LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K160799

    Validate with FDA (Live)

    Device Name
    GenNarino
    Manufacturer
    SALIWELL LTD.
    Date Cleared
    2017-02-17

    (331 days)

    Product Code
    LTF
    Regulation Number
    872.5560
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Predicate For
    K180838
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    GenNarino is an electrical salivary stimulator system, indicated for use in patients with xerostomia (dry mouth), under prescription of a dental practitioner or physician.

    Device Description

    GenNarino is an electrical salivary system device. It is comprised of two units: a mouthpiece shaped to the contour of the lower dental arch and an infra-red remote control to turn the stimulation On or Off. The mouthpiece comprises of two dental grade plastic sheets. GenNarino embed an electronic module hermetically sealed between both sheets and a power source of two 3V small coin batteries. Two electrodes made of biocompatible materials are connected to the electronic module, protrude from the plastic sheet and contact the mucosa of the lower dental arch, at the lingual side. The electronic circuit allows switching the stimulation "On" and "Off" by an external remote control. The user pushes the remote control's "ON" button to turn the electronic circuit on and afterwards places the device on his/her lower dental arch. Typically after up to five minutes of use, the user removes the device from his/her mouth and deactivates the stimulation by pushing the remote control's "OFF" button. The device is used on "as need" base (i.e. when the users feels oral dryness) but not more than 5 times per day. The device and replacement devices are allowed for a cumulative use of up to 50 months.

    AI/ML Overview

    The provided text describes the GenNarino electrical salivary stimulator system and its clinical performance evaluation to demonstrate substantial equivalence to a predicate device, the Salitron System. However, it does not explicitly state specific acceptance criteria in a quantifiable manner for the device performance itself, nor does it present the data in a table format with "device performance" separate from "acceptance criteria" as requested. Instead, it presents clinical study results that show positive outcomes.

    Therefore, I will extract relevant performance metrics from the clinical studies and present them as "reported device performance." Since explicit acceptance criteria are not provided, I will infer them as generally requiring a statistically significant improvement in the measured parameters.

    Here's an attempt to structure the information based on your request, acknowledging the limitations of the provided text:

    1. Table of Acceptance Criteria and Reported Device Performance

    Performance Metric (Implied Acceptance Criteria)Reported Device Performance (GenNarino)
    Short-term Oral Dryness ReliefSignificant decrease in oral dryness (measured by wetness sensors) with p<0.0001 for mechanical-electrical stimulation vs. mechanical stimulation alone.
    Long-term Patient-Reported Oral Moisture Improvement (Mechanical Mode)18% improvement in patient-reported degree of oral moisture.
    Long-term Patient-Reported Oral Moisture Improvement (Mechanical-Electrical Mode)26% improvement in patient-reported degree of oral moisture.
    Long-term Patient-Reported Xerostomia Frequency Decrease (Mechanical Mode)12% decrease in xerostomia frequency.
    Long-term Patient-Reported Xerostomia Frequency Decrease (Mechanical-Electrical Mode)18% decrease in xerostomia frequency.
    Statistical Significance for Long-term Xerostomia Severityp<0.002 for the difference between mechanical-electrical and mechanical modes.
    Statistical Significance for Long-term Xerostomia Frequencyp<0.05 for the difference between mechanical-electrical and mechanical modes.
    Overall Improvement (End of Stage II for Oral Moisture)34% improvement (p<0.001) in self-perceived oral moisture.
    Overall Improvement (End of Stage II for Xerostomia Frequency)17% improvement (p<0.002) in xerostomia frequency.
    Increase in Resting Saliva Production (End of Stage II)25% increase (p<0.001) in collected saliva under resting conditions.
    Increase in Masticatory Stimulated Saliva Production (End of Stage II)18% increase (p<0.02) in collected saliva under masticatory stimulation.
    Restoration of Salivary Flow in Aptyalic PatientsSalivary flow could be collected on follow-up examinations in 7 out of 8 patients with no salivary flow at the start of the study.
    SafetyNo significant side-effects observed in short-term study. No severe or irreversible systemic or local adverse effects unequivocally attributed to GenNarino usage in long-term study.

    2. Sample Size and Data Provenance for Test Set (Clinical Studies)

    • First Clinical Trial (Short-term):
      • Sample Size: Not explicitly stated, but indicated as a "controlled, short-term usage, double-blinded study."
      • Data Provenance: Multi-national; performed in three medical centers in Europe. Retrospective or prospective is not explicitly stated, but the description of "performed" suggests prospective.
    • Second Clinical Trial (Long-term):
      • Sample Size:
        • Stage I: 96 patients completed.
        • Stage II: 56 patients completed.
      • Data Provenance: Multi-national; performed in 14 institutions in 13 countries, including the US and countries in Europe and the Americas. The description of "performed" suggests prospective.

    3. Number of Experts and Qualifications for Ground Truth

    The document does not specify the number of experts or their qualifications used to establish ground truth for the clinical studies. The results rely on "patient-reported degree of oral moisture" and "xerostomia symptoms changes," as well as objective measurements such as "wetness sensors" and "amount of collected saliva."

    4. Adjudication Method for the Test Set

    The document does not describe a specific adjudication method. The studies were described as "double-blinded" for parts of their design, meaning neither the patients nor the clinicians administering the intervention knew whether the device was in mechanical-only or mechanical-electrical mode.

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

    No MRMC comparative effectiveness study is mentioned. This device is an electrical salivary stimulator system, not an imaging or diagnostic device that typically employs MRMC studies to evaluate human reader performance with or without AI assistance.

    6. Standalone (Algorithm Only) Performance Study

    Not applicable. The GenNarino is a physical medical device (an electrical salivary stimulator system), not an AI algorithm or software-only device. Its performance is inherent to its physical function and electrical stimulation, not an algorithm running independently.

    7. Type of Ground Truth Used

    The ground truth used appears to be a combination of:

    • Patient-reported outcomes: Subjective assessment of oral dryness, xerostomia symptoms, oral moisture, and xerostomia frequency.
    • Objective physiological measurements: Wetness sensors and collected saliva volume.
    • Observation of clinical effects: Restoration of salivary flow in previously aptyalic patients.

    8. Sample Size for the Training Set

    The document does not mention a "training set" in the context of an AI algorithm. The clinical trials described are for the evaluation of the device itself.

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

    Not applicable, as no AI algorithm training set is referenced.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1