance metrics or acceptance criteria for a new study on the Discovery XR and XA. Its core argument is that it performs as well as currently marketed devices (the predicate), rather than demonstrating new performance against defined metrics.
- No details on sample size, data provenance, experts, adjudication, MRMC, standalone performance, or ground truth for a new study.
The "Conclusion" section in {1} reinforces this: "In the opinion of GE Healthcare, the GE Discovery XR and XA Systems are substantially the same in design, materials, energy sources, and technology, do not introduce new safety concerns, perform as well as currently marketed devices, and are therefore substantially equivalent in terms of safety and effectiveness to the currently marketed Discovery VCT System."
§ 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.