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DynaCAD is a MR image analysis software medical device used during clinical diagnosis, reporting, and interventional pre-planning and is intended to assist the physician through a series of sequential tasks. DynaCAD consists of: • MR Analysis Server post-processing software application facilitates the analysis of dynamic MR datasets to provide study review, lesion characterization, and additional mathematical and/or statistical analysis. · Viewer application facilitates the analysis and presentation of datasets generated by the MR Analysis Server. · Interventional Planning image-guidance application for diagnostic and interventional procedure planning for biopsy and/ or soft tissue ablation. DynaCAD is indicated for medical conditions that require interventional and/or diagnostic procedures of the prostate gland or breast tissue.

DynaCAD is a MR image analysis software only medical device used during clinical diagnosis, reporting, and interventional pre-planning and is intended to assist the physician through a series of sequential tasks. DynaCAD consists of: - . MR Analysis Server post-processing software application, which facilitates the analysis of dynamic and non-dynamic MR datasets to provide study review, lesion characterization, and additional mathematical and/or statistical analysis. It includes the following software modules: DynaCAD Breast, DynaCAD Prostate, DynaLOC Breast, DynaLOC Prostate, and PK MRI Analysis. - . Viewer application, which facilitates the analysis and presentation of datasets generated by the MR Analysis Server. It includes the following functions: Region of Interest (ROI) curve, Pixel of Interest (POI) curve, Report Card, Volume Calculation, Statistical Analysis, 3-D visualization of image series, and DICOM reporting, among other capabilities. - Interventional Planning image-guidance application, i.e. Ablation Planning, which facilitates diagnostic and interventional procedure planning for biopsy and/or soft tissue ablation. It helps the user to prepare for ablation procedures by presenting the target regions along with critical structures identified in MR, and previously acquired biopsy data. It provides information about the ablation devices and applicators for automatic ablation plan computation, which the user can adjust as necessary. DynaCAD is used in both the radiology, i.e. DynaCAD Radiology, and urology domain, i.e. DynaCAD Urology.

The provided text does not contain information about the acceptance criteria or a study that proves the device meets specific performance criteria. It is a 510(k) summary for DynaCAD, a medical image analysis software, asserting its substantial equivalence to a predicate device.

The document focuses on:

• Description of the Device: DynaCAD, its components (MR Analysis Server, Viewer application, Interventional Planning application), and its use in radiology and urology for breast and prostate tissue.
• Intended Use/Indications for Use: Confirms similarity to the predicate device, emphasizing assistance to physicians for diagnosis, reporting, and interventional pre-planning.
• Technological Characteristics: Details the similarities and minor differences (e.g., urology workflow, ablation planning) between the subject and predicate devices, stating that these differences do not raise new safety or effectiveness questions.
• Non-Clinical Performance Data: Mentions compliance with international and FDA-recognized consensus standards (IEC 62304, IEC 62366-1, ISO 14971, ISO 15223-1, NEMA PS 3.1-3.20 DICOM). It states that software verification and validation testing (including usability and in-house simulated use) were performed, and all tests "passed." These tests demonstrated that DynaCAD meets "acceptance criteria of the device requirements" and is adequate for its intended use.
• Clinical Performance Data: Explicitly states, "The subject DynaCAD did not require clinical performance data to demonstrate safe and effective use."

Therefore, I cannot provide the requested information regarding acceptance criteria and performance study details because they are not present in the provided text. The text asserts that non-clinical tests were performed and that "all executed verification test passed" and "all executed validation protocols were passed," indicating the device "Meets the acceptance criteria of the device requirements," but it does not list what those specific acceptance criteria are or the quantitative results of those tests.

The document makes a claim of substantial equivalence based on the device's technological characteristics and non-clinical performance (software verification and validation), rather than a comparative effectiveness study with human readers or a standalone performance study with specific metrics.

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DynaCAD software consists of the MR Analysis Server software and the viewer workstation software.

The MR Analysis Server software, which includes the DynaCAD Breast, DynaCAD Prostate, and DynaCAD PK for other MR Analysis modules, is intended to be used as a post-processing software package designed to provide a reliable means for analyzing MR datasets. The software facilitates the analysis of dynamic and non-dynamic MR datasets to provide study review and additional mathematical and/or statistical analysis. The resulting analysis can be displayed in a variety of formats, including parametric images overlaid onto source MRI images.

The viewer workstation software is intended for use in conjunction with the MR Analysis Server software and facilitates the analysis and presentation of datasets generated by the MR Analysis Server software and incorporates the following functions: Region of Interest (ROI) curve, Pixel of Interest (POI) curve, Report Card, Volume Calculation, Statistical Analysis, 3-D visualization of image series, and DICOM reporting, among other capabilities.

DynaCAD software serves as a workflow roadman tool that organizes and guides the radiologist through the series of sequential tasks that must be performed in order to arrive at a diagnosis. The specific configuration of product features drives the DynaCAD software underlying workflow solution for lesion characterization and reporting. This inherent workflow regimen integrates into the radiologist's existing departmental workflow and can be adapted to fit the needs of each user. In the hands of a trained physician the information provided by the data analysis could yield information that may assist in the interpretation of dynamic and nondynamic MR studies.

