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510(k) Data Aggregation

    K Number
    K060412
    Device Name
    ACTIVE UNICOMPARTMENTAL KNEE SYSTEM
    Manufacturer
    AUSTRALIAN SURGICAL DESIGN & MANUFACTURE
    Date Cleared
    2006-05-17

    (90 days)

    Product Code
    HRY
    Regulation Number
    888.3530
    Type
    Traditional
    Panel
    Orthopedic
    Reference & Predicate Devices
    K971938
    Why did this record match?
    Applicant Name (Manufacturer) :

    AUSTRALIAN SURGICAL DESIGN & MANUFACTURE

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

    The Active Unicompartmental Knee System is a modular unicompartmental system that is intended to resurface one diseased or damaged condyle of a knee where the other condyle remains intact. It is intended to be used only with bone cement in patients suffering from the following conditions:

    • . Non-inflammatory degenerative joint disease including osteoarthritis, traumatic arthritis, or avascular necrosis.
    • Inflammatory degenerative joint disease excluding rheumatoid arthritis .
    • Correction of functional deformity such as varus or valgus deformities. .
    Device Description

    The Active Unicompartmental Knee System is a modular re-surfacing unicompartmental knee implant system, consisting of a metallic femoral component and a UHMWPE partial tibial component.

    AI/ML Overview

    The provided text describes a 510(k) premarket notification for the "Active Unicompartmental Knee System." This document primarily focuses on demonstrating substantial equivalence to a predicate device through mechanical testing and material descriptions, rather than detailing a study that meets specific acceptance criteria for diagnostic or AI-driven performance.

    Therefore, many of the requested sections (2, 3, 4, 5, 6, 7, 8, 9) cannot be answered from the provided text, as they pertain to clinical studies or performance evaluation of a diagnostic/AI device, which is not the subject of this 510(k) summary.

    Here's what can be extracted:

    1. Table of Acceptance Criteria and Reported Device Performance

    Acceptance Criteria CategorySpecific Criteria / TestReported Device Performance
    Mechanical TestingFEA (Stress Testing)Demonstrated similar performance characteristics to other unicompartmental knee designs.
    Fatigue Testing (femoral component)Demonstrated similar performance characteristics to other unicompartmental knee designs.
    Adhesion Testing (tibial component)Demonstrated similar performance characteristics to other unicompartmental knee designs.
    Microstructural evaluation (femoral component)Conducted and part of the overall demonstration of similar performance.
    Influence of heat treatment on CoCrMo componentsTesting conducted to demonstrate similar performance.
    Effect of varying web heightTesting conducted to demonstrate similar performance.
    Material ConformanceFemoral Component MaterialCast cobalt/chrome/molybdenum alloy conforming to ASTM F75.
    Tibial Component MaterialUltra High Molecular Weight Polyethylene meeting ASTM F468. Materials designed and used for surgical implant applications.
    SterilizationMetal Components (gamma radiation)25 to 42 kGy (2.5 to 4.2 Mrad) gamma radiation per ISO 11137.
    Polyethylene Components (Ethylene Oxide)Ethylene Oxide per EN 550.
    Risk AnalysisManufacturing Process ImpactRisk analysis and an independent report indicated the process is unlikely to impact the safety of the materials used.

    2. Sample size used for the test set and the data provenance: Not applicable. This is a medical device (knee implant) submission, not a study involving a test set of data for a diagnostic device. The "testing" refers to mechanical and material property testing of the physical components.

    3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.

    4. Adjudication method (e.g. 2+1, 3+1, none) 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.

    6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable.

    7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable. The "ground truth" here is compliance with material standards, successful mechanical testing, and demonstrating substantial equivalence to a predicate device.

    8. The sample size for the training set: Not applicable.

    9. How the ground truth for the training set was established: Not applicable.

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