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510(k) Data Aggregation

    K Number
    K140529
    Device Name
    EVEREST SPINAL SYSTEM
    Manufacturer
    K2M, LLC
    Date Cleared
    2014-05-22

    (79 days)

    Product Code
    NKB,KWP,KWQ,MNH,MNI,OSH
    Regulation Number
    888.3070
    Type
    Special
    Panel
    Orthopedic
    Reference & Predicate Devices
    K103440,K120656,K132757,K070229,K072914,K080792,K081381,K100851,K112037,K112920,K961633,K090390,K132328
    Predicate For
    K140765,K142360,K143334,K173508
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The EVEREST Spinal System may be used in conjunction with the RANGE® (MESA® and DENALI®) Spinal Systems, all of which are cleared for the following indications:

    Non-cervical fixation as an adjunct to fusion for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis and/or lordosis); tumor; pseudarthrosis; and/or failed previous fusion.

    Except for hooks, when used as an anterolateral thoracic/lumbar system the EVEREST Spinal System may also be used for the same indications as an adjunct to fusion.

    When used for posterior non-cervical pedicle screw fixation in pediatric patients the EVEREST Spinal System implants are indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. These devices are to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.

    Device Description

    The Everest Spinal System is a top-loading, multiple component, posterior (thoraciclumbar) spinal fixation system which consists of pedicle screws, rods, locking set screws, and hooks.

    Materials: The devices are manufactured from Titanium Alloy and Cobalt Chrome per ASTM and ISO standards.

    Function: The system functions as an adjunct to fusion to provide immobilization and stabilization of the posterior thoracic and lumbar spine.

    The purpose of this 510(k) submission is to add modified screws, rods, hooks and rod to rod connectors.

    AI/ML Overview

    The provided text is a 510(k) Summary for the Everest Spinal System, which is a medical device. This document focuses on the regulatory submission for clearance of a spinal fixation system and its substantial equivalence to predicate devices, primarily through mechanical testing. It does not contain information on clinical studies involving human patients, AI/human reader performance, or ground truth establishment relevant to the questions asked.

    Therefore, many of the requested items cannot be extracted from this document, as they pertain to clinical or AI-related performance studies that were not part of this 510(k) submission.

    Here's a breakdown of what can and cannot be answered based on the provided text:

    1. A table of acceptance criteria and the reported device performance

    Acceptance Criteria (Bench Test)Reported Device Performance (Bench Test)
    Performance equal to or better than predicate devices in:Performed equally to or better than predicate devices in:
    * Static compression* Static compression
    * Static torsion* Static torsion
    * Dynamic compression* Dynamic compression
    (in accordance with ASTM F1717)(per ASTM F1717)

    Note: The document only refers to mechanical performance based on bench testing (ASTM F1717) for the medical device's structural integrity, not clinical performance or AI diagnostic accuracy.

    2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

    • Sample Size for Test Set: Not applicable. The "test set" here refers to mechanical testing of implants, not a clinical data set. The document does not specify the number of implants tested, only that "worst case implants" were tested.
    • Data Provenance: Not applicable. This refers to bench testing of physical devices, not patient data.

    3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

    • Not applicable. Ground truth in this context would refer to clinical diagnoses or pathology. The submission focuses on device mechanics, assessed against ASTM standards, not clinical ground truth.

    4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

    • Not applicable. This pertains to clinical assessment or AI performance, not mechanical testing.

    5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

    • No. This document does not mention any MRMC study or AI assistance.

    6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

    • No. This document does not describe any algorithm or standalone performance study.

    7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

    • For the mechanical testing, the "ground truth" was adherence to performance levels established by ASTM F1717 and comparison to predicate devices, interpreted by engineering rationale. This is not clinical ground truth.

    8. The sample size for the training set

    • Not applicable. There is no mention of a "training set" as this document describes a physical medical device, not an AI or algorithm.

    9. How the ground truth for the training set was established

    • Not applicable.
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