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510(k) Data Aggregation

    K Number
    K192316
    Device Name
    Matrix HA PEEK Cervical Implant System
    Manufacturer
    Sapphire Medical Group
    Date Cleared
    2019-10-17

    (52 days)

    Product Code
    ODP
    Regulation Number
    888.3080
    Type
    Special
    Panel
    Orthopedic
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    Matrix HA PEEK Cervical Implant System

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

    The Matrix HA PEEK Cervical Implant System is intended for spinal fusion procedures at one level (C2 to T1) in skeletally mature patients with degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) of the cervical spine. Implants are intended to be packed with autogenous bone graft. The Matrix HA PEEK Cervical Implant System is intended to be used with a supplemental fixation system.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided text only contains an FDA 510(k) clearance letter for a medical device (Matrix HA PEEK Cervical Implant System). It outlines the device's classification, regulation, and indications for use.

    The document does not contain any information about the acceptance criteria, study design, or performance data for a device that relies on AI or machine learning. Therefore, I cannot extract the details requested in your prompt regarding:

    • A table of acceptance criteria and reported device performance.
    • Sample sizes for test and training sets, data provenance.
    • Number of experts for ground truth establishment and their qualifications.
    • Adjudication methods.
    • MRMC comparative effectiveness study results.
    • Standalone algorithm performance.
    • Type of ground truth used.
    • How ground truth for the training set was established.

    This document pertains to a physical implant system, not a software device or AI-driven system requiring such detailed performance validation against acceptance criteria as might be expected for an AI/ML medical device.

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