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nordicBrainEx is an image processing software package to be used by trained professionals including but not limited to physicians and medical technicians. The software runs on a standard "off-the-shelf" PC workstation and can be used to perform image viewing, processing and analysis of medical images. Data and images are acquired through DICOM compliant imaging devices and modalities.

nordicBrainEx provides both viewing and analysis capabilities of functional and dynamic imaging datasets acquired with MRI or other relevant modalities, including blood oxygen level dependent (BOLD) fMRI, diffusion weighted MRI (DWI) / fiber tracking and dynamic analysis.

BOLD fMRI: BOLD analysis is used to highlight small magnetic susceptibility changes in the human brain in areas with altered blood-flow resulting from neuronal activity.

DWI/Fiber Tracking: Diffusion analysis is used to visualize local water diffusion properties from the analysis of diffusion-weighted MRI data. Fiber tracking utilize the directional dependency of the diffusion to display the white matter structure in the brain.

Dynamic Analysis: Dynamic analysis is used for visualization and analysis of dynamic imaging data of the brain, showing properties of changes in contrast over time where such techniques are useful or necessary.

The nordicBrainEx·Software is a post-processing application for functional MRI data developed with a view to ease of use and high performance on a standard Windows workstation. The software provides comprehensive functionality for processing and analyzing BOLD fMRI and DTI data, in addition to efficient and easy to use tools for visualization and report generation. The application workflow has been optimized to ensure efficiency and high throughput in a clinical environment.

The provided text does not contain detailed information about specific acceptance criteria, reported device performance metrics, or a study that uses a test set, ground truth, or expert review for the nordicBrainEx Software. The documentation focuses on establishing substantial equivalence to a predicate device (nordicICE Software, K090546) through general "verification and validation activities" rather than presenting a performance study with quantitative results against specific criteria.

Therefore, many of the requested fields cannot be filled.

Here's a summary of what information is available in relation to your request:

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

The document does not specify quantitative acceptance criteria or report specific device performance metrics in the way you've requested (e.g., sensitivity, specificity, accuracy). It broadly states that "Prospectively defined verification and validation activities for the nordicBrainEx Software assure that the nordicBrainEx Software is substantially equivalent to the cleared nordicICE Software and meets design and performance specifications as well as user needs when operated according to the operating instructions." This implies that the acceptance criteria revolved around demonstrating functional equivalence to the predicate device and meeting internal design specifications and user needs.

2. Sample size used for the test set and the 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

Not specified in the provided text.

4. Adjudication method for the test set

Not specified in the provided text.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done

No MRMC study is mentioned. The focus is on substantial equivalence to a predicate device, not on improving human reader performance.

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

The document describes the software as a "post-processing application" and "image processing software package to be used by trained professionals including but not limited to physicians and medical technicians." This indicates it's designed to be used by humans, implying human-in-the-loop. No standalone algorithm performance is detailed.

7. The type of ground truth used

Not specified in the provided text.

8. The sample size for the training set

Not specified in the provided text. The document refers to "verification and validation activities" but doesn't detail specific training sets.

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

Not specified in the provided text.

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nordiclCE is an image processing software package to be used by trained professionals including but not limited to physicians and medical technicians-The software-runs on a standard "off-the-shelf" PC -workstation and can be used to perform image viewing, processing and analysis of medical images. Data and images are acquired through DICOM compliant imaging devices and modalities.

nordic!CE provides both viewing and analysis capabilities of functional and dynamic imaging datasets acquired with MRI or other relevant modalities, including blood oxygen level dependent (BOLD) fMRJ, diffusion weighted MRI (DWI) / fiber tracking and dynamic analysis.

BOLD fMRI: BOLD analysis is used to highlight small magnetic susceptibility changes in the human brain in areas with altered blood-flow resulting from neuronal activity.

DWI/Fiber Tracking: Diffusion analysis is used to visualize local water diffusion properties from the analysis of diffusion-weighted MRI data. Fiber tracking utilize the directional dependency of the diffusion to display the white matter structure in the brain.

