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510(k) Data Aggregation

    K Number
    K093021
    Device Name
    ATLANTIS SLIT LAMP
    Manufacturer
    USOPTHALMIC, LLC
    Date Cleared
    2010-01-28

    (121 days)

    Product Code
    HJO
    Regulation Number
    886.1850
    Type
    Traditional
    Panel
    Ophthalmic
    Reference & Predicate Devices
    K033190
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Atlantis Slit Lamp is an AC-power slit lamp biomicroscope intended for use in eye examination of the anterior eye segment, from the cornea epithelium to the posterior capsule. It is used to aid in the diagnosis of diseases or trauma which affect the structural properties of the anterior eye segment.

    Device Description

    The Atlantis Slit Lamp is an AC-power slit lamp biomicroscope intended for use in eye examination There are 2 models 2000 and 2000 Plus. These models differ only in the supplied accessories (beam-splitter, camera mount and observation tube). All models have the same operating characteristics and intended use.

    AI/ML Overview

    The provided text describes a 510(k) premarket notification for the Atlantis Slit Lamp. The information focuses on demonstrating substantial equivalence to a predicate device rather than conducting a detailed clinical study with specific acceptance criteria related to disease diagnosis performance.

    Therefore, many of the requested categories related to clinical study design, ground truth, and AI performance cannot be filled from the provided document.

    Here's a breakdown of the available and unavailable information:

    1. Table of Acceptance Criteria and Reported Device Performance

    Acceptance CriteriaReported Device Performance
    Compliance with ISO 10939:2007, Ophthalmic instruments -- Slit-lamp microscopesThe USOphthalmic, LLC Atlantis Slit Lamp complies with the requirements of listed FDA Recognized Consensus Standards, including ISO 10939:2007.
    Compliance with IEC 60601-1, Medical Electrical Equipment Part 1: General Requirements for SafetyThe USOphthalmic, LLC Atlantis Slit Lamp complies with the requirements of listed FDA Recognized Consensus Standards, including IEC 60601-1.
    Substantial Equivalence to 66 Vision-Tech YZ Slit Lamp (K033190) based on technological characteristicsDemonstrated through an 8-point technological comparison of features, concluding the devices are substantially equivalent.
    Safety and EffectivenessBelieved to be safe and effective and performs as well as or better than the predicate device due to meeting standards and having essentially identical technological characteristics.

    2. Sample size used for the test set and the data provenance:

    • Not applicable / Not provided. No specific clinical test set data is mentioned. The submission relies on technological comparison and compliance with performance standards.

    3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

    • Not applicable / Not provided. No clinical ground truth establishment is described.

    4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

    • Not applicable / Not provided. No clinical test set adjudication 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. This device is a traditional medical instrument (slit lamp), not an AI-powered diagnostic tool. Therefore, an MRMC study with AI assistance is not relevant or described.

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

    • No. This is a hardware device; thus, standalone algorithm performance is not applicable.

    7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

    • Not applicable / Not provided. For this type of device submission, the "ground truth" is primarily compliance with established performance standards and substantial equivalence to a legally marketed predicate device, rather than a clinical ground truth for diagnostic accuracy.

    8. The sample size for the training set:

    • Not applicable / Not provided. This is not an AI/machine learning device, so there is no concept of a training set as understood in that context.

    9. How the ground truth for the training set was established:

    • Not applicable / Not provided. As above, no training set or ground truth establishment for such a set is relevant for this device.
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