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510(k) Data Aggregation

    K Number
    K151704
    Device Name
    Diplomat® Spinal System
    Manufacturer
    SIGNUS Medizintechnik GmbH
    Date Cleared
    2016-04-13

    (294 days)

    Product Code
    NKB,MNH,MNI
    Regulation Number
    888.3070
    Type
    Traditional
    Panel
    Orthopedic
    Reference & Predicate Devices
    K000236,K131820,K103490,K033901,K955348,K081080,K020279,K051971,K024096,K102870,K120838,K110280,K123717
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    Device Name :

    Diplomat**®** Spinal System

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

    The DIPLOMAT® Spinal System, when used as a posterior pedicle screw system, is 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 the thoracic, lumbar and sacral spine:

    • Degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies)
    • Spondylolisthesis
    • Spinal stenosis
    • Fracture
    • Dislocation
    • Scoliosis
    • Kyphosis
    • Spinal tumor
    • Pseudoarthrosis
    • Failed previous fusion

    In addition, the DIPLOMAT® Spinal 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 attainment of a solid fusion. Levels of pedicle screw fixation for these patients are L3-sacrum/ilium.

    The DIPLOMAT® Spinal System is intended to be used with autograft and/or allograft.

    Device Description

    The DIPLOMAT® Spinal System is a multiple component posterior spinal fixation system which consists of pedicle screws, rods, and connectors. All of the components are available in a variety of sizes to match more closely to the patient's anatomy. All components are manufactured from Ti-6AL-4V ELI per ASTM F136 and cobalt chrome per ASTM F75. The safety and effectiveness of this device has not been established when used in conjunction with bone cement or for use with poor bone quality (e.g., osteoporosis, osteopenia). This device is intended only to be used with saline or radiopaque dye

    AI/ML Overview

    This document is a 510(k) Premarket Notification for the DIPLOMAT® Spinal System, a medical device for spinal fixation. It describes the device's indications for use, technological characteristics, and performance data to demonstrate substantial equivalence to predicate devices.

    1. Table of Acceptance Criteria and Reported Device Performance

    Acceptance Criteria (Test Mode per ASTM F1717-14)Reported Device Performance
    Static Compression-Bending TestStrength sufficient for intended use and substantially equivalent to legally marketed predicate devices.
    Static Torsion TestStrength sufficient for intended use and substantially equivalent to legally marketed predicate devices.
    Dynamic Compression-Bending TestStrength sufficient for intended use and substantially equivalent to legally marketed predicate devices.

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

    The document does not specify a "test set" in the context of human patient data or a clinical study. The performance evaluation is based on non-clinical mechanical testing. Therefore, information regarding human sample size and data provenance (country of origin, retrospective/prospective) is not applicable or provided.

    3. Number of Experts Used to Establish Ground Truth and Qualifications

    This information is not applicable. The study is a non-clinical mechanical testing study, not a study involving expert assessment of patient data.

    4. Adjudication Method

    This information is not applicable for a non-clinical mechanical testing study.

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

    No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This document describes mechanical testing of a spinal implant, not a study evaluating human reader performance with or without AI assistance.

    6. Standalone (Algorithm Only) Performance Study

    No, a standalone (algorithm only) performance study was not done. This document focuses on the mechanical performance of a physical medical device, not an algorithm or AI.

    7. Type of Ground Truth Used

    The "ground truth" for this study is established by engineering standards and specifications as defined in the ASTM F1717-14 test methodology. The performance of the DIPLOMAT® Spinal System is compared against the expected mechanical properties for devices of its type and against predicate devices.

    8. Sample Size for the Training Set

    This information is not applicable. There is no concept of a "training set" in a non-clinical mechanical testing study.

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

    This information is not applicable, as there is no training set mentioned in the context of this non-clinical mechanical testing.

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