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510(k) Data Aggregation

    K Number
    K040850
    Device Name
    TSY SHOULDER PLATE IMPLANT
    Manufacturer
    ORTHOPEDIC SCIENCES, INC
    Date Cleared
    2004-06-24

    (85 days)

    Product Code
    HRS
    Regulation Number
    888.3030
    Type
    Traditional
    Panel
    Orthopedic
    Reference & Predicate Devices
    K022139
    Why did this record match?
    Device Name :

    TSY SHOULDER PLATE IMPLANT

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

    The TSY™ Shoulder Plate Implant is intended to stabilize a bone graft within the humeral head and neck to assist healing of an intraosseous fracture.

    Device Description

    Not Found

    AI/ML Overview

    The provided document is a 510(k) summary for a medical device called the "TSY™ Shoulder Plate Implant," which is a bone fixation appliance. It details the administrative information, predicate device, and intended use. However, this document does not contain any information regarding acceptance criteria or a study that proves the device meets such criteria.

    The 510(k) summary serves to establish substantial equivalence to a legally marketed predicate device, not to present performance study results against specific acceptance criteria in the manner you've described. The content provided is typical of a premarket notification where the focus is on device description, intended use, and comparison to a predicate, rather than detailed performance data from clinical or non-clinical studies.

    Therefore, I cannot fill in the requested table or answer the specific questions about acceptance criteria, study details, sample sizes, expert qualifications, adjudication, or ground truth, as none of this information is present in the provided text.

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