LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K111167
    Device Name
    XTENDER FILM PROCESSOR, SPRINT FILM PROCESSOR MODEL XTENDER MODEL SPRINT
    Manufacturer
    VELOPEX INTERNATIONAL, INC.
    Date Cleared
    2011-08-18

    (114 days)

    Product Code
    IXW
    Regulation Number
    892.1900
    Type
    Traditional
    Panel
    Radiology
    Reference & Predicate Devices
    K093503,K874118
    Why did this record match?
    Device Name :

    XTENDER FILM PROCESSOR, SPRINT FILM PROCESSOR MODEL XTENDER MODEL SPRINT

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

    The ExtraXtender Film Processor is an automatic film processor used by dental offices to develop X-ray films. The Extra Xtender processes all film sizes of intra-oral and extra oral film. High quality archivable radiographs are delivered dry in 5 minutes. Films may be viewed wet after 2 1/2 minutes.

    The Sprint Film Processor is an automatic film processor used by dental offices to develop xray films. The Sprint Film Processor processes all sizes of intra-oral film. Films may be viewed wet after 2 1/2 minutes.

    Device Description

    Automatic Film processor

    AI/ML Overview

    The provided text is a 510(k) summary for the Velopex ExtraXtender Film Processor and Sprint Film Processor. It focuses on establishing substantial equivalence to previously marketed devices and does not contain information about acceptance criteria or specific studies proving a device meets
    these criteria. This document is a regulatory submission, not a scientific study report.

    Therefore, I cannot fulfill your request to describe acceptance criteria and a study that proves the device meets them based on the provided text. The document does not include information on:

    1. A table of acceptance criteria and reported device performance.
    2. Sample sizes for test sets or data provenance.
    3. Number of experts used or their qualifications for ground truth establishment.
    4. Adjudication method for the test set.
    5. MRMC comparative effectiveness studies or effect sizes for AI assistance.
    6. Standalone (algorithm only) performance studies.
    7. Type of ground truth used.
    8. Sample size for the training set.
    9. How ground truth for the training set was established.

    The document primarily provides:

    • Device names and regulatory information.
    • Contact details for the 510(k) holder.
    • Predicate devices for demonstrating substantial equivalence.
    • Indications for Use for both film processors.

    To answer your questions, a different type of document, such as a validation study report or a different section of a regulatory submission (e.g., performance data), would be needed.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1