(48 days)
The Siemens syngo® Volume Perfusion-CT Neuro software package has been designed to evaluate areas of brain perfusion. The software can calculate cerebral blood flow (CBF), cerebral blood volume (CBV), local bolus timing (i.e. time to start, time to peak), mean transit time (MTT), and vascular permeability (blood brain barrier disturbances) from sets of images or volumes reconstructed from continuously acquired CT data after the injection of contrast media. The package also allows the calculation of mirrored regions or volumes of interest and the visual inspection of time attenuation curves.
One clinical application is to visualize the apparent blood perfusion in brain tissue affected by acute stroke. Areas of decreased perfusion, as is observed in acute cerebral infarcts, appear as areas of changed signal intensity (lower for CBF and CBV, higher for time to peak and MTT).
Syngo® Volume Perfusion-CT Neuro supports the physician in identifying areas of decreased perfusion which indicate the occurrence of acute stroke during the first 6 hours after onset of symptoms.
A second application is the visualization of the permeability. It is used for the modeling of extra-vascular leakage of blood into the interstitial space. This additional capability can display blood brain barrier disturbances and thus may improve the differential diagnosis of brain tumors and be helpful in therapy monitoring.
syngo® Volume Perfusion-CT Neuro is a post-processing software package, which runs on an Intel-based PC platform designed to post-process images acquired with SOMATOM CT scanners, which meet certain minimal requirements (i.e. Siemens Definition, Sensation 64, ... }. It is a package containing evaluation software that supports the evaluation of Dynamic CT data gathered after the injection of a compact bolus of contrast media, where the contrast media acts as a pure intravascular tracer.
The Siemens syngo® Volume Perfusion-CT Neuro software package has been designed to evaluate areas of brain perfusion. The software can calculate cerebral blood flow (CBF), cerebral blood volume (CBV), local bolus timing (i.e. time to start, time to peak), mean transit time (MTT), and vascular permeability (blood brain barrier disturbances) from sets of images or volumes reconstructed from continuously acquired CT data after the injection of contrast media. The package also allows the calculation of mirrored regions or volumes of interest and the visual inspection of time attenuation curves.
The provided text does not contain specific acceptance criteria or an explicit study description proving the device meets those criteria. The document is a 510(k) summary for syngo® Volume Perfusion-CT Neuro, focusing on its substantial equivalence to previously cleared devices.
It states that "Risk management is ensured via a hazard analysis, which is used to identify potential hazards. These potential hazards are controlled via software development, verification and validation testing." However, it does not provide details on the methods, sample sizes, or results of these verification and validation tests in a way that would allow filling out the requested table or answering the specific questions about standalone performance, MRMC studies, or ground truth establishment.
Therefore, most of the requested information cannot be extracted from the provided text.
§ 892.1750 Computed tomography x-ray system.
(a)
Identification. A computed tomography x-ray system is a diagnostic x-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.