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The ADDNOX is indicated for the treatment of pediatric Attention Deficit Hyperactivity Disorder (ADHD) as a monotherapy in patients ages 7 through 12 years old who are not currently taking prescription ADHD medications.

The ADDNOX is intended for patient treatment by prescription only and for use at home under the supervision of a caregiver during periods of sleep.

The ADDNOX is a transcutaneous electrical trigeminal nerve stimulator for Attention Deficit Hyperactivity Disorder. It is a prescription device that stimulates transcutaneously or percutaneously through electrodes placed on the forehead.

The ADDNOX is intended for patient treatment by prescription only and for use at home under the supervision of a caregiver during periods of sleep.

The provided text describes a 510(k) premarket notification for the ADDNOX device, a transcutaneous electrical nerve stimulator for Attention Deficit Hyperactivity Disorder (ADHD). However, it explicitly states:

"No clinical testing was performed on the device."

This means that the submission does not include a study demonstrating device performance against specific acceptance criteria. The clearance for ADDNOX is based on its substantial equivalence to a legally marketed predicate device (SMILE) and non-clinical data (biocompatibility, electrical safety, performance, and software tests).

Therefore, I cannot fulfill your request to describe acceptance criteria and a study proving the device meets them, nor can I provide information about sample sizes, expert involvement, adjudication methods, MRMC studies, standalone performance, or ground truth establishment for a clinical study, as these were not part of this 510(k) submission.

The document focuses on demonstrating that the ADDNOX has similar technological characteristics and performs as safely and effectively as the predicate device through non-clinical testing and comparison.

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