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syngo.CT Extended Functionality is intended to provide advanced visualization tools to prepare and process medical images for diagnostic purpose. The software package is designed to support technicians and physicians in qualitative and quantitative measurements and in the analysis of clinical data that was acquired and reconstructed by Computed Tomography (CT) scanners, and possibly other medical imaging modalities (e.g. MR scanners). An interface shall enable the connection between the syngo. CT Extended Functionality software package and the interconnected CT Scanner system.

Resulting images created with the syngo.CT Extended Functionality software package can be used to assist trained technicians or physicians in diagnosis.

syngo.CT Extended Functionality is a software bundle that offers tools to support special clinical evaluations. The "tools" are represented by the so-called Extensions. syngo.CT Extended Functionality can be used to create advanced visualizations and measurements on clinical data that was acquired and reconstructed by Computed Tomography (CT) scanners or other medical imaging modalities (e.g. MR scanners) by using the Extensions. Advanced visualizations and measurements are listed as follows. The subject device in the current software version SOMARIS/8 VB70 has been extended/modified as follows:

• Support of the extension "Average"
• Modifications to the extension "Vessel"
• Modifications to the extension "Interactive Spectral Imaging"
• Modifications to the extension "Oncology"
• "Trauma" Extension – No changes
• "Osteo" Extension - No changes
• "Neuro DSA" Extension – No changes
• "ROI HU Threshold" Extension – No changes
• . "Dual Energy" Extension – No changes
• "Endoscopic Viewing" Extension - No changes
• . "Pulmonary Density" Extension – No changes
• . "General" (Extension Independent Features) – No changes

The provided text is a 510(k) Summary for a medical device called "syngo.CT Extended Functionality." It extensively describes the device, its intended use, comparison to a predicate device, and the non-clinical testing performed.

However, the document does not contain the specific information requested regarding acceptance criteria and a study proving the device meets those criteria. The provided text states:

• "This submission contains performance tests (Non-clinical test reports) to demonstrate continued conformance with special controls for medical devices containing software. Non-clinical tests (integration and functional) were conducted for syngo.CT Extended Functionality during product development. These tests have been performed to test the ability of the included features of the subject device. The results of these tests demonstrate that the subject device performs as intended." (Page 6)
• "The risk analysis was completed, and risk control implemented to mitigate identified hazards. The testing results support that all the software specifications have met the acceptance criteria. Testing for verification and validation of the device was found acceptable to support the claims of substantial equivalence." (Page 6)

While it mentions that tests were conducted and acceptance criteria were met, it does not detail what those acceptance criteria are in a tabular format, nor does it describe a specific study with sample sizes, expert involvement, ground truth methods, or MRMC comparative effectiveness. The tests mentioned are high-level "integration and functional" tests, and "verification and validation" tests, common for software development, but not a detailed clinical performance study as might be expected for an AI/ML-driven device with specific performance claims.

The key modifications to the device, as noted in the document, are:

• Support of the extension "Average" (new functionality)
• Modifications to the extension "Vessel" (improved bone removal using a deep learning algorithm)
• Modifications to the extension "Interactive Spectral Imaging" (support of circular and elliptic ROIs)
• Modifications to the extension "Oncology" (spectral information for arbitrarily shaped ROIs)

Given that the "Vessel" extension now incorporates a deep learning algorithm for bone removal, one might expect a study to validate the performance of this AI-driven component. However, the provided document only states that "Non-clinical tests (integration and functional) were conducted" and that "The testing results support that all the software specifications have met the acceptance criteria." No specific study details are given for this, or any other, AI/ML component.

Therefore, for your specific questions:

1. A table of acceptance criteria and the reported device performance: Not provided in the document.
2. Sample sizes used for the test set and the data provenance: Not provided in the document.
3. Number of experts used to establish the ground truth for the test set and the qualifications: Not provided in the document.
4. Adjudication method for the test set: Not provided in the document.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and its effect size: Not provided in the document. The document primarily focuses on non-clinical software testing for substantial equivalence to a predicate device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not explicitly detailed. The document mentions "non-clinical tests" and "verification and validation," but these are general software testing terms, not specific performance evaluations for an AI component.
7. The type of ground truth used: Not provided in the document.
8. The sample size for the training set: Not provided in the document. (Only mentions a deep learning algorithm in the "Vessel" extension, but no training details).
9. How the ground truth for the training set was established: Not provided in the document.

In summary, the provided FDA 510(k) summary focuses on demonstrating substantial equivalence through non-clinical software testing and quality system compliance, rather than detailing a specific clinical performance study with defined acceptance criteria for AI components. The document indicates that the device's software specifications met acceptance criteria through general testing (integration, functional, verification, validation), but the specifics of those criteria and the studies proving they were met are not disclosed in this summary.

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