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510(k) Data Aggregation

    K Number
    K161894
    Device Name
    SurgTech Trauma System
    Manufacturer
    SURGTECH INC
    Date Cleared
    2017-02-21

    (225 days)

    Product Code
    HWC,HRS
    Regulation Number
    888.3040
    Type
    Traditional
    Panel
    Orthopedic (OR)
    Reference & Predicate Devices
    K092493,K100111,K060156,K033756,K052368,K120070,K080184,K050852,K031677,K041860,K063166,K063672,K082300,K141383,K991407,K051642,K100776,K091479,K915818,K000682,K000684,K090047,K063298,K083912,K112583,K050636,K080943,K014154,K962011,K092754
    Why did this record match?
    Device Name :

    SurgTech Trauma System

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

    The SurgTech Trauma System plates and screws are intended to be used for internal bone fixation for bone fractures, fusions, osteotomies and non-unions appropriate for the size and design of the device.
    The large plate set components are indicated for the use including the femur and tibia. The small plate set is indicated for use in various bones including the clavicle, scapula, humerus, radius, ulna, pelvis, tibia and fibula. The mini plate set is indicated for use in various small bones including the metacsals, phalanges, calcaneus and those of the ankle.
    In addition, the SurgTech Trauma System cancellous, cannulated lag, headless compression and non-locking cortical screws are indicated for use in bone reconstruction, arthrodesis, joint fusion, fracture repair and fracture fixation, appropriate for the size of the device.

    Device Description

    The SurgTech Trauma System is a plate and screw fixation system. Plates are offered in "mini," "small" and "large" set sizes in a variety of shapes based upon the anatomical fixation required. Screws are also offered in "mini" "small" and "large" sets and, in addition, in locking cortical, non-locking cortical, cancellous and headless versions. Screws can also be used for fixation without the plates.

    AI/ML Overview

    The provided text describes a 510(k) premarket notification for the "SurgTech Trauma System," which consists of bone plates and screws. This document is a regulatory submission to the FDA demonstrating substantial equivalence to existing legally marketed devices.

    Crucially, the provided text DOES NOT contain information about an AI/ML-based medical device study.

    Instead, the "Performance Data" section explicitly states that the device's performance was evaluated through mechanical testing of the plates and screws according to ASTM standards (ASTM F382 for bending, and other standards for torsion, insertion/removal, and pullout for screws).

    Therefore, I cannot fulfill your request for information related to AI/ML acceptance criteria or a study proving its performance, as this document pertains to a traditional orthopedic implant, not an AI-powered diagnostic or therapeutic device.

    To reiterate, the document details:

    • Device: SurgTech Trauma System (bone plates and screws)
    • Purpose of Submission: 510(k) premarket notification for substantial equivalence.
    • Performance Evaluation Method: Mechanical testing (e.g., static and dynamic bending, torsion, insertion/removal, pullout) against ASTM standards.

    It does not mention any AI/ML components, ground truth establishment by experts, MRMC studies, or any other elements relevant to AI/ML device performance evaluation.

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