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Syngo.CT Cardiac Function is an image analysis software package for evaluating cardiac CT angiography (CTA) volume data sets. Combining digital image processing and visualization tools (multiplanar reconstruction (MPR) thin/thick, minimum intensity projection (MIP) thin/thick, inverted MIP thin/thick, volume rendering technique (VRT)), evaluation tools (left and right ventricular (LV/RV) volume calculation, left ventricular myocardial wall calculation and visualization of myocardial enhancement by color coding of hypo-/hyperdense areas) and reporting tools (finding location, finding characteristics and key images), the software package is designed to support the physician in determining the functional parameters of the left and right ventricles, confirming the presence of physician-identified myocardial enhancement defects and evaluation, documentation and follow-up of any such finding.

These visualization/evaluation tools allow for quantification of functional parameters and characterization of myocardial enhancements defects over time, helping the physician to assess any changes. It is also designed to help the physician classify conspicuous regions of tissue.

Syngo.CT Cardiac Function is an image analysis software package for evaluating cardiac CT angiography (CTA) volume data sets. Combining digital image processing and visualization tools (multiplanar reconstruction (MPR) thin/thick, minimum intensity projection (MIP) thin/thick, inverted MIP thin/thick, volume rendering technique (VRT)), evaluation tools (left and right ventricular (LV/RV) volume calculation, left ventricular myocardial wall calculation and visualization of myocardial enhancement by color coding of hypo-/hyperdense areas) and reporting tools (finding location, finding characteristics and key images), the software package is designed to support the physician in determining the functional parameters of the left and right ventricles, confirming the presence or absence of physician-identified myocardial enhancement defects and evaluation, documentation and follow-up of any such finding.

These visualization/evaluation tools allow for quantification of functional parameters and characterization of myocardial enhancements defects over time, helping the physician to assess any changes. It is also designed to help the physician classify conspicuous regions of tissue.

I am sorry, but the provided text does not contain specific acceptance criteria or an explicit study proving the device meets those criteria. The document is a 510(k) summary for the Siemens syngo.CT Cardiac Function software, primarily focused on establishing substantial equivalence to previously cleared devices.

It mentions that "The testing results supports that all the software specifications have met the acceptance criteria" in section 10, but it does not detail:

• What those acceptance criteria are.
• The specifics of the study that demonstrates the device meets these criteria (e.g., sample size, data provenance, ground truth establishment, expert qualifications, adjudication methods, or specific performance metrics).
• Any multi-reader multi-case (MRMC) comparative effectiveness studies or standalone performance studies with quantitative results.

Therefore, I cannot provide the requested table and detailed information based on the given input.

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syngo TrueD is a medical diagnostic application for viewing, manipulation, 3D- visualization and comparison of medical images from multiple imaging modalities and/or multiple time-points. The application supports functional data, such as PET or SPECT as well as anatomical datasets, such as CT or MR. The images can be viewed in a number of output formats including MIP and volume rendering.

syngo TrueD enables visualization of information that would otherwise have to be visually compared disjointedly. syngo TrueD provides analytical tools to help the user assess, and document changes in morphological or functional activity at diagnostic and therapy follow-up examinations.

syngo TrueD is designed to support the oncological.workflow by helping the user to confirm the absence or presence of lesions, including evaluation, quantification, follow-up and documentation of any such lesions. The application allows to store and export volume of interest (VOI) structures in DICOM RT format for use in radiation therapy planning systems.

syngo TrueD allows visualization and analysis of respiratory gated studies to support accurate delineation of the target or treatment volume over a defined phase of the respiratory cycle and thus provide information for radiation therapy planning.

Note: The clinician retains the ultimate responsibility for making the pertinent diagnosis based on their standard practices and visual comparison of the separate unregistered images. syngo Truen in a complement to these standard procedures.

syngo TrueD is a medical diagnostic application for viewing, manipulation, 3D- visualization and comparison of medical images from multiple imaging modalities and/or multiple time-points. The application supports functional data, such as PET or SPECT as well as anatomical datasets, such as CT or MR. The images can be viewed in a number of output formats including MIP and volume rendering.

syngo TrueD enables visualization of information that would otherwise have to be visually compared disjointedly. syngo TrueD provides analytical tools to help the user assess, and document changes in morphological or functional activity at diagnostic and therapy follow-up examinations.

syngo TrueD is designed to support the oncological workflow by helping the user to confirm the absence or presence of lesions, including evaluation, quantification, follow-up and documentation of any such lesions. The application allows to store and export volume of interest (VOD structures in DICOM RT format for use in radiation therapy planning systems.

syngo TrueD allows visualization and analysis of respiratory gated studies to support accurate delineation of the target or treatment volume over a defined phase of the respiratory cycle and thus provide information for radiation therapy planning.

