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syngo Circulation is a self-contained image analysis software package for evaluating cardiac and pulmonary CTA, PET and SPECT volume data sets.

syngo Circulation combines commercially available digital image processing and visualization tools (MIP thin/thick, MPR thin/thick, vessel aligned MPR, CPR, VRT, AngioView, hybrid visualization), evaluation tools (myocardial and volumetric analysis of the left ventricle, coronary tree segmentation, stenosis and plaque evaluation) and reporting tools (lesion and pulmonary embolism (PE) 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, in evaluation of the hearts functional parameters and/or in confirming the presence or absence of physician identified filling defects, e.g. emboli, in the pulmonary arteries in addition to documentation and follow-up of any lesions.

syngo Circulation is a self-contained image analysis software package for evaluating cardiac and pulmonary CTA, PET and SPECT volume data sets.

syngo Circulation combines commercially available digital image processing and visualization tools (MIP thin/thick, MPR thin/thick, vessel aligned MPR, CPR, VRT, AngioView, hybrid visualization), evaluation tools (myocardial and volumetric analysis of the left ventricle, coronary tree segmentation, stenosis and plaque evaluation) and reporting tools (lesion and pulmonary embolism (PE) 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, in evaluation of the hearts functional parameters and/or in confirming the presence or absence of physician identified filling defects, e.g. emboli, in the pulmonary arteries in addition to documentation and follow-up of any lesions.

The provided document is a 510(k) Summary for the Siemens syngo® Circulation Software Package with Extended Functionality. This document, primarily focused on establishing substantial equivalence to a predicate device, does not contain the detailed clinical study information about acceptance criteria and device performance that you requested.

Specifically, the document does not include:

• A table of acceptance criteria and reported device performance.
• Sample sizes used for test sets or their data provenance.
• Number/qualifications of experts for ground truth establishment.
• Adjudication methods.
• Information on Multi-Reader Multi-Case (MRMC) comparative effectiveness studies.
• Information on standalone algorithm performance studies.
• The type of ground truth used (e.g., pathology, outcomes data).
• Sample size for training sets.
• How ground truth for training sets was established.

The document mainly focuses on:

• Identifying the device and its classification.
• Listing manufacturer and contact information.
• Stating the substantial equivalence to predicate devices (K052029, K010938, K022013).
• Describing the device's intended use and general safety/effectiveness concerns.
• Providing the FDA's clearance letter.

Therefore, I cannot fulfill your request for details on acceptance criteria and study results based on the provided text.

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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