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510(k) Data Aggregation

    K Number
    K061092
    Device Name
    BAXTER DUPLOSPRAY MIS APPLICATOR
    Manufacturer
    MICROMEDICS, INC.
    Date Cleared
    2006-09-13

    (147 days)

    Product Code
    FMF
    Regulation Number
    880.5860
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    BAXTER DUPLOSPRAY MIS APPLICATOR

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

    This device is for the application of Tisseel® Fibrin Sealant.

    Device Description

    Not Found

    AI/ML Overview

    This is a 510(k) clearance letter for the Baxter DuploSpray MIS Applicator, a Piston Syringe. The letter indicates that the device is substantially equivalent to legally marketed predicate devices. This type of regulatory document typically does not contain the kind of detailed study data, acceptance criteria, or ground truth information you're asking for regarding AI-driven device performance.

    Therefore,Based on the provided document, the requested information regarding acceptance criteria and study details for device performance cannot be extracted. The document is a 510(k) clearance letter for a medical device (Baxter DuploSpray MIS Applicator), not a study report or a detailed technical specification with performance metrics.

    Specifically, the document does not contain:

    1. A table of acceptance criteria and reported device performance.
    2. Sample size used for a test set, data provenance, or details about retrospective/prospective studies.
    3. Number and qualifications of experts used to establish ground truth.
    4. Adjudication method for a test set.
    5. Information about a multi-reader multi-case (MRMC) comparative effectiveness study, including human reader improvement with/without AI assistance.
    6. Results of a standalone (algorithm only) performance study.
    7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.).
    8. The sample size for a training set.
    9. How the ground truth for a training set was established.

    This document serves as regulatory clearance based on substantial equivalence to existing devices, implying that its safety and effectiveness are comparable, but it doesn't detail specific performance studies with quantitative metrics or AI components.

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