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510(k) Data Aggregation

    K Number
    K120292
    Device Name
    CAPLOX II PEDICLE SCREW SYSTEM
    Manufacturer
    CAPTIVA SPINE, INC
    Date Cleared
    2012-04-13

    (73 days)

    Product Code
    MNI,MNH
    Regulation Number
    888.3070
    Type
    Special
    Panel
    Orthopedic
    Reference & Predicate Devices
    K111115
    Predicate For
    K122332,K131538
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The CapLOX II Spinal System is a posterior. non-cervical pedicle fixation system intended to provide immobilization and stabilization of spinal seements in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic. lumbar and sacral spine including degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, pseudoarthrosis and failed previous fusion.

    In addition, when used as a pedicle screw fixation system, the CapLOX II Spinal System is intended for skeletally mature patients with severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar-first sacral, L5-S1 vertebra, who are receiving fusion by autogenous bone graft only, who are having the device attached to the lumbar and sacral spine (levels may be from L3 to the sacrum/ilium), who are having the device removed after the attainment of a solid fusion.

    Device Description

    The CapLOX II Pedicle Screw System is a permanent implant device made from a titanium alloy TI 6AL4V-ELI. It is to be implanted from the posterior approach. The screws are available in diameters from 4.9-8.0mm and in lengths from 30-55mm. Rods are available in 5.5mm diameter, as either straight rods available in lengths from 30-500mm or precurved rods available in lengths from 30-120mm. The system includes a set screw, tulip heads, a cap and cross connectors to complete the assembly.

    AI/ML Overview

    1. Acceptance Criteria and Device Performance

    The provided document, K120292 for the CapLOX II Pedicle Screw System, describes a Special 510(k) submission for minor changes to an already cleared device. As such, the performance testing focuses on demonstrating that the mechanical characteristics of the modified device are not altered compared to the predicate device.

    Acceptance Criteria (Implicit)Reported Device Performance
    Mechanical characteristics not altered by design changes.Test results confirm that the changes did not alter the mechanical characteristics of the system.
    Compliance with ASTM F1798 standard.New performance testing per ASTM F1798 was completed.
    Substantial Equivalence to predicate device (K111115).Concludes that the changes to the system do not introduce any new risks and therefore, the system is Substantially Equivalent to the predicate device.

    2. Sample Size for Test Set and Data Provenance

    The document states: "New performance testing per ASTM F1798 was completed at an independent laboratory." However, the specific sample size used for this mechanical testing is not explicitly stated within the provided text.

    The data provenance is from mechanical testing performed at an independent laboratory, rather than from patient data. Therefore, the concepts of "country of origin of the data" and "retrospective or prospective" do not directly apply in the context of this mechanical performance study.

    3. Number of Experts and Qualifications for Ground Truth

    This information is not applicable to this submission. The ground truth for this device's performance is established through mechanical testing per a recognized standard (ASTM F1798), not through expert review of clinical cases or data.

    4. Adjudication Method for the Test Set

    This information is not applicable. Mechanical testing results are objective measurements against a standard, not subject to adjudication by multiple parties in the way clinical data might be.

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

    An MRMC comparative effectiveness study was not performed, nor is it applicable to this type of device and submission. This device is a pedicle screw system, and the submission addresses mechanical characteristics, not diagnostic or interpretive tasks where human readers' performance with/without AI assistance would be relevant.

    6. Standalone Performance Study

    Yes, a standalone performance study was done in the sense that the device's mechanical performance was evaluated independently against the ASTM F1798 standard. This was an "algorithm only" (or rather, "device only") performance evaluation, without human interpretation in the loop.

    7. Type of Ground Truth Used

    The ground truth used was compliance with the mechanical testing standard ASTM F1798. This standard sets specific methodologies and acceptance criteria for evaluating the mechanical properties of pedicle screw systems.

    8. Sample Size for the Training Set

    This information is not applicable. This submission is for a physical medical device (pedicle screw system), not a machine learning or AI algorithm that requires a training set of data.

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

    This information is not applicable, as there is no training set for a physical medical device.

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