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510(k) Data Aggregation

    K Number
    K983491
    Device Name
    DEPUY DURALOC ACETABULAR CUP SYSTEM-ENDURON LINER
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Date Cleared
    1998-12-02

    (58 days)

    Product Code
    LPH
    Regulation Number
    888.3358
    Type
    Traditional
    Panel
    Orthopedic
    Reference & Predicate Devices
    K900832,K900891,K961186
    Why did this record match?
    Device Name :

    DEPUY DURALOC ACETABULAR CUP SYSTEM-ENDURON LINER

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

    The DePuy Duraloc Acetabular Cup Liners are to be used with the DePuy Duraloc Acetabular Cup System's metal acetabular shells to resurface the acetabular socket in cemented or cementless total hip arthroplasty.

    Device Description

    The DePuy Duraloc Acetabular Liners are manufactured from ultra high molecular weight polyethylene (UHMWPE) and are available in two designs. standard and Charnley Bore (CB), Both designs are available in two styles, a neutral and 10° lip, with an inner diameter (I.D.) of 22.225mm and are available in sizes to fit Duraloc metal acetabular shells with outer diameters of 48mm-74mm. The Duraloc liners are locked into the Duraloc metal acetabular shells with a metal wire locking ring supplied with the shells.

    AI/ML Overview

    Here's an analysis of the provided text regarding acceptance criteria and the supporting study, structured as requested.

    It's important to note that the provided text is a 510(k) summary for a medical device (DePuy Duraloc® Acetabular Cup System - Enduron Liner). 510(k) submissions typically focus on demonstrating substantial equivalence to a predicate device rather than presenting a detailed new performance study against specific acceptance criteria for a novel device. Therefore, many of the requested fields related to a performance study will be "Not Applicable" or "Not Provided" in this context.

    Acceptance Criteria and Device Performance Study Analysis

    1. Table of Acceptance Criteria and Reported Device Performance

    Acceptance Criteria CategorySpecific Acceptance CriteriaReported Device Performance
    Substantial EquivalenceDesign: Similar to predicate devices (K900832, K900891, K961186) with minor changes (smaller I.D., larger O.D. range, additional 2mm PE for CB liners).The standard liners are "identical in design" to previously cleared devices except for smaller inner diameter. CB liners are "identical in design" except for smaller inner diameter and additional 2mm PE.
    Material: Identical material (UHMWPE, ASTM F-648) to predicate devices.UHMWPE, ASTM F-648.
    Intended Use: Identical intended use to predicate devices."Intended use... has not changed from the cleared... UHMWPE liners of the DePuy Duraloc Acetabular Cup System."
    Technological Characteristics: Fundamental scientific technology has not changed."Fundamental scientific technology... has not changed."
    Key Specifications ComparisonInner Diameters: Proposed 22.225mm.Matches current submission, comparable but smaller than some predicates (26, 28, 32mm) and within range of others (22.225, 26, 28mm).
    Outer Diameters: Proposed 48-74mm.Matches current submission, larger range than some predicates (38-46mm) and comparable to others (46-74mm).
    Design Type: Proposed Standard and Charnley Bore (CB).Matches current submission, predicate devices were primarily "Standard."
    Lip: Proposed Neutral and 10°.Matches current submission, predicate devices had Neutral, 10°, and 20°.
    Locking Mechanism: Proposed Metal Wire Ring.Matches current submission and all predicate devices.

    2. Sample size used for the test set and the data provenance

    • Sample Size: Not applicable. This submission is based on demonstrating substantial equivalence through design and material comparison, not a performance study involving a test set of data.
    • Data Provenance: Not applicable.

    3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

    • Not applicable. Ground truth for a performance study is not relevant to a substantial equivalence demonstration based on design, material, and intended use comparison.

    4. Adjudication method for the test set

    • Not applicable.

    5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

    • Not applicable. This device is a component of a hip prosthesis, not an AI-powered diagnostic or assistive tool for human readers.

    6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

    • Not applicable. This device is a physical medical implant, not an algorithm.

    7. The type of ground truth used

    • Not applicable. For a substantial equivalence claim, the "ground truth" is largely the established safety and effectiveness of the predicate devices based on their prior clearances and clinical history.

    8. The sample size for the training set

    • Not applicable. No training set is relevant for this type of device and submission.

    9. How the ground truth for the training set was established

    • Not applicable.
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