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510(k) Data Aggregation

    K Number
    K131250
    Device Name
    TIGER SPINE SYSTEM
    Manufacturer
    CORELINK LLC
    Date Cleared
    2013-09-10

    (131 days)

    Product Code
    NKB,KWP,MNH,MNI
    Regulation Number
    888.3070
    Type
    Traditional
    Panel
    Orthopedic
    Reference & Predicate Devices
    K110321,K120696,K113058,K121728,K101070,K024348,K010576,K014137,K001357,K992333,K991721,K990303,K973683,K021170
    Predicate For
    K151648,K210539
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The TIGER® 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 the following acute and chronic instabilities or deformities of thoracic. lumbar. and sacral spine (T)-S1/Ileum): degenerative disc discase (defined as discogenic back pain with degeneration of disc confirmed by history of and radiographic studies), degenerative spondylolisthesis with objective evidence of neurological impairment. fracture, dislocation, scoliosis, spinal tumor, and failed previous fusion (pseudoarthrosis).

    Device Description

    The TIGER® Spine System is a multiple component, posterior spinal fixation system which consists of pedicle screws, cannulated pedicle screws, posted pedicle screws, rods, crossconnectors, locking cap screws, hooks, and lateral offset connectors. All of the components are available in a variety of sizes to match more closely to the patient's anatomy. All components are made from titanium alloy described by such standards as ASTM F136.

    AI/ML Overview

    This document describes a 510(k) premarket notification for the TIGER® Spine System, a medical device for spinal fixation. Let's break down the acceptance criteria and the supporting study, focusing on the requested information.

    1. Table of Acceptance Criteria and Reported Device Performance

    The provided document describes physical performance testing rather than algorithm-based acceptance criteria for a medical imaging device. However, we can infer the "acceptance criteria" as meeting the specified ASTM standards and the "reported device performance" as having been tested to those standards.

    Acceptance Criteria (Inferred from Study Type)Reported Device Performance
    Compliance with ASTM F1717-11aTIGER® Posted Spine System constructs were tested in static axial compression, static torsion, and dynamic axial compression per ASTM F1717-11a.
    Compliance with ASTM F1798-97TIGER® Spine System Hook constructs were tested in static axial and torsion grip per ASTM F1798-97.
    Compliance with ASTM F1717-11aTIGER® Spine System Cannulated Screw constructs were tested in static axial compression, static torsion, and dynamic axial compression per ASTM F1717-11a.
    Substantial equivalence to predicate devices"The overall technology characteristics and mechanical performance data lead to the conclusion that TIGER® Spine System is substantially equivalent to the predicate devices."

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

    This information is not available in the provided text. The document refers to mechanical testing of physical device components, not a study involving human subjects or image data. Therefore, concepts like a "test set" and "data provenance (e.g. country of origin of the data, retrospective or prospective)" are inapplicable in this context.

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

    This information is not applicable/available. The study described is mechanical testing of medical device components, not a clinical study involving experts establishing ground truth for diagnostic or prognostic purposes.

    4. Adjudication Method for the Test Set

    This information is not applicable/available as the study did not involve a test set requiring adjudication in the context of expert review.

    5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

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

    6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study Was Done

    No, a standalone study in the context of an algorithm's performance was not done. This device is a physical spinal fixation system, not an algorithm.

    7. The Type of Ground Truth Used

    The "ground truth" for the mechanical performance testing was the engineering specifications and established test methods defined by ASTM standards (ASTM F1717-11a and ASTM F1798-97). The device components were tested to see if they met the performance requirements outlined in these standards for static axial compression, static torsion, dynamic axial compression, and torsion grip.

    8. The Sample Size for the Training Set

    This information is not applicable/available. The device is a physical product, 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/available as there is no training set for a physical medical device like the TIGER® Spine System.

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