LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K072187

    Validate with FDA (Live)

    Device Name
    PIONEER LOWTOP SPINAL ROD SYSTEM
    Manufacturer
    PIONEER SURGICAL TECHNOLOGY
    Date Cleared
    2007-10-12

    (67 days)

    Product Code
    MNI,MNH
    Regulation Number
    888.3070
    Type
    Traditional
    Panel
    Orthopedic
    Reference & Predicate Devices
    K070933,K070973
    Predicate For
    K080026,K080504,K080518,K093771
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Pioneer LowTop Spinal Rod System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute instabilities or deformities of the thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurological impairment, trauma (i.e., fracture or dislocation), deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), spinal tumor, and failed previous fusion (pseudoarthrosis).

    In addition, this device is a pedicle screw system indicated for the treatment of severe spondylolisthesis (Grade 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to S1) with removal of the implants after the attainment of a solid fusion.

    Device Description

    Materials used to manufacture the implants and instruments of this system are in conformance with ASTM Standard Specifications.

    AI/ML Overview

    The provided text is for a 510(k) premarket notification for a medical device (Pioneer LowTop Spinal Rod System) and does not describe an AI/ML device or its performance study. Therefore, I cannot extract the requested information regarding acceptance criteria and a study proving an AI/ML device meets them.

    The document discusses:

    • Device name, classification, and intended use.
    • Predicate devices.
    • Material specifications.
    • Performance data: "Testing per recognized ASTM standards was presented."
    • Substantial equivalence determination based on comparisons to predicate devices.

    It does not contain any information about:

    • Acceptance criteria in the context of an AI/ML device.
    • Reported device performance of an AI/ML system.
    • Sample sizes for test sets or data provenance for AI/ML.
    • Experts for ground truth, adjudication methods, or MRMC studies.
    • Standalone AI algorithm performance.
    • Ground truth types for AI/ML.
    • Training set size or ground truth establishment for a training set.
    Ask a Question

    Ask a specific question about this device

    Page 1 of 1