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    K Number
    K221621
    Device Name
    Pro-X1™ Trochanteric Nailing System
    Manufacturer
    X-Bolt Orthopedics
    Date Cleared
    2023-03-06

    (276 days)

    Product Code
    HSB
    Regulation Number
    888.3020
    Type
    Traditional
    Panel
    Orthopedic
    Reference & Predicate Devices
    K034002,K181640
    Why did this record match?
    Reference Devices :

    K034002

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

    The Pro-X1™ Trochanteric Nailing System is intended for use in fracture fixation in the femur in adults with osteopenia or osteoporosis. The Pro-X1™ Trochanteric Nailing System is indicated for use in:

    • · Intertrochanteric and subtrochanteric fractures
    • · Segmental fractures
    • Comminuted fractures
    • Pathological fractures
    • · Fractures with bone loss
    • · Pseudoarthrosis, non-union, mal-union, and delayed union
    • · Surgically created defects such as osteotomies
    Device Description

    The Pro-X1" Trochanteric Nailing System is a single use device intended for long-term implantation into the femur. The Pro-X1™ Trochanteric Nailing System consists of the following components:

    • . Pro-X1™ Expanding Bolt: is a metal expanding hip bolt available in various lengths.
    • Pro-X1"" Trochanteric Nail: is a metal intramedullary (IM) nail which is designed ● to be used in conjunction with the Pro-X1"" Expanding Bolt to provide fixation of fractures of the femur. It is available in various lengths, in right and left configurations.
    • Set-Screw: The set-screw prevents the Pro-X1™ Expanding Bolt from rotating, while ● still allowing for dynamic movement.
    • Interlocking Screws: The interlocking screws are used in conjunction with the Pro-● X1" Trochanteric Nail to achieve distal fixation of the nail. The interlocking screws are available in various lengths.
    AI/ML Overview

    This document describes the Pro-X1™ Trochanteric Nailing System, a device for fracture fixation in the femur. However, the provided text does not contain the kind of information that would be used to assess the performance of an AI/ML medical device, such as acceptance criteria, sample sizes for test/training sets, expert qualifications, or details about standalone or MRMC studies.

    The document is a 510(k) summary for a physical medical device (an intramedullary rod system), not an AI/ML-driven diagnostic or prognostic tool. The performance data presented refers to non-clinical bench testing for mechanical properties, not clinical accuracy or utility in an AI context.

    Therefore, I cannot provide the requested information in the format of AI/ML device performance.

    The "acceptance criteria" discussed in the document are about the mechanical performance of the physical device (e.g., fatigue, bending, torque, pull-out strength) and its substantial equivalence to a predicate device based on these mechanical characteristics.

    Here’s a summary of what is available in the document, which pertains to a traditional medical device:

    Device: Pro-X1™ Trochanteric Nailing System

    Intended Use: Fracture fixation in the femur in adults with osteopenia or osteoporosis.

    Predicate Device: X-BOLT IM Hip Nail System (K181640)

    Reference Device (for comparison, but not direct predicate): Howmedica Osteonics Corp.'s Gamma 3 Nail System (K034002)

    Non-Clinical Performance Data (Bench Testing):

    TestStandard/BasisReported Device Performance
    Gliding hip nail fatigue testEPI-19 based on ISO 7206-4Met pre-determined acceptance criteria
    Static four-point bending testASTM F1264Met pre-determined acceptance criteria
    Dynamic four-point bending testASTM F1264Met pre-determined acceptance criteria
    Torsional yield testing of the bone screwASTM F543Met pre-determined acceptance criteria
    Insertion torque testing of the bone screwASTM F543Met pre-determined acceptance criteria
    Pull-out testing of the bone screwASTM F543Met pre-determined acceptance criteria
    Torque testing to expand X-BoltNot specifiedMet pre-determined acceptance criteria
    Fatigue bending strength testing of X-BoltNot specifiedMet pre-determined acceptance criteria
    Characterization of coating adhesionNot specifiedMet pre-determined acceptance criteria

    Substantial Equivalence Conclusion: The Pro-X1™ Trochanteric Nailing System is substantially equivalent to the X-BOLT IM Hip Nail System (K181640) based on:

    • Same intended use
    • Same fundamental scientific technology
    • Similar functional and technological characteristics via similar operational principles
    • Evaluation of risk and performance data demonstrating it is as safe and effective for its intended use.

    Missing Information (as pertains to AI/ML device assessment):

    1. A table of acceptance criteria and reported device performance (in an AI/ML context)
    2. Sample sized used for the test set and the data provenance
    3. Number of experts used to establish the ground truth for the test set and the qualifications
    4. Adjudication method for the test set
    5. If a multi reader multi case (MRMC) comparative effectiveness study was done, and the effect size of human readers improving with AI vs without AI assistance
    6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
    7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
    8. The sample size for the training set
    9. How the ground truth for the training set was established

    This document describes a traditional medical device and its mechanical testing, not an AI/ML product.

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