Search Results

syngo Circulation is a self-contained image analysis software package for evaluating cardiac CTA volume data sets. syngo Circulation combines commercially available digital image processing and visualization tools (MIP thin/thick, MPR thin/thick, VRT, CPR), evaluation tools (volumetric analysis of the left ventricle, coronary tree segmentation and stenosis evaluation) and reporting tools (lesion location and characteristics) with a workflow including dedicated scanning protocols. The software package is designed to support the physician in confirming the presence or absence of physician identified coronary lesions and evaluation of the hearts functional parameter in addition to evaluation, documentation and follow-up of any such lesions. These visualization/evaluation tools allow for volumetric analysis of the left ventricle and characterization of coronary lesions over time, helping the physician to assess the changes. It is also designed to help the physician classify conspicuous regions of tissue unambiguously, with respect to their size, dimensions, shape and position.

syngo Circulation is a self-contained image analysis software package for evaluating cardiac CTA volume data sets. syngo Circulation combines commercially available digital image processing and visualization tools (MIP thin/thick, MPR thin/thick, VRT, CPR), evaluation tools (volumetric analysis of the left ventricle, coronary tree segmentation and stenosis evaluation) and reporting tools (lesion location and characteristics) with a workflow including dedicated scanning protocols. The software package is designed to support the physician in confirming the presence of physician identified coronary lesions and evaluation of the hearts functional parameter in addition to evaluation, documentation and follow-up of any such lesions. These visualization/evaluation tools allow for volumetric analysis of the left ventricle and characterization of coronary lesions over time, helping the physician to assess the changes. It is also designed to help the physician classify conspicuous regions of tissue unambiguously, with respect to their size, dimensions, shape and position.

I am sorry, but the provided text does not contain any information about acceptance criteria or a study proving the device meets them. The document is primarily a 510(k) summary, which focuses on device description, intended use, and substantial equivalence to a predicate device, rather than detailed performance study results.

Therefore, I cannot fulfill your request for:

1. A table of acceptance criteria and reported device performance.
2. Sample size used for the test set and data provenance.
3. Number of experts used to establish ground truth and their qualifications.
4. Adjudication method.
5. MRMC comparative effectiveness study results.
6. Standalone performance study details.
7. Type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

Ask a specific question about this device