Dynamic Analysis: Dynamic analysis is used for visualization and analysis of dynamic imaging data of the brain, showing properties of changes in contrast over time where such techniques are useful or necessary.

nordiclCE – Nordic Image Control and Evaluation software – is a medical viewing, analysis, and processing package developed with a view to ease of use and high performance on a standard Windows platform. The software provides a wide range of basic image processing and manipulation functions, in addition to comprehensive functionality for dynamic image analysis and processing/display of functional MRI (fMRI) data. The main user of the program will be imaging professionals who need to visualize and analyze images taken primarily from a MRI system.

The provided 510(k) summary (K090546) for the nordicICE Software does not contain the detailed information required to describe the acceptance criteria and the study that proves the device meets those criteria.

This document is a 510(k) premarket notification for a modification to an existing device (nordicICE). The modification involves adding new software modules for dynamic contrast-enhanced imaging data analysis (Perfusion and DCE Modules).

Here's what can be extracted and what is missing, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

• Missing. The document states, "The nordicICE software has been tested for function and safety and fulfills all requirement specifications." However, it does not provide any specific acceptance criteria (e.g., performance metrics, thresholds) or report any quantitative device performance data from a validation study.

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

• Missing. The document does not mention any test set, sample size, or the provenance (country of origin, retrospective/prospective) of any data used for testing.

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

• Missing. There is no mention of experts, ground truth establishment, or their qualifications.

4. Adjudication Method

• Missing. No information on adjudication methods is provided.

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

• Missing. There is no indication that an MRMC study was performed, nor any data on human reader improvement with or without AI assistance. The device is primarily a viewing, processing, and analysis tool, not an AI-assisted diagnostic tool in the sense of a standalone algorithm for interpretation.

6. Standalone (Algorithm Only) Performance Study

• Missing. While the device offers analysis capabilities, the document does not describe a standalone performance study where the algorithm's output is compared against a ground truth without human intervention. The nature of the device as a "viewing, analysis, and processing package" suggests it's primarily a tool for professionals, rather than a fully autonomous diagnostic algorithm.

7. Type of Ground Truth Used

• Missing. The document does not describe any specific ground truth used for testing or validation of the expanded functionality.

8. Sample Size for the Training Set

• Missing. There is no mention of a training set, as the document focuses on modifications to an existing software package and its functional testing rather than a new machine learning algorithm that requires extensive training data.

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

• Missing. As no training set is mentioned, information on how its ground truth was established is also absent.

Summary of available information related to testing:

The document states:
"The nordicICE software has been tested for function and safety and fulfills all requirement specifications."

This statement confirms that testing was conducted to ensure the device met its functional and safety requirements, but it does not provide any details about the methodologies, data, or results of these tests, especially concerning clinical performance or diagnostic accuracy. The 510(k) process for this type of modification often relies on functional verification and validation that the new modules perform as intended and do not introduce new safety concerns, rather than extensive clinical comparative studies, particularly when the device is an image processing tool rather than a diagnostic algorithm.

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nordicICE is an image processing software package to be used by trained professionals including but not limited to physicians and medical technicians. The software runs on a standard "off-the-shelf" PC workstation and can be used to perform image viewing, processing and analysis of medical images. Data and images are acquired through DICOM compliant imaging devices and modalities.

nordicICE provides both viewing and analysis capabilities of functional and dynamic imaging datasets acquired with MRI or other relevant modalities, including blood oxygen level dependent (BOLD) fMRI, diffusion weighted MRI (DWI) / fiber tracking and dynamic analysis.

BOLD fMRI: BOLD analysis is used to highlight small magnetic susceptibility changes in the human brain in areas with altered blood-flow resulting from neuronal activity.

DWI/Fiber Tracking: Diffusion analysis is used to visualize local water diffusion properties from the analysis of diffusion-weighted MRI data. Fiber tracking utilize the directional dependency of the diffusion to display the white matter structure in the brain.

Dynamic Analysis: Dynamic analysis is used for visualization and analysis of dynamic imaging data, showing properties of changes in contrast over time where such techniques are useful or necessary.

nordicICE (nlCE) - Nordic Image Control and Evaluation software - is a medical viewing, analysis, and processing package developed with a view to ease of use and high performance on a standard Windows platform. The software provides a wide range of basic image processing and manipulation functions, in addition to comprehensive functionality for dynamic image analysis and processing/display of functional MRI (fMRI) data. The main user of the program will be imaging professionals who need to visualize and analyze images taken primarily from a MRI system.

