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    K Number
    K121136
    Device Name
    RENOIR POSTERIOR CERVIAL FIXATION SYSTEM
    Manufacturer
    ACCEL SPINE
    Date Cleared
    2012-08-09

    (118 days)

    Product Code
    KWP,MNI
    Regulation Number
    888.3050
    Type
    Traditional
    Panel
    Orthopedic
    Reference & Predicate Devices
    K031985,K050979,K060152,K003780,K103414,K120879
    Why did this record match?
    Device Name :

    RENOIR POSTERIOR CERVIAL FIXATION SYSTEM

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

    The RENOIR Posterior Cervical Fixation System is indicated for the following:

    • DDD (neck pain of discogenic origin with degeneration of the disc as confirmed by patient history and radiographic studies)
    • Spondylolisthesis
    • Spinal stenosis
    • Fracture/dislocation
    • Failed previous fusion
    • Tumors

    The implants are intended to provide stabilization as an adjunct to fusion when used with autogenous bone graft or allograft following the reduction of fractures/dislocations or trauma in the spine.

    Hooks and rods are also intended to provide stabilization to promote fusion following reduction of fracture/dislocation or trauma in the cervical/upper thoracic (C1 -T3) spine.

    The pedicle screws are limited to placement in T1 -T3 in treating thoracic conditions only. The pedicle screws are not intended to be placed in or treat conditions involving the cervical spine.

    Device Description

    The RENOIR Posterior Cervical Fixation System is a top-loading, multiple component, posterior (cervical-thoracic) spinal fixation system which consists of polyaxial screws, semi-reduction poly screws, reduction poly screws, straight rods, curved rods, set screws, hooks and set screws.

    AI/ML Overview

    The provided document describes the predicate device and the non-clinical testing performed on the RENOIR Posterior Cervical Fixation System. It does not contain information about a clinical study with human subjects, device performance in vivo, or an AI component. Therefore, many of your requested details cannot be extracted from this document.

    Here's what can be extracted based on the provided text:

    Acceptance Criteria and Study Details for RENOIR Posterior Cervical Fixation System

    CategoryDescription
    1. Acceptance Criteria & Reported Device PerformanceAcceptance Criteria: The RENOIR Posterior Cervical Fixation System must "perform as well as the predicate device" in mechanical tests.
    Reported Device Performance: "The mechanical test results demonstrated that the RENOIR Posterior Cervical Fixation System performs as well as the predicate device."
    2. Sample Size (Test Set) & Data ProvenanceThe document mentions "Worst-case, Screw construct" for the mechanical tests, implying specific configurations were tested. However, a numerical sample size is not provided. The data provenance is from non-clinical laboratory testing (mechanical tests), not from human subjects, and therefore no country of origin is applicable in this context. It is a prospective test in a lab setting.
    3. Number & Qualifications of Experts for Ground TruthThis information is not applicable as the study was non-clinical mechanical testing, not interpretation of clinical data requiring expert human review.
    4. Adjudication Method (Test Set)This is not applicable as the study was non-clinical mechanical testing.
    5. MRMC Comparative Effectiveness StudyNo such study was conducted or reported. This device is a medical implant, not an AI diagnostic tool.
    6. Standalone Algorithm PerformanceThis is not applicable as the device is a physical medical implant, not an algorithm.
    7. Type of Ground Truth UsedThe ground truth was based on mechanical performance standards (ASTM F1717) and comparative performance against a predicate device.
    8. Sample Size for Training SetThis is not applicable as there is no training set for a physical implant device subjected to mechanical testing.
    9. How Ground Truth for Training Set was EstablishedThis is not applicable.

    Summary of Non-Clinical Testing Performed:

    • Tests Conducted: Static compression bending, tension, torsion, and dynamic compression bending.
    • Standard Followed: ASTM F1717.
    • Test Subject: "Worst-case, Screw construct" of the RENOIR Posterior Cervical Fixation System.
    • Comparison: Performance was compared against a predicate device.
    • Conclusion: The RENOIR Posterior Cervical Fixation System "performs as well as the predicate device."

    Missing Information:

    The document does not include any information regarding:

    • Clinical studies involving human subjects.
    • Performance metrics (e.g., sensitivity, specificity, accuracy) typically associated with AI/diagnostic devices.
    • AI algorithms or human-in-the-loop performance.
    • Specific numerical data from the mechanical tests, only the general conclusion of equivalency.
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