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Prism View™ provides visualization of functional and physiologic brain imaging data. The software package provides both analysis and viewing capabilities that promote the integration of physiologic and functional imaging data sets, including blood oxygen level dependent (BOLD) fMRI, magnetic resonance spectroscopy (MRS), and MR diffusion including diffusion tensor imaging (DTI). 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.

Prism View is an image processing software package for the visualization and manipulation of clinical imagery of multiple kinds. It brings sets of anatomical, physiologic and/or functional imagery into alignment and provides a variety of display and analysis options for utilizing the imagery relationships.

The provided text describes the Kyron™ Clinical Imaging Prism View™ software, but it does not contain information about acceptance criteria or a study proving that the device meets specific performance criteria.

The document is a 510(k) summary for a medical device (Prism View) that received FDA clearance. It focuses on device description, intended use, comparison to a predicate device, and regulatory classification.

Here's what can be extracted and what is missing based on your request:

Missing Information/Cannot be Determined from the provided text:

• Table of Acceptance Criteria and Reported Device Performance: This information is not present. The document states "FDA has not established special controls or performance standards for this device," and a specific performance study with quantitative acceptance criteria and results is not detailed.
• Sample size used for the test set and the data provenance: Not mentioned.
• Number of experts used to establish the ground truth for the test set and the qualifications: Not mentioned.
• Adjudication method for the test set: Not mentioned.
• Multi Reader Multi Case (MRMC) comparative effectiveness study: Not mentioned. There is no information about human readers improving with or without AI assistance.
• Standalone (i.e. algorithm only without human-in-the-loop performance) study: While the device is described as "image processing software," no standalone performance study results or methodology are provided.
• Type of ground truth used: Not mentioned.
• Sample size for the training set: Not mentioned.
• How the ground truth for the training set was established: Not mentioned.

Information that can be extracted from the document related to performance/validation (though not in the format requested):

7. Performance Study:

• Statement: "FDA has not established special controls or performance standards for this device. Software verification and validation was conducted to confirm proper function of the device's features."

This statement indicates that a "software verification and validation" was conducted, which is a general requirement for software medical devices. However, it does not provide details on specific acceptance criteria, study design, or results in the way you've requested for demonstrating device performance. It implies functionality was confirmed, but not necessarily clinical performance against a specific metric or clinical ground truth in a detailed study format.

In summary, the provided 510(k) summary focuses on demonstrating substantial equivalence to a predicate device and software functionality, rather than detailing a specific clinical performance study with acceptance criteria and results regarding diagnostic accuracy or similar metrics.

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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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BrainViewRxTM provides visualization of functional and physiologic brain imaging data. The software package provides both analysis and viewing capabilities that promote the integration of physiologic and functional imaging data sets, including blood oxygen level dependent (BOLD) fMRI, magnetic resonance spectroscopy (MRS), and MR diffusion including diffusion tensor imaging (DT). 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.

BrainViewRx is an image processing software package for the visualization and manipulation of clinical imagery of multiple kinds. It brings sets of anatomical, physiologic and/or functional imagery into alignment and provides a variety of display and analysis options for utilizing the imagery relationships.

The Kyron™ Clinical Imaging BrainViewRx™ Viewer is an image processing software package for the visualization and manipulation of clinical imagery.

Here's an analysis of the acceptance criteria and study information provided in the 510(k) summary:

• Acceptance Criteria and Device Performance: The document states that "FDA has not established special controls or performance standards for this device." This means there were no specific quantitative acceptance criteria set by the FDA for this device to meet to demonstrate performance for a 510(k) submission. Instead, the performance evaluation focused on verification and validation of the software's proper function and its substantial equivalence to predicate devices.

  Therefore, a table of acceptance criteria and reported device performance as typically understood with quantitative metrics (e.g., sensitivity, specificity, accuracy) cannot be provided in this case, as such criteria were not explicitly defined or measured for this type of device in the context of this 510(k) submission. The "device performance" in this context refers to its ability to correctly implement its intended functions as a visualization and processing tool.

• Study That Proves the Device Meets Acceptance Criteria:
  The document indicates: "Software verification and validation was conducted to confirm proper function of the device's features." This statement describes the study performed.

  Here's a breakdown of the requested information:

  1. Table of Acceptance Criteria and Reported Device Performance:

     Acceptance Criteria (Implicit)	Reported Device Performance
     Proper function of device features (visualization, manipulation, alignment, display options)	Software verification and validation confirmed proper function.
     Substantial equivalence to predicate aesthetic imaging devices	BrainViewRx Viewer image display capabilities are substantially equivalent to Mirada Solutions Fusion 7D and MRI Devices Eloquence workstation. The selection of imagery displayed is substantially equivalent to Siemens syngo software.

  2. Sample size used for the test set and the data provenance: Not specified. The document only mentions "software verification and validation," which typically involves testing with various types of input data but does not provide details on the size or origin of such test data.

  3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not specified. For this type of software (visualization and processing), the "ground truth" would likely be the expected accurate rendering and manipulation of image data, as judged by software engineers, quality assurance personnel, and potentially medical professionals for usability and correctness of display. However, specific numbers or qualifications are not provided.

  4. Adjudication method 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: No. This device is a viewer and processing tool, not an AI-powered diagnostic algorithm that assists human readers directly in interpretation to improve their performance in a way measurable by such a study. Its function is to present data.

  6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: The "software verification and validation" study inherently evaluates the standalone performance of the algorithm in terms of its ability to process and display images as intended. However, no specific metrics for "standalone performance" in a diagnostic sense (e.g., sensitivity/specificity of an automatic detection or diagnosis) are provided as the device's function is not automated diagnosis.

  7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not explicitly stated, but for software functionality, ground truth would be based on expected computational and display accuracy, possibly verified against known datasets or established imaging standards/benchmarks. Clinical correctness of displayed data would be implicitly verified by ensuring accurate representation of input medical images.

  8. The sample size for the training set: Not applicable. As an image processing software for visualization and manipulation, this device is unlikely to utilize a "training set" in the machine learning sense. Its functionality is based on algorithms that process data deterministically rather than learning from a dataset.

  9. How the ground truth for the training set was established: Not applicable, as there is no mention of a training set.

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