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syngo.CT Pulmo 3D is an image analysis software for CT volume data sets. It analyses the lunq, either completely or in parts, identifying areas with lower or higher Hounsfield values in comparison to a predefined threshold. These areas are evaluated using statistical methods such as histograms and percentiles.

Using syngo.CT Pulmo 3D, you can examine the lung parenchyma and the airways of the lung.

The following evaluation tools are provided:

• Computation of lung volumes .
• Display of statistics related to the lung .
• Setting of markers .
• Airway measurements .

syngo.CT Pulmo 3D facilitates the reporting by using of appropriate reporting tools, for example, key image creation.

You can use syngo.CT Pulmo 3D to create a DiCOM Structured Report.

syngo.CT Pulmo 3D allows the evaluation of lung tissue and airways. In contrast to lung function tests, CT evaluations can show the effect of a disease on the parenchyma and the airways. The lungs as well as the airways are segmented in the preprocessing, and divisions of the lungs like thirds, core/peel, and lung lobes are calculated.

The provided text does not contain details of specific acceptance criteria or an explicit study that proves the device meets them in the format requested.

The document is a 510(k) Summary for the SIEMENS syngo.CT Pulmo 3D device, which focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed performance validation studies with specific acceptance criteria.

However, based on the non-clinical testing section, we can infer some general information:

Inferred Information from the Document:

• Acceptance Criteria & Device Performance: The document generally states that "The testing results supports that all the software specifications have met the acceptance criteria." However, it does not provide a table specifying these criteria or the reported performance metrics. The criteria are likely tied to the software's functional specifications, such as accurate lung and airway segmentation, volume computation, and statistical analysis as described in the "Device Description" and "Indications for Use" sections.
• Sample Size and Data Provenance: Not mentioned for any test sets.
• Number of Experts and Qualifications: Not mentioned.
• Adjudication Method: Not mentioned.
• Multi Reader Multi Case (MRMC) Comparative Effectiveness Study: Not mentioned. The focus is on the software's functionality, not comparative effectiveness with human readers.
• Standalone Performance: The testing mentioned in Section 6 ("Nonclinical Testing") refers to verification and validation of the device's software package to ensure it fulfills requirements and specifications. This implies standalone (algorithm-only) testing.
• Type of Ground Truth: Not explicitly stated, but for software functionality like segmentation and measurement, the ground truth would typically be established by expert radiologists or phantoms, though this is not confirmed in the document.
• Training Set Sample Size: Not mentioned.
• Ground Truth for Training Set: Not mentioned.

Summary of what is present and what is missing:

This 510(k) summary focuses more on demonstrating regulatory compliance and substantial equivalence through adherence to standards (IEC, ISO, DICOM) and risk management, rather than detailed clinical or performance validation studies with explicit quantitative acceptance criteria.

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