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510(k) Data Aggregation

    K Number
    K072888
    Device Name
    REVELATION AND LINEAR HIP STEMS AND FMP ACETABULAR SHELLS (SPIKED, HEMISPHERICAL AND FLARED)
    Manufacturer
    ENCORE MEDICAL, L.P.
    Date Cleared
    2008-01-10

    (92 days)

    Product Code
    LPH
    Regulation Number
    888.3358
    Type
    Special
    Panel
    Orthopedic (OR)
    Reference & Predicate Devices
    K974093,K974095,K973119
    Why did this record match?
    Device Name :

    REVELATION AND LINEAR HIP STEMS AND FMP ACETABULAR SHELLS (SPIKED, HEMISPHERICAL AND FLARED)

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

    Joint replacement is indicated for patients suffering from disability due to:

    • noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis of the natural femoral head;
    • rheumatoid arthritis;
    • correction of functional deformity;
    • femoral fracture
      This device may also be indicated in the salvage of previously failed surgical attempts.
    Device Description

    The modification consists of an additional method of porous coating currently conducted on the hip devices listed above.

    AI/ML Overview

    The provided document, K072888, is a 510(k) summary for Encore Medical's Foundation® Porous Coated (FMPTM) Acetabular Shells. This document is a clearance summary for a medical device and not a study report demonstrating acceptance criteria for an AI/ML device. It focuses on demonstrating substantial equivalence to a predicate device, which is different from proving performance against specific acceptance criteria for a new AI/ML algorithm.

    Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert involvement, and ground truth for an AI/ML device is not present in this document. The document describes a traditional orthopaedic implant and its indications for use.

    No information regarding acceptance criteria or a study proving an AI/ML device meets them can be extracted from this document.

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