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510(k) Data Aggregation

    K Number
    K212044
    Device Name
    TrueLok Evo
    Manufacturer
    Orthofix SRL
    Date Cleared
    2021-11-05

    (128 days)

    Product Code
    KTT,LXT
    Regulation Number
    888.3030
    Type
    Traditional
    Panel
    Orthopedic (OR)
    Reference & Predicate Devices
    K152171,K161417,K941048
    Why did this record match?
    Device Name :

    TrueLok Evo

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

    The TrueLok™ EVO is intended to provide bone fixation.

    The TrueLok™ EVO is indicated for fractures, pseudarthrosis / non-unions, joint arthrodesis and correction of bony or soft tissue deformities and defects (e.g. bone transport) in long bones and in the foot.

    Device Description

    The TrueLok™ EVO system is a modular circular external fixation system based on Ilizarov fixation apparatus principles. The TrueLok™ consists of external supports (rings and footplates), variable length struts and a variety of connection elements that build the external frame. The TrueLok™ external frame is secured by using the Orthofix predicates pin and wires. The Subject external support components (rings, footplates and struts), are made from AISI 316LVM, AISI 630, Aluminum alloy (EN-AW 6082 T6) and Epoxy carbon fiber. Application and removal of the TL-EVO can be performed with Orthofix general orthopedic instrumentation. TrueLokTM EVO fixator components are provided in single-use sterile configuration and they are available as single component packaged in double pouches or in multiple components packaged in double rigid blister.

    AI/ML Overview

    The provided text describes the 510(k) premarket notification for the TrueLok™ Evo, a bone fixation device. However, it does not contain information about acceptance criteria for a device's performance, a study proving it meets such criteria, or any details related to AI/algorithm performance.

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

    • Indications for Use: Comparing the intended use of the TrueLok™ Evo to predicate devices.
    • Technological Characteristics: Highlighting similarities in materials, design, and general principles of operation.
    • Performance Analysis (Non-Clinical): Detailing specific non-clinical tests conducted, such as MRI compatibility testing and mechanical testing according to ASTM standards.

    Here's why the requested information cannot be extracted from this document:

    1. Acceptance Criteria & Reported Performance: The document states that the performance data supports substantial equivalence and that the device performs "as well as or better than the predicate devices." It also lists the standards used for testing (ASTM F2052, F2213, F2182, F2119 for MRI, and ASTM F1541-17 for mechanical testing). However, it does not quantify specific acceptance criteria (e.g., "displacement must be less than X mm") nor does it report the specific measured performance values (e.g., "displacement was Y mm") that would allow for a direct comparison in a table as requested. The "Effectiveness" mentioned refers to the device's ability to achieve its intended function, not a quantifiable performance metric for an algorithm.

    2. Sample Size & Data Provenance (Test Set): This document does not describe a "test set" in the context of an algorithm or AI. The performance analysis refers to physical testing of the device components.

    3. Number of Experts & Qualifications / Adjudication Method (Test Set): This information is relevant for studies involving human interpretation or ground truth establishment for AI. It is not applicable to the non-clinical mechanical and MRI compatibility testing described here.

    4. MRMC Comparative Effectiveness Study: There is no mention of an MRMC study or AI assistance for human readers as the device is a physical bone fixation system, not an AI diagnostic tool.

    5. Standalone Performance Study: No standalone algorithm performance study is mentioned for the same reason as above.

    6. Type of Ground Truth: The ground truth for the non-clinical tests described would be the physical measurements and observations during those tests, compared against the limits defined by the regulatory standards. This is not "expert consensus," "pathology," or "outcomes data" in the typical sense used for AI.

    7. Sample Size for Training Set: Not applicable as there is no AI/algorithm being trained.

    8. How Ground Truth for Training Set was Established: Not applicable as there is no AI/algorithm being trained.

    In summary, the provided document details a 510(k) submission for a physical medical device (bone fixation system) and its non-clinical testing to demonstrate substantial equivalence, not the performance of an AI or algorithm. Therefore, the requested information regarding acceptance criteria, study details, and AI-specific metrics cannot be extracted from this text.

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