LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K180087
    Device Name
    A.M. Surgical Intramedullary Fixation Device
    Manufacturer
    A.M. Surgical, Inc
    Date Cleared
    2018-05-18

    (126 days)

    Product Code
    HTY
    Regulation Number
    888.3040
    Type
    Traditional
    Panel
    Orthopedic
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Intramedullary Fixation Device is indicated for the fixation of extra-articular fractures of the hand including the metacarpals and the proximal and middle phalanges, and the metatarsal bones of the foot.

    Device Description

    Intramedullary Fixation Device

    AI/ML Overview

    Based on the provided text, the document is an FDA 510(k) clearance letter for a medical device called the "A.M. Surgical Intramedullary Fixation Device." This letter does NOT contain information about acceptance criteria, study design, or performance metrics for an AI/ML device. It is a regulatory clearance for a physical medical device (an intramedullary fixation device) used for bone fixation.

    Therefore, I cannot extract the requested information regarding acceptance criteria and performance data for an AI/ML device from this document. The questions you've asked (about sample sizes, experts for ground truth, adjudication methods, MRMC studies, standalone performance, training set details, etc.) are pertinent to studies evaluating AI/ML models, not traditional hardware medical devices like the one described in this 510(k) letter.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1