DynaLOC Breast

The DynaLOC Breast Interventional Planning software module supports the use of interventional breast coils and MR stereotactic localization devices to perform MR-guided breast interventional procedures. Using information from MR images regarding the coordinates of a user-specified region of interest, and fiducial coordinates, the software provides an automatic calculation of the location and depth of the targeted region of interest, such as a lesion or suspected lesion, relative to the interventional device.

DynaLOC Prostate

DynaLOC Prostate Interventional is a computer-based image-guidance accessory for use with commercially available Magnetic Resonance (MR) imaging systems and interventional devices.

The application provides the user with patient data processing, visualization and storage functions. It allows image analysis, display and recording of simulated images of a tracked insertion tool, such as a needle guide or sleeve, on a computer monitor or other display that shows images of the target organs and the current and/ or projected path of the interventional instrument.

The device is intended to be used by physicians in a clinical setting for treatment planning and guidance for clinical, interventional and/or diagnostic procedures of the prostate.

DynaCAD is a software platform for post-processing of MR datasets to provide a reliable means for visualizing MR datasets. It is also designed to provide study review and mathematical and/or statistical analysis. DynaCAD serves as a workflow roadmap tool that organizes and guides the radiologist through the series of sequential tasks that must be performed in order to arrive at a diagnosis. that runs software modules that use algorithms to evaluate MR images as a postprocessing module. The DynaCAD software platform consists of a viewer workstation and the MR Analysis Server. The MR Analysis Server consists of 5 software modules controlled by license keys:

• DynaCAD Breast
• DynaCAD Prostate ●
• PK MR Analysis
• DynaLoc Breast Intervention ●
• DynaLoc Prostate Intervention .

It is used to review, analyze, and generate reports for MRI studies, as well as post-processing of MR raw images directly from the scanner for viewing and analysis. The software facilitates the analysis of dynamic and non-dynamic MR Datasets to provide study review and additional mathematical and statistical analysis. The results can be displayed in a variety of formats, including parametric images overlaid onto source MRI images.

The viewer workstation software is intended for use in conjunction with the MR Analysis Server software and facilitates the analysis and presentation of datasets generated by the MR Analysis Server software and incorporates the following functions: Region of Interest (ROI) curve, Pixel of Interest (P01) curve, Report Card, Volume Calculation, Statistical Analysis, 3-D visualization of image series, and DICOM reporting, among other capabilities.

DynaCAD software serves as a workflow roadmap tool that organizes and guides the radiologist through the series of sequential tasks that should be performed to arrive at a diagnosis. The specific configuration of product features drives the DynaCAD software underlying workflow solution for lesion characterization and reporting. This inherent workflow regimen integrates smoothly into the radiologist's existing departmental workflow and can be adapted to fit the needs of each user, thereby streamlining diagnosis. In the hands of a trained physician, the information provided by the data analysis could yield information that may assist in the interpretation of dynamic and non-dynamic MR studies.

DynaLOC Breast

The DynaLOC Breast Interventional Planning software module supports the use of interventional breast coils and MR stereotactic localization devices to perform MR-guided breast interventional procedures.

DynaLOC Prostate

DynaLOC Prostate Interventional is a computer-based image-guidance accessory for use with commercially available Magnetic Resonance (MR) imaging systems and the DynaTRIM Interventional device. The device is intended to be used by physicians in a clinical setting for treatment planning and guidance for clinical, interventional or diagnostic procedures of the prostate. The application provides the user with patient data processing, visualization, and storage functions.

PK MRI Analysis

The PK analysis software is designed to allow radiologists to visualize the presence and pattern of contrast induced enhancement for protocols other than Breast and Prostate MR datasets. The option uses the same core processing algorithm contained within All-Time Point pharmacokinetic analysis software, permitting the calculation of Ktrans and Ve values for all voxels within a region of interest in contrast-enhanced MRI studies. The resulting information can be displayed in a variety of formats, including a parametric image overlaid onto source MR images.

The provided text describes the DynaCAD software, a post-processing software package for analyzing MR datasets. However, it does not provide specific details about acceptance criteria or a dedicated study proving performance against those criteria.

Instead of a specific performance study, the document mentions adherence to international and FDA-recognized consensus standards for nonclinical testing and performance information.

Here's a breakdown of the requested information based on the provided text, highlighting what is available and what is not:

1. A 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 in the provided text.
• Data Provenance: Not specified in the provided text.

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 describes DynaCAD as a tool to "assist in the interpretation of dynamic and non-dynamic MR studies" by a "trained physician," but doesn't detail how ground truth was established for testing the software itself.

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

• No MRMC study is explicitly mentioned. The document focuses on the substantial equivalence of DynaCAD to predicate devices based on similar technology, functions, and adherence to standards, rather than comparative effectiveness with human readers.

