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510(k) Data Aggregation

    K Number
    K970422

    Validate with FDA (Live)

    Device Name
    RIGHT ANGLE LASER FIBERS;OPTILASE ND:YAG LASER;OPTILASE PL100 ND LASER SYSTEMS
    Manufacturer
    TRIMEDYNE, INC.
    Date Cleared
    1997-04-21

    (77 days)

    Product Code
    GEX
    Regulation Number
    878.4810
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Age Range
    All
    Reference & Predicate Devices
    K954597
    Predicate For
    K053457
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Right Angle Laser Fibers and Optilase Lasers are indicated for a wide variety of surgical uses including incision, excision, resection, vaporization, ablation, coagulation and hemostasis. In addition, they are indicated for coagulation of soft tissue for prostatectomy in the treatment of benign prostatic hyperplasia (BPH).

    Device Description

    The Optilase laser systems are continuous wave Nd: YAG energy sources equipped with an aiming beam, adjustable power output, and a fiber optic connector.

    The Right Anale Laser Fibers are fiber optic Nd:YAG energy delivery systems consisting of : a three meter length of buffered quartz fiber, a tip which allows delivery of laser energy, and a fiber optic connector.

    AI/ML Overview

    The provided text does not contain information about acceptance criteria and a study proving a device meets those criteria in the way a medical device submission for AI/ML would. The document describes a 510(k) submission for laser fibers and laser systems for BPH treatment from 1997.

    Therefore, I cannot fulfill your request with the given input. The categories you listed (e.g., acceptance criteria table, sample size for test set, number of experts for ground truth, MRMC study, standalone performance, training set details) are typical for AI/ML device evaluations, which are not detailed in this historical 510(k) summary.

    The document states:

    • No nonclinical tests were submitted.
    • A limited clinical study was undertaken to provide information related to Visual Laser Ablation of the Prostate (VLAP) with 60 watts of laser power. These data were compared to data obtained from an earlier study in which VLAP at 40 watts of laser power was compared to TURP.
    • Conclusions: "The results of the comparative data submitted... demonstrate that VLAP, whether it be performed at 40 watt treatment parameters, is a viable alternative to TURP."

    This indicates a clinical comparison study, but it does not specify acceptance criteria, test set details, ground truth methods, or other elements pertinent to AI/ML device validation.

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