LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K112533
    Device Name
    ZAVATION CERVICAL PLATE SYSTEM
    Manufacturer
    ZAVATION LLC
    Date Cleared
    2011-12-08

    (101 days)

    Product Code
    KWQ,KWO
    Regulation Number
    888.3060
    Type
    Traditional
    Panel
    Orthopedic (OR)
    Reference & Predicate Devices
    K993066,K070681,K013877
    Why did this record match?
    Reference Devices :

    K993066,K070681,K013877

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

    The Zavation Cervical Plate System is intended for anterior screw fixation of the cervical spine (C2-C7) as an adjunct to fusion. These implants have been designed to provide stabilization for the treatment of the following indications: degenerative disc disease (defined as neck pain of discogenic origin with the degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fractures or dislocations), spinal stenosis, deformity (i.e., kyphosis, lordosis or scoliosis), tumor, pseudarthrosis or failed previous fusion.

    Device Description

    The Zavation Cervical Plate System consists of self-tapping/self-drilling screws and plates. Screws are available in a variety of diameter and length combinations. Plates are available in a variety of lengths.

    AI/ML Overview

    The provided text describes a 510(k) submission for the Zavation Cervical Plate System, a medical device. This type of submission is for establishing substantial equivalence to a predicate device, not for proving novel clinical effectiveness through extensive studies as one might see for a new drug or a highly innovative device.

    Therefore, many of the typical acceptance criteria and study elements listed in the prompt (like sample sizes for test and training sets, expert ground truth, adjudication methods, MRMC studies, standalone algorithm performance, or specific effect sizes) are not applicable to this type of regulatory submission for this device.

    The study presented here is a mechanical performance study comparing the new device against a predicate device.

    Here's a breakdown based on the provided text:

    1. Table of Acceptance Criteria and Reported Device Performance

    Acceptance Criteria CategorySpecific Acceptance Criteria (Implied)Reported Device Performance
    Material CompositionComply with ASTM F136 for titanium alloy (Ti-6Al-4V).Components manufactured from titanium alloy (Ti-6Al-4V) as described by ASTM F136.
    Mechanical PerformancePerform equally or superior to the predicate device in static and dynamic loading.Mechanical test results demonstrated that the Zavation Cervical Plate System performs as well as or better than the predicate device in static compression bending/torsion, and dynamic compression bending.
    Design CharacteristicsPossess similar basic design, material, sizes, and intended use as the predicate (Technological Characteristics).Same basic design (plate designed fixation system with various screw sizes), material (titanium alloy), sizes (variety of plate and screw sizes), and intended use.

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

    • Sample Size: Not explicitly stated as human or animal subjects as this was a mechanical bench test. The "worst-case, cervical plate construct" was used for testing. The number of constructs tested for each mechanical test (static and dynamic) is not specified.
    • Data Provenance: Not applicable in the context of human data. The tests were performed according to ASTM F1717, an established standard for spinal implant testing. These are laboratory-generated data.

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

    • Not applicable. Ground truth in this context refers to the pass/fail criteria of the ASTM F1717 standard and comparison of mechanical output values against the predicate device's performance. No human experts were used to establish "ground truth" for the mechanical characteristics of the device in the way a radiologist reviews images.

    4. Adjudication Method for the Test Set

    • Not applicable. This was a mechanical study, not a clinical study requiring human adjudication of outcomes or diagnoses. The "adjudication" was based on objective measurements adhering to ASTM F1717 and comparison to predicate device data.

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

    • No. This was a mechanical performance study, not a clinical study involving human readers or comparative effectiveness in a clinical setting.

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

    • Not applicable. This device is a physical implant, not an AI algorithm. Therefore, "standalone algorithm performance" is not relevant.

    7. The Type of Ground Truth Used

    • The "ground truth" for this submission is based on engineering standards (ASTM F1717) and the performance data of legally marketed predicate devices. The new device's mechanical performance in specific tests (static compression bending, torsion, and dynamic compression bending) was compared to that of the predicate devices. The aim was to demonstrate equivalent or superior performance.

    8. The Sample Size for the Training Set

    • Not applicable. There is no "training set" in the context of a mechanical performance study for a physical medical device. This term is relevant for machine learning or AI models.

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

    • Not applicable. As there is no training set, there is no ground truth for it to be established.
    Ask a Question

    Ask a specific question about this device

    Page 1 of 1