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QCU has been developed for the objective and reproducible analysis of intravascular ultrasound images. Intended purposes are:

1. Supporting clinical diagnoses about stenosis and/or control of the placement of intervention devices;
2. Supporting subsequent clinical decision making purposes;
3. Supporting the use in clinical research trials, directed at studying changes in vessel conditions over time as a result of interventions and or medication.

QCU has been developed for the objective and reproducible analysis of tomograhic images of both lumen and arterial wall of a coronary or vascular segment, in particular the assessment of a stenosis or atherosclerotic plaque. This information supports the the aboutinent of intervention devices in these vessels. QCU-CMS enables an advanced assessment of vessel, lumen, and stent morphology. It also avoids the very time-consuming conventional manual tracing of boundaries, which suffers from high intro- and inter observer variability. QCU-CMS can be used to control stent placement ind to assess in-stent restenosis. QCU software package enables the automatically calculation and the display of various parameters such as: areas and diameters in individual slices; volumes over the segment of interest (Simpson's Rule) for the vessel, lumen and stent contours; plaque and in-stent restenosis parameters.

QCU-CMS analytical software is intended to support all clinicians, i.e. cardiologists, radiologists, and referring physicians involved in the assessment of ultrasound images. radiological, and refering ped physician these parameters may be useful in supporting the determination of a diagnosis.

QCU-CMS is a state-of-the-art analytical software tool designed for Windows NT operating systems. QCU-CMS analytical software facilitates the import and visualization of ultrasound images via CD-ROM and digital network. The QCU-CMS functionality is independent of the ultrasound equipment vendor. QCU-CMS, using automated contour detection, provides quantitative analysis with objective and reproducible data of length and diameter, area and volume in regions of interest. The results of selected analysis can be reported in user-defined configuration, exported in general formats and transported for storage via communication with standard Microsoft office packages.

Here's an analysis of the provided text, focusing on the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text does not explicitly state specific numerical acceptance criteria for the QCU-CMS analytical software. It focuses more on the intended use and qualitative benefits of the device in comparison to manual tracing.

However, based on the description of the device's capabilities and its intended use to provide "objective and reproducible analysis," the implicit acceptance criteria would likely revolve around aspects of accuracy, reproducibility, and agreement with established references (which are hinted at in the "Evaluation by hospitals and literature" and comparison to manual methods).

The reported device performance, similarly, is presented qualitatively rather than quantitatively against specific benchmarks.

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

The document does not provide details on the sample size used for the test set. It mentions "Evaluation by hospitals and literature," but without specifying the number of cases or the nature of this evaluation. Therefore, the data provenance (e.g., country of origin, retrospective/prospective) for a formal test set is also not specified.

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

The document does not specify the number of experts or their qualifications used to establish ground truth for a test set.

4. Adjudication Method for the Test Set

The document does not describe any adjudication method used for a test set.

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

The document does not describe an MRMC comparative effectiveness study. It mentions that the software "avoids the very time-consuming conventional manual tracing of boundaries, which suffers from high intro- and inter observer variability," implying an improvement over manual methods, but no formal comparative study with human readers (with or without AI assistance) is detailed. Therefore, an effect size of human readers improving with AI vs. without AI assistance is not reported.

6. Standalone Performance Study

The document implies a standalone performance for the algorithm. The description states it provides "automated contour detection" and "automatically calculation and the display of various parameters." The "Evaluation by hospitals and literature" mentioned might indirectly relate to standalone performance, but no dedicated standalone study with quantitative results like sensitivity, specificity, or accuracy is explicitly presented.

7. Type of Ground Truth Used

The document does not explicitly state the type of ground truth used for any formal testing. Given its intended use for analyzing intravascular ultrasound images, it is highly likely that comparison would be made against:

• Expert Consensus: Manual tracings and measurements performed by highly experienced clinicians (cardiologists, radiologists). The mention of "manual tracing of boundaries, which suffers from high intro- and inter observer variability" strongly implies this as a baseline.
• Pathology/Histology: For very specific cases, tissue analysis could be a gold standard for plaque characterization, but this is less common for routine IVUS measurements.
• Other established imaging modalities: Comparison to other well-validated imaging techniques for vessel dimensions.

8. Sample Size for the Training Set

The document does not mention the sample size used for a training set. As an early submission (2001), the concept of distinct training and test sets as rigidly defined in modern AI/ML development might not have been as systematically applied or documented in this type of submission.

9. How Ground Truth for the Training Set Was Established

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

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