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C-THV, an image acquisition and processing modular software package, is indicated for use as follows:

• Assists in projection selection using 3D modeling based on 2D images
• Performs dimensional measurements based on DICOM images.
• Assists in device positioning by providing real time localization on predefined roadmaps and live fluoroscopy.
  The system is to be used in-procedure and off-line for post-procedural analysis.

The C-THV (version 4.6) system is an image acquisition and processing modular software package designed as an add-on to conventional X-ray angiography systems. This system enhances the output of cardiovascular angiography by providing software modules that assist in diagnosis, procedure planning, therapeutic staging and post deployment analysis. The C-THV provides quantitative data of vessel and localizes device on predefined roadmaps. The C-THV is intended to be used in patients with vascular, congenital, valvular, and myopathic heart disease as well as with patients undergoing artificial valve deployment. The C-THV package includes and elaborates on previously developed, 510(k) cleared, and marketed modules of IC-PRO (version 3.5, model B) system. It comprised of the following modules:

1. Optimal Projection
2. Dimensional Measurements
3. Virtual Valve
4. Positioning

Here's a breakdown of the acceptance criteria and the study information based on the provided text, where available:

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

The provided 510(k) summary does not explicitly list "acceptance criteria" with numerical targets. Instead, it states that "Performance tests have yielded accuracy and precision results within the predetermined specifications." This implies that the device met internal specifications defined by the manufacturer, but these specific criteria are not detailed in the public summary.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not specify the sample size used for the test set, nor does it provide information about the data provenance (country of origin, retrospective/prospective).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not available in the provided text.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not available in the provided text.

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

The document does not mention a multi-reader multi-case (MRMC) comparative effectiveness study, nor does it provide any information on the effect size of human readers improving with AI assistance. The C-THV system is described as an "image acquisition and processing modular software package" that "assists" in various tasks, implying a tool for human use rather than an AI-driven autonomous system.

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

The provided text focuses on the device's role in assisting in diagnosis, procedure planning, and measurements, implying human interaction. It does not indicate that a standalone (algorithm only) performance study was conducted.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The document states that "Performance tests have yielded accuracy and precision results within the predetermined specifications," but it does not specify how this ground truth was established (e.g., expert consensus, pathology, other validated methods). The nature of the device (angiography analysis for dimensional measurements and positioning) suggests that ground truth would likely involve highly accurate measurements or expert consensus based on established medical imaging practices.

8. The sample size for the training set

This information is not available in the provided text.

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

This information is not available in the provided text.

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