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510(k) Data Aggregation

    K Number
    K140749
    Device Name
    INFINITY TOTAL ANKLE SYSTEM
    Manufacturer
    WRIGHT MEDICAL TECHNOLOGY, INC.
    Date Cleared
    2014-04-25

    (31 days)

    Product Code
    HSN
    Regulation Number
    888.3110
    Type
    Special
    Panel
    Orthopedic
    Reference & Predicate Devices
    K123954
    Predicate For
    K141740,K142117,K152217,K153008,K172633,K181557,K192778,K193067,K232595
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The INFINITY™ Total Ankle System is intended to give a patient limited mobility by reducing pain, restoring alignment and replacing the flexion and extension movement in the ankle joint.

    Indications for Use: The INFINITY™ Total Ankle is indicated for patients with ankle joints damaged by severe rheumatoid, post-traumatic, or degenerative arthritis.

    The INFINITY™ Total Ankle is additionally indicated for patients with a failed previous ankle surgery.

    CAUTION: The ankle prosthesis is intended for cement use only.

    Device Description

    The INFINITY® Total Ankle System is a fixed-bearing, bone-sparing total ankle prosthesis that restores mobility to a failing ankle joint. It encompasses three components (i.e., tibial tray, tibial insert, and talar dome) that are assembled together to create a two-piece prosthesis. The device is composed of Titanium Alloy, Cobalt Chrome, Ultra High Molecular Weight Polyethylene and commercially pure Titanium and each component is available in multiple sizes to accommodate variable patient anatomy.

    AI/ML Overview

    This document describes a 510(k) premarket notification for the WMT INFINITY® Total Ankle System. The document focuses on demonstrating substantial equivalence to a predicate device, rather than providing a study proving performance against acceptance criteria for a novel device. Therefore, much of the requested information regarding acceptance criteria, performance studies, sample sizes, expert ground truth, and comparative effectiveness studies is not applicable or not provided in the given text.

    Here's an analysis based on the provided text:

    1. Table of Acceptance Criteria and Reported Device Performance:

    • Acceptance Criteria: Not explicitly defined in terms of measurable performance metrics. The core "acceptance criterion" for this 510(k) submission is demonstrating substantial equivalence to a predicate device.
    • Reported Device Performance: The document states that "Through mechanical analysis the subject devices do not represent a new worst-case. Therefore, no additional mechanical testing was performed to support the subject devices." This implies that the performance is considered to be equivalent to the predicate device, which is presumably already proven safe and effective.
    Acceptance Criteria CategorySpecific Criteria (Implicit for Substantial Equivalence)Reported Device Performance
    Mechanical PerformanceNo new worst-case mechanical behavior compared to predicate.No new worst-case identified through mechanical analysis.
    Material CompositionSame materials as predicate.Composed of Titanium Alloy, Cobalt Chrome, Ultra High Molecular Weight Polyethylene, and commercially pure Titanium (same as predicate).
    Design FeaturesClinically relevant design features maintained; differences do not raise new safety/effectiveness questions.Maintains clinically relevant design features. Differences are an anterior-posterior (AP) tray length and neutral posterior curvature, which do not raise new safety/effectiveness questions.
    Intended Use/IndicationsIntended use and indications are substantially equivalent to predicate.Intended use and indications are equivalent to the predicate.

    2. Sample Size for Test Set and Data Provenance: Not applicable. This submission relies on a comparison to a predicate device and mechanical analysis, not a clinical trial with a test set of data.

    3. Number of Experts and Qualifications for Ground Truth for Test Set: Not applicable. Ground truth as typically defined for algorithm performance in AI/ML is not established here. The "ground truth" is the established safety and effectiveness of the predicate device.

    4. Adjudication Method for Test Set: Not applicable. No test set requiring expert adjudication is described.

    5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: Not applicable. This is not a study comparing human readers with and without AI assistance.

    6. Standalone (Algorithm Only) Performance Study: Not applicable. This device is a physical medical implant, not an algorithm.

    7. Type of Ground Truth Used: The "ground truth" in this context is the established safety and effectiveness of the legally marketed predicate device (K123954 INFINITY® Total Ankle System).

    8. Sample Size for Training Set: Not applicable. This document describes a medical device, not an AI/ML algorithm that requires a training set. The "training" in a regulatory sense would refer to the historical data and experience with the predicate device.

    9. How Ground Truth for Training Set was Established: Not applicable. As above, this is a medical device, not an AI/ML algorithm. The safety and effectiveness of the predicate device would have been established through its own regulatory pathway, which may have included clinical data, mechanical testing, and biocompatibility assessments.

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