LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K041262
    Device Name
    DURALITE-GL
    Manufacturer
    LASER SCIENTIFIC
    Date Cleared
    2004-08-13

    (94 days)

    Product Code
    GEX
    Regulation Number
    878.4810
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    K024371,K024260,K024335,K994260
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The DuraLite-GL is a replacement fiber optic component for the Candela GentleLASE family of lasers. The DuraLite-GL may be used as a replacement part for ail procedures as cleared by the FDA for the Candela GentleLase family of lasers.

    Device Description

    The DuraLITE-GL is an exact replacement component for the Candela GentleLASE Plus fiber optic.

    AI/ML Overview

    Here's a breakdown of the acceptance criteria and study information for the DuraLITE-GL, based on the provided document:

    1. Table of Acceptance Criteria and Reported Device Performance:

    Acceptance Criteria CategoryAcceptance Criteria (Explicitly Stated or Implied)Reported Device Performance
    PhysicalNot explicitly stated, but implied to be equivalent to predicate.Testing validated that the performance of the DuraLITE-GL is identical to the fiber optic components manufactured by Candela for the GentleLase family of lasers.
    OpticalNot explicitly stated, but implied to be equivalent to predicate.Testing validated that the performance of the DuraLITE-GL is identical to the fiber optic components manufactured by Candela for the GentleLase family of lasers.
    ConnectivityNot explicitly stated, but implied to be equivalent to predicate.Testing validated that the performance of the DuraLITE-GL is identical to the fiber optic components manufactured by Candela for the GentleLase family of lasers.
    EnvironmentalNot explicitly stated, but implied to be equivalent to predicate.Testing validated that the performance of the DuraLITE-GL is identical to the fiber optic components manufactured by Candela for the GentleLase family of lasers.
    Clinical EquivalenceThe DuraLite-GL must be able to be used as a replacement part for all procedures as cleared by the FDA for the Candela GentleLase family of lasers.The submission concludes the DuraLITE-GL is substantially equivalent to other existing fiber optic components in commercial distribution for use in Dermatology and Plastic Surgery, based on physical, optical, connectivity, and environmental testing.

    2. Sample Size Used for the Test Set and Data Provenance:

    The document does not specify a sample size for a "test set" in the context of clinical or diagnostic performance. The testing described is for physical, optical, connectivity, and environmental performance of the device itself, rather than evaluating a diagnostic algorithm on a dataset.

    Data Provenance: Not applicable in the context of this type of device and testing.

    3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

    Not applicable. This device is an accessory to a laser, and the "ground truth" for its performance is related to its physical and functional equivalence to the predicate device, not clinical outcomes directly. No experts in a clinical "ground truth" capacity are mentioned for the test set.

    4. Adjudication Method for the Test Set:

    Not applicable. No clinical test set or adjudication process is described.

    5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance:

    No MRMC comparative effectiveness study was done. This document describes a replacement component for a laser, not an AI-powered diagnostic or assistive tool.

    6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done:

    Not applicable. This device is a physical component, not an algorithm.

    7. The Type of Ground Truth Used:

    The "ground truth" in this context is the performance of the legally marketed predicate device (Candela GentleLASE Plus Fiber Optic). The study aimed to demonstrate that the DuraLITE-GL's physical, optical, connectivity, and environmental performance was "identical" to this predicate.

    8. The Sample Size for the Training Set:

    Not applicable. This device is a physical component, not an AI model requiring a training set.

    9. How the Ground Truth for the Training Set Was Established:

    Not applicable. No training set is involved.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1