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uWS-MI is a software solution intended to be used for viewing, manipulation, and storage of medical images. It supports interpretation and evaluation of examinations within healthcare institutions. It has the following additional indications:

The PET/CT Oncology application is intended to provide tools to display and analyze the follow-up PET/CT data, with which users can do image registration, lesion segmentation, and statistical analysis.

The PET/CT Dynamic Analysis application is intended to display the dynamic PET image data and its associated timeactivity curve.

The PET/CT Brain Analysis (NeuroQ™) application is intended to analyze the brain PET scan, give quantitative results of the relative activity of 240 different brain regions, and make comparison of activity of normal brain regions in AC database.

The PET/CT Cardiac Analysis (ECTbTM) application is intended to provide cardiac short axis reconstruction, browsing function. And it also performs perfusion analysis and cardiac function analysis of the cardiac short axis.

uWS-MI is a comprehensive software solution designed to process, review and analyze PET, CT and PET/CT patient studies. It can transfer images in DICOM 3.0 format over a medical imaging network or import images from external storage devices such as CD/DVDs or flash drives. These images can be functional data, such as PET as well as anatomical datasets, such as CT. It can be at one or more time-points or include one or more time-frames. Multiple display formats including MIP and volume rendering and multiple statistical analysis including mean. maximum and minimum over a user-defined region is supported. A trained, licensed physician can interpret these displayed images as well as the statistics as per standard practice.

The acceptance criteria and study proving device performance are not explicitly detailed in the provided text in the format requested. However, based on the scattered information, I can infer some points and explicitly state what is missing.

The device is uWS-MI, a software solution for viewing, manipulation, and storage of medical images, with specific applications for PET/CT Oncology, PET/CT Dynamic Analysis, PET/CT Brain Analysis (NeuroQ™), and PET/CT Cardiac Analysis (ECTb™).

The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices rather than providing a detailed performance study with specific acceptance criteria and detailed quantitative results.

Here's an attempt to extract and synthesize the information based on your requested format:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state the sample size used for the test set or the data provenance (e.g., country of origin, retrospective/prospective). However, it mentions "Performance evaluation Report for PET/CT Oncology and Image Fusion" as part of Performance Verification. Details about this report, including the data used, are not provided. Given the nature of a 510(k) summary, the data often comes from internal testing designed to show equivalence, rather than large-scale clinical trials.

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

This information is not provided in the document. Ground truth establishment details are absent.

4. Adjudication Method for the Test Set

This information is not provided in the document.

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

A MRMC comparative effectiveness study was not specifically mentioned or detailed. The document focuses on demonstrating substantial equivalence based on features and software verification, and states "No clinical study was required." for general device clearance. The performance of specific applications (NeuroQ™ and ECTb™) leverages their prior clearances, implying that their functionalities, rather than a new comparative effectiveness study of the full uWS-MI system, were reviewed.

6. Standalone Performance (Algorithm Only Without Human-in-the-Loop Performance)

The device is described as "stand-alone software," and its primary verification listed is "Software Verification and Validation." This suggests that the performance verification would have evaluated the algorithm's output independently, as a standalone system. However, the exact metrics and results of this standalone performance are not explicitly provided beyond the statement of functional equivalence to predicate/reference devices.

7. Type of Ground Truth Used

The type of ground truth used for specific performance evaluations is not explicitly stated. However, considering the device's function as an image post-processing and analysis tool, the ground truth would typically involve:

• Expert consensus or expert readings: For evaluating the accuracy of image analysis, measurements, or lesion segmentation outputs.
• Pathology or clinical outcomes data: For validating the diagnostic accuracy of features, particularly for oncology applications, though "no clinical study was required" suggests this was not the primary method for this 510(k).
• Phantom or synthetic data: For testing algorithm robustness and accuracy in controlled environments.

Since the PET/CT Brain Analysis (NeuroQ™) and PET/CT Cardiac Analysis (ECTb™) applications were cleared previously, their ground truth would have been established during their initial clearances, likely involving expert-derived truth based on clinical images or phantoms.

8. Sample Size for the Training Set

The document does not provide information regarding the sample size of any training set. As a 510(k) for a software device, the focus is often on functional equivalence and verification/validation, rather than detailing the machine learning model training process if such models are embedded.

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

This information is not provided in the document.

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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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