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510(k) Data Aggregation

    K Number
    K123497
    Device Name
    FACET SCREW SYSTEM
    Manufacturer
    FACET-LINK, INC.
    Date Cleared
    2013-02-28

    (107 days)

    Product Code
    MRW,PRE
    Regulation Number
    N/A
    Type
    Traditional
    Panel
    Orthopedic (OR)
    Reference & Predicate Devices
    K101284,K012773
    Why did this record match?
    Reference Devices :

    K101284,K012773

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

    The Facet-Link Facet Screw System is intended to stabilize the spine as an aid to fusion through immobilization of the facet joints. The methods of fixation are:

    Transfacet fixation - The screws are inserted bilaterally through the superior side of the facet, across the facet joint and into the inferior pedicle.

    Translaminar-facet fixation - The screws are inserted bilaterally through the lateral aspect of the spinous process, through the lamina, through the superior side of the facet across the facet joint and into the inferior pedicle.

    The Facet-Link Facet Screw System is indicated for facet fixation, with or without bone graft, at single or multiple levels, from C2 to S1 (inclusive). The Facet-Link Facet Screw System is indicated for treatment of any or all of the following:

    (a) pseudoarthrosis and failed previous fusion;

    (b) spondylolisthesis: and

    (c) degenerative disc disease (DDD) as defined by neck and/or back pain of discogenic origin as confirmed by radiographic studies.

    The Facet-Link Facet Screw System is intended for conventional surgical placement.

    Device Description

    The Facet-Link Facet Screw System consists of a conical and threaded head, partially threaded lag screws and fully threaded screws designed to compact or fixate juxtaposed facet articular processes to enhance spinal fusion and stability. The screws and washers are fabricated from anodized titanium alloy (Ti-6AI-4V) and are supplied in various sizes.

    The Facet-Link Facet Screw System requires accessory general instruments for implantation. Instruments required for implantation may include a variety of k-wires, cannulae, drills, taps, and drivers.

    AI/ML Overview

    The provided text describes a medical device, the Facet-Link Facet Screw System, and its performance testing to demonstrate substantial equivalence for 510(k) clearance. However, it does not include information about AI/algorithm performance, ground truth establishment for AI, expert consensus for AI, or multi-reader multi-case studies related to AI. The information provided is solely for the mechanical testing of a physical medical device.

    Therefore, many of the requested sections related to AI/algorithm performance cannot be filled from the given text.

    Here's a breakdown of the available information:

    1. Table of Acceptance Criteria and Reported Device Performance

    Acceptance Criteria / Test PerformedReported Device Performance
    Static Axial Compression via Cantilever Bending TestMeets intended performance specifications and is substantially equivalent to predicate devices.
    Static Axial Pullout TestMeets intended performance specifications and is substantially equivalent to predicate devices.
    Dynamic Axial Compression via Cantilever Bending TestMeets intended performance specifications and is substantially equivalent to predicate devices.
    BiocompatibilityConfirmed by cytotoxicity testing following ISO 10993-5 and based on prior cleared devices of similar materials.
    MR ConditionalNon-clinical testing demonstrated MR Conditional, in accordance with ASTM F2052-06.

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

    • Sample Size: Not explicitly stated for each test, but it refers to "in vitro bench tests." This implies a set of physical samples of the device were tested.
    • Data Provenance: In vitro bench tests. No country of origin is specified for the data itself as it's mechanical testing of a manufactured product. The manufacturing location is Facet-Link, Inc. in Rockaway, NJ, USA.
    • Retrospective/Prospective: Not applicable, as this refers to physical device testing, not data analysis on patient outcomes.

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

    • This question is not applicable as the study describes mechanical bench testing of a physical device, not an AI algorithm requiring expert ground truth.

    4. Adjudication Method for the Test Set

    • This question is not applicable for the same reasons as above.

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

    • No. An MRMC study was not done. This type of study is relevant for evaluating human performance, often with AI assistance, which is not described here.

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

    • No. This is not an algorithm; it is a physical medical device.

    7. The Type of Ground Truth Used

    • The "ground truth" for the mechanical tests would be the established engineering standards (ASTM F1717, ASTM F2193, and ASTM F543) and the performance of the predicate devices. The device's performance was compared against these standards and predicates to determine substantial equivalence.

    8. The Sample Size for the Training Set

    • This question is not applicable as there is no mention of a training set for an AI algorithm.

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

    • This question is not applicable as there is no mention of a training set for an AI algorithm.
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