LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K062328
    Device Name
    VITREAACCESS, VERSION 1.0
    Manufacturer
    VITAL IMAGES, INC.
    Date Cleared
    2006-08-21

    (11 days)

    Product Code
    LLZ
    Regulation Number
    892.2050
    Type
    Traditional
    Panel
    Radiology
    Reference & Predicate Devices
    K040876,K061624
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    VitreaACCESS software is intended to be used for remote review of Vitrea2 Software outputs, such as: processing, analysis, communication and media interchange of multidimensional digital images acquired from a variety of imaging devices.

    Device Description

    VitreaACCESS software specifically allows remote review of Vitrea® outputs.

    AI/ML Overview

    The provided text doesn't contain a detailed study with specific acceptance criteria and performance metrics for the VitreaACCESS™ 1.0 Medical Image Processing Software. It primarily focuses on the regulatory submission (510(k) summary) for the device.

    However, based on the information provided, here's what can be extracted and inferred regarding the "studies" mentioned:

    1. Table of Acceptance Criteria and Reported Device Performance:

    No specific numerical acceptance criteria or detailed performance metrics (sensitivity, specificity, accuracy, etc.) are provided in the document. The "performance" described is in very general terms related to software development and validation processes.

    Acceptance Criteria (Inferred from text)Reported Device Performance
    Successfully complete verification testing prior to Beta validationVitreaACCESS software will successfully complete verification testing prior to Beta validation.
    Successfully complete Beta testing/validation prior to releaseSoftware Beta testing/validation will be successfully completed prior to release.
    Adherence to written procedures for development, testing, validation, and maintenanceThe software utilized was developed, tested, and validated according to written procedures.
    Control of potential hazards through a Risk Management PlanPotential hazards have been studied and controlled by a Risk Management Plan.
    Substantial equivalence to predicate device regarding safety and effectivenessVitreaACCESS software is substantially equivalent to the predicate device, with minor technological differences not raising new safety or effectiveness questions.

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

    • Sample Size: Not specified. The document mentions "verification testing" and "Beta testing/validation" but does not give any numbers for the test cases or datasets used.
    • Data Provenance: Not specified. There is no mention of the country of origin of the data or whether the data was retrospective or prospective.

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

    Not specified. The document does not mention the use of experts to establish ground truth for any test set. The validation seems to be focused on software functionality and adherence to internal procedures rather than clinical performance evaluated by experts.

    4. Adjudication Method:

    Not specified. Since there is no mention of experts establishing ground truth or a clinical evaluation, an adjudication method is not discussed.

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

    No, an MRMC comparative effectiveness study is not mentioned or described. The document does not compare human readers with or without AI assistance.

    6. If a Standalone (Algorithm Only) Performance Study Was Done:

    Not specified in terms of clinical performance metrics. The document describes software "verification testing" and "Beta testing/validation" which relate to the algorithm's functionality and bug-free operation, but not a standalone clinical performance study typically associated with AI algorithms (e.g., diagnostic accuracy compared to ground truth).

    7. The Type of Ground Truth Used:

    Not explicitly stated. Given the context, the "ground truth" for the software's functionality and validation appears to be defined by:

    • Internal product specifications and requirements.
    • Successful execution of pre-defined test cases during verification and beta testing.
    • Adherence to risk management plans.

    It does not appear to be based on expert consensus, pathology, or outcomes data in a clinical sense.

    8. The Sample Size for the Training Set:

    Not applicable. This device is described as "Medical Image Processing Software" intended for "remote review of Vitrea2 Software outputs." It is not presented as an AI/ML algorithm that requires a training set in the conventional sense to learn patterns from data. It appears to be a software tool for viewing and processing existing outputs.

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

    Not applicable, as there's no mention of a training set for an AI/ML algorithm.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1