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510(k) Data Aggregation

    K Number
    K062505
    Device Name
    NEX-LINK SPINAL FIXATION SYSTEM OFFSET CONNECTORS, 2121-XX SERIES
    Manufacturer
    ABBOTT SPINE, INC.
    Date Cleared
    2006-09-26

    (29 days)

    Product Code
    MNI,KWP
    Regulation Number
    888.3070
    Type
    Special
    Panel
    Orthopedic
    Reference & Predicate Devices
    K031985,K021009
    Predicate For
    K113346,K142752
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    When intended to promote fusion of the cervical spine and the thoracic spine, (C1-T3), the NexLink Spinal Fixation System is indicated for the following:

    DDD (neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, spinal stenosis, fracture, dislocation, failed previous fusion and/or tumors.

    Hooks and rods are also intended to provide stabilization to promote fusion following reduction of fracture/dislocation or trauma in the cervical/upper thoracic (C1-T3) spine.

    The use of multiaxial screws is limited to placement in T1-T3 in treating thoracic conditions only. The multiaxial screws are not intended to be placed in the cervical spine.

    Device Description

    The Nex-Link Spinal Fixation System is intended for fixation to, and stabilization of, the cervicothoracic spine (C1-T3). The system consists of a series of longitudinal members, anchors, transverse connectors, and instruments for inserting and securing the implants.

    The subject devices are the result of design modifications made to previously existing Abbott Spine implants intended for use in the posterior cervico-thoracic spine. The subject devices share the same intended use and fundamental scientific technology as the predicate.

    AI/ML Overview

    The provided document describes a medical device submission (K062505) for the Nex-Link Spinal Fixation System by Abbott Spine, Inc. This submission focuses on design modifications, specifically the addition of Poly-axial Offset Connectors, to an already cleared predicate device.

    The document states that the Nex-Link Spinal Fixation System is intended for fixation to and stabilization of the cervicothoracic spine (C1-T3) to promote fusion.

    Based on the information provided, here's a breakdown of the requested details:

    1. Table of Acceptance Criteria and Reported Device Performance

    Acceptance CriteriaReported Device Performance
    Safety and Effectiveness (demonstrated via equivalence to predicate, and non-clinical testing)Non-Clinical Performance: "Laboratory and bench testing results demonstrate that the proposed devices are safe and effective in use as intended, in accordance with the indications for use of the Nex-Link System." Clinical Performance: "Clinical data and conclusions were not needed for this submission."
    Substantial Equivalence to Predicate Device"The subject device is the result of design modifications to the predicate device; they have the same intended use and are substantially equivalent to the predicate devices." (Predicate devices: Nex-Link Spinal Fixation System, K031985; OctaFix Occipital Cervical Plating System, K021009)

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

    • Sample Size for Test Set: Not applicable. The submission explicitly states, "Clinical data and conclusions were not needed for this submission." The evaluation for this 510(k) was based on non-clinical (laboratory and bench) testing and substantial equivalence to predicate devices, not on a clinical test set.
    • Data Provenance: Not applicable for clinical data. For non-clinical testing, the provenance is internal laboratory and bench testing by Abbott Spine, Inc.

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

    • Number of Experts: Not applicable. No clinical test set with human ground truth establishment was conducted for this submission.
    • Qualifications of Experts: Not applicable.

    4. Adjudication Method for the Test Set

    • Adjudication Method: Not applicable. No clinical test set was conducted.

    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

    • MRMC Study: No. This submission is for a medical implant (spinal fixation system), not an AI-powered diagnostic device. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant or included.

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

    • Standalone Performance: Not applicable. This document is for a physical medical implant, not a software algorithm.

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

    • Type of Ground Truth: Not applicable for clinical ground truth. The "ground truth" for the device's performance was established through non-clinical laboratory and bench testing demonstrating mechanical safety and effectiveness, and through comparison to legally marketed predicate devices for substantial equivalence.

    8. The Sample Size for the Training Set

    • Sample Size for Training Set: Not applicable. There is no mention of a "training set" as this is not an AI/machine learning device. The design and validation of the device are based on engineering principles, materials science, and testing against performance standards, not a data-driven training set in the context of an algorithm.

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

    • Ground Truth for Training Set Establishment: Not applicable, as there is no training set mentioned or implied for this medical device submission.
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