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510(k) Data Aggregation

    K Number
    K241180
    Device Name
    Consensus Knee System with TiNbN
    Manufacturer
    Shalby Advanced Technologies
    Date Cleared
    2025-01-14

    (260 days)

    Product Code
    JWH
    Regulation Number
    888.3560
    Type
    Traditional
    Panel
    Orthopedic (OR)
    Reference & Predicate Devices
    K122239,K182251,K110950,K001456
    Why did this record match?
    Device Name :

    Consensus Knee System with TiNbN

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

    The indications for use are:

    A. Primary intervention of rheumatoid arthritis, osteoarthritis, post-traumatic arthritis, or degenerative arthritis

    B. Failed osteotomy or unicompartmental replacements

    C. Replacement of unsatisfactory cemented or press-fit knee components when sufficient bone stock exists

    D. The non-porous (uncoated, coated with CoCr beads without Titanium, and uncoated with a TiNbN overcoat) components may only be used with cement

    E. The porous coated (CoCr beads with Titanium) components may be used with or without cement

    Device Description

    The femoral implants are provided in left and right-side versions and designed to replicate the natural anatomy of the femur. They are available in a single variant only - CR, with sizes ranging from 1 to 6. The femoral implants have a R.P design, which offers surgeon an option for patients where a more minimal anatomic design is preferred. The femoral implants are manufactured using cast CoCrMo alloy (ASTM F75). A monolayer of TiNbN coating (thickness: 3 to 7 microns) is applied to the femoral implants.

    The tibial baseplates are provided in left and right-side versions and designed to replicate the natural anatomy of the tibial baseplates are available in three variants – holed, pegged, and pegless, with sizes ranging from 0 to 6. The tibial baseplates are manufactured using cast CoCMo alloy (ASTM F75). A monolayer of TiNbN coating (thickness: 3 to 7 microns) is applied to the entire surface of the tibial baseplates.

    AI/ML Overview

    The provided text describes the regulatory clearance for the "Consensus Knee System with TiNbN" and discusses its substantial equivalence to predicate devices, primarily focusing on the addition of a TiNbN coating. However, this document does not contain information about acceptance criteria or a study proving the device meets acceptance criteria related to AI/software performance.

    The text is a 510(k) summary for a medical device (knee prosthesis), which focuses on demonstrating substantial equivalence to existing devices. The "tests" mentioned are non-clinical, primarily material and mechanical tests (biocompatibility, wear performance, fatigue, range of motion) conducted for the physical implant and its new coating, not for any AI or software component.

    Therefore, I cannot provide the requested information, as the input document does not contain details about:

    • Acceptance criteria for AI/software performance.
    • A study validating AI/software performance.
    • Sample sizes for test sets (in the context of AI/software).
    • Expert involvement in establishing ground truth for AI/software.
    • Adjudication methods for AI/software test sets.
    • MRMC studies.
    • Standalone AI algorithm performance.
    • Types of ground truth for AI/software.
    • Training set sample sizes or ground truth establishment for an AI/software component.

    The document is about a physical medical device (a knee implant), not an AI/software device.

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