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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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Arterys Viewer is intended to be used as a Digital Imaging and Communications in Medicine (DICOM) and non-DICOM information and data management system. The Arterys Viewer displays, processes, stores, and transfers medical data from original equipment manufacturers (OEMs) that support the DICOM standard, with the exception of mammography. It provides the capability to store images and patient information from OEM equipment, and perform filtering, digital manipulation and quantitative measurements.

The client software is designed to run on standard personal and business computers. The product is intended to be used by trained medical professionals, including but not limited to radiologists, and physicians. It is intended to provide image and related information that is interpreted by a trained professional to render findings and/or diagnosis, but it does not directly generate any diagnosis or potential findings.

Arterys Viewer is intended to be used as a Digital Imaging and Communications in Medicine (DICOM) and non-DICOM information and data management system. The Arterys Viewer displays, processes, stores, and transfers medical data from original equipment manufacturers (OEMs) that support the DICOM standard, with the exception of mammography. It provides the capability to store images and patient information from OEM equipment, and perform filtering, digital manipulation and quantitative measurements.

The client software is designed to run on standard personal and business computers. The product is intended to be used by trained medical professionals, including but not limited to radiologists, oncologists, and physicians. It is intended to provide image and related information that is interpreted by a trained professional to render findings and/or diagnosis. but it does not directly generate any diagnosis or potential findings.

The following visualization, quantification and data-reporting functionalities are provided by the software:

Visualization:

• 2D image review -
• 3D image review by means of MIP, MinIP, Surface or Average -
• Multi-planar reconstruction (MPR) views (axial, coronal, sagittal, and oblique) -
• Image navigation tools -
• Cine play -

Quantification:

• Distance and area measurements -
  Data reporting:
  The distance, area, and user-selected annotated images are displayed to the user within the software client web browser. The user has the option to save the data for later use. The user can also send the data to PACS, for review.

This document describes the Arterys Viewer, a medical imaging software. However, the provided text does not contain acceptance criteria, a study proving the device meets those criteria, or specific performance data related to accuracy or clinical effectiveness.

The document focuses on:

• General Information: Manufacturer, contact, date prepared.
• Device Description: Intended use (DICOM and non-DICOM data management, display, processing, storage, transfer), functionalities (visualization, quantification, data reporting).
• Indications for Use: What the device is intended for and who uses it (trained medical professionals).
• Comparison to Predicate and Reference Devices: A detailed table comparing feature sets, highlighting similarities and minor differences, and concluding substantial equivalence to a predicate PACS system and a previous version of their own software. This comparison is primarily about feature parity and technological characteristics, not clinical performance.
• Performance Data (General Statement): A general statement that safety and performance have been evaluated and verified according to software specifications, applicable performance standards, and relevant FDA/IEC guidance documents.

Therefore, I cannot provide the requested table or detailed study information because it is not present in the given text. The document asserts that the device is substantially equivalent to a predicate, meaning it performs similarly and raises no new questions of safety or effectiveness, but it does not present a specific study with acceptance criteria and a detailed demonstration of the device meeting those criteria.

Here's a summary of what can be extracted from the provided text regarding performance context:

• Device Name: Arterys Viewer
• Regulation Number: 21 CFR 892.2050
• Regulation Name: Picture archiving and communications system
• Product Code: LLZ
• Regulatory Class: II

Regarding the specific questions:

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

   • Acceptance Criteria: Not explicitly stated as quantifiable performance metrics for clinical use. The "acceptance" is implied through substantial equivalence to a predicate device, meaning it performs its intended functions similarly and safely.
   • Reported Device Performance: No specific numerical performance data (e.g., accuracy, sensitivity, specificity, or measurement agreement) is provided. The performance is described in terms of its functionalities (display, processing, storage, measurements) and claimed to be verified through software V&V.

2. Sample size used for the test set and the data provenance: Not provided. The document mentions "software verification and validation testing" but does not detail the size or nature of the test data (e.g., retrospective/prospective, country of origin).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not provided.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not provided.

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 provided. The device is a "Viewer" and "does not directly generate any diagnosis or potential findings," implying it's a tool for professionals rather than an AI-assisted diagnostic algorithm in the sense of directly improving reader performance on a diagnostic task specified here.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not provided. The device is intended to be used by "trained medical professionals" who interpret the information, so a purely standalone performance claim would be contrary to its stated use.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not provided.