TrueD will be marketed as a software only solution for the end-user (with recommended hardware requirements) . It will be installed by Siemens service engineers. The TrueD described supports DICOM formatted images and information. It is based on the Windows XP operating system.

This 510(k) summary primarily focuses on the substantial equivalence of the "syngo™ TrueD Software" to existing predicate devices, rather than providing detailed acceptance criteria and a specific study demonstrating performance against those criteria. It's a submission for a software device used for image viewing, manipulation, and 3D visualization, targeting applications in oncology and radiation therapy planning.

Based on the provided text, the following information can be extracted:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not specify quantitative acceptance criteria or report specific performance metrics for the syngo™ TrueD Software that would typically be found in a performance study (e.g., sensitivity, specificity, accuracy for a diagnostic task). The submission emphasizes substantial equivalence to predicate devices for its intended use and technical characteristics.

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

The document does not mention a specific test set, its sample size, or data provenance (e.g., country of origin, retrospective/prospective). This type of information is usually associated with performance studies assessing diagnostic accuracy or similar metrics.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

The document does not describe any specific ground truth establishment process for a test set, nor does it mention the number or qualifications of experts involved.

4. Adjudication Method for the Test Set:

No adjudication method is mentioned as there is no described test set or ground truth establishment process.

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

No MRMC comparative effectiveness study is mentioned. The document primarily argues for substantial equivalence based on intended use and technological characteristics compared to predicate devices. The final "Note" states: "The clinician retains the ultimate responsibility for making the pertinent diagnosis based on their standard practices and visual comparison of the separate unregistered images. syngo TrueD in a complement to these standard procedures." This suggests the device is an assistive tool and not designed to replace human interpretation in diagnostic decision-making, which is often the focus of MRMC studies.

6. If a Standalone (algorithm only without human-in-the-loop performance) was done:

The document does not describe a standalone performance study. The device is presented as an image viewing and manipulation tool to support clinicians.

7. The Type of Ground Truth Used:

No specific ground truth type is mentioned as no performance study with a defined test set is described.

8. The Sample Size for the Training Set:

The document does not mention any training set or its sample size. This suggests the device may not heavily rely on machine learning models that require extensive training data in the same way as some contemporary AI diagnostics. Its function is primarily visualization and analysis, with tools to help users assess changes.

9. How the Ground Truth for the Training Set was Established:

Not applicable, as no training set is mentioned.

Summary of what the document does provide regarding "proof":

The document argues for the device's substantial equivalence to existing legally marketed predicate devices, rather than providing direct "proof" of meeting novel acceptance criteria through a performance study. It emphasizes:

• Identical Intended Use: The device's intended use is described as viewing, manipulation, 3D visualization, and comparison of medical images, similar to the functions of its predicate devices. It supports oncology workflows (lesion evaluation, quantification, follow-up, documentation) and radiation therapy planning (visualization/analysis of respiratory gated studies).
• Similar Technological Characteristics: It is a software-only solution, supports DICOM images, and runs on Windows XP, implying comparable technology to its predicates.
• Safety Information: A hazard analysis was conducted, and appropriate preventive measures were taken, resulting in a determination of "minor level of concern." It highlights that the device has no patient-contacting materials, is used by trained professionals, and device output is subject to review by these professionals. It also states the device "does not impact the quality or status of the original acquired data."

Conclusion:

This 510(k) submission for syngo™ TrueD software in 2009 is a premarket notification for substantial equivalence. It does not include a detailed study with quantitative acceptance criteria and performance data like those commonly seen for AI/ML diagnostic algorithms today. Instead, its "proof" is centered on demonstrating that it is as safe and effective as, and performs as well as, already legally marketed predicate devices with similar intended uses and technological features.

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