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510(k) Data Aggregation

    K Number
    K241008
    Device Name
    Tricera Arthroscopic System; Tricera Controller (R-10001); Tricera Handpiece, Autoclavable (R-10023); Veriflow (R-10003); Exoflow (R-10017); 3-in-1 Shaver 4.2mm (R-10008); 3-in-1 Shaver 5.0mm (R-10014); Dynablator (R-10005); Standard Burr 5.0mm (R-10021); Standard Shaver 3.4mm (R-10012); Curved Standard Shaver 3.4mm (R-10024); Curved Standard Ball Burr XL, 5.0mm (R-10025); Curved Shaver XL 4.2mm (R-10026); Curved Dynablator, XL (R-10027)
    Manufacturer
    Relign Corporation, Subsidiary of Zimmer Biomet
    Date Cleared
    2024-05-08

    (26 days)

    Product Code
    GEI,HRX
    Regulation Number
    878.4400
    Type
    Special
    Panel
    Orthopedic (OR)
    Reference & Predicate Devices
    K233493,K162770
    Why did this record match?
    Applicant Name (Manufacturer) :

    Relign Corporation, Subsidiary of Zimmer Biomet

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

    The Tricera™ Arthroscopic System is indicated for use in orthopedic and arthroscopic procedures. The Fluid Management System of the Tricera™ Arthroscopic System provides fluid distension and irrigation of the knee, shoulder, ankle, elbow, wrist and hip, and fluid suction during diagnostic and operative arthroscopic procedures. The Shaver Blade/RF Probe of the Tricera™ Arthroscopic System provides abrasion, resection, debridement, and removal of bone through its shaver blade; removal, ablation, and coagulation of soft tissue; as well as hemostasis of blood vessels through its shaver blade and probe. Examples of uses of the product include resection of torn knee cartilage, subacromial decompression, and resection of synovial tissue in other joints.

    Device Description

    The device description and principles of operation for the modified devices are equivalent to the device description of the predicate devices cleared per Primary Predicate-K233493 and additional predicate-K162770. A brief device description of the subject devices is provided in the table below.

    DeviceDescription
    Curved Standard Ball
    Burr XL, 5.0mmAn arthroscopic burr that provides abrasion, resection, debridement, and removal of bone. The Curved Dynablator XL is specifically designed for use in hip joints with a spherical ball burr and bent outer tube for access to hip pathology.
    Curved Standard
    Shaver XL, 4.2mmAn arthroscopic shaver that provides resection and removal of soft tissue. The Curved Dynablator XL is specifically designed for use in hip joints with a bent outer tube for access to hip pathology.
    Curved Dynablator XLAn arthroscopic RF probe that provides removal, ablation, and coagulation of soft tissue; as well as hemostasis of blood vessels. The Curved Dynablator XL is specifically designed for use in hip joints with a bent outer tube for access to hip pathology.
    AI/ML Overview

    The provided document is a 510(k) premarket notification letter from the FDA regarding the Tricera™ Arthroscopic System. It states that the device has been determined to be substantially equivalent to previously marketed predicate devices.

    Crucially, this document is an administrative letter of substantial equivalence for a medical device (an arthroscopic system) and not an AI/ML-enabled medical device.

    Therefore, the requested information regarding acceptance criteria and studies proving the device meets AI/ML-specific acceptance criteria (such as performance metrics for an algorithm, ground truth establishment, training/test set details, MRMC studies, etc.) is not applicable to this document's content.

    The document describes a physical medical device (an arthroscopic system) and its accessories, including fluid management, shaver blades, and RF probes, used for orthopedic and arthroscopic procedures. The "performance data" mentioned (Section 8) refers to testing related to packaging, verification and validation, shelf life, and electromagnetic compatibility (EMC), which are standard for physical medical devices and do not involve AI/ML performance metrics.

    In summary, because this is not an AI/ML device, I cannot provide the requested information related to AI/ML acceptance criteria and studies.

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