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510(k) Data Aggregation

    K Number
    K130877

    Validate with FDA (Live)

    Device Name
    EXPEDIUM SPINE SYSTEM
    Manufacturer
    MEDOS INTERNATIONAL SARL
    Date Cleared
    2013-06-20

    (83 days)

    Product Code
    NKB,KWP,KWQ,MNH,MNI,OSH
    Regulation Number
    888.3070
    Type
    Traditional
    Panel
    Orthopedic
    Reference & Predicate Devices
    K041119,K062174,K071495,K073364,K082942,K090230,K101070,K111136
    Predicate For
    K132644,K141291,K170163,K210963
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The EXPEDIUM Spine System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine.

    The EXPEDIUM Spine System is intended for noncervical pedicle fixation and nonpedicle fixation for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, and/or lordosis); tumor, pseudoarthrosis; and failed previous fusion in skeletally mature patients.

    When used for posterior non-cervical pedicle screw fixation in pediatric patients, the EXPEDIUM System metallic implants are indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. The EXPEDIUM system is intended to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.

    Device Description

    The subject additions to the EXPEDIUM 4.5mm, 5.5mm, and 6.35mm Spine Systems consist of open angled extended, slotted connectors and various rods. The connectors are available in titanium alloy with lengths of 5, 10, 15, and 20mm. The rods vary in size and geometries to accommodate patient anatomy and are available in materials of titanium, stainless steel, and cobalt chrome.

    AI/ML Overview

    The provided text is a 510(k) summary for the EXPEDIUM® Spine System and primarily focuses on establishing substantial equivalence to predicate devices, rather than describing a study with acceptance criteria for device performance in a clinical or AI context. The performance data mentioned is for mechanical testing per ASTM F 1798.

    Therefore, many of the requested fields cannot be filled as they pertain to clinical or AI-based performance studies, which are not detailed in this document.

    Here's an attempt to answer the questions based on the provided text:

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

    Acceptance CriteriaReported Device Performance
    Mechanical Performance per ASTM F 1798Performance data per ASTM F 1798 was submitted to characterize the subject EXPEDIUM Spine System connector. This testing comprised of static axial slip and both static and dynamic cantilever beam bending.
    Substantial Equivalence to Predicate DevicesBoth the Performance Testing and Substantial Equivalence Justification demonstrate that the subject devices are as safe, as effective, and perform as well as the predicate devices.

    Note: The document specifies that "a rationale is provided in place for performance testing for the subject rods of this submission," implying that not all aspects underwent direct performance testing, but justification was provided for equivalence based on existing data or design similarities.

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

    This information is not provided in the document. The testing described is mechanical, not clinical, and details on sample sizes for mechanical tests are not included. Data provenance is also not mentioned.

    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. The ground truth for mechanical testing is based on engineering standards and measurement, not expert review of clinical data.

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

    Not applicable. This is for mechanical testing, not a clinical study requiring adjudication of expert opinions.

    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

    Not applicable. This document describes a medical device (spinal implant), not an AI system.

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

    Not applicable. This document describes a medical device (spinal implant), not an AI system.

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

    For the mechanical performance testing, the ground truth would be the established engineering standards and specifications defined by ASTM F 1798. For substantial equivalence, the ground truth is the performance of the predicate devices.

    8. The sample size for the training set

    Not applicable. This document describes a medical device (spinal implant) and its mechanical testing, not a machine learning model.

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

    Not applicable. This document describes a medical device (spinal implant) and its mechanical testing, not a machine learning model.

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