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510(k) Data Aggregation

    K Number
    K132912
    Device Name
    DUAFIT INTERGPHALANGEAL IMPLANT, PEEK-FUSE INTERPHALANGEAL IMPLANT
    Manufacturer
    IN2BONES SAS
    Date Cleared
    2014-07-30

    (316 days)

    Product Code
    HWC
    Regulation Number
    888.3040
    Type
    Traditional
    Panel
    Orthopedic
    Reference & Predicate Devices
    K022599,K111536,K102326,K120645,K112675,K071586,K100414,K143477
    Why did this record match?
    Device Name :

    DUAFIT INTERGPHALANGEAL IMPLANT, PEEK-FUSE INTERPHALANGEAL IMPLANT

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

    The DUAFIT® Interphalangeal implant is intended for fixation of proximal interphalangeal joint arthrodesis of the lesser toes. Examples include: Rigid or semi-rigid deformity of the PIP joint Revision of failed arthroplasty or arthrodesis 2nd toe shortening.

    Device Description

    The DUAFIT® interphalangeal implant is an intramedullary implant, designed to act as a bone fastener for proximal interphalangeal arthrodesis of the lesser rays. Design is a combination of a proximal taper with barbs and a distal blade for enhanced stabilization. It is made available in multiple lengths and diameters, and in 3 different angles. The implant is manufactured from PEEK-OPTIMA®, polymer from Invibio®, and is designed for single use only.

    AI/ML Overview

    The provided text describes a medical device (DUAFIT® interphalangeal implant) and its regulatory submission. It focuses on demonstrating substantial equivalence to predicate devices rather than directly presenting acceptance criteria for a new AI/ML device or a comparative effectiveness study with human readers.

    Therefore, the requested information elements related to AI/ML device performance, ground truth establishment, expert adjudication, and comparative effectiveness studies are not applicable or cannot be extracted from the given document.

    The document primarily covers the engineering and regulatory aspects of a physical medical implant.

    However, I can extract information related to the device's performance demonstration.

    1. A table of acceptance criteria and the reported device performance

    Acceptance Criteria (Implied)Reported Device Performance
    Device is substantially equivalent to predicate devices for its intended use and design.The technological characteristics of the DUAFIT® interphalangeal implant are the same as the characteristics of predicate devices in terms of intended use and design, including features like insertion into bone, tapered barded design, blade design, cannulated design, straight/angled design, PEEK material, and equivalent size range.
    Mechanical properties are at least equivalent to the predicate device (Merete MetaToe).Results from testing confirmed that the DUAFIT® interphalangeal implant is at least equivalent to the Merete MetaToe EndoSorb (K100414) in terms of mechanical properties.
    Performance in specific mechanical tests (static and cyclic four-point bending) meets criteria.The DUAFIT® interphalangeal implant met the acceptance criteria for the static four-point bending test and the cyclic four-point bending test. The implants performed as expected for each test.
    Biocompatibility (implied from material and predicate equivalence)The DUAFIT® interphalangeal implant is manufactured from PEEK-OPTIMA®, polymer from Invibio®, as per ASTM 2026, a material used in predicate devices (e.g., Smith and Nephew Bioraptor 2.3 PK suture anchor (K071586), Parcus PEEK CF push-in suture anchor (K102326), and Synchro Toegrip (K133477)), suggesting established biocompatibility.
    Sterilization effective (implied)The DUAFIT® interphalangeal implant is supplied sterile, using gamma irradiation.

    2. Sample size used for the test set and the data provenance
    The document does not specify the sample size for the mechanical tests (static and cyclic four-point bending). Data provenance is not explicitly stated beyond "testing performed by the test lab," but it is implicitly from product-specific laboratory testing.

    3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
    Not applicable. This device is a physical implant, not an AI/ML diagnostic device requiring expert interpretation for ground truth. Performance was demonstrated through engineering bench testing.

    4. Adjudication method for the test set
    Not applicable. Performance was determined through objective mechanical testing, not by human adjudication of interpreted data.

    5. 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
    Not applicable. This is not an AI-assisted device.

    6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
    Not applicable. This is a physical medical implant, not an algorithm.

    7. The type of ground truth used
    The ground truth for the device's performance was established through engineering bench testing (static four-point bending test and cyclic four-point bending test) against established mechanical performance criteria, and comparison to predicate devices' mechanical properties.

    8. The sample size for the training set
    Not applicable. This is a physical medical implant, not a machine learning model that requires a training set.

    9. How the ground truth for the training set was established
    Not applicable. This is a physical medical implant, not a machine learning model.

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