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510(k) Data Aggregation

    K Number
    K130655
    Device Name
    RESPONSE SPINE SYSTEM
    Manufacturer
    ORTHOPEDIATRICS, CORP.
    Date Cleared
    2013-05-08

    (57 days)

    Product Code
    OSH,KWP
    Regulation Number
    888.3070
    Type
    Traditional
    Panel
    Orthopedic
    Reference & Predicate Devices
    K120291,K121250,K091445
    Predicate For
    K150600,K160466
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Response Spine System is intended for posterior, non-cervical fixation (pedicle screw fixation T1-S2/ilium and hook fixation (T1-L5)) in pediatric patients is indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. The device is intended to be used with autograft and/or allograft.

    Device Description

    The Response Spine System consists of longitudinal members (rods), anchors (hooks and screws), interconnection components (rod-to-rod and anchor-to-rod connectors) and fasteners in a variety of sizes, including fixed angled screws, to accommodate differing anatomic requirements.

    AI/ML Overview

    The OrthoPediatrics Response Spine System (K130655) relies on substantial equivalence to predicate devices rather than a standalone clinical study to demonstrate its safety and effectiveness. The acceptance criteria and the "study" proving it meets those criteria are articulated through mechanical testing designed to show equivalence.

    Here's a breakdown of the requested information based on the provided document:

    1. Table of Acceptance Criteria and Reported Device Performance

    Acceptance Criteria (Set by ASTM F1717 Standard and Equivalence to Predicates)Reported Device Performance (as stated in the 510(k) Summary)
    Mechanical Performance: - Static Compression Bending - Dynamic Compression Bending - Static Torsion (Demonstrates that the device's mechanical strength and durability are comparable to predicate devices and meet established standards for spinal implant constructs.)"Static and dynamic compression bending tests and static torsion tests, performed according to ASTM F1717, demonstrated the device to be substantially equivalent to the predicate devices."

    Note: The specific numerical acceptance values for these tests are not provided in the summary but would be detailed in the full test report, confirming that the Response Spine System's results fell within acceptable ranges or were comparable to the predicate devices.

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

    • Sample Size for Test Set: Not explicitly stated as the evaluation focuses on mechanical testing of devices rather than patient data. The "sample" here refers to the number of devices (rods, screws, hooks, connectors) tested under various mechanical loads.
    • Data Provenance: Not applicable in the traditional sense of patient data. The testing would have been conducted in a laboratory setting, likely in the US, by the manufacturer or a contracted testing facility. This is a retrospective comparison to existing predicate device data and established ASTM standards.

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

    • Number of Experts: Not applicable in the context of mechanical testing. "Ground truth" for mechanical testing is established by the ASTM F1717 standard itself, which is developed by a consensus of engineering and medical experts in the field of spinal implants. The results are physical measurements.
    • Qualifications of Experts: The "experts" in this context are the engineers and material scientists who designed and conducted the tests, and those who developed the ASTM F1717 standard.

    4. Adjudication Method for the Test Set

    • Adjudication Method: Not applicable. Mechanical testing results are objective measurements against a standard. There is no human adjudication of "truth" in the way there is for clinical interpretations. The results either meet the standard/equivalence or they don't.

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

    • MRMC Study: No. This device is a surgical implant undergoing mechanical performance testing, not an imaging or diagnostic device requiring human interpretation of results. Therefore, an MRMC study is not relevant.

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

    • Standalone Performance: Not applicable. This is a physical medical device, not a software algorithm. Its "performance" is its mechanical integrity under specified loads, which is evaluated directly in a lab.

    7. Type of Ground Truth Used

    • Type of Ground Truth: The ground truth for this evaluation is based on:
      • Established ASTM F1717 Standard: This standard dictates the methodology and acceptable criteria for static and dynamic testing of spinal implant constructs.
      • Performance of Predicate Devices: The measured mechanical properties (e.g., stiffness, fatigue life) of the Response Spine System are compared to those of the legally marketed predicate devices (OrthoPediatrics' OP Spine System and Medtronic CD Horizon) to establish substantial equivalence.

    8. Sample Size for the Training Set

    • Sample Size for Training Set: Not applicable. This is a physical device being evaluated for mechanical equivalence, not a machine learning model requiring a training set.

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

    • Ground Truth for Training Set: Not applicable, as there is no training set for this type of device evaluation.
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