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510(k) Data Aggregation

    K Number
    K202808
    Device Name
    Brainance MD
    Manufacturer
    Advantis Medical Imaging Single Member P.C.
    Date Cleared
    2021-10-14

    (386 days)

    Product Code
    LLZ
    Regulation Number
    892.2050
    Type
    Traditional
    Panel
    Radiology
    Reference & Predicate Devices
    K090546,K162513,K163324
    Why did this record match?
    Device Name :

    Brainance MD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    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.

    Device Description

    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.

    AI/ML Overview

    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

    Acceptance Criteria (Set by Manufacturer)Reported Device Performance
    Equivalence of results between Brainance MD and primary predicate device for DSC Perfusion, fMRI, and DTI sequences, demonstrated by:ICC & Bland-Altman analysis on all valid pixel values (for processed maps)Mean Relative Difference (MRD) as Percentage across each tract (for fiber tracts)"The final results matched the criteria of acceptance/approval priorly set by the manufacturer and thus equivalent the two devices on a result level was proven."

    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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