LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K190885
    Device Name
    Elevation Spine Saber-C System
    Manufacturer
    Elevation Spine
    Date Cleared
    2019-08-07

    (125 days)

    Product Code
    OVE,KWQ,ODP
    Regulation Number
    888.3080
    Type
    Traditional
    Panel
    Orthopedic (OR)
    Reference & Predicate Devices
    K173115,K142218
    Why did this record match?
    Device Name :

    Elevation Spine Saber-C System

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

    The Elevation Spine Saber-C System is a cervical interbody for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine (C2-T1) and is for use at a single spinal level. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) weeks of non-operative treatment. The SABER-C Spacer is to be filled with autograft bone and/or allogenic bone graft composed of cancellous and/or corticocancellous bone.

    The SABER-C Spacer is intended to be used with supplemental fixation, such as anterior cervical plates or posterior cervical screw fixation. When the SABER-C Spacer is used with the SABER-C Anterior Cervical Plate and screws, the plate-spacer-screw assembly can be used as a stand-alone device with the SABER-C Anterior Cervical Plate acting as the supplemental fixation. When the SABER-C Spacer is used with the SABER-C Anterior Cervical Plate and spikes, the plate-spacer-spike assembly should be used with additional supplemental fixation such as posterior cervical screw fixation.

    The SABER-C Anterior Cervical Plate, when used without the spacer component and with screws, is intended for anterior screw fixation to the cervical spine (C2-C7) for the following indications: degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), trauma (including fractures), tumors, deformity (defined as kyphosis, lordosis, or scoliosis), pseudoarthrosis, failed previous fusion, spondylolisthesis, and spinal stenosis. The Anterior Cervical Plate is not to be used with spikes when used without the Spacer component.

    Device Description

    The SABER-C System is a cervical interbody fusion device used to provide structural stability in skeletally mature individuals following discectomy. The SABER-C System is inserted through an anterior cervical approach and is available in various geometric and material options to fit the clinical needs of the patient. The SABER-C System Anterior Cervical Plate is an anterior cervical fixation device this is available in various geometric and fixation options and can be used with various types of interbody spacers.

    The SABER-C System is made from radiolucent polymer, with titanium alloy or tantalum markers, as specified in ASTM F2026. ASTM F136. ASTM F1295, and ASTM F560. The SABER-C Anterior Cervical Plate and two fixation options, spike or screws, are manufactured from titanium alloy, as specified in ASTM F136 and ASTM F1295. The plate is not to be used with spikes when used without the Spacer component.

    AI/ML Overview

    The provided text describes a 510(k) submission for the Elevation Spine Saber-C System, an intervertebral body fusion device. The document focuses on demonstrating substantial equivalence to predicate devices through performance testing.

    Here's an analysis of the acceptance criteria and study information based on the provided text:

    1. Table of Acceptance Criteria and Reported Device Performance:

    Acceptance Criteria CategorySpecific Test/StandardAcceptance Criteria (Implicit)Reported Device Performance
    Mechanical PerformanceStatic Axial CompressionDevice performance should be comparable or superior to predicate devices, demonstrating structural integrity under static axial loading.Tested per ASTM F2077-14. "The results of the performance testing demonstrate that the Elevation Spine SABER-C is substantially equivalent..." implying it met expectations of comparable performance.
    Dynamic Axial CompressionDevice performance should be comparable or superior to predicate devices, demonstrating structural integrity and fatigue resistance under dynamic axial loading.Tested per ASTM F2077-14. "The results of the performance testing demonstrate that the Elevation Spine SABER-C is substantially equivalent..." implying it met expectations of comparable performance.
    Compression-ShearDevice performance should be comparable or superior to predicate devices, demonstrating stability under combined compression and shear forces.Tested per ASTM F2077-14. "The results of the performance testing demonstrate that the Elevation Spine SABER-C is substantially equivalent..." implying it met expectations of comparable performance.
    TorsionDevice performance should be comparable or superior to predicate devices, demonstrating resistance to torsional forces.Tested per ASTM F2077-14. "The results of the performance testing demonstrate that the Elevation Spine SABER-C is substantially equivalent..." implying it met expectations of comparable performance.
    SubsidenceDevice resistance to subsidence into vertebral bodies should be comparable or superior to predicate devices.Tested per ASTM F2267-11. "The results of the performance testing demonstrate that the Elevation Spine SABER-C is substantially equivalent..." implying it met expectations of comparable performance.
    ExpulsionDevice resistance to expulsion from the intervertebral space should be comparable or superior to predicate devices.Tested for expulsion (standard not explicitly cited, but likely related to F2077 or F2267). "The results of the performance testing demonstrate that the Elevation Spine SABER-C is substantially equivalent..." implying it met expectations of comparable performance.
    Implantation CompatibilityCadaver Implantation StudySuccessful implantation and stability of the plate and spacer assembly with spiked fixation in cadaveric models."Additionally, a cadaver implantation study was performed on the plate and spacer assembly when used with spiked fixation." This indicates successful demonstration of implantation.
    Material ComplianceMaterial Standards (PEEK, Titanium, Coating)Materials used must conform to specified ASTM standards for surgical implant applications.All listed materials (Implant Grade PEEK, Titanium, Titanium alloy coating) are explicitly stated to conform to their respective ASTM standards (F2026-17, F136-13, F1472-14, F1580-18).

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

    • Sample Size: The document does not specify the exact numerical sample size for individual mechanical tests (e.g., number of devices tested for axial compression). It only states that "Three configurations of the Elevation Spine Saber-C System were tested". For the cadaver implantation study, the sample size is also not specified, only that "a cadaver implantation study was performed".
    • Data Provenance: The data provenance is not explicitly mentioned (e.g., country of origin, specific testing facility). However, given that it's an FDA submission, the testing would typically be performed in a controlled laboratory setting, likely in the US or a country with comparable regulatory standards. The studies appear to be prospective in nature, as they involve testing the actual device configurations.

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

    • This type of information is not applicable to the mechanical and cadaveric testing described. These tests rely on objective physical measurements and adherence to engineering standards (ASTM), not on expert human interpretation of data for ground truth establishment.

    4. Adjudication Method for the Test Set:

    • This is not applicable as the tests performed are objective mechanical and implantation studies, not studies involving human interpretation or consensus.

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

    • A MRMC comparative effectiveness study was not conducted. The provided text describes mechanical performance testing and a cadaver implantation study, not studies involving human readers and interpretation of medical images.

    6. Standalone (Algorithm Only) Performance Study:

    • A standalone performance study of an algorithm was not conducted. This device is a physical intervertebral fusion system, not an AI/algorithm-based diagnostic or therapeutic tool. The testing focuses on its mechanical and physical performance.

    7. Type of Ground Truth Used:

    • The "ground truth" for the performance testing is based on objective engineering standards and physical measurements. For mechanical tests, this means adherence to the specifications and performance envelopes outlined in ASTM F2077-14 and F2267-11, and comparison to predicate device performance. For the cadaver study, successful implantation and observation of stability would serve as the "ground truth" for that aspect.

    8. Sample Size for the Training Set:

    • This information is not applicable. This submission details a physical medical device. There is no AI model or algorithm that requires a "training set" in the context described.

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

    • This information is not applicable as there is no training set for an algorithm.
    Ask a Question

    Ask a specific question about this device

    Page 1 of 1