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The Philips Spectral CT Applications support viewing and analysis of images at energies selected from the available spectrum in order to provide information about the chemical composition of the body materials and/or contrast agents. The Spectral CT Applications provide for the quantification and graphical display of attenuation, material density, and effective atomic number. This information may be used by a trained healthcare professional as a diagnostic tool for the visualization and analysis of anatomical and pathological structures.

The Spectral enhanced Advanced Vessel Analysis (SAVA) application is intended to assist clinicians in viewing and evaluating CT images, for the inspection of contrast-enhanced vessels.

The Spectral enhanced Comprehensive Cardiac Analysis (SCCA) application is intended to assist clinicians in viewing and evaluating cardiovascular CT images.

The Spectral enhanced Tumor Tracking (sTT) application is intended to assist clinicians in viewing and evaluating CT images, for the inspection of tumors.

The Spectral CT Applications package introduces a set of three SW clinical applications: spectral enhanced Comprehensive Cardiac Analysis (sCCA), spectral enhanced Advanced Vessel Analysis (sAVA), and spectral enhanced Tumor Tracking (sTT). Each application provides tools that assist a trained personal in visualization and analysis of anatomical and pathological structures.

The sCCA application is targeted to assist the user in analysis and diagnostic of Cardiac Cases, as contrast enhanced and ECG triggered scans. The application input is a cardiac case that was acquired on the IQon CT scanner; the application takes the user through typical workflow steps that allow him to extract qualitative and quantitative information on the coronary tree and chambers. The output of this application is information on physical (length, width, volume) and composition properties (Effective Atomic number, Attenuation, HU) of the coronary vessel & findings along it.

The sAVA application is targeted to assist the user in analysis and diagnostic of CT Angiography cases, as contrast enhanced and whole body CT-angiography scans. The application input is a CT Angiography case that was acquired on the IQon CT scanner; the application takes the user through typical workflow steps that allow him to extract qualitative and quantitative information on the vessel of interest. The output of this application is information on physical (length, width, volume) and composition properties (Effective Atomic number, Attenuation, HU) of the vessels & findings along it.

The sTT application is targeted to assist the user in analysis of tumors, as contrast enhanced, soft tissue oriented, and whole body scans. The application input is a tumor suspected contrast enhanced case that was acquired on the IQon CT scanner; the application takes the user through typical workflow steps that allow him to extract qualitative and quantitative information on the tumor of interest. The output of this application is information on physical (length, width, volume) and composition properties (Effective Atomic number, Attenuation, HU) of the tumor.

The provided text describes the Philips Spectral CT Applications, a set of software clinical applications (sCCA, sAVA, sTT) designed to assist clinicians in viewing and evaluating CT images with spectral data. While the document mentions verification and validation, it does not provide explicit acceptance criteria in a quantitative table or detailed performance metrics against those criteria. It generally states that "SW requirements were met" and "intended uses and defined user needs were met."

Therefore, I cannot populate a table of acceptance criteria and reported device performance with specific numerical values from the provided text. However, I can extract information related to the study that proves the device meets its intended uses and user needs, as described in the "Summary of Clinical Testing" section.

Here's a breakdown of the available information:

1. A table of acceptance criteria and the reported device performance:

No explicit quantitative acceptance criteria or corresponding reported device performance metrics are provided in the document. The document states that "SW requirements were met" and "intended uses and defined user needs were met."

2. Sample sized used for the test set and the data provenance:

• Test Set Sample Size: "clinical datasets" – specific number not provided.
• Data Provenance: The datasets were "derived from Philips IQon Spectral CT system (K133674)." The country of origin is not specified, but the manufacturer is Philips Medical Systems Nederland B.V. and the regulatory contact is in the USA. The data appears to be retrospective, as it's referred to as "clinical datasets" used for validation, not newly acquired data specifically for this study.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Number of Experts: "Philips Internal certified radiologists" – specific number not provided.
• Qualifications of Experts: "certified radiologists" - specific experience level (e.g., 10 years) not provided. They are referred to as representing "a typical user."

4. Adjudication method for the test set:

• Adjudication Method: Not explicitly stated. The document mentions that "The evaluators were questioned against each of the intended uses and provided score to describe their level of satisfaction." This suggests individual evaluation rather than a formal consensus or adjudication process among multiple readers for ground truth establishment.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

• MRMC Study: No MRMC comparative effectiveness study, comparing human readers with and without AI assistance, is described. The validation focused on whether the applications meet intended uses and user needs, as evaluated by radiologists. The applications are described as "assistive tools" for clinicians.

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

• Standalone Performance: Not explicitly evaluated or described. The validation confirms that the applications "allow visualization, manipulation and analysis of spectral data" and "assist clinicians in viewing and evaluating CT images." This implies human interaction as part of the intended use.

7. The type of ground truth used:

• Ground Truth Type: The ground truth for the validation appears to be based on the subjective evaluation and "satisfaction scores" provided by "Philips Internal certified radiologists" against the stated intended uses and user needs. It is based on expert consensus/evaluation of the utility of the application's outputs, rather than a separate, independent "ground truth" like pathology or outcomes data.

8. The sample size for the training set:

• Training Set Sample Size: Not specified. The document primarily discusses verification and validation using "datasets that were generated by the Philips IQon Spectral CT system" and "clinical datasets." It does not provide details on a distinct training set.

9. How the ground truth for the training set was established:

• Ground Truth for Training Set: Not specified, as details about a separate training set or how its ground truth was established are not provided in the document.

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