This study objective is to test the Silk'n Toothwave self-selection, by potential end users. Additionally, this study will evaluate if contraindicated subjects will self-exclude from use of the device and the ability to understand accurately the labeling content (box and user manual).
The Silk'n Toothwave Device, in its original packaging, along with the user manual will be provided to the patient in a simulated home use environment. The patient labeling will be in the format intended for distribution. All subjects will sign an informed consent before any study activity. Five (5) potential end users and Additional five (5) contraindicated subjects will be screened for this self-selection study. Subjects will be provided with the device in its original packaging and will be evaluated for their ability to decide if they are eligible or they should self-exclude themselves from use of the device based solely on reading the device labeling (box and user manual). Once the subjects complete reviewing the labeling materials (box and user manual) they will be requested to perform a labeling comprehension exam for testing the ability to correctly understand the labeling content. The study will not include treatment.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
SCREENING
Masking
SINGLE
Enrollment
10
Subjects get the device's box with the user manual and the device. However, they don't use the device, but only read the user manual and fill questionnaires.
Hellman Dermatology clinic
New York, New York, United States
Subjects will mention in the post-reading questionnaire if they should use the Toothwave device or not.
Post-reading questionnaire includes the question: "are you allowed to use this device?". Based on reading the user manual and box labeling, subjects should answer "yes" or "no" according to their condition.
Time frame: 30 minutes
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