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510(k) Data Aggregation

    K Number
    K191084
    Device Name
    The Optimotion Blue Total Knee System
    Manufacturer
    Optimotion Implants, LLC
    Date Cleared
    2020-04-07

    (349 days)

    Product Code
    MBH,JWH,OIY
    Regulation Number
    888.3565
    Type
    Traditional
    Panel
    Orthopedic (OR)
    Reference & Predicate Devices
    K102927,K131864,K160515,K123486,K051380
    Why did this record match?
    Device Name :

    The Optimotion Blue Total Knee System

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

    Painful, disabling joint disease of the from: noninflammatory degenerative joint disease (including osteoarthritis, traumatic arthritis, or avascular necrosis), rheumatoid arthritis or post-traumatic arthritis. Post-traumatic loss of knee joint configurations and function. Moderate varus, valgus, or flexion deformity in which the ligamentous structures can be returned to adequate function and stability. Revision of previous unsuccessful knee replacement or other procedure. Fracture of the distal femur and or proximal tibia that cannot be stabilized by standard fracture-management techniques. Optimotion™ Blue Porous Tibial Baseplate components are indicated for Cementless use. The Optimotion™ Blue Porous CR Femoral components are indicated for Cementless use. The Optimotion™ Blue CEMENTED CR Femoral and CEMENTED Tibial Baseplate components are indicated for cemented use only.

    Device Description

    Optimotion™ Blue Total Knee System consists of femoral, tibial tray, tibial insert, and patella resurfacing components, tibial stem extensions and a tibial trays are composed of Ti-6Al-4V alloy, both non-porous (uncoated - cemented) or porous (cemented or cementless). All tibial insert and patella components are composed of UHMWPE with Vitamin E. The tibial stem extensions and plug are composed of Ti-6AI-4V alloy. The femoral components are composed of CoCrMo alloy either uncoated (non-porous - cemented), and coated with porous CoCrMo sintered porous coating. The non-porous cemented tibial tray and femur are only to be used with PMMA bone cement. The porous tibial tray can either be used with cement or cementless. The porous CoCr femur is compatible with both cemented and cementless applications. The Optimotion™ Blue Total Knee System is intended for cemented or uncemented replacement of the tibia, patella and femur articular surfaces of the knee.

    AI/ML Overview

    I apologize, but the provided text from the FDA 510(k) notification for "The Optimotion Blue Total Knee System" does not contain information about:

    • Acceptance criteria related to AI/algorithm performance.
    • A study proving the device meets acceptance criteria for AI/algorithm performance.
    • Sample sizes, data provenance, expert numbers, adjudication methods, MRMC studies, standalone AI performance, or ground truth details for an AI/algorithm.
    • Training set details for an AI/algorithm.

    The document is a submission for a traditional medical device (a knee replacement system), not an AI/ML-driven device. The "Performance Data" section (G) lists various mechanical, material, and biological tests relevant to orthopedic implants (e.g., fatigue strength, range of motion, wear, porous surface evaluation, packaging, and and endotoxin testing), which are standard for such devices. It does not mention any digital or AI performance metrics.

    Therefore, I cannot fulfill your request using the provided input, as the information you're asking for (regarding AI/algorithm performance) is not present in this document.

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