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510(k) Data Aggregation

    K Number
    K122959
    Device Name
    HAMMER TOE IMPLANT
    Manufacturer
    TRILLIANT SURGICAL LTD
    Date Cleared
    2012-11-07

    (43 days)

    Product Code
    HWC
    Regulation Number
    888.3040
    Type
    Traditional
    Panel
    Orthopedic
    Reference & Predicate Devices
    K121008,K111536,K081510
    Why did this record match?
    Reference Devices :

    K121008

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

    The Hammer Toe System implants are intended for fixation of osteotomies and reconstruction of the lesser phalanges during procedures to correct deformities of the lesser toes and fingers. Indications include: hammer toe deformity, claw toe deformity, mallet toe deformity, and other deformities of the foot and hand.

    Device Description

    The Hammer Toe Implant is a threaded/spaded device used for bone fixation in the phalanges of the lesser digits in the foot and hand. The implant, which is a cannulated, threaded and spaded device, is offered in multiple diameters and lengths. The system will also consist of K-wires (K121008) to be used in the delivery of the implant and also for use of temporary stabilization of outlying joints.

    AI/ML Overview

    Here's a summary of the acceptance criteria and the study information for the Trilliant Hammer Toe Implant, based on the provided text:

    Acceptance Criteria and Reported Device Performance

    Acceptance Criteria (Test Performed)Reported Device Performance
    Static axial pull-out of threaded portion from polyurethane foam test blockEquivalent to predicate devices
    Static axial pull-out of barbed (spade) section from polyurethane foam test blockEquivalent to predicate devices
    Driving torque into polyurethane foam test blockEquivalent to predicate devices
    Static testing to determine failure torqueEquivalent to predicate devices

    Study Information

    1. Sample size used for the test set and the data provenance: Not applicable. The study was non-clinical (mechanical testing) and did not use patient data. The test material was polyurethane foam.

    2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. The ground truth was established by physical properties and mechanical testing standards (ASTM F543).

    3. Adjudication method for the test set: Not applicable.

    4. 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: No MRMC study was performed. This is a medical device (implant), not an AI diagnostic tool.

    5. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: No standalone algorithm performance was assessed. This is a medical device (implant), not an AI diagnostic tool.

    6. The type of ground truth used: Mechanical properties and performance evaluated against ASTM F543 standards, demonstrating equivalence to predicate devices. This is a form of engineering or physical ground truth.

    7. The sample size for the training set: Not applicable. No training set was involved as this was a non-clinical mechanical performance study for a physical implant.

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

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