LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K133066
    Device Name
    SPINESELECT POLYSCREW PEDICLE SCREW SYSTEM
    Manufacturer
    SPINESELECT, LLC
    Date Cleared
    2014-01-13

    (108 days)

    Product Code
    NKB,MNH,MNI
    Regulation Number
    888.3070
    Type
    Traditional
    Panel
    Orthopedic (OR)
    Reference & Predicate Devices
    K022623,K031585,K001319
    Why did this record match?
    Device Name :

    SPINESELECT POLYSCREW PEDICLE SCREW SYSTEM

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

    The SpineSelect Polyscrew Pedicle Screw System is intended for immobilization and stabilization of the spine. The SpineSelect Polyscrew Pedicle Screw System is intended for posterior, noncervical pedicle fixation as an adjunct to fusion in skeletally mature patients using autograft and/or allograft for the following indications: degenerative disc disease (DDD) (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; pseudoarthrosis; and failed previous fusion.

    Device Description

    The SpineSelect Polyscrew Pedicle Screw System is an implant device made from a titanium alloy TI 6Al 4V-ELI. It is to be implanted from the posterior approach. The screws are available as either solid or cannulated in diameters from 5.5-7.5 mm and in lengths from 30-55 mm. Rods are available in 5.5mm diameter either straight or precurved. The straight rods range in lengths from 30-400 mm, whereas the pre-curved rods range in length from 30-150mm. The system includes a screw assembly which includes a polyscrew (solid or cannulated), a saddle and tulip head, Rods are locked in place with a set screw. Associated instrumentation to complete the procedure are provided.

    AI/ML Overview

    The provided text is a 510(k) summary for the SpineSelect Polyscrew Pedicle Screw System, a medical device. It details the device's indications for use, description, and comparison to predicate devices, but does not describe a study involving an AI/algorithmic device or human readers interpreting data. Instead, it focuses on the mechanical performance of a physical implantable device.

    Therefore, I cannot provide information on:

    • Acceptance criteria and reported device performance related to an algorithm's output. The acceptance criteria discussed are for the mechanical performance of the pedicle screw system, not an algorithm's performance.
    • Sample size used for the test set and data provenance. No such test set is described for an AI device.
    • Number of experts used to establish ground truth and their qualifications. Not applicable to a mechanical device submission.
    • Adjudication method for the test set. Not applicable.
    • Multi-reader multi-case (MRMC) comparative effectiveness study. Not applicable.
    • Standalone (algorithm only) performance. Not applicable as this is a physical device.
    • Type of ground truth used (expert consensus, pathology, outcomes data, etc.) for an algorithm. Not applicable.
    • Sample size for the training set and how ground truth was established for the training set. Not applicable.

    Based on the provided text, the relevant information regarding acceptance criteria and the study that proves the device meets those criteria is as follows:

    1. Table of Acceptance Criteria and Reported Device Performance:

    Acceptance Criteria (Performance Standard)Reported Device Performance
    Pre-clinical static compression bending"SpineSelect concludes that the SpineSelect Polyscrew Pedicle Screw System is substantially equivalent to the predicates in regard to...mechanical test results." (Implied to meet or exceed predicate performance)
    Pre-clinical dynamic compression bending"SpineSelect concludes that the SpineSelect Polyscrew Pedicle Screw System is substantially equivalent to the predicates in regard to...mechanical test results." (Implied to meet or exceed predicate performance)
    Pre-clinical static torsion bending"SpineSelect concludes that the SpineSelect Polyscrew Pedicle Screw System is substantially equivalent to the predicates in regard to...mechanical test results." (Implied to meet or exceed predicate performance)

    2. Study that Proves the Device Meets Acceptance Criteria:

    • Study Type: Pre-clinical mechanical testing.
    • Methods: The testing performed includes "static and dynamic compression bending and static torsion bending per ASTM F1717-10." ASTM F1717-10 is a standard specification for spinal implant constructs in a corrosive environment intended for internal fixation.
    • Conclusion: SpineSelect concluded that the SpineSelect Polyscrew Pedicle Screw System is "substantially equivalent to the predicates in regard to indications for use, materials, function, sizes and mechanical test results and raises no new questions of safety or effectiveness." This implies that the device's mechanical test results were comparable to or better than those of the predicate devices.

    Missing Information (as per the prompt's request for AI-related details):

    As this submission is for a physical pedicle screw system and not an AI or algorithmic device, the specific details requested regarding test sets, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, standalone algorithm performance, and training set information are not available and not applicable to this document.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1