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510(k) Data Aggregation

    K Number
    K991853
    Device Name
    INTERACOUSTICS EP 15 ABR STAND ALONE UNIT
    Manufacturer
    IDEM (INT'L DIST. OF ELECTRONICS FOR MEDICINE)
    Date Cleared
    1999-10-25

    (146 days)

    Product Code
    GWJ
    Regulation Number
    882.1900
    Type
    Traditional
    Panel
    Neurology
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Interacoustics EP15 ABR Stand Alone Unit is a diagnostic tool for computer-based testing. Data is collected in a Windows 95,98 database format that allows for easy inspection of results. The EP15 Stand Alone Unit produces a sound stimuly is for use in evoked response measurements or electroencephalogram activation.

    Device Description

    The Interacoustics EP15 ABR Stand Alone Unit is a diagnostic tool for computerbased testing. Data is collected in a Windows 95,98 database format that allows for easy inspection of results. The EP15 Stand Alone Unit produces a sound stimuly is for use in evoked response measurements or electroencephalogram activation.

    AI/ML Overview

    The provided 510(k) summary (K991853) is for the Interacoustics Model EP15 ABR Stand Alone Unit. Based on the document, this is a comparison study against a predicate device, not a study proving device performance against specific acceptance criteria in the typical sense of a new technology. The summary mainly outlines the technical specifications and functional equivalency to the predicate device, not empirical performance data from clinical trials.

    Therefore, many of the requested fields regarding acceptance criteria, study sample sizes, expert involvement, and ground truth are not applicable or cannot be extracted from this type of regulatory submission. The 510(k) process for this device focuses on demonstrating substantial equivalence to a legally marketed predicate device.

    However, I can extract the comparative "acceptance criteria" through the lens of technical specifications between the proposed device and its predicate.

    1. Table of Acceptance Criteria (as inferred from comparison to predicate) and Reported Device Performance

    For this 510(k) submission, "acceptance criteria" are implicitly met by demonstrating that the proposed device, Interacoustics Model EP15 ABR, is either identical to or has equivalent or superior specifications compared to the predicate device, ICS Medical Corp. Chartr EP System, for key functional and safety aspects. The reported device performance is presented as its technical specifications.

    Feature / Acceptance Criteria CategoryPredicate Device (Chartr EP)Proposed Device (EP15 ABR)Substantial Equivalence Justification / Performance
    Indications for UseSameSameIdentical
    Display Description15" SVGA Monitor12.1" Wide Angle Industrial TFTDifferent size/type, but both provide necessary display.
    Software FeaturesWindows 95/98 Operating SystemWindows 95/98 Operating SystemSame operating system implies similar user interface and functionality.
    Amplifier Channels2 (optionally up to 8)2Equivalent baseline channels.
    Amplifier GainX50 - X500000080 dBExpressed differently, but assumed to meet diagnostic needs. (Specific dB gain needs to be evaluated against voltage gain range for direct comparison, but for 510k, it's considered functionally equivalent if appropriate for ABR).
    Preamplifier Frequency ResponseSame (as EP15)100 to 8000 HzIdentical.
    Preamplifier CMR Ratio>100dB at 50/60 Hz>120dB at 50/60 HzEP15 ABR is superior in Common Mode Rejection.
    Preamplifier Noise
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