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510(k) Data Aggregation

    K Number
    K182684
    Device Name
    HammerTechTM Fixation System
    Manufacturer
    Fusion Orthopedics, LLC
    Date Cleared
    2018-11-23

    (58 days)

    Product Code
    HWC
    Regulation Number
    888.3040
    Type
    Traditional
    Panel
    Orthopedic
    Reference & Predicate Devices
    K161449,K150252,K121008
    Why did this record match?
    Device Name :

    HammerTechTM Fixation System

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

    The HammerTech device is indicated for the fixation of osteotomies and reconstruction of the lesser toes following correction procedures for hammertoe, claw toe and mallet toe.

    Device Description

    The HammerTech Fixation System consists of PEEK (Polyetheretherketone (ASTM F2026)) and titanium alloy (Ti6Al4V ELI (ASTM F136)) threaded bone implants intended for fixation of the interphalangeal joint of the lesser toes. The device is offered in three configurations; straight cannulated PEEK, straight cannulated titanium, and angled solid titanium. Each configuration is offered in five different sizes to address to a variety of patient anatomy. The specialized instruments are made primarily of surgical grade stainless steel (ASTM F899). The implant and associated instrumentation is supplied sterile and non-sterile.

    AI/ML Overview

    This document is a 510(k) premarket notification for the HammerTech™ Fixation System, a bone fixation device. As such, it does not contain any information about a study proving that an AI/software device meets acceptance criteria.

    The document primarily focuses on demonstrating substantial equivalence to predicate devices based on:

    • Intended Use: Fixing osteotomies and reconstructing lesser toes for hammertoe, claw toe, and mallet toe correction.
    • Design & Materials: PEEK and titanium alloy threaded bone implants, offered in various configurations and sizes.
    • Mechanical Safety and Performance: Non-clinical tests like static/dynamic 4-point bending, pull-out, torsion, and insertion torque were conducted to show equivalence to predicate devices, and pyrogenicity was evaluated.
    • No Clinical Studies: The document explicitly states, "No clinical studies were performed."

    Therefore, I cannot provide the requested information regarding:

    1. A table of acceptance criteria and reported device performance for an AI/software.
    2. Sample sizes or data provenance for an AI/software test set.
    3. Number of experts or their qualifications for ground truth establishment for an AI/software.
    4. Adjudication method for an AI/software test set.
    5. MRMC comparative effectiveness study for AI assistance.
    6. Standalone performance of an AI algorithm.
    7. Type of ground truth used for AI.
    8. Sample size for the training set for AI.
    9. How ground truth for the training set was established for AI.

    The document pertains to a physical medical device (bone fixation system) and its mechanical and material properties, not an AI or software-as-a-medical-device (SaMD).

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