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510(k) Data Aggregation

    K Number
    K192465
    Device Name
    DigiFix Sterile Kit
    Manufacturer
    Virak Orthopedics, LLC
    Date Cleared
    2019-10-10

    (31 days)

    Product Code
    JEC
    Regulation Number
    888.3040
    Type
    Special
    Panel
    Orthopedic (OR)
    Reference & Predicate Devices
    K132731
    Why did this record match?
    Applicant Name (Manufacturer) :

    Virak Orthopedics, LLC

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

    The DIGIFIXTM External Fixation System is intended to be used in skeletally mature patients in treatment of:

    DYNAMIC MODE:

    1. complex fracture-dislocations or fracture-subluxations, and pilon fractures of the interphalangeal (IP) joint;
    2. Post-traumatic joint contracture of the proximal interphalangeal (PIP) joint;
    3. Dupuytren's contracture

    STATIC MODE:

    1. Fractures of the phalanges and
    2. interphalangeal (IP) joint arthrodesis.
    Device Description

    The DigiFix TM External Fixation System Sterile Kit includes various elements including brackets, locking pins, set screws and k-wires. The elements are used to create an assembled frame which capture and support the k-wires on the medial and lateral aspect of finger. The brackets, locking pins and set screws are assembled intraoperatively. External fixator components are provided sterile and are intended for single use only.

    AI/ML Overview

    This submission describes a medical device, the "DigiFix Sterile Kit," which is a smooth or threaded metallic bone fixation fastener for external fixation. It is not an AI/ML device, hence the request for acceptance criteria and study details related to AI/ML performance is not applicable. The provided text refers to a traditional medical device and its clearance based on substantial equivalence to a predicate device.

    Therefore, I cannot provide the information requested for AI/ML device performance. The document does not contain information about:

    • A table of acceptance criteria and reported device performance for an AI/ML model.
    • Sample size used for a test set or data provenance for an AI/ML model.
    • Number of experts or their qualifications for establishing ground truth for an AI/ML model.
    • Adjudication method for an AI/ML model's test set.
    • Multi-reader multi-case (MRMC) comparative effectiveness study for an AI/ML model.
    • Standalone performance of an AI/ML algorithm.
    • Type of ground truth used for an AI/ML model.
    • Sample size for a training set or how ground truth was established for an AI/ML model.

    The provided information focuses on the device's indications for use, its components, and the validation of its sterility and cleaning processes, which are standard for orthopedic fixation devices. The conclusion states that the device is substantially equivalent to predicate devices based on test results (sterilization and cleaning) and comparison, not on AI/ML performance metrics.

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