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DynaCAD is a post-processing software package intended for use in viewing and analyzing magnetic resonance imaging (MRI) studies. DynaCAD V1.0 supports evaluation of dynamic MR data acquired during contrast administration. DynaCAD automatically registers serial patient image acquisitions to minimize the impact of patient motion, segments and labels tissue types based on enhancement characteristics (parametric image maps), and performs other user-defined post-processing functions (image subtractions, multiplanar reformats, maximum intensity projections). The resulting information can be displayed in a variety of formats, including a parametric image overlaid onto the source image. DynaCAD is designed to provide a reliable means of visualizing the presence and pattern of contrast induced enhancements of MRI data sets. DynaCAD also provides an intervention planning tool (DynaLOC) which assists with MRI guidance of percutaneous interventional procedures.

When interpreted by a skilled physician, this device provides information that may be useful in screening, diagnosis, intervention planning and monitoring. DynaCAD can also be used to provide accurate measurements of the diameters, areas, volumes and uptake characteristics of segmented tissues. Patient management decisions should not be made based solely on the results of DynaCAD analysis.

DynaCAD image analysis relies on the assumption that pixels having similar MRI signal intensities represent similar tissues. The DynaCAD software simultaneously analyzes the pixel signal intensities from multiple MRI sequences and applies parametric fitting methods to perform tissue segmentation and classification.

The DynaCAD system consists of proprietary software developed by MRI Devices Corporation which is installed on an off-the-shelf personal computer and a monitor configured as a DynaCAD display station.

The provided text describes the DynaCAD V1.0, a post-processing software package for viewing and analyzing MRI studies. However, it does not contain acceptance criteria for device performance or any specific study details (like sample sizes, ground truth establishment, or expert qualifications) that would allow for a comprehensive table of acceptance criteria and reported device performance to be constructed.

The document mostly focuses on the device's intended use, general description, software development processes, and its substantial equivalence to predicate devices for regulatory approval. It mentions "Performance testing" and "Clinical Evaluation" but provides no quantitative results, acceptance thresholds, or specifics of these evaluations.

Therefore, many of the requested fields cannot be filled from the provided text.

Here's a breakdown of what can and cannot be extracted:

1. Table of acceptance criteria and the reported device performance

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

• Sample size for test set: Not specified. The document mentions "clinical datasets" but does not quantify them.
• Data provenance: Not specified (e.g., country of origin, retrospective or 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)

• Not specified. The document indicates that a "skilled physician" interprets the device information, but it does not describe how ground truth was established for testing purposes or the specific qualifications of experts involved in such a process.

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

• Not specified.

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

• Not specified. The document refers to DynaCAD as a "Computer Aided Detection (CAD) system" but does not describe any MRMC studies or comparative effectiveness with or without AI assistance.

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

• This is implied to some extent for the "Target accuracy was verified for the DynaLOC package in a clinical setting, using a realistic patient care procedure and placing needles in a phantom." This sounds like an evaluation of the system's ability to assist in needle placement, which would involve the algorithm's direct output. However, a formal "standalone" performance study with metrics separate from human interaction is not explicitly described or quantified. The device is generally described as a post-processing tool to be interpreted by a skilled physician, suggesting it's always human-in-the-loop.

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

• For DynaLOC (intervention planning): The "target accuracy was verified... using a realistic patient care procedure and placing needles in a phantom." This implies the "ground truth" for DynaLOC's accuracy was the known target within the phantom.
• For other features (segmentation, enhancement characteristics): Not specified.

8. The sample size for the training set

• Not specified.

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

• Not specified. The document mentions "parametric fitting methods" for tissue segmentation and classification, but not how these models were trained or how ground truth was established for any training data.

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