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510(k) Data Aggregation

    K Number
    K152890
    Device Name
    SACCADOMETER PLUS, SACCADOMETER ADVANCED
    Manufacturer
    OBER CONSULTING SP. Z.O.O.
    Date Cleared
    2016-08-11

    (316 days)

    Product Code
    HLL
    Regulation Number
    886.1510
    Type
    Traditional
    Panel
    Ophthalmic
    Reference & Predicate Devices
    K902954
    Why did this record match?
    Device Name :

    SACCADOMETER PLUS, SACCADOMETER ADVANCED

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

    Measuring temporal characteristics of saccadic refixation responses when viewing lateral visual stimulus and identifying the individual time delays of moving the eyes toward the stimuli.

    Device Description

    The Saccadometer system measures eye movements in horizontal axis with temporal 1kHz and spatial resolution

    AI/ML Overview

    The provided FDA 510(k) summary for the Saccadometer Plus and Saccadometer Advanced devices describes performance data, but does not explicitly state "acceptance criteria" in a quantitative, pass/fail manner typical for clinical trials or formal validation studies. Instead, it presents results of various tests demonstrating the device's characteristics and performance.

    Therefore, the table below will list the reported device performance characteristics based on the provided text, rather than explicitly stated acceptance criteria. For questions where the information is not provided in the document, it will be stated as "Not provided."

    Acceptance Criteria and Reported Device Performance

    Characteristic / Acceptance Criteria TypeReported Device Performance
    Saccade Detection Algorithm AccuracyMean absolute error of saccadic latency measurement is below 2 ms. The influence of parameters of pseudosaccade course (amplitude, rising edge, trigger to slope delay-simulated latency) changes on the latency of measurement error is also below the value 1ms.
    Measurement LinearityMean averaged maximal linearity error for range ±15 degrees was observed. Linearity error increased with the increase of measurement ranges, but it is noted that human fixation has an error of ±0.3 degrees. The device is primarily used for ±10 degree measurement range.
    Spatial ResolutionAll gathered results were within the declared measurement resolution (5 arcmin or better). The device's eye movement sensor has a spatial resolution
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