LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K983206
    Device Name
    SMALL VAGINAL/RECTAL ELECTRODE
    Manufacturer
    EMPI
    Date Cleared
    1998-11-03

    (50 days)

    Product Code
    KPI
    Regulation Number
    876.5320
    Type
    Traditional
    Panel
    Gastroenterology/Urology
    Reference & Predicate Devices
    K952688,K954272,K964577,K940091
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The electrode is indicated for pelvic floor stimulation use in the treatment of urinary incontinence and monitors and allows assessment of EMG activity of the pelvic floor muscles. The electrode can be used either vaginally and rectally; it should not be interchanged between the two positions. The electrode is reusable between patients if reuse instructions are followed.

    Device Description

    The Small Vaginal and Rectal Stimulation Electrode is identical in design to the predicate rectal electrode device except for the addition of vaginal use for stimulation. There were no design changes required or made to allow for this change.

    AI/ML Overview

    Innova Small Vaginal and Rectal Stimulation Electrode - Study Summary

    This document describes the acceptance criteria and the supporting clinical study for the Innova Small Vaginal and Rectal Stimulation Electrode.

    Note: The provided documentation primarily focuses on establishing substantial equivalence for a medical device (510(k) submission) rather than presenting a detailed performance study with explicit acceptance criteria and corresponding results in a typical scientific paper format. Therefore, some information requested (e.g., specific performance metrics with numerical targets, detailed ground truth establishment for training sets) is not explicitly present in the provided text and will be inferred or marked as "Not explicitly stated."

    1. Table of Acceptance Criteria and Reported Device Performance

    The provided documentation does not explicitly state quantitative acceptance criteria or detailed performance metrics. The primary objective of the clinical study was to establish "equivalence" to currently marketed stimulation electrodes. This implies a non-inferiority or comparative effectiveness approach, rather than meeting specific performance thresholds.

    Acceptance Criteria (Inferred from document)Reported Device Performance
    Functional Equivalence: The electrode, when used vaginally, performs similarly to currently marketed stimulation electrodes for pelvic floor stimulation in the treatment of urinary incontinence and assessment of EMG activity.The clinical study "confirmed the suitability of performance of this electrode" and established "equivalence between this electrode used vaginally and the currently marketed stimulation electrodes."
    Safety: The device is safe for its intended use (vaginal and rectal stimulation).Not explicitly detailed, but implied by regulatory clearance and the statement about re-use instructions for safety.
    Intended Use Compliance: The device can be used vaginally and rectally for pelvic floor stimulation and EMG activity assessment.Supported by device description and intended use statement.

    2. Sample Size and Data Provenance for Test Set

    • Sample Size: Not explicitly stated. The documentation mentions "A Clinical study was performed," but the number of participants is not provided.
    • Data Provenance: Not explicitly stated. The document is from Empi, Inc. in St. Paul, Minnesota, USA, suggesting the study likely took place in the USA. The study is described retrospectively in the 510(k) submission as having been "performed."

    3. Number of Experts and Qualifications for Ground Truth

    • Number of Experts: Not explicitly stated.
    • Qualifications of Experts: Not explicitly stated. Given the context of a medical device for urinary incontinence and EMG activity, it is reasonable to infer that the ground truth for the clinical study would have been established by medical professionals, likely including urologists, gynecologists, physical therapists specializing in pelvic floor dysfunction, or other relevant clinicians.

    4. Adjudication Method for the Test Set

    • Adjudication Method: Not explicitly stated.

    5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

    • MRMC Study: Not explicitly mentioned or indicated. The study's focus was on establishing equivalence of the device itself rather than the improvement of human readers with AI assistance.

    6. Standalone Performance Study

    • Standalone Performance: Not applicable in this context. This device is a physical electrode used in conjunction with other equipment and by clinicians, not a standalone algorithm. The "suitability of performance" was confirmed in a clinical setting with human involvement.

    7. Type of Ground Truth Used

    • Type of Ground Truth: Clinical assessment and outcomes. The study aimed to confirm "suitability of performance" and "equivalence" in the context of treating urinary incontinence and assessing EMG activity. This would likely involve clinical evaluations of patient outcomes, symptom improvement, and/or physiological measurements (EMG readings) from the device compared to predicate devices.

    8. Sample Size for the Training Set

    • Sample Size: Not applicable. This device is a physical medical electrode, not an AI/ML algorithm that requires a training set.

    9. How the Ground Truth for the Training Set was Established

    • Ground Truth Establishment: Not applicable, as there is no training set for this type of device.
    Ask a Question

    Ask a specific question about this device

    Page 1 of 1