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The Siemens syngo Volume Perfusion-CT Body software package with extended functionality has been designed to evaluate perfusion of organs and tumors.

The software can calculate blood flow, blood volume, mean transit time and permeability from sets of images reconstructed from dynamic CT data acquired after the injection of contrast media.

The package also allows the separate calculation of the arterial and portal venous component of hepatic perfusion. It supports evaluation of regions of interest and the visual inspection of time density curves.

A potential application is the characterization of tumors by analysing the differences of perfusion parameters to normal tissue. Determination of the change of perfusion parameters during the course of treatment may be helpful in therapy monitoring.

syngo® Volume Perfusion-CT Body software package with extended functionality 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 provided text does not contain detailed information about the acceptance criteria or a specific study proving the device meets those criteria. It is a 510(k) summary and clearance letter for the Siemens syngo® Volume Perfusion-CT Body software, which primarily focuses on establishing substantial equivalence to previously cleared devices.

Therefore, most of the requested information cannot be extracted directly from this document.

Here's what can be stated based on the provided text:

1. A table of acceptance criteria and the reported device performance:

This information is not provided in the document. The 510(k) summary focuses on general safety and effectiveness and substantial equivalence, not on specific performance metrics against pre-defined acceptance criteria.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

This information is not provided in the document. There is no mention of a specific test set or data used for performance evaluation.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

This information is not provided in the document.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

This information is not provided in the document.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

This information is not provided in the document. The document describes a "post-processing software package" that assists in evaluating CT data, but it does not detail any comparative effectiveness studies involving human readers.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:

The document describes the device as a "post-processing software package" that "calculates blood flow, blood volume, mean transit time and permeability." This suggests a standalone algorithmic function. However, details of a specific "standalone study" with performance metrics are not provided. The 510(k) process for this type of device often relies on demonstrating the accuracy of the calculations or its equivalence to existing methods rather than a standalone clinical performance study in the same way an AI diagnostic tool might.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc):

This information is not provided in the document.

8. The sample size for the training set:

This information is not provided in the document. The device is described as "software package," which could imply algorithms, but there is no mention of machine learning or a training set.

9. How the ground truth for the training set was established:

This information is not provided in the document, as no training set is mentioned.

Summary of available information regarding acceptance criteria and studies:

The provided document, a 510(k) summary for the Siemens syngo® Volume Perfusion-CT Body, focuses on demonstrating substantial equivalence to predicate devices (K073373 and K073238).

• General Safety and Effectiveness Concerns (Section 6): The document 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." This generally indicates that internal testing was conducted to ensure the software met its specifications and did not pose undue risks, which would implicitly involve acceptance criteria related to software functionality and safety. However, the specific metrics and criteria for these tests are not detailed in this public summary.

In essence, the 510(k) process for this device, as presented in this document, primarily relies on showing that the new device is as safe and effective as a legally marketed predicate, rather than presenting a de novo clinical study with detailed acceptance criteria and performance data against a specific ground truth.

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The Siemens syngo Volume Perfusion-CT Body software package has been designed to evaluate perfusion of organs and tumors.

The software can calculate blood flow, blood volume and permeability from sets of images reconstructed from dynamic CT data acquired after the injection of contrast media.

The package also allows the separate calculation of the arterial and portal venous component of hepatic perfusion. It supports evaluation of regions of interest and the visual inspection of time density curves.

A potential application is the characterization of tumors by analysing the differences of perfusion parameters to normal tissue. Determination of the change of perfusion parameters during the course of treatment may be helpful in therapy monitoring.

syngo® Volume Perfusion-CT Body 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 Body software package has been designed to evaluate perfusion of organs and tumors.

The software can calculate blood flow, blood volume and permeability from sets of images reconstructed from dynamic CT data acquired after the injection of contrast media.

The package also allows the separate calculation of the arterial and portal venous component of hepatic perfusion. It supports evaluation of regions of interest and the visual inspection of time density curves.

A potential application is the characterization of tumors by analysing the differences of perfusion parameters to normal tissue. Determination of the change of perfusion parameters during the course of treatment may be helpful in therapy monitoring.

The provided document is a 510(k) summary for the Siemens syngo® Volume Perfusion-CT Body software. It primarily focuses on demonstrating substantial equivalence to predicate devices and detailing the device's intended use and general safety concerns.

Crucially, the provided text does not include information about specific acceptance criteria or a study proving the device meets those criteria, as typically found in detailed performance studies. The document describes the device, its intended use, and states that "verification and validation testing" are used to control potential hazards, but it does not present the results of such testing or outline the acceptance criteria.

Therefore, I cannot fulfill your request for a table of acceptance criteria and reported device performance, nor can I provide details about sample sizes, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, or training set information directly from this document.

The document mainly serves as a regulatory submission demonstrating substantial equivalence to pre-existing similar devices based on their functional purpose (evaluating perfusion from CT data) rather than a detailed performance study with quantifiable acceptance criteria.

Ask a specific question about this device