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510(k) Data Aggregation

    K Number
    K153622
    Device Name
    First Ray Internal Bone Staple System
    Manufacturer
    FIRST RAY LLC
    Date Cleared
    2016-04-08

    (112 days)

    Product Code
    JDR,HWC
    Regulation Number
    888.3030
    Type
    Traditional
    Panel
    Orthopedic
    Reference & Predicate Devices
    K011716,K963192
    Why did this record match?
    Device Name :

    First Ray Internal Bone Staple System

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

    The First Ray Internal Bone Staple System is indicated for fixation of bone fractures, fusions, or for bone reconstructions, including:

    • · Arthrodesis in hand or foot surgery
    • · Mono or bi-cortical osteotomies in the foot or hand
    • · Fracture management in the foot or hand
    • · Distal or proximal metatarsal or metacarpal osteotomies
    • · Fixation of osteotomies for Hallux Valgus treatment such as scarf, chevron, etc.
    Device Description

    The Internal Bone Staple System fixes bone fractures and osteotomies and achieves joint fusion by engaging two bone fragments and holding them together.

    AI/ML Overview

    The provided text is a 510(k) summary for the First Ray Internal Bone Staple System. It describes the device, its indications for use, and a comparison to predicate devices, but it does not contain acceptance criteria for an AI/ML powered device or a study proving its performance against such criteria.

    The document states:
    "Clinical data were not needed to support the safety and effectiveness of the subject device."
    "The Internal Bone Staple System performance was characterized through static pullout testing in bone analog material and static and fatigue four-point bend testing per ASTM F564-10 (2015) with a side-by-side comparison to the predicate device."

    Therefore, I cannot provide the requested information for an AI/ML powered device based on the given text. The device is a physical bone staple system, and its evaluation relies on mechanical testing against predicate devices.

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