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510(k) Data Aggregation

    K Number
    K241666
    Device Name
    EVOS Pelvic and Acetabular System
    Manufacturer
    Smith & Nephew
    Date Cleared
    2025-02-19

    (254 days)

    Product Code
    HRS,HTN,HWC
    Regulation Number
    888.3030
    Type
    Traditional
    Panel
    Orthopedic (OR)
    Reference & Predicate Devices
    K162078,K140814,K060736,K170887,K173293,K122538,K063166,K210935,K221809,K993106
    Why did this record match?
    Device Name :

    EVOS Pelvic and Acetabular System

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

    The EVOS Pelvic and Acetabular System is indicated for fixation of fractures and/or disruptions of the pelvis and acetabulum in skeletally mature patients.

    Device Description

    The subject EVOS Pelvic and Acetabular System consists of Class II bone plate and screw implants. The subject bone plates are available in a variety of shapes and sizes. The subject screws consist of locking screws as well as cannulated screws. The subject plates are also compatible with the previously cleared EVOS locking screws, and partially and fully threaded osteopenia screws (K140814 S.E. 5/7/2014 and K162078 S.E. 7/27/2016). The proposed plates and screws are manufactured from implant-grade 316L Stainless Steel material and will be available in a sterile packaged condition.

    AI/ML Overview

    I am sorry, but based on the provided text, there is no information about acceptance criteria or a study proving that a device meets those criteria in the context of an AI/ML medical device.

    The document is a 510(k) clearance letter from the FDA for the "EVOS Pelvic and Acetabular System," which is a metallic bone fixation appliance. The clearance is based on substantial equivalence to legally marketed predicate devices, not on the performance of a software algorithm or AI model.

    The "Non-Clinical and/or Clinical Tests Summary & Conclusions" section explicitly states that "No clinical testing was performed on the subject devices." The tests conducted are mechanical and materials testing for the implants (e.g., Finite Element Analysis, fatigue testing, static evaluation of screws, MRI compatibility, and packaging verification), which are standard for orthopedic hardware, not for AI performance.

    Therefore, I cannot provide details on:

    • A table of acceptance criteria and reported device performance (for an AI/ML device)
    • Sample size used for the test set and data provenance (for an AI/ML device)
    • Number of experts and qualifications (for establishing ground truth for an AI/ML device)
    • Adjudication method (for an AI/ML device)
    • Multi-reader multi-case comparative effectiveness study (for an AI/ML device)
    • Standalone performance (for an AI/ML device)
    • Type of ground truth used (for an AI/ML device)
    • Sample size for the training set (for an AI/ML device)
    • How ground truth for the training set was established (for an AI/ML device)

    The document is about a traditional medical device (surgical implants) and does not contain the information requested about AI/ML device performance or studies.

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