This 510(k) summary for the Nordic Image Control and Evaluation (nordicICE) Software primarily focuses on demonstrating substantial equivalence to a predicate device (Nordic Image Control and Evaluation (nordicICE) Software, K063539) and detailing its intended use and features rather than providing extensive details about specific acceptance criteria and a structured study to prove those criteria.

Based on the provided text, a comprehensive table of acceptance criteria and reported device performance, as well as many of the requested study details, cannot be fully extracted because the document does not contain this specific information in the format requested for a detailed AI/CAD device study. This document is a regulatory submission for a PACS-like software, which historically did not require the same rigorous, quantitative performance studies as modern AI/CAD algorithms. Instead, the focus is on verification and validation (V&V) of software functionality and substantial equivalence.

However, I can extract what is implied and stated regarding validation and equivalence:

1. Table of Acceptance Criteria and Reported Device Performance

"The information provided by nordicICE was found to be substantially equivalent with the predicate device Nordic Image Control and Evaluation (nordicICE) Software (K063539)." |
| Safety and Effectiveness: Ensuring the software functions without introducing new risks or compromising diagnostic accuracy compared to the predicate. | Demonstrated through verification and validation procedures, and determination of substantial equivalence. |
| Adherence to Design Specifications: Software performs as intended per internal design documents. | "nordicICE has been verified and validated according to NIL's procedures for product design and development." |

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

• Not specified. The document mentions "verification and validation" but does not detail a specific "test set" in terms of patient cases or images, sample size, or data provenance (e.g., country of origin, retrospective/prospective). This is typical for software validation focused on functional correctness rather than diagnostic performance against ground truth.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

• Not applicable/Not specified. The document does not describe a study involving human experts establishing ground truth for a test set to measure diagnostic performance. The validation appears to be against internal specifications and comparison to a predicate device's functionality.

4. Adjudication Method for the Test Set

• Not applicable/Not specified. No mention of adjudication, as there is no described study comparing the software's output against an expert-adjudicated ground truth.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the effect size of how much human readers improve with AI vs without AI assistance

• No. An MRMC study was not done. This device is a general image viewing, processing, and analysis software, not an AI/CAD diagnostic aid for which MRMC studies are typically performed. The document focuses on the software's functionality and its equivalence to a predicate, not its impact on human reader performance.

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

• Not applicable in the typical sense of AI algorithms. While the software itself performs analysis (e.g., BOLD fMRI analysis, DWI processing), the validation described is for the software's computational correctness and functional equivalence to a predicate, not for its standalone diagnostic performance. There is no "algorithm only" performance reported against a clinical outcome or expert ground truth in the document.

7. The Type of Ground Truth Used

• Internal specifications and predicate device functionality. The "ground truth" for the validation appears to be the expected behavior as defined in the product design and development procedures, and the established functionality of the predicate device. It is not clinical ground truth like pathology, expert consensus, or outcomes data, which would be expected for a diagnostic AI device.

8. The Sample Size for the Training Set

• Not applicable/Not specified. This software is described as an image processing, viewing, and analysis package. It is not an AI/Machine Learning algorithm that typically requires a large 'training set' for model development.

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

• Not applicable/Not specified. As there is no mention of a training set for an AI/ML algorithm, the method for establishing ground truth for such a set is not discussed.

Summary of the Study (Implied):

The "study" described is a verification and validation (V&V) process and a substantial equivalence comparison to a predicate device. This type of submission, especially from 2008 for a PACS-like viewing/processing software, focuses on:

• Confirming the software meets its design specifications (internal V&V).
• Demonstrating that the new device has the same intended use and technological characteristics as a previously cleared device (the predicate K063539), and any differences do not raise new questions of safety or effectiveness.

The document explicitly states: "nordicICE has been verified and validated according to NIL's procedures for product design and development. The validation proves the safety and effectiveness of the system. The information provided by nordicICE was found to be substantially equivalent with the predicate device Nordic Image Control and Evaluation (nordicICE) Software (K063539)." This is the core "study" proving the device met its implied acceptance criteria (functional correctness, safety, effectiveness, and substantial equivalence).

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