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510(k) Data Aggregation

    K Number
    K990721
    Device Name
    ISOLOCK SPINAL SYSTEM
    Manufacturer
    SCIEN'TX USA INC.
    Date Cleared
    1999-05-27

    (83 days)

    Product Code
    MNH
    Regulation Number
    888.3070
    Type
    Traditional
    Panel
    Orthopedic
    Reference & Predicate Devices
    K951846,K984350
    Why did this record match?
    Device Name :

    ISOLOCK SPINAL SYSTEM

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

    The ISOLOCK Spinal System is a pedicle screw system intended to provide immobilization and stabilization 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, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis).

    As a pedicle screw system, the ISOLOCK Spinal System is intended for the treatment of severe spondylolisthesis (Grade 3 and 4) of the L5-S1 vertebrae in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion.

    Device Description

    The ISOLOCK Spinal System consists of pedicle screws, rods, nuts, crosslink members and plates. It can be used for single or multiple level fixation. All components are manufactured from titanium alloy (Ti-6Al-4V) that conforms to ASTM F136.

    This system consists of pedicle screws that require plate assembly directly over the top of the screw and a combination of screws and clamps that allow the rod to be offset from the screw.

    AI/ML Overview

    This document describes the ISOLOCK Spinal System, a pedicle screw system. Here's a breakdown of the requested information:

    1. Table of Acceptance Criteria and Reported Device Performance

    Acceptance CriteriaReported Device Performance
    No specific acceptance criteria were provided directly in the supplied text. The submission focuses on demonstrating substantial equivalence to predicate devices rather than meeting predefined performance criteria through testing.The device underwent static and fatigue compression testing of its Plates and Rods with Crosslinking according to ASTM F1717-96. The successful completion of this testing is the reported performance, implying it met the standards outlined in that ASTM guideline.

    2. Sample Size Used for the Test Set and Data Provenance

    • Sample Size: Not specified in the provided text. The testing appears to be mechanical (static and fatigue compression) on device components, not on patient data.
    • Data Provenance: The document does not mention data provenance in terms of country of origin or retrospective/prospective for patient data, as the performance data is related to component testing.

    3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts

    • This information is not applicable as the performance data described relates to mechanical testing (static and fatigue compression) of the device components according to an ASTM standard, not clinical expert review of human data.

    4. Adjudication Method for the Test Set

    • This information is not applicable as the performance data described relates to mechanical testing, not clinical data requiring adjudication.

    5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

    • No, an MRMC comparative effectiveness study was not done. The study described is mechanical testing of physical device components.

    6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

    • No, this is not applicable. The device is a physical pedicle screw spinal system, not an algorithm or AI.

    7. Type of Ground Truth Used

    • The "ground truth" for the mechanical testing would be the specifications and requirements set forth in the ASTM F1717-96 standard. The device's components were tested to ensure they performed within the acceptable parameters defined by this engineering standard for static and fatigue compression.

    8. Sample Size for the Training Set

    • This information is not applicable as the device is a physical medical implant, not an AI or algorithm that requires a training set.

    9. How the Ground Truth for the Training Set Was Established

    • This information is not applicable for the same reason as above (physical implant, not an AI/algorithm).
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