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510(k) Data Aggregation

    K Number
    K112097
    Device Name
    GIBRALT SPINE SYSTEMS FACET SCREW 04.0,04.5
    Manufacturer
    EXACTECH, INC.
    Date Cleared
    2011-11-21

    (122 days)

    Product Code
    MRW
    Regulation Number
    N/A
    Type
    Traditional
    Panel
    Orthopedic
    Reference & Predicate Devices
    K073515,K092568,K083442,K061041,K012773,K071420
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Gibralt Spine System Facet Screw is indicated for the posterior surgical treatment at C2- S1 (inclusive) spinal levels for the following: DDD (neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, spondylolysis, fracture, or failed previous fusion.

    Device Description

    The proposed Gibralt Spine System Facet Screw is a new facet screw device intended to provide posterior fixation as an aid to fusion. The Gibralt Spine System Facet Screw components are available in a variety of sizes and are manufactured from titanium alloy per ASTM F136.

    The system components are provided non-sterile. The products must be steam sterilized by the hospital prior to use.

    The Gibralt Spine System Facet Screw is provided with a complete instrumentation system to assist the surgeon in implantation according to a traditional open surgical procedure.

    AI/ML Overview

    The provided text describes a medical device, the Exactech® Gibralt™ Spine System Facet Screw, for which a 510(k) premarket notification was submitted. The approval is based on substantial equivalence to legally marketed predicate devices, not on a study proving the device meets specific acceptance criteria in terms of clinical performance or diagnostic accuracy. Instead, the study conducted focused on biomechanical assessment.

    Therefore, many of the requested categories related to clinical study design, ground truth, expert adjudication, and multi-reader effectiveness are not applicable to the information provided.

    Here's a breakdown of the available information:

    1. Table of Acceptance Criteria and Reported Device Performance

    The core acceptance criterion for a 510(k) application in this context is substantial equivalence to existing legally marketed devices. For a mechanical device like a facet screw, this often means demonstrating comparable mechanical performance.

    Acceptance Criteria CategorySpecific Criteria (Implicit for Substantial Equivalence)Reported Device Performance (from "510(k) Summary")
    Mechanical PerformanceComparable mechanical properties to predicate devices."The results of mechanical testing and analysis demonstrate the proposed device is substantially equivalent to cited predicates."
    Material CompositionBiocompatible, recognized medical-grade materials."manufactured from titanium alloy per ASTM F136."
    SterilizationCapable of being sterilized to ensure patient safety."The products must be steam sterilized by the hospital prior to use."
    Indications for UseConsistent with predicate devices."posterior surgical treatment at C2-S1 (inclusive) spinal levels for ... DDD, spondylolisthesis, spondylolysis, fracture, or failed previous fusion." (This matches the scope of predicate devices for similar spinal fixation).

    2. Sample Size Used for the Test Set and Data Provenance

    • Sample Size for Test Set: Not explicitly stated as this was a biomechanical study, not a clinical trial or AI evaluation. It would involve a sufficient number of devices for mechanical testing.
    • Data Provenance: The study was a "biomechanical assessment," implying laboratory testing. The country of origin for the data is not specified, but it would presumably be performed by or for the manufacturer (Exactech®, Inc. in Gainesville, FL, USA). It is a retrospective comparison to previously established performance data of predicate devices.

    3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

    • Not Applicable. For a biomechanical study, "ground truth" is typically established by engineering standards and validated testing protocols, not by expert medical opinion. The "experts" would be engineers and biomechanical scientists.

    4. Adjudication Method for the Test Set

    • Not Applicable. Adjudication is relevant for subjective assessments (e.g., image interpretation). Biomechanical testing results are objective measurements.

    5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

    • No. This type of study is for evaluating human performance, often in conjunction with AI for diagnostic tasks. The provided information describes a mechanical device assessment.

    6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

    • Not Applicable. This is a mechanical device, not an algorithm.

    7. The Type of Ground Truth Used

    • For the biomechanical assessment, the "ground truth" is based on accepted engineering standards and physical laws for material strength, fatigue, and structural integrity, as applied to spinal implants. This includes compliance with standards like ASTM F136 for materials.

    8. The Sample Size for the Training Set

    • Not Applicable. There is no "training set" in the context of a 510(k) biomechanical assessment for a mechanical device. This concept applies to machine learning or AI algorithm development.

    9. How the Ground Truth for the Training Set Was Established

    • Not Applicable. No training set was used.
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