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510(k) Data Aggregation

    K Number
    K192800
    Device Name
    Streamline TL Spinal Fixation System
    Manufacturer
    Pioneer Surgical Technology, Inc. (DBA RTI Surgical, Inc.)
    Date Cleared
    2020-01-14

    (106 days)

    Product Code
    NKB,KWP
    Regulation Number
    888.3070
    Type
    Traditional
    Panel
    Orthopedic
    Reference & Predicate Devices
    K101790,K140696
    Predicate For
    K241892
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Streamline TL Spinal Fixation System components are non-cervical spinal fixation devices intended as an adjunct to fusion for use as a pedicle screw (T1-S2), posterior hook (T1-L5) or sacral/iliac screw fixation is limited to skeletally mature patients. These devices are indicated for all of the following indications: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma, (i.e., fracture or dislocation), deformities or curvatures (i.e., scoliosis, and/or lordosis, Scheuermann's Disease), tumor, stenosis, pseudarthrosis, and failed previous fusion.

    Device Description

    The Streamline TL Spinal System consists of a variety of rods, screws (poly-axial, fixed, and reduction), rod connectors, crosslinks, set screws, hooks and other connecting components used to build a spinal construct. The implant components can be rigidly locked into a variety of configurations, with each construct being tailor-made for the individual case. The Streamline TL Spinal System includes Class I manual instrumentation to facilitate implantation of the device components.

    AI/ML Overview

    The provided document is a 510(k) premarket notification letter from the FDA regarding a spinal fixation system. It details the device's indications for use, its description, and a summary of performance testing.

    However, the document does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria in the context of an Artificial Intelligence (AI) or machine learning (ML) enabled medical device. The device in question is a physical spinal fixation system, not a software or AI/ML product.

    Therefore, I cannot provide the requested information for the acceptance criteria and the study that proves the device meets them, as the provided text pertains to a mechanical medical device and not an AI/ML system.

    To answer your request, I would need a document describing the validation activities for an AI/ML-enabled medical device.

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