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The BrainAcquireRx™ / BrainProcessRx™ Data Suite is software used in conjunction with a Magnetic Resonance scanner to acquire and process blood oxygen level dependent (BOLD) functional magnetic resonance imaging (fMRI) and other MRI data sets.

The BrainAcquireRx software application presents a scripted series of synchronized visual and/or auditory stimuli and/or cognitive/motor tasks to the patient being scanned. The patient's responses and image data from the MRI scanner are stored for use by the BrainProcessRx application, which performs post-processing for quality control and subsequent viewing of fMRI and other MRI data. These applications can also be used to assist in scripted data acquisition and post-processing of anatomical, functional, and physiologic MR imagery including magnetic resonance spectroscopy (MRS) and MR diffusion. The integration of these data, when interpreted by a trained physician, yields information that may assist in the diagnosis of brain pathology and the planning and monitoring of medical treatments.

The software provides support for functional MRI (fMRI) data acquisition and post-processing, as well as other anatomical, functional and physiologic MRI studies. BrainAcquireRx provides a scripted approach to performing fMRI and other functional, anatomical and physiologic MRI studies. BrainProcessRx performs post-processing of fMRI and other data sets. The processed data is ready for report generation utilizing the Kyron BrainViewRx™ Viewer.

The provided text states that "Software verification and validation was conducted to confirm proper function of the device's features," but it does not specify acceptance criteria, present performance metrics, or detail the study design elements typically found in a comprehensive performance study. Therefore, most of the requested information cannot be extracted from the given text.

Here is a summary of what can and cannot be extracted:

1. Table of Acceptance Criteria and Reported Device Performance

Not available in the provided text. The document states "Software verification and validation was conducted to confirm proper function of the device's features," but it does not specify what those "proper functions" entail as measurable acceptance criteria, nor does it report any specific performance metrics.

2. Sample Size for the Test Set and Data Provenance

Not available in the provided text. No information is given about the size or origin of any test set used in the software verification and validation.

3. Number of Experts and their Qualifications for Ground Truth Establishment (Test Set)

Not available in the provided text. No mention of experts or their qualifications for establishing ground truth is made.

4. Adjudication Method (Test Set)

Not available in the provided text. There is no information regarding any adjudication methods.

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

Not available in the provided text. The document makes no mention of an MRMC study or any comparison of human readers with and without AI assistance.

6. Standalone (Algorithm Only) Performance Study

The text indicates that "Software verification and validation was conducted to confirm proper function of the device's features." While this implies a standalone assessment of the algorithm's functionality, no specific quantitative or qualitative results from such a study are provided. The "performance study" section simply states that it was conducted but offers no details of its findings.

7. Type of Ground Truth Used

Not available in the provided text. The document does not specify the type of ground truth used for any validation or verification activities.

8. Sample Size for the Training Set

Not available in the provided text. The document does not mention a training set or its size.

9. How Ground Truth for the Training Set Was Established

Not available in the provided text. The document does not mention a training set or how its ground truth was established.

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