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510(k) Data Aggregation

    K Number
    K140531
    Device Name
    BIOFOAM BONE WEDGE
    Manufacturer
    WRIGHT MEDICAL TECHNOLOGY, INC.
    Date Cleared
    2014-07-09

    (127 days)

    Product Code
    HRS,HWC
    Regulation Number
    888.3030
    Type
    Traditional
    Panel
    Orthopedic
    Reference & Predicate Devices
    K093950
    Predicate For
    K142724,K150394,K151256,K192645,K193414
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The BIOFOAM® Bone Wedge is internal bone fixation for bone fractures, fusions, or osectornies in the ankle and foot, such as:

    • Cotton and Evans Wedges:
    • Opening wedge osteotomics of the bones of the foot including osteotomics for Hallux Valgus
    • Opening wedge of Medial Cunciform or Cotton osteotomies
    • Lateral Column Lengthening (Evans Lengthening Osteotomy or Calcancal Z Osteotomy)
    • Metatarsal/Cunciform arthrodesis
    • Midfoot Wedges
    • Opening wedge osteotomics of the bones of the foot including osteotomies for Hallux Valgus
    • Nonunion of arthrodesis of the Midfoot including Metatarsal/Cunciform arthrodesis (TMT or Lapidus)
      This device is intended for use with ancillary fixation. The BIOFOAM® Bone Wedge is not intended for use in the spine.
    Device Description

    The BIOFOAM® Bone Wedge is a titanium metal foam wedge used for angular correction of small bones of the foot. It is offered with varying widths and thicknesses to accommodate a variety of small bone applications.

    AI/ML Overview

    The provided text describes the 510(k) summary for the WMT BIOFOAM® Bone Wedge. It focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study proving performance against acceptance criteria in the context of AI/ML device testing.

    Therefore, many of the requested categories related to AI/ML device studies (such as sample size for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth establishment for AI models) are not applicable to this submission.

    Here's an analysis based on the available information:

    1. Table of Acceptance Criteria and Reported Device Performance

    Acceptance CriteriaReported Device Performance
    Substantial Equivalence (Non-Clinical)A testing rationale related to compression and fatigue testing was provided to support the equivalence of the subject device.
    Material IdentityThe subject and predicate devices are identical in material.
    Safety and EffectivenessThe safety and effectiveness of the BIOFOAM® Bone Wedge is adequately supported by the testing rationale, substantial equivalence information, materials information, and comparison of design characteristics.
    No New Worst-Case Devices IntroducedThe testing rationale confirmed that no new worst-case devices are introduced in this system.
    No New Questions of Safety or EffectivenessThe design characteristics of the subject system do not raise any new types of questions of safety or effectiveness.
    Performance "at least as well as predicate"From the evidence submitted, the subject devices can be expected to perform at least as well as the predicate device.

    2. Sample Size Used for the Test Set and Data Provenance

    • Not applicable. This submission relies on non-clinical engineering testing (compression and fatigue testing) and comparison to a predicate device, not a test set of data in the AI/ML sense. No specific "sample size" of clinical cases or data is mentioned. Data provenance is therefore not relevant.

    3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

    • Not applicable. There was no expert-established ground truth for a test set in the context of an AI/ML device. The evaluation was based on engineering principles and comparison to a predicate.

    4. Adjudication Method

    • Not applicable. No adjudication method was mentioned as it was not a clinical study involving human interpretation.

    5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

    • No. An MRMC study was not done. This is a medical device (bone wedge), not an AI/ML diagnostic or assistive tool for human readers.

    6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

    • Not applicable. This is a physical medical device, not an algorithm.

    7. The Type of Ground Truth Used

    • The "ground truth" for this submission is based on:
      • Engineering specifications and test standards: for compression and fatigue performance.
      • Material properties: showing identity to the predicate device.
      • Design characteristics comparison: ensuring no new safety or effectiveness concerns.

    8. The Sample Size for the Training Set

    • Not applicable. There was no training set, as this is not an AI/ML device.

    9. How the Ground Truth for the Training Set Was Established

    • Not applicable. There was no training set.
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