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510(k) Data Aggregation

    K Number
    K971795
    Device Name
    AUTOMATED CHAMBER MAINTENANCE MODULE
    Manufacturer
    PARADIGM MEDICAL INDUSTRIES, INC.
    Date Cleared
    1997-07-14

    (60 days)

    Product Code
    HQC
    Regulation Number
    886.4670
    Type
    Traditional
    Panel
    Ophthalmic
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    AUTOMATED CHAMBER MAINTENANCE MODULE

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

    The ACM Module is an accessory device incorporated in the aspiration line behind the handpiece to neutralize vacuum surge during phacoemulsification.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but based on the provided text, there is no information about the acceptance criteria or a study that proves the device meets any specific criteria. The document is a 510(k) clearance letter from the FDA for a device called "Automated Chamber Maintenance (ACM) Module," indicating that it is substantially equivalent to a previously marketed device. It provides regulatory information and contact details, but does not include details about performance studies, acceptance criteria, or ground truth establishment.

    Therefore, I cannot fulfill your request for:

    1. A table of acceptance criteria and reported device performance.
    2. Sample sizes for test sets or data provenance.
    3. Number and qualifications of experts for ground truth.
    4. Adjudication method.
    5. MRMC comparative effectiveness study results.
    6. Standalone performance study results.
    7. Type of ground truth used.
    8. Sample size for the training set.
    9. How ground truth for the training set was established.
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