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510(k) Data Aggregation

    K Number
    K960711
    Device Name
    ACUMED BONE GRAFT SYSTEM
    Manufacturer
    ACUMED, INC.
    Date Cleared
    1996-05-07

    (76 days)

    Product Code
    KIJ
    Regulation Number
    878.4820
    Type
    Traditional
    Panel
    Orthopedic
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    ACUMED BONE GRAFT SYSTEM

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

    Not Found

    Device Description

    The Acumed Bone Grafting System is a set of various size drills, a Hudson adaptor fitting, a starting punch, a bone plug extractor, and a removal key. A manual drill handle will be added to the system eventually so that the drills may be operated manually. The Hudson adaptor fitting attaches to a standard DC-powered surgical drill. The drill size is selected and attached to the adaptor. The starting punch dimples the bone so a reference point for the drill tip is made. After drilling and harvesting the bone, the drill assembly is removed. The drill piece is detached with the removal key and the bone material is extracted or pushed out by the plug extractor.

    AI/ML Overview

    I apologize, but the provided text is a 510(k) summary for a medical device called the "Acumed Bone Grafting System." This document describes the device, its components, materials, sterilization information, and a comparison to a similar device on the market.

    It does not contain any information about acceptance criteria, performance studies, sample sizes, ground truth, expert opinions, or any of the other specific details regarding the evaluation of a device's performance that you have requested.

    Therefore, I cannot fulfill your request to describe the acceptance criteria and the study proving the device meets those criteria based on the provided input. The information you are asking for typically comes from clinical trial reports, validation studies, or performance evaluation documents, which are not present in this 510(k) summary.

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