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    K Number
    K150294
    Device Name
    DPZ Pedicular Fixation System
    Manufacturer
    Osteomed Implantes, LTDA
    Date Cleared
    2015-06-05

    (119 days)

    Product Code
    MNI,MNH
    Regulation Number
    888.3070
    Type
    Traditional
    Panel
    Orthopedic (OR)
    Reference & Predicate Devices
    K042673,K071890,K093077,K100685,K940631,K950099,K000536,K920116,K062912,K081331,K092929,K071373,K113666
    Why did this record match?
    Device Name :

    DPZ Pedicular Fixation System

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

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

    The DPZ Pedicular Fixation System is also intended for non-cervical pedicle screw fixation for the following indications: severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft having having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion. It is also intended for the following indications: trauma (i.e., fracture or dislocation); spinal stenosis, deformities or curvatures (i.e., scoliosis, and/or lordosis), tumor, pseudarthrosis and failed previous fusion.

    Device Description

    The DPZ Pedicular Fixation System is a top loading, multiple component, posterior spinal fixation system which consists of pedicle screws, rods and cross links. All of the components are available in a variety of sizes to more closely match the patient's anatomy.

    AI/ML Overview

    The provided text describes the DPZ Pedicular Fixation System, its intended use, and the non-clinical tests conducted to demonstrate its equivalence to predicate devices. However, it explicitly states: "No clinical studies were performed."

    Therefore, I cannot provide information on acceptance criteria based on human performance or studies involving human readers/experts, as no such clinical data is presented in this document.

    Here's the information that can be extracted from the provided text regarding the device's acceptance criteria and the study that proves it meets them:

    1. Table of Acceptance Criteria and Reported Device Performance

    Acceptance Criteria (Test Standard)Reported Device Performance (Result Summary)
    Static compression per ASTM F1717"The results of these evaluations indicate that the DPZ Pedicular Fixation System is equivalent to predicate devices."
    Dynamic compression per ASTM F1717"The results of these evaluations indicate that the DPZ Pedicular Fixation System is equivalent to predicate devices."
    Static torsion per ASTM F1717"The results of these evaluations indicate that the DPZ Pedicular Fixation System is equivalent to predicate devices."

    2. Sample size used for the test set and the data provenance:

    • Sample Size: Not specified for the non-clinical tests. The document only mentions "The following analyses were conducted."
    • Data Provenance: Not explicitly stated, but it refers to "non-clinical tests" which typically involve laboratory or bench testing of the device hardware.

    3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

    • Not applicable. The "ground truth" for non-clinical mechanical testing is based on the specifications within the ASTM F1717 standard and the measured performance of the device compared to predicate devices. Human experts are not involved in establishing this ground truth for a mechanical test.

    4. Adjudication method for the test set:

    • Not applicable, as this refers to human reader review and consensus, which was not performed.

    5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

    • No MRMC study was done, as "No clinical studies were performed."

    6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

    • Not applicable. This is a medical device (pedicle fixation system), not an algorithm or AI. The standalone performance refers to the device's mechanical integrity under specified ASTM standards.

    7. The type of ground truth used:

    • The ground truth for the non-clinical tests was based on the performance requirements and methodologies outlined in the ASTM F1717 standard for spinal implant constructs. The device's performance was then compared to that of predicate devices to establish substantial equivalence.

    8. The sample size for the training set:

    • Not applicable. This is a non-AI/algorithm medical device. "Training set" refers to data used to train an AI model.

    9. How the ground truth for the training set was established:

    • Not applicable for the same reason as above.
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