8. The sample size for the training set: Not applicable based on the available information. The device is described as a "Viewer" with visualization and measurement tools, rather than a machine learning model that requires a distinct "training set" in the common understanding of AI/ML devices.

9. How the ground truth for the training set was established: Not applicable, as no training set is described.

In conclusion, the document primarily makes a case for substantial equivalence based on functional and technological characteristics compared to predicate devices, supported by general software verification and validation activities, rather than presenting a detailed clinical performance study with acceptance criteria.

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Arterys Cardio DL consists of software that analyzes DICOM-compliant cardiovascular images acquired from magnetic resonance (MR) scanners. Arterys Cardio DL specifically analyzes the blood flow to the heart and its major vessels using multi-slice, multi-phase and velocity encoded MR images. It provides clinically-relevant and reproducible, quantitative data, and it has been tested and validated on MR images acquired from both 1.5T and 3.0 T MR Scanners. The data produced by Arterys Cardio DL is intended to support qualified cardiologist, radiologist, or other licensed professional healthcare practitioners for clinical decision-making. It is a support tool that provides relevant clinical data as a resource to the clinician and is not intended to be a source of medical advice or to determine or recommend a course of action or treatment for a patient.

Arterys Cardio DL is a web-accessible image post-processing analysis software device used for viewing and quantifying cardiovascular MR images. The device is intended to visualize and quantify MRI data in DICOM format. Manual and semi-automatic border detection forms the basis for analysis. The software has features for loading, saving, generating screen displays, and aggregating quantitative data from cardiovascular images acquired from magnetic resonance (MR) scanners. Arterys Cardio DL is intended for use in both pediatric (neonate, infant, child and adolescent) and adult populations.

Here's an analysis of the acceptance criteria and study information for the Arterys Cardio DL device, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The provided FDA 510(k) summary (K163253) for Arterys Cardio DL does not explicitly list specific quantitative acceptance criteria or their corresponding reported device performance values in a table format.
Instead, it indicates that "Safety and performance of Arterys Cardio DL has been evaluated and verified in accordance with software specifications and applicable performance standards through software verification and validation testing." The submission focuses on demonstrating substantial equivalence to predicate devices (Arterys Software v2.0 and Medis Imaging QMass) by comparing technological characteristics and asserting that it "raises no new questions of safety and effectiveness."

The "Features/Functions" table (pages 5-6) compares the proposed device's capabilities to its predicates but does not include quantitative performance metrics or acceptance criteria for those metrics.

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

The document does not specify the sample size used for the test set.
Data provenance (e.g., country of origin, retrospective or prospective) is not explicitly stated for any test data.

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

The document does not provide information regarding the number of experts used to establish ground truth or their specific qualifications for any test set.

4. Adjudication Method for the Test Set

The document does not describe any adjudication method (e.g., 2+1, 3+1, none) used for establishing ground truth on a test set.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

The document does not mention or describe a Multi-Reader Multi-Case (MRMC) comparative effectiveness study investigating human readers' improvement with AI assistance. The focus is on the device's standalone performance and substantial equivalence to predicates.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study Was Done

Yes, a standalone study (algorithm-only performance) appears to have been done. The statement "Safety and performance of Arterys Cardio DL has been evaluated and verified in accordance with software specifications and applicable performance standards through software verification and validation testing" (page 7) implies that the software's inherent capabilities were tested and validated. The entire submission focuses on the algorithm's functionality and its output.

7. The Type of Ground Truth Used

The document does not explicitly state the type of ground truth used for validation. While the device provides "clinically-relevant and reproducible, quantitative data," it doesn't specify if this was validated against expert consensus, pathology, or outcomes data. Given that it's a post-processing analysis software intended to quantify existing MR images, it's highly probable that some form of expert consensus or highly accurate manual measurements served as ground truth for quantitative validation (e.g., comparing algorithm-derived volumes or flow measurements to manually delineated ones). However, this is not stated.

8. The Sample Size for the Training Set

The document does not specify the sample size used for the training set.

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

The document does not provide information on how the ground truth for the training set was established. Given the "DL" (Deep Learning) in the product name, it's implied that machine learning was used, which would typically involve a training set with established ground truth, but the details are absent.

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