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510(k) Data Aggregation

    K Number
    K220618
    Device Name
    SaliPen
    Manufacturer
    Saliwell Ltd.
    Date Cleared
    2022-08-30

    (180 days)

    Product Code
    QTT,OTT
    Regulation Number
    872.5560
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    K180838
    Predicate For
    K232063
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    SaliPen is an electrical salivary stimulator system, indicated for use in patients with xerostomia (dry mouth).

    Device Description

    SaliPen is an electrical salivary stimulatory system device. It is comprised of two units: an intraoral stimulating unit and an extra-oral command unit. The latter includes an electronic circuit, a compartment containing a 3V coin battery, and a bottom for switching the stimulation "On" and "Off".

    The stimulating unit is made of silicone rubber and includes a stem and two flexible arms. The stem is used to hold SaliPen between the lips. The flexible arms are shaped to the inner contour of the lower dental arch. Each arm carries one pair of gold-plated stimulating electrodes. The device is designed in a manner that allows placing the electrodes on the lingual mucosa in the mandibular third molar region. The lingual nerve, which runs closely to this location, is the target of the stimulation due to its crucial role in the salivary reflex.

    Electrical stimulation is achieved by the delivery of low-power, low voltage, biphasic electrical pulses. The selected stimulating parameters provide effective stimulation, yet are well below the sensation thresholds, and definitely below the pain threshold.

    The user turns the device "On" and afterwards places the device in his/her mouth. After up to five minutes of use, the user removes the device from his/her mouth and deactivates the stimulation. The device is used 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 does not describe a study that proves the device meets specific acceptance criteria based on performance metrics (e.g., sensitivity, specificity, accuracy). Instead, it outlines the substantial equivalence determination for a medical device (SaliPen) by the FDA. The "performance data" section primarily discusses non-clinical testing for safety and regulatory compliance, and a "Human Factors validation trial."

    Therefore, I cannot fulfill most of the requested information regarding acceptance criteria and performance study details. The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than a detailed performance study like what would typically be conducted for a new diagnostic AI/ML device.

    However, I can extract the following relevant information from the provided text:

    1. A table of acceptance criteria and the reported device performance:

    • Acceptance Criteria: The document does not specify quantitative performance acceptance criteria in terms of clinical outcomes (e.g., a certain percentage increase in salivary flow). The "acceptance" is centered on demonstrating substantial equivalence to a predicate device, and the "performance" described is about safety, compliance with standards, and usability.
    • Reported Device Performance:
      • Nonclinical Performance: Compliance with various ISO, EN, IEC, and UL standards for electromagnetic compatibility, electrical safety, biocompatibility, and risk analysis. (Specific numerical results are not provided).
      • Clinical Performance (Human Factors Validation Trial):
        • Outcome 1: Study subjects (with and without xerostomia) were able to correctly decide eligibility for using the device based on the external label.
        • Outcome 2: Study subjects who used the device were able to follow the over-the-counter labeling instructions for use.
      • Mechanism of Action: Promote salivary function by mechanical and electrical stimulation of nerves involved in the salivary reflex.
      • Stimulation Parameters: Low-power, low voltage, biphasic electrical pulses, below sensation and pain thresholds.

    Due to the nature of the document (510(k) summary for a substantial equivalence claim, not a detailed clinical performance study report), the following points cannot be answered from the provided text:

    • 2. Sample sized used for the test set and the data provenance: Not specified for the human factors trial, other than "study subjects." Data provenance (country of origin, retrospective/prospective) is not mentioned.
    • 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as the "ground truth" was about user comprehension and ability to follow instructions, not clinical diagnosis by experts.
    • 4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
    • 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: Not applicable. This device is a stimulator, not an AI diagnostic tool.
    • 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI algorithm.
    • 7. The type of ground truth used (expert concensus, pathology, outcomes data, etc): For the human factors trial, the "ground truth" was whether subjects correctly understood eligibility and followed instructions, likely assessed by direct observation and questionnaires.
    • 8. The sample size for the training set: Not applicable (no traditional "training set" for an AI model).
    • 9. How the ground truth for the training set was established: Not applicable.
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