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syngo.CT Applications is a set of software applications for advanced visualization, measurement, and evaluation for specific body regions.

This software package is designed to support the radiologists and physicians from emergency medicine, specialty care, urgent care, and general practice e.g. in the:

• · Evaluation of perfusion of organs and tumors and myocardial tissue perfusion
• · Evaluation of bone structures and detection of bone lesions
• · Evaluation of CT images of the heart
• · Evaluation of the coronary lesions
• · Evaluation of the mandible and maxilla
• · Evaluation of dynamic vessels and extended phase handling

· Evaluation of the liver and its intrahepatic vessel structures to identify the vascular territories of sub-vessel systems in the liver

• Evaluation of neurovascular structures
• · Evaluation of the lung parenchyma
• · Evaluation of non-enhanced Head CT images
• · Evaluation of vascular lesions

The syngo.CT Applications are syngo based post-processing software applications to be used for viewing and evaluating CT images provided by a CT diagnostic device and enabling structured evaluation of CT images.

The syngo.CT Applications is a combination of fourteen (14) medical devices which are handled as features / functionalities within syngo.CT Applications.

The provided text is a 510(k) summary for the device "syngo.CT Applications." It describes the device, its indications for use, and a comparison to a predicate device. However, it does not explicitly detail the acceptance criteria for the device's performance nor does it present a study that proves the device meets specific performance metrics.

Instead, the document primarily focuses on:

• Substantial Equivalence: Arguing that the new version of syngo.CT Applications is substantially equivalent to a previously cleared version and other reference devices.
• Software Verification and Validation: Stating that V&V activities were performed and that the device conforms to special controls and standards.
• Risk Analysis: Confirming risk analysis was completed and controls implemented.
• Compliance with Standards: Listing recognized consensus standards the device meets.

Therefore, many of the requested details about acceptance criteria and a specific performance study are not available in the provided text.

Here's an attempt to answer based on the information available and what can be inferred:

Acceptance Criteria and Device Performance Study Information

Disclaimer: The provided document is a 510(k) summary, primarily focused on demonstrating substantial equivalence to a predicate device, rather than a detailed report of a performance study with specific acceptance criteria and results. Therefore, much of the requested information regarding specific quantitative acceptance criteria and the details of a primary performance study is not explicitly stated in the text. The document refers to "testing supports that all software specifications have met the acceptance criteria," but does not list these criteria or detailed results.

1. Table of Acceptance Criteria and Reported Device Performance

As mentioned above, specific quantitative acceptance criteria and their corresponding reported performance values are not detailed in the provided 510(k) summary. The document broadly states:

• "The testing supports that all software specifications have met the acceptance criteria."
• "The testing results support that all the software specifications have met the acceptance criteria."
• "The result of all testing conducted was found acceptable to support the claim of substantial equivalence."

This indicates that internal acceptance criteria were established and met, but their specifics are not published here.

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

The document does not specify the sample size used for any test set or the provenance (e.g., country of origin, retrospective/prospective) of data used for testing. It refers to "testing for verification and validation" but does not provide these details.

3. Number of Experts and Qualifications for Ground Truth

The document does not provide any information regarding the number of experts used to establish ground truth for a test set, nor their qualifications. Given the nature of the device (advanced visualization and measurement tools), it is likely that such evaluation involved clinical experts, but this is not stated.

4. Adjudication Method for the Test Set

The document does not specify any adjudication method (e.g., 2+1, 3+1, none) used for establishing ground truth or evaluating the test set.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study and Effect Size

The document does not mention that a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done, nor does it provide any effect size regarding human reader improvement with or without AI assistance. The submission focuses on software changes and bundling previously cleared functionalities.

6. Standalone (Algorithm Only) Performance Study

The document primarily describes a software application that assists radiologists and physicians. While it refers to "software verification and validation," it does not explicitly describe a standalone (algorithm only without human-in-the-loop performance) study for any specific AI or image processing component with quantitative results. The functions described are tools for evaluation by a human user.

7. Type of Ground Truth Used

The document does not explicitly state the type of ground truth used for any testing. Given the nature of medical imaging software, potential ground truth sources could include:

• Expert consensus (e.g., radiologists, cardiologists)
• Pathology reports
• Clinical outcomes
• Reference standards or phantoms
  However, the document does not specify which, if any, were used.

8. Sample Size for the Training Set

The document does not provide any information regarding the sample size used for the training set. This information is typically relevant for machine learning-based algorithms, and while syngo.CT Pulmo 3D mentions a "lung lobe segmentation algorithm," and syngo.CT CaScoring involves calculations, the document doesn't delve into the specifics of their underlying models or training.

9. How Ground Truth for the Training Set Was Established

The document does not provide any information on how ground truth for the training set was established.

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