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

• The document describes DynaCAD as a "post-processing software package" and a "workflow roadmap tool" that "guides the radiologist." This implies a human-in-the-loop system where the software assists the radiologist, rather than a standalone algorithm making diagnoses independently. The nonclinical testing mentioned would likely include software validation of its functions.

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

• Not specified. Given the nature of the software (analysis and workflow guidance), ground truth for its validation would likely relate to the accuracy of its calculations, display of information, and adherence to specified workflows, rather than direct diagnostic accuracy against a histological or outcome ground truth.

8. The sample size for the training set

• Not applicable. DynaCAD is described as a post-processing and workflow tool, not specifically an AI/ML algorithm that requires a "training set" in the conventional sense for learning patterns from data. While it uses "algorithms to evaluate MR images," these are likely pre-defined analytical algorithms rather than machine learning models that undergo extensive training.

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

• Not applicable (as above).

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DynaCAD/Prostate Interventional is a computer-based image-guidance accessory for use with commercially available Magnetic Resonance (MR) imaging systems and interventional devices.

The application provides the user with patient data processing, visualization and storage functions. It allows image analysis, display and recording of simulated images of a tracked insertion tool, such as a needle guide or sleeve, on a computer monitor or other display that shows images of the target organs and the current and/or projected path of the interventional instrument.

The device is intended to be used by physicians in a clinical setting for treatment planning and guidance for clinical, interventional and/or diagnostic procedures of the prostate.

DynaCAD/Prostate Interventional (a.k.a. Dynal.OC/Prostate) is medical device software that is intended to be loaded onto a commercially available computer workstation. The DynaLOC/Prostate software application is designed for use with the DynaTRIM positioning device. The software receives DICOM images from a pre-procedure magnetic resonance (MR) study and performs calculations to assist the clinician with adjustments to the DynaTRIM positioning device. The software does not directly control the Dynall'RIM device, the interventional accessories or the MR scanner. The users must manually adjust the DynaTRIM device and confirm proper positioning of the interventional accessories via an MR verification scan. Additionally, the users must manually control the MRI scanner to obtain the correct MR data sets.

The provided text describes the DynaCAD/Prostate Interventional software, but it does not contain the specific details required to complete all sections of your request regarding acceptance criteria and a detailed study proving performance. The document focuses on the substantial equivalence discussion to predicate devices.

However, based on the limited information available, here's what can be extracted and inferred:

1. Table of Acceptance Criteria and Reported Device Performance:

The document states: "The safety and effectiveness of the DynaCAD/Interventional software (a.k.a. DynaLOC/Prostate) for the proposed indications for use is supported by preclinical software verification and validation testing. This includes validation of the software with the DynaTRIM device is a simulated clinical use setting."

This indicates that acceptance criteria and performance were assessed during software verification and validation testing, but the specific metrics (e.g., accuracy, precision, sensitivity, specificity, user task completion rates, time savings) and their corresponding performance values are not provided in the given text. Thus, a detailed table cannot be created.

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

The document mentions "validation of the software with the DynaTRIM device is a simulated clinical use setting." However, it does not specify the sample size for this test set (e.g., number of cases, number of simulated procedures).

The data provenance is also not specified (e.g., no mention of country of origin, or whether the data was retrospective or prospective).

3. Number of Experts Used to Establish Ground Truth and Their Qualifications:

The document does not mention the use of experts to establish a ground truth for a test set, nor does it specify their number or qualifications. The validation appears to be software-centric and in a simulated environment, suggesting ground truth might have been established through engineering specifications or simulated scenarios rather than expert interpretations of clinical data.

4. Adjudication Method for the Test Set:

Given that expert involvement for ground truth is not mentioned, an adjudication method is not applicable or described in the provided text.

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

The document does not indicate that a multi-reader multi-case (MRMC) comparative effectiveness study was performed. There is no mention of human readers improving with or without AI assistance, as the device is an "image-guidance accessory" and not an AI diagnostic tool in the sense of automating interpretation.

6. Standalone Performance (Algorithm Only without Human-in-the-Loop):

The document primarily describes the software as an "image-guidance accessory" that "assists the clinician with adjustments" and provides "patient data processing, visualization and storage functions." The clinicians "must manually adjust the DynaTRIM device and confirm proper positioning." This strongly implies that the device is designed for human-in-the-loop use and does not provide information on a standalone performance study (i.e., algorithm only without human-in-the-loop).

7. Type of Ground Truth Used:

The document states, "The safety and effectiveness... is supported by preclinical software verification and validation testing. This includes validation of the software with the DynaTRIM device is a simulated clinical use setting." This suggests the ground truth was likely based on engineering specifications, simulated accuracy targets, and functional correctness within the simulated environment, rather than expert consensus on clinical findings, pathology, or outcomes data from real patients.

8. Sample Size for the Training Set:

The document does not provide any information regarding a training set sample size. Given that the device performs calculations and visualization for assistance rather than complex pattern recognition or diagnostic assessment typical of machine learning, a "training set" in the conventional AI sense may not be applicable or explicitly used for this type of software.

9. How the Ground Truth for the Training Set Was Established:

As there is no mention of a training set, there is no information on how its ground truth might have been established.

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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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