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510(k) Data Aggregation

    K Number
    K191367
    Device Name
    Harrier-SA Lumbar Interbody System
    Manufacturer
    ChoiceSpine LLC
    Date Cleared
    2019-07-05

    (44 days)

    Product Code
    MAX
    Regulation Number
    888.3080
    Type
    Special
    Panel
    Orthopedic
    Reference & Predicate Devices
    K163269,K180519
    Why did this record match?
    Reference Devices :

    K163269

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

    The ChoiceSpine Harrier-SATM Lumbar Interbody System is indicated for intervertebral body fusion of the lumbar spine, from L2 to S1, in skeletally mature patients who have had six months of non-operative treatment. This device is intended for use at either one level or two contiguous levels for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. This device is designed to be used with autogenous bone graft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft.

    The ChoiceSpine Harrier-SATM Lumbar Interbody System is a stand-alone device intended to be used with four bone screws. Supplemental fixation, cleared by the FDA for use in the lumbosacral spine, must be used with implants ≥20°. Supplemental fixation must also be used whenever fewer than four bone screws are used.

    Device Description

    The Choice Spine HARRIER-SA™ Lumbar Interbody System is available in various sizes to accommodate individual patient anatomy. The Choice Spine HARRIER-SA™ Lumbar Interbody System is a stand-alone device intended to be used with (4) bone screws. The implant spacer components are made from two materials: Invibio PEEK-OPTIMA™ HA Enhanced and Ti-6AI-4V ELI Titanium per ASTM F3001 Class C, Tantalum markers per ASTM F560. Titanium Ti-6AI-4V ELI plate and screws per ASTM F136.

    AI/ML Overview

    The provided text focuses on the FDA 510(k) clearance of the ChoiceSpine Harrier-SA™ Lumbar Interbody System, specifically for a modification to make the use of anterior components optional. This document is a regulatory submission, not a clinical study report or a detailed performance and acceptance criteria document for AI/software-based medical devices.

    Therefore, the information required to answer your request (acceptance criteria, study details of AI algorithms, sample sizes, expert ground truthing, MRMC studies, standalone performance, etc.) is not present in the provided text.

    The document describes a mechanical testing comparison to predicate devices, not a study involving AI or human reader performance.

    To reiterate, the provided text does not contain any of the following:

    • A table of acceptance criteria and reported device performance related to an AI/software.
    • Sample sizes for a test set or data provenance for AI/software.
    • Number of experts for ground truth establish for AI/software, nor their qualifications.
    • Adjudication method for a test set of AI/software.
    • Information on a multi-reader multi-case (MRMC) comparative effectiveness study for AI assistance.
    • Standalone performance of an AI algorithm.
    • Type of ground truth used for AI data (expert consensus, pathology, outcomes).
    • Sample size for training set for an AI algorithm.
    • How ground truth for a training set for an AI algorithm was established.

    This document pertains to a physical medical device (spinal interbody system) and its mechanical equivalence to existing predicate devices, not an AI/software medical device.

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