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510(k) Data Aggregation

    K Number
    K960395

    Validate with FDA (Live)

    Device Name
    PLANCON MIRCOLAMELLAR KERATOME
    Manufacturer
    PLANCON INSTRUMENTS
    Date Cleared
    1996-04-26

    (88 days)

    Product Code
    HNO
    Regulation Number
    886.4370
    Type
    Traditional
    Panel
    Ophthalmic
    Age Range
    All
    Reference & Predicate Devices
    N/A
    Predicate For
    K973294
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    To perform microlamellar keratoo asty for the correction of myopia or hyperopia

    Device Description

    Power urit Turbine motor Adjustable keratome head Keratome blade Pneumatic fixation rings Applanation lenses Plate check ng gauge

    AI/ML Overview

    I understand you're looking for a detailed breakdown of acceptance criteria and study information for a medical device. However, the provided text snippets (K960395) are primarily descriptive comparisons of device features (intended use, system composition, turbine motor, keratome, etc.) between a submitted device and two predicated devices.

    This information does not contain any details about:

    • Acceptance Criteria: There are no stated performance metrics, thresholds, or targets.
    • Study Design or Results: There's no mention of any clinical trials, pre-clinical studies, sample sizes, data provenance, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, standalone performance, or training set details.

    It seems this document is a summary for demonstrating substantial equivalence based on device features and intended use, rather than a performance study report.

    Therefore, I cannot fulfill your request for the tables and study details based on the provided text.

    To answer your request, I would need a document that describes:

    1. Specific numerical or qualitative performance targets the device must meet.
    2. Details of a study conducted to evaluate the device's performance against those targets. This would include information on the study's methodology, data collection, analysis, and results.
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