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syngo. CT Clinical Extensions 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 Clinical Extensions software package and the interconnected CT Scanner system.

Result images created with the syngo. CT Clinical Extensions software package can be used to assist trained technicians or physicians in diagnosis.

syngo.CT Clinical Extensions is a software bundle that offers tools to support special clinical evaluations. syngo.CT Clinical Extensions 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). syngo.CT Clinical Extensions is an extension of the previously cleared primary predicate device post-processing application software syngo.CT Extended Functionality and includes the following modifications in comparison to the primary predicate device:

• 1. New Marketing Name: syngo.CT Clinical Extensions
• 2. Modified Indications for Use Statement
• 3. Support of software version SOMARIS/8 VB30 which supports the following functionality:
  • a. Vascular Tool modification:
    • i. Modified Coronary Vessel Tracing Support
    • ii. Heart and Coronary Tree Isolation Tools
    • iii. Support of MR data
    • iv. Support of additional workflow improvement visualization tools
  • b. Oncology Tool modification:
    • i. Support of Mean Diameter Value
    • ii. Support of Lung Lesion Segmentation Tool
  • ﻥ Support of Dual Energy Tool
  • Support of Endoscopic View Tool ರ
  • Editing of Pre-generated Results e.

Depending on the clinical question, the user can select functionality which supports the explicit clinical fields as listed below. The syngo.CT Clinical Extensions software package is designed to operate on syngo-compatible post-processing platforms, software version SOMARIS/8 VB30 or later.

The provided text is a 510(k) summary for the syngo.CT Clinical Extensions device, which is a software bundle for advanced visualization and measurement of medical images. Based on the document, here's a breakdown of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not provide a specific table of quantitative acceptance criteria for device performance. Instead, it states that "The testing supports that all software specifications have met the acceptance criteria" and "The result of all conducted testing was found acceptable to support the claim of substantial equivalence."

The device's performance is reported in a comparative manner, asserting substantial equivalence to predicate devices based on:

• Functionality: The subject device offers an extension of previously cleared post-processing application software, including modifications to the Vascular Tool and Oncology Tool, and support for additional functionalities like Dual Energy Tool and Endoscopic View Tool.
• Technological Characteristics: The subject device uses the same or similar technological characteristics as the predicate devices, with differences noted as not raising "different questions of safety and effectiveness."
• Safety and Effectiveness: "Test results show that the subject device, syngo.CT Clinical Extensions are comparable to the predicate devices in terms of technological characteristics and safety and effectiveness."

Summary of Reported Performance (Qualitative, based on stated substantial equivalence):

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify the sample size (number of images or cases) used for the test set.

Data provenance is also not explicitly stated in terms of country of origin or whether it was retrospective or prospective. The statement "The subject device is also tested using the same methods as used for the predicate devices" implies that similar types of data as used for predicate devices (likely retrospective clinical images) were utilized for testing.

3. Number of Experts Used to Establish Ground Truth and Qualifications

The document does not mention the number of experts used or their specific qualifications for establishing ground truth for the test set. It describes the device as supporting "trained technicians or physicians in diagnosis," implying that the expected users are medical professionals, but it doesn't detail how the ground truth for testing was established. Given the nature of a 510(k) for a software update/bundle, it's possible that the "ground truth" was established by comparing the software's output with existing, clinically accepted measurements or visualizations, rather than through independent expert consensus on raw images.

4. Adjudication Method for the Test Set

The document does not describe any adjudication method (e.g., 2+1, 3+1) for the test set.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

The document does not mention an MRMC comparative effectiveness study comparing human readers with AI vs. without AI assistance. The submission focuses on the software's performance against its own specifications and its equivalence to predicate devices, rather than a human-in-the-loop performance study.

6. If a Standalone (i.e., Algorithm Only Without Human-in-the-Loop Performance) was Done

The testing described appears to be primarily focused on the standalone performance of the algorithm/software functionalities. "Non-clinical tests (integration and functional) were conducted... Performance tests were conducted to test the functionality... The results of these tests demonstrate that the subject device performs as intended." This implies testing the software's ability to process images, perform measurements, and generate visualizations accurately, which is a standalone evaluation of its capabilities.

7. The Type of Ground Truth Used

The document does not explicitly state the type of ground truth used. However, given the device's function (advanced visualization and quantitative measurements), the ground truth for the "functional" and "performance" tests would likely involve:

• Reference Measurements: Comparing the software's quantitative measurements (e.g., vessel diameter, lesion mean diameter, bone mineral content) against established or known values, or measurements performed by validated methods/tools.
• Visual Fidelity: Assessing the accuracy and clinical utility of the advanced visualizations in comparison to a reference standard.
• Software Specifications: Meeting predefined software specifications for each tool's output and behavior.

It is unlikely to be pathology or outcomes data, as this device primarily focuses on image processing and measurement for diagnosis assistance rather than direct disease detection or prognosis.

8. The Sample Size for the Training Set

The document does not mention a training set or its sample size. This is typical for a 510(k) for a software platform that bundles existing functionalities and adds incremental updates. While the underlying algorithms within these functionalities might have been developed using training data, this specific 510(k) submission does not detail the training set for the syngo.CT Clinical Extensions bundle itself. The changes described (e.g., "Semi-automatic vessel tracing tool that allows tracing with less user-interaction") suggest algorithmic improvements, which would benefit from training data, but the specifics are not provided in this summary.

9. How the Ground Truth for the Training Set Was Established

Since a training set is not mentioned, the method for establishing its ground truth is also not described.

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