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510(k) Data Aggregation

    K Number
    K172294
    Device Name
    Osteotomy Truss System (OTS)
    Manufacturer
    4Web, Inc.
    Date Cleared
    2018-02-22

    (206 days)

    Product Code
    HRS
    Regulation Number
    888.3030
    Type
    Traditional
    Panel
    Orthopedic
    Reference & Predicate Devices
    K130185,K152062
    Predicate For
    K201314,K220463
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Osteotomy Truss System (OTS) is intended to be used for internal bone fractures or osteotomies in the foot, such as:

    -Opening wedge osteotomies of the bones of the foot including osteotomies for Hallux Valgus

    -Opening wedge of Medial Cuneiform or Cotton osteotomies

    -Lateral Column Lengthening (Evans Lengthening Osteotomy or Calcaneal Z Osteotomy)

    -Metatarsal Cuneiform osteotomies

    • -Nonunion of arthrodesis of the Midfoot including Metatarsal Cuneiform osteotomies(TMT or Lapidus) -Hindfoot osteotomies
      These devices are intended to be used with supplemental fixation. The Osteotomy Truss System is not intended for use in the spine.
    Device Description

    The Osteotomy Truss System is a titanium alloy implant used for correction of small bones in the foot. It is offered in three footprints and multiple sizes for each footprint with varying widths and thicknesses to accommodate a variety of small bone applications. Each device uses the 4WEB truss system of architecture. Implants are made from medical grade titanium allow (6Al4V-ELI) per ASTM F-136/ISO 5832-3.

    AI/ML Overview

    The provided text is a 510(k) summary for a medical device (Osteotomy Truss System - OTS) and primarily focuses on demonstrating substantial equivalence to predicate devices based on non-clinical testing. It does not contain information about acceptance criteria or a study proving the device meets those criteria, particularly in the context of AI/algorithm performance.

    Therefore, I cannot fulfill your request with the provided input text. The information requested (acceptance criteria, device performance, sample size, data provenance, expert ground truth, adjudication, MRMC studies, standalone performance, training set details, etc.) would be typical for a clinical study evaluating the performance of a diagnostic or AI-driven device, which is not what this 510(k) summary describes.

    This document describes a submission for a metallic bone fixation appliance, and the "Non-clinical testing" section refers to mechanical and MRI compatibility tests (ASTM standards), not clinical performance or AI algorithm validation.

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