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510(k) Data Aggregation

    K Number
    K024239
    Device Name
    CHEMO DISPENSING PIN, MODEL 12495
    Manufacturer
    ABBOTT LABORATORIES
    Date Cleared
    2003-01-13

    (21 days)

    Product Code
    LHI
    Regulation Number
    880.5440
    Type
    Special
    Panel
    General Hospital
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    CHEMO DISPENSING PIN, MODEL 12495

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

    For preparing and dispensing I.V. fluids and chemotherapeutic medications from stoppered vials

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided text does not contain the information requested to describe the acceptance criteria and the study that proves the device meets the acceptance criteria. The text is a 510(k) clearance letter from the FDA for a device called "Chemo Dispensing Pin," which primarily addresses regulatory approval based on substantial equivalence to a predicate device.

    Specifically, the document does not include:

    • A table of acceptance criteria and reported device performance.
    • Details about sample sizes or data provenance for any test sets.
    • Information on the number or qualifications of experts establishing ground truth.
    • Adjudication methods.
    • Any mention of a multi-reader multi-case (MRMC) comparative effectiveness study or human-in-the-loop performance.
    • Details of a standalone algorithm performance study.
    • The type of ground truth used.
    • Sample sizes for a training set or how ground truth for a training set was established.

    This document is a regulatory approval notice, not a study report or technical specification outlining performance metrics and validation studies.

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