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510(k) Data Aggregation

    K Number
    K170611
    Device Name
    SETx Pedicle Screw System
    Manufacturer
    Xenco Medical, LLC
    Date Cleared
    2017-05-25

    (85 days)

    Product Code
    NKB,KWQ
    Regulation Number
    888.3070
    Type
    Traditional
    Panel
    Orthopedic
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    SETx Pedicle Screw System

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

    The SETx Pedicle Screw System is intended to provide immobilization of spinal segments in sketally mature patients as an adjunct to fusion. The SETx Pedicle Screw System is intended for posterior, non-cervical pedicle fixation or anterolateral fixation 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); curvatures (i.e., scoliosis, kyphosis, or lordosis); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; and failed previous fusion.

    Device Description

    Not Found

    AI/ML Overview

    This document is a 510(k) premarket notification decision letter for the SETx Pedicle Screw System. It declares that the device is substantially equivalent to legally marketed predicate devices. This type of document does not contain information about acceptance criteria or specific study results proving the device meets those criteria.

    The information you are requesting (acceptance criteria, performance data, sample sizes, expert qualifications, ground truth establishment, etc.) for an AI/software-as-a-medical-device (SaMD) study is typically found in:

    • Clinical study reports: Detailed documents submitted to regulators describing the design, conduct, results, and analysis of clinical trials.
    • 510(k) Summary: A public summary provided by the manufacturer outlining the key information about the device and its substantial equivalence claims, which sometimes includes a high-level summary of performance data, especially for AI/ML devices.
    • PMA (Premarket Approval) applications: For higher-risk devices, these applications require more extensive clinical evidence and detail.
    • Publications in peer-reviewed journals: Manufacturers may publish their study results.
    • FDA Premarket Submissions (PMA/510k) databases: While limited, some information might be accessible.

    Therefore, based solely on the provided text, I cannot answer your request. The document is a regulatory approval letter for a mechanical pedicle screw system, not an AI/ML diagnostic or therapeutic device. It pertains to spinal implants, not software performance.

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