LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K192915
    Device Name
    GMA 2.0 Pedicle Screw System
    Manufacturer
    Grafton Medical Alliance
    Date Cleared
    2019-11-13

    (29 days)

    Product Code
    NKB
    Regulation Number
    888.3070
    Type
    Special
    Panel
    Orthopedic
    Reference & Predicate Devices
    K133063
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The GMA 2.0 Pedicle Screw System is intended for immobilization of the spine. The GMA 2.0 Pedicle Screw System is indicated for posterior, noncervical pedicle fixation as an adjunct to fusion in skeletally mature patients using autograft and/or allograft for the following indications: degenerative disc disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion.

    Device Description

    The GMA 2.0 Pedicle Screw System is comprised of pre-bent rods, pedicle screw assemblies with dual lead non-cannulated screws, and a set screw. Various forms and sizes of these implants are available to account for the unique anatomy of individual patients. Components are made of Ti6A14V ELI conforming to ASTM F136. The system includes a set of instruments to aid in the implantation of the device. The instruments are made of medical grade stainless steel per ASTM F899.

    AI/ML Overview

    The provided document is a 510(k) premarket notification for the GMA 2.0 Pedicle Screw System. It describes the device, its intended use, and its similarities to a predicate device (K133063 SANTIS™ Pedicle Screw System). The document focuses on demonstrating substantial equivalence to the predicate device, primarily through technological characteristics and mechanical testing.

    However, the document does not contain any information regarding acceptance criteria or a study that uses an AI/ML algorithm or software for analysis or prediction related to the device's performance in a clinical or diagnostic setting. The device described is a physical pedicle screw system used for spinal immobilization.

    Therefore, I cannot fulfill your request to describe the acceptance criteria and the study proving the device meets those criteria for an AI/ML system, as the provided document pertains to a medical device's mechanical and material characteristics, not its performance as an AI/ML system.

    If you have a document related to an AI/ML medical device, please provide that, and I will be happy to assist you.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1