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510(k) Data Aggregation

    K Number
    K153735
    Device Name
    Release Laminoplasty Fixation System
    Manufacturer
    Pioneer Surgical Technology, Inc. (DBA RTI Surgical, Inc.)
    Date Cleared
    2016-01-21

    (24 days)

    Product Code
    NQW
    Regulation Number
    888.3050
    Type
    Special
    Panel
    Orthopedic
    Reference & Predicate Devices
    K113218,K091994
    Why did this record match?
    Reference Devices :

    K113218, K091994

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

    The Release® Laminoplasty Fixation System is intended for use in the lower cervical and upper thoracic spine (C3 to T3) in laminoplasty procedures. The Release® Laminoplasty Fixation System is used to hold the graft material in place in order to prevent the graft material from expulsion, or impinging the spinal cord.

    Device Description

    The Release Laminoplasty Fixation System consists of a variety of sizes of implantable plates and screws that are attached to the lamina after a laminoplasty or laminectomy procedure. The implantable components are manufactured from medical grade ASTM F 136 Titanium alloy. The system also contains Class I manual surgical instruments and cases that are considered exempt from premarket notification.

    AI/ML Overview

    The provided text describes a 510(k) premarket notification for a medical device called the "Release® Laminoplasty Fixation System." It includes information about the device's intended use, classification, and a summary of performance data. However, it does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria in the context of an AI-powered device or diagnostic.

    This document is a regulatory submission for a physical implantable device (plates and screws for spinal fixation), not an AI/ML-driven diagnostic or medical device. Therefore, the requested information regarding "acceptance criteria and the study that proves the device meets the acceptance criteria" in the context of AI performance metrics, sample sizes for test/training sets, expert adjudication, MRMC studies, or ground truth establishment is not applicable to the content provided.

    The "Non-Clinical Performance Data" section mentions:

    • ASTM F543 (screw insertion torque, torque to failure, pull-out)
    • ASTM F2193 cantilever bend testing
    • Finite Element Analysis

    These are standard mechanical and material performance tests for physical orthopedic implants, not software or AI-based diagnostics. The document explicitly states: "Clinical performance data was not provided in this submission for a determination of substantial equivalence." This further indicates that no clinical study (which would be relevant for establishing performance characteristics in the context of AI) was conducted or reported in this submission.

    Therefore, I cannot fulfill the request as the provided text does not contain the pertinent information for an AI/ML device.

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