(13 days)
The Siemens syngo Perfusion-CT 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) and vascular permeability (blood brain barrier disturbances) from sets of images reconstructed from continuously acquired CT data after the injection of contrast media. The package also allows the calculation of mirrored regions of interest and the visual inspection of time density curves.
One potential 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).
Syngo Perfusion-CT is sensitive in identifying the areas of decreased perfusion which indicates the occurrence of acute stroke, during the first 6 hours after onset of symptoms.
A second potential application is the visualization of blood-brain-barrier disturbances in brain tumors. A modified Patlak approach is used for the modeling of extra-vascular leakage of blood into the interstitial space. This additional capability may improve the differential diagnosis of brain tumors and be helpful in therapy monitoring.
Syngo Perfusion-CT is a post-processing software package, which runs on an Intelbased PC platform designed to post-process images acquired with SOMATOM CT scanners, which meet certain minimal requirements (i.e. Siemens Sensation 16, Sensation 10, Sensation Cardiac, Sensation 4, Volume Zoom, Volume Access, Emotion 6, Emotion Duo, Emotion, SOMATOM Plus 4, SOMATOM AR.STAR, SOMATOM Classic). 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.
Syngo Perfusion-CT calculates the parameters related to brain perfusion and cerebral blood flow (CBF) using a simple linear relationship between the defected change of signal and the actual concentration of contrast media.
The Siemens syngo Perfusion-CT package has been designed to image cerebral blood flow (CBF), cerebral blood volume (CBV), local bolus timing (i.e. time to start, time to peak) and vascular permeability from sets of images reconstructed from CT data that were continuously acquired after the injection of a bolus of contrast media. It also allows the calculation of mirrored regions of interest and the visual inspection of time density curves.
The provided document does not contain all the requested information for acceptance criteria and the study proving the device meets them. Here's a summary of what can be extracted and what is missing:
1. Table of Acceptance Criteria and Reported Device Performance:
The document describes the device's intended use and capabilities, but it does not provide a table of acceptance criteria or specific reported performance metrics. It focuses on demonstrating substantial equivalence to predicate devices rather than defining and validating performance against specific criteria.
2. Sample Size for Test Set and Data Provenance:
This information is not available in the provided document.
3. Number of Experts Used to Establish Ground Truth and Qualifications:
This information is not available in the provided document.
4. Adjudication Method for Test Set:
This information is not available in the provided document.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
The document does not mention a multi-reader multi-case comparative effectiveness study or any effect size of human reader improvement with AI.
6. Standalone (Algorithm Only) Performance:
The document describes the device as a "post-processing software package" that "calculates parameters," implying a standalone algorithm's function. However, it does not provide performance metrics specifically for standalone algorithm-only performance.
7. Type of Ground Truth Used:
The document does not explicitly state the type of ground truth used for any validation. It mentions "syngo Perfusion-CT is sensitive in identifying the occurrences of acute stroke," implying a clinical correlation.
8. Sample Size for the Training Set:
This information is not available in the provided document.
9. How the Ground Truth for the Training Set Was Established:
This information is not available in the provided document.
Summary of Available Information from the Document:
The document is a 510(k) summary for the "syngo Perfusion-CT" software. Its primary purpose is to establish substantial equivalence to previously cleared predicate devices (Siemens syngo Perfusion-CT K982536 and General Electric CT Perfusion 2 K010042).
- Intended Use: To post-process images acquired with SOMATOM CT scanners to calculate parameters related to brain perfusion and cerebral blood flow (CBF), cerebral blood volume (CBV), local bolus timing (time to start, time to peak), and vascular permeability.
- Clinical Applications:
- Visualizing apparent brain perfusion in brain tissue affected by acute stroke. It is stated to be "sensitive in identifying the occurrences of acute stroke during the first 6 hours after onset of symptoms."
- Visualization of blood-brain-barrier disturbances in brain tumors, which "may improve the differential diagnosis of brain tumors and be helpful in therapy monitoring."
- Methodology: Calculates parameters using a simple linear relationship between the defected change of signal and the actual concentration of contrast media. A modified Patlak approach is used for modeling extra-vascular leakage in brain tumors.
Why the requested information is largely absent:
This document is a 510(k) summary for a Class II medical device. For such devices, a common pathway to clearance is demonstrating substantial equivalence to a legally marketed predicate device. This often means showing that the new device has the same intended use, similar technological characteristics, and raises no new questions of safety or effectiveness. Extensive de novo clinical studies with detailed acceptance criteria, ground truth establishment, and expert adjudication are often not required for 510(k) clearance if substantial equivalence can be demonstrated effectively. The document focuses on this substantial equivalence argument rather than presenting detailed performance study results against predefined acceptance criteria.
§ 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.