(452 days)
The SMILE external Trigeminal Nerve Stimulation (eTNS) System is indicated for 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 device is to be used for patient treatment by prescription only and is intended to be used in the home under the supervision of a caregiver during periods of sleep.
Transcutaneous electrical nerve stimulator for Attention Deficit Hyperactivity Disorder. A transcutaneous electrical nerve stimulator for Attention Deficit Hyperactivity Disorder (ADHD) is a prescription device that stimulates transcutaneously or percutaneously through electrodes placed on the forehead.
The SMILE eTNS System treatment protocol is administered each night while the patient is sleeping, for 7-9 hours. The device is designed to provide non-invasive electrical stimulation of the trigeminal nerve.
The provided document is a 510(k) summary for the Nu Eyne Co., Ltd. SMILE device, a transcutaneous electrical nerve stimulator for Attention Deficit Hyperactivity Disorder (ADHD). This document focuses on demonstrating substantial equivalence to a predicate device (Monarch eTNS System), rather than presenting a clinical study where the device performance against specific acceptance criteria is measured for an AI/algorithm-driven device.
Therefore, the requested information regarding acceptance criteria, device performance, sample sizes, expert involvement, adjudication, MRMC studies, standalone performance, and ground truth establishment for an AI/algorithm is not available in this document.
The document details the device's technical specifications, indications for use, and a comparison to a predicate device to establish substantial equivalence. It also lists the non-clinical tests performed (electrical safety, EMC, performance, usability, and software validation according to relevant standards), which support the device's safety and effectiveness in general, but not a specific performance metric against a clinical acceptance criterion in the context of an AI/algorithm.
To directly answer your request based only on the provided text, I must state that the information is not present. This document describes a medical device clearance process focused on equivalence, not on the performance of a machine learning algorithm against a clinical endpoint with a dedicated test set and ground truth.
§ 882.5898 Transcutaneous electrical nerve stimulator for attention deficit hyperactivity disorder.
(a)
Identification. A transcutaneous electrical nerve stimulator for attention deficit hyperactivity disorder (ADHD) is a prescription device that stimulates transcutaneously or percutaneously through electrodes placed on the forehead.(b)
Classification. Class II (special controls). The special controls for this device are:(1) The patient-contacting components of the device must be demonstrated to be biocompatible.
(2) Performance testing must demonstrate the electromagnetic compatibility and electrical, mechanical, and thermal safety of the device.
(3) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use. The following must be performed:
(i) Electrical performance testing must validate electrical output and duration of stimulation;
(ii) Battery performance testing must be performed; and
(iii) Adhesive integrity testing of the electrodes must be conducted.
(4) The technical parameters of the device including waveform, maximum output current and voltage, pulse duration, frequency, net charge per pulse, maximum current density, maximum average current, and maximum average power density must be fully characterized.
(5) Software verification, validation, and hazard analysis must be performed.
(6) Shelf life testing of the electrodes must be performed to demonstrate continued package integrity and component functionality over the labeled shelf life.
(7) Labeling must include the following:
(i) A contraindication for patients with an implanted metallic or electronic device in the head, a cardiac pacemaker, or an implanted or wearable defibrillator;
(ii) A warning that the device is only for use on clean, intact skin;
(iii) Information on how the device operates and the typical sensations experienced during treatment;
(iv) A detailed summary of the device technical parameters;
(v) A shelf life for the electrodes;
(vi) Instructions for use, including placement of the device on the patient; and
(vii) Cleaning instructions.