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Advantis Platform provides analysis and visualization capabilities of dynamic MRI data of the brain and prostate, presenting the derived properties and parameters in a clinically useful context.

Advantis Platform is intended as a general medical image management and processing system. Advantis Platform is intended to be used by trained healthcare professionals and provides information that, in a clinical setting, may assist in the interpretation of brain and prostate MR studies of adult population.

Diagnosis should not be made solely based on the analysis performed using Advantis Platform.

Advantis Platform is a web-accessible medical viewing and post-processing software application.

Advantis Platform offers comprehensive functionality for dynamic image analysis and visualization of brain and prostate MRI data which are acquired through DICOM-compliant imaging devices and modalities.

The main functionalities of Advantis Platform are listed below.

Brain MRI-related functionalities include:

• BOLD: BOLD fMRI analysis is used to highlight small magnetic susceptibility changes in the human brain in areas with altered blood flow resulting from neuronal activity.
• · DTI: Diffusion analysis is used to visualize local water diffusion properties from the analysis of diffusionweighted MRI data. Fiber tracking utilizes the directional dependency of the diffusion to display the white matter structure in the brain.
• DSC Perfusion: Calculations of perfusion-related parameters that provide information about the blood vessel structure and characteristics as a response of the brain to a specific contrast agent.

Prostate MRI-related functionalities include:

• · Diffusion-Weighted Imaging (DWI) processing: Diffusion analysis is used to visualize local water diffusion properties from the analysis of diffusion-weighted MRI data.
• · Dynamic Contrast-Enhanced Perfusion (DCE Perfusion) processing: Calculations of perfusion-related parameters that provide information about the tissue response to the injection of a contrast medium.

Advantis Platform, apart from the image processing and manipulation functions, provides a wide range of visualization tools, data handling, and reporting features.

• · Image uploading, storing, and exporting
• Data handling
• · Image viewing
• · Reporting feature

Here's a breakdown of the acceptance criteria and study details based on the provided text for the Advantis Platform's prostate module:

1. Table of Acceptance Criteria and Reported Device Performance (Prostate Module)

2. Sample Size and Data Provenance for the Test Set

The document does not explicitly state the specific sample size (number of cases or patients) used for the comparative study for the prostate module. It mentions "all valid pixel values for every subject in the dataset," implying multiple subjects were included, but the exact count is not given.

The data provenance (country of origin, retrospective/prospective) is also not specified in the provided text.

3. Number and Qualifications of Experts for Ground Truth

The document does not provide information on the number of experts used to establish ground truth or their qualifications. The study focused on comparing the device's output to predicate devices, implying that the predicate devices' outputs or methodologies served as a form of "ground" or reference truth for comparison, rather than an independent expert adjudication of the cases themselves.

4. Adjudication Method for the Test Set

The document does not describe an adjudication method for establishing ground truth for the test set. Instead, it performed a comparative study between the Advantis Platform and predicate devices using statistical methods.

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

A MRMC comparative effectiveness study was not explicitly stated as having been done in the provided text. The study described is a comparative study of the device's output against predicate devices, not a study of human readers' performance with and without AI assistance.

6. Standalone Performance Study (Algorithm Only)

Yes, a standalone performance study in the form of a comparative study against predicate devices was done for the prostate module. The document states: "Concerning the Prostate module, a comparative study was conducted in order to validate the equivalency between the results computed by Advantis Platform and the Primary predicate device 2 and the Reference device." This assesses the algorithm's performance (results) independent of human interpretation loops.

7. Type of Ground Truth Used

The "ground truth" for the prostate module's comparative study was the results computed by the Primary Predicate Device 2 (syngo.MR Applications) and the Reference Device (CADstream Version 5). This is a comparison to established, legally marketed software, rather than expert consensus on patient outcomes, pathology, or direct outcomes data.

8. Sample Size for the Training Set

The document does not specify the sample size for the training set. The focus is on the performance testing of the prostate module.

9. How Ground Truth for the Training Set was Established

The document does not provide information on how the ground truth for any potential training set was established. The description of performance testing only pertains to the comparative study for the prostate module, implicitly comparing the device's output to other cleared devices.

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Brainance MD provides analysis and visualization capabilities of dynamic MRI data of the brain, presenting the derived properties and parameters in a clinically useful context.

Brainance MD is a web-accessible medical viewing and post-processing software application. Brainance MD offers comprehensive functionality for dynamic image analysis and visualization of brain MRI data which are acquired through DICOM compliant imaging devices and modalities. The following algorithms provide the main functional analyses of the software application. BOLD: BOLD fMRI analysis is used to highlight small magnetic susceptibility changes in the human brain in areas with altered bloodflow resulting from neuronal activity. DTI: Diffusion analysis is used to visualize local water diffusion properties from the analysis of diffusion-weighted MRI data. Fiber tracking utilizes the directional dependency of the diffusion to display the white matter structure in the brain. DSC Perfusion: Calculations of perfusion related parameters that provide information about the blood vessel structure and characteristics. Examples of such maps are blood flow, time to peak, mean transit time and leakage. Apart from the aforementioned functionalities, Brainance MD offers general visualization tools, a data upload, data download and a reporting feature.

The provided text describes a comparative study conducted to establish the substantial equivalence of the Brainance MD device to a primary predicate device (nordicBrainEx) concerning the processing of DSC Perfusion, fMRI, and DTI sequences.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size for the Test Set and Data Provenance

• Sample Size: "two sequences that were part of two different exams/subjects (either healthy control or diseased) were selected for the comparison conducted for each modality." This implies a total of 6 sequences (2 sequences * 3 modalities).
• Data Provenance: The subjects were "all adults and either healthy controls or diseased diagnosed with metastasis or glioblastoma multiforme." The country of origin is not specified but given the submitter is from Greece, it's possible the data originated from there or a European context. The study is retrospective, as existing "exams/subjects" were selected.

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

The text does not provide information on the number of experts used to establish ground truth or their qualifications. The study focused on comparing the results of the two software devices rather than establishing novel ground truth through expert consensus for each case. The "ground truth" in this context is implicitly the results generated by the predicate device, as the goal was to demonstrate equivalence.

4. Adjudication Method for the Test Set

The text does not mention any adjudication method like 2+1 or 3+1. The study directly compared software outputs without involving multiple human readers to resolve discrepancies in the outputs. The comparison relied on statistical methods (ICC, Bland-Altman, MRD) between the two software outputs.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not explicitly done. The study described is a direct comparison between two software devices, and there is no mention of human readers improving with AI assistance.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Yes, a standalone performance study was done for the Brainance MD device in comparison to the predicate device. The study explicitly states: "The two sequences selected for each modality were processed with each one of the software MD and primary predicate device) using the exact same processing protocol and parameters for each user defined function." This indicates an algorithm-only comparison without a human-in-the-loop component for the performance evaluation itself.

7. Type of Ground Truth Used

The ground truth used was the output of the primary predicate device (nordicBrainEx). The study aimed to prove that Brainance MD produces results equivalent to those of the already cleared predicate device, rather than comparing against a clinical "gold standard" like pathology or long-term outcomes.

8. Sample Size for the Training Set

The text does not provide information on the sample size for the training set. The descriptions focus on the performance testing carried out for regulatory submission.

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

The text does not provide information on how the ground truth for the training set was established.

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