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510(k) Data Aggregation

    K Number
    K013962
    Device Name
    EQUATION FIXATION SYSTEM
    Manufacturer
    MEDTRONIC SOFAMOR DANEK, INC.
    Date Cleared
    2002-06-20

    (199 days)

    Product Code
    MNH,MNI
    Regulation Number
    888.3070
    Type
    Traditional
    Panel
    Orthopedic
    Reference & Predicate Devices
    N/A
    Predicate For
    K042453,K060081,K152781,K162576
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The EQUATION™ Fixation System is a temporary implant system used for correction and stabilization of the posterior spine for the development of a solid spinal fusion. When used as a pedicle screw fixation system of the non-cervical posterior spine in skeletally mature patients, the EQUATION™ Fixation System is indicated for one or more of the following: (1) degenerative spondylolisthesis with objective evidence of neurologic impairment, (2) fracture, (3) dislocation, (4) scoliosis, (6) spinal tumor, and/or (7) failed previous fusion (pseudarthrosis).

    In addition, when used as a pedicle screw fixation system, the EQUATION™ Fixation System is indicated for skeletally mature patients: (a) having severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar-first sacral (L5-S1) vertebral joint; (b) who are receiving fusions using autogenous bone graft only; (c) who are having the device fixed or attached to the lumbar and sacral spine (L3 and below); and (d) who are having the device removed after the development of a solid fusion mass.

    Device Description

    The Medtronic Sofamor Danek EQUATION™ Fixation System consists of a variety of shapes and sizes of screws, nuts, and 3.6mm rods and cross connectors. The implant components can be rigidly locked in a variety of configurations, with each construct being tailor-made for the individual case. The implants are made of titanium alloy (Ti-6Al-4V) described by ASTM Standard F136 or ISO 5832-3. Stainless steel and titanium implant components must not be used together in a construct.

    AI/ML Overview

    The Medtronic Sofamor Danek EQUATION™ Fixation System is a temporary implant system used for correction and stabilization of the posterior spine for the development of a solid spinal fusion. The acceptance criteria and the study that proves the device meets the acceptance criteria are described below.

    1. Acceptance Criteria and Reported Device Performance

    Acceptance CriteriaReported Device Performance
    The EQUATION™ Fixation System must demonstrate substantial equivalence in functionality and safety to the predicate device, the CD HORIZON® Spinal System, through mechanical testing.Mechanical testing was performed on the EQUATION™ Fixation System and the results were directly compared to test data previously obtained for the cleared CD HORIZON® Spinal System. The submission states that the test results supported the conclusion of substantial equivalence.

    2. Sample Size and Data Provenance

    The document does not explicitly state a "test set" in the context of clinical data or human subjects. The evaluation was primarily based on mechanical testing.

    • Sample size for the test set: Not explicitly stated for mechanical testing, but the implication is that sufficient units of the EQUATION™ Fixation System components were tested to make a comparison with the predicate device.
    • Data Provenance: The data is from mechanical testing of the device and its components. The country of origin for this testing is not specified, but the submitter is Medtronic Sofamor Danek USA, Inc. The data is prospective in the sense that the testing was conducted specifically for this submission.

    3. Number of Experts and Qualifications for Ground Truth

    Not applicable. The "ground truth" for this device's performance is established through mechanical engineering principles and testing standards, not through expert clinical consensus on images or patient data. No human experts were used to establish ground truth in the way it is typically understood for diagnostic AI.

    4. Adjudication Method for the Test Set

    Not applicable. As the evaluation was based on mechanical testing, there was no need for an adjudication method as would be used with human readers or clinical data. The results of mechanical tests are usually objective measurements.

    5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

    Not applicable. This device is a surgical implant, not a diagnostic or AI-assisted system requiring a MRMC study.

    6. Standalone (Algorithm Only) Performance Study

    Not applicable. This is a physical medical device (spinal fixation system), not a software algorithm.

    7. Type of Ground Truth Used

    The ground truth used was objective mechanical test results that demonstrate the physical performance, strength, and durability of the device components, comparing them against the established performance of the legally marketed predicate device (CD HORIZON® Spinal System). The safety and effectiveness are inferred from demonstrating equivalent mechanical properties to a device already deemed safe and effective.

    8. Sample Size for the Training Set

    Not applicable. There is no "training set" in the context of an AI/algorithm. For a physical device, the development and manufacturing process involves iterative design and testing, but these are not referred to as "training sets."

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

    Not applicable as there is no training set. Design specifications and engineering requirements guide the development of such a device, and compliance with these, along with comparison to predicate devices, forms the basis of its "ground truth" for regulatory approval.

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