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510(k) Data Aggregation

    K Number
    K990632

    Validate with FDA (Live)

    Device Name
    OPTICAL TRACKING SYSTEM (OTS)
    Manufacturer
    RADIONICS, INC.
    Date Cleared
    1999-04-29

    (62 days)

    Product Code
    HAW
    Regulation Number
    882.4560
    Type
    Traditional
    Panel
    Neurology
    Reference & Predicate Devices
    K964801,K974602,K954276,K971247
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The OTS is a graphical planning tool that allows for preoperative planning of, and intraoperative navigation during, cranial and spinal surgical procedures. This includes use in frameless cranial biopsy procedures.

    Device Description

    The OTS is a graphical planning tool that allows for preoperative planning of, and intraoperative navigation during, cranial and spinal surgical procedures.

    AI/ML Overview

    The provided document is a 510(k) summary for a medical device (Radionics Optical Tracking System - OTS) and its FDA clearance letter. It does not contain information about specific acceptance criteria, a study proving device performance against those criteria, or details regarding sample sizes, ground truth establishment, or expert involvement as requested in the prompt.

    The document discusses:

    • The device name and its classification.
    • Its substantial equivalence to predicate devices.
    • Revised indications for use (specifically for frameless cranial biopsy).
    • General information about its function as a graphical planning and intraoperative navigation tool for cranial and spinal surgical procedures.
    • The FDA's confirmation of market clearance.

    Therefore, I cannot provide the requested table and study details based on the given information. The information needed to answer the prompt (acceptance criteria, study design, performance results, ground truth, sample sizes, expert qualifications, etc.) is typically found in design validation reports or clinical study summaries, which are not part of this 510(k) summary.

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