LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K153446
    Device Name
    OLYMPIC Posterior Spinal Fixation System
    Manufacturer
    Astura Medical
    Date Cleared
    2016-04-08

    (133 days)

    Product Code
    OSH,MNH,MNI
    Regulation Number
    888.3070
    Type
    Traditional
    Panel
    Orthopedic
    Reference & Predicate Devices
    K143633,K142381,K113666,K071373,K060748,K111136,K131802,K111358,K100952,K000536,K955348,K940631,K950099,K920116,K062912,K050451,K093434
    Predicate For
    K181139
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The OLYMPIC Posterior Spinal Fixation System is intended to provide immobilization of spinal segments in skeletally mature patients as an adjunct to fusion in the following acute and chronic instabilities of thoracic, lumbar, and sacral spine (T1-S2/ilium): degenerative spondylolisthesis with objective evidence of neuroment, fracture, dislocation, deformities or curvatures (i.e. scoliosis, and/or lordosis), spinal tumor, and failed previous fusion (pseudarthrosis). When used as an adjunct to fusion, the OLYMPIC Posterior System is intended to be used with autograft/allograft.

    In addition, the OLYMPIC Posterior System is intended for treatment of severe spondylolisthesis (grades 3 and 4) of the LS-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft, having implants attached to the lumbosacral spine and/or illum with removal of the implants after the attainment of a solid fusion. Levels of pedicle screw fixation for these patients are L3-sacrum/ilium.

    When used for posterior non-cervical pediatic patients, the OLYMPIC Posterior Spinal Fixation System implants are indicated as an adjunct to fusion to treat adolescent idionathic scoliosis. The OLYMPIC Posterior Spinal Fixation System is intended to be used with autograft. Pediatric pedicle screw fixation is limited to a posterior approach.

    Device Description

    The OLYMPIC Posterior Spinal Fixation System is a top loading thoracolumbar, sacral, and iliac fixation system implanted from the posterior approach and designed to provide fixation during the fusion process. The system is composed of preassembled polyaxial screws, monoaxial screws, rods, crosslinks, and rod connectors. The system is supported by a comprehensive set of instruments to install the implants within the system.

    AI/ML Overview

    This document is a 510(k) Summary for the OLYMPIC Posterior Spinal Fixation System. It describes the device, its intended use, and argues for its substantial equivalence to previously marketed predicate devices primarily based on non-clinical testing.

    Here's a breakdown of the requested information based on the provided text:

    1. A table of acceptance criteria and the reported device performance

    The document does not explicitly present a table of acceptance criteria with corresponding device performance values. Instead, it lists the types of non-clinical tests performed and states a general conclusion of equivalence to predicate devices. The "acceptance criteria" are implied by the standards cited for each test.

    Test TypeStandardReported Device Performance / Outcome
    Finite Element Analysis(Not a specific ASTM standard listed for FEA)Determined worst case for testing
    Static Compression BendingASTM F1717"Results of these evaluations indicate that the OLYMPIC Posterior Spinal Fixation System is equivalent to the predicate devices."
    Dynamic Compression BendingASTM F1717"Results of these evaluations indicate that the OLYMPIC Posterior Spinal Fixation System is equivalent to the predicate devices."
    Static TorsionASTM F1717"Results of these evaluations indicate that the OLYMPIC Posterior Spinal Fixation System is equivalent to the predicate devices."
    Axial gripASTM F1798"Results of these evaluations indicate that the OLYMPIC Posterior Spinal Fixation System is equivalent to the predicate devices."
    Torsional gripASTM F1798"Results of these evaluations indicate that the OLYMPIC Posterior Spinal Fixation System is equivalent to the predicate devices."
    Corrosion testingASTM F2129"Results of these evaluations indicate that the OLYMPIC Posterior Spinal Fixation System is equivalent to the predicate devices."

    2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

    • Sample Size for Test Set: Not applicable as the study involved non-clinical bench testing rather than human or animal subjects. The "test set" here refers to the physical device components and constructs subjected to mechanical testing. The specific number of samples for each test (e.g., how many constructs were tested for static bending) is not provided in this summary.
    • Data Provenance: Not applicable in the context of clinical data. The tests are bench tests performed on actual device components. The location where these tests were conducted is not specified, but the applicant (Astura Medical, LLC) is based in Carlsbad, CA, USA.

    3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

    Not applicable. This study is a non-clinical, mechanical performance evaluation of a spinal fixation system. "Ground truth" in the sense of expert clinical consensus or pathology is not relevant for this type of testing. The performance is measured against engineering standards (ASTM).

    4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

    Not applicable. As this is a non-clinical, mechanical testing study, there is no adjudication of findings by experts. The results are objective measurements against defined engineering standards.

    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. This document explicitly states: "No clinical studies were performed." Therefore, an MRMC study related to AI assistance is not relevant.

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

    No. This device is a physical spinal implant, not a software algorithm or AI device.

    7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

    The "ground truth" for the non-clinical tests are the established mechanical performance requirements and limits defined by the cited ASTM standards. The device's performance is compared against the performance of predicate devices and the requirements of these standards to demonstrate substantial equivalence, not against clinical expert consensus or pathology data.

    8. The sample size for the training set

    Not applicable. There is no training set for this device, as it is a physical medical implant and not an AI/ML algorithm.

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

    Not applicable. There is no training set.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1