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510(k) Data Aggregation

    K Number
    K181139

    Validate with FDA (Live)

    Device Name
    OLYMPIC Posterior Spinal Fixation System
    Manufacturer
    Astura Medical, LLC
    Date Cleared
    2018-07-06

    (67 days)

    Product Code
    NKB,KWP
    Regulation Number
    888.3070
    Type
    Traditional
    Panel
    Orthopedic
    Age Range
    All
    Reference & Predicate Devices
    K153446,K143633,K124058,K113395,K142381,K113666,K071373,K060748,K111136,K131802,K111358,K100952,K000536,K955348,K940631,K950099,K920116,K090390,K162494,K162379
    Predicate For
    K231694,K242764
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis 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 treatment of the following acute and chronic instabilities or deformities of thoracic, lumbar, and sacral spine (T1-S2/Ilium): degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, deformities or curvatures (i.e. scoliosis, kyphosis, and/or lordosis), spinal tumor, and failed previous fusion (pseudarthrosis). When used as an adjunct to fusion, the OLYMPIC Posterior Spinal Fixation System is intended to be used with autograft/allograft.

    In addition, the OLYMPIC Posterior Spinal Fixation System is intended for treatment of severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft, having implants attached to the lumbosacral spine and/or ilium with removal of the implants after the attainment of a solid fusion. Levels of pedicle and non-pedicle fixation for these patients are L3-sacrum/ilium.

    When used for posterior non-cervical pedicle and non-pediatric patients, the OLYMPIC Posterior Spinal Fixation System is intended to be used with autograft. Pediatric pediatric pedicle and non-pedicle fixation is limited to a posterior approach.

    Device Description

    The OLYMPIC PSFS 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 uniplanar screws, hooks, 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

    The provided text is a 510(k) summary for the OLYMPIC Posterior Spinal Fixation System. This document is a premarket notification for a medical device to demonstrate that it is substantially equivalent to a legally marketed predicate device.

    Based on the content of the provided document, here's an analysis regarding acceptance criteria and supporting studies:

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

    The document does not provide a table of acceptance criteria or specific numerical performance metrics for the device. Instead, it relies on demonstrating substantial equivalence to predicate devices through a non-clinical test.

    Acceptance CriteriaReported Device Performance
    Not explicitly defined as numerical acceptance criteria. The underlying acceptance is likely to meet or exceed the performance of the predicate devices.The results of the Dynamic Compression Bending – ASTM F1717 evaluations indicate that the OLYMPIC PSFS is equivalent to predicate devices.
    1. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

    The document describes a non-clinical test (Dynamic Compression Bending – ASTM F1717) but does not specify a sample size for this test. It also does not mention data provenance as it's a mechanical test, not data from patients.

    1. 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)

    This is not applicable. The study conducted was a non-clinical mechanical test, not a study requiring expert interpretation or ground truth establishment based on human observation or diagnosis.

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

    This is not applicable. As explained above, the study was a mechanical test, not one involving human interpretation or adjudication.

    1. 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, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This device is a spinal fixation system (implants), not an AI-powered diagnostic tool. Therefore, the concept of human readers improving with AI assistance is not relevant to this submission.

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

    No, a standalone (algorithm only) performance study was not done. This device is a physical medical implant, not an algorithm or AI system.

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

    This is not applicable. As it was a non-clinical mechanical test, the "ground truth" would be established by the physical properties and mechanical behavior of the materials and device in controlled laboratory settings, against established standards (ASTM F1717) and comparative predicate device performance.

    1. The sample size for the training set

    This is not applicable. There was no training set as this is a physical medical device and not an AI/ML or software device that undergoes a training phase.

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

    This is not applicable, as there was no training set.

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