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510(k) Data Aggregation

    K Number
    K103623
    Device Name
    NEWDEAL INTERPHALANGEAL IMPLANT
    Manufacturer
    NEWDEAL SAS
    Date Cleared
    2012-03-20

    (466 days)

    Product Code
    HTY
    Regulation Number
    888.3040
    Type
    Traditional
    Panel
    Orthopedic (OR)
    Reference & Predicate Devices
    K022599,K100414,K070598
    Why did this record match?
    Reference Devices :

    K022599, K100414

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

    The Newdeal Interphalangeal Implant is intended for fixation of proximal interphalangeal joint arthrodesis of the lesser toes.

    Examples include:

    • rigid or semi-rigid hammertoe deformity .
    • revision of failed arthroplasty or arthrodesis .
    • 2nd toe shortening .
    Device Description

    The Newdeal Interphalangeal implant is designed to respect anatomical flexion to achieve fixation of interphalangeal arthrodesis of the lesser toes in case of:

    • . Fixed or semi-fixed hammer toe
    • Revision of failed arthrodesis or arthroplasty ●
    • . Shortening due to length excess of the second toe

    This interphalangeal implant configuration will be offered in two different sizes.

    AI/ML Overview

    The provided text describes the Newdeal® Interphalangeal implant and its substantial equivalence to other devices. It focuses on the regulatory submission (510(k) summary) for this medical device. As such, the information required to populate the table (acceptance criteria and device performance based on a study of AI/algorithm performance) and subsequent questions about AI/algorithm-related studies are not present in the document. This document is a regulatory submission for a physical medical implant, not an AI or algorithm-based device.

    Therefore, I cannot provide the requested information.

    Here's why:

    • Acceptance Criteria & Device Performance: The document mentions "Static and Fatigue Bending tests were performed comparing the mechanical properties" but does not detail specific quantitative acceptance criteria or the reported device performance against those criteria. It only states that the results "helped to support substantial equivalence."
    • AI/Algorithm Related Questions (2-7): The entire submission is for a physical orthopedic implant. It does not involve an AI or algorithm. Therefore, there are no test sets, data provenance, experts for ground truth, adjudication methods, MRMC studies, standalone algorithm performance, or ground truth types related to AI.
    • Training Set (8-9): Similarly, the concept of a "training set" and establishing ground truth for it is irrelevant for a physical mechanical implant.
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