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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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