Protocol
Validation of the IKE BLE System for Age-Gating and Control of an ENDS Device: A Multi-Center Human Factors Study
A comprehensive human factors validation study was conducted to evaluate the effectiveness of the IKE Bluetooth Low Energy (BLE) System in age-gating and controlling an Electronic Nicotine Delivery System (ENDS) device.
This study assessed the IKE application user interface, mitigated potential use-related hazards through observational analysis of participants interacting with the IKE application and a test device, and evaluated participant feedback.
The IKE BLE System, integrated on a System-on-Chip (SoC) with an interactive on-market user interface, was tested in simulated-use environments with representative user populations. Results indicate high efficacy in age verification, with 100% of participants successfully completing the process, though challenges in device deactivation post-idle time were identified. These findings are under review by the U.S. Food and Drug Administration (FDA) as part of a Pre-Market Tobacco Application (PMTA) for the IKE BLE System on a Chip.
The IKE BLE System is designed to restrict access to ENDS devices by implementing robust age-gating mechanisms, a critical public health measure to prevent youth initiation of nicotine use.This study aimed to validate the system’s effectiveness in age verification and device control through a human factors approach, focusing on the usability of the IKE application and its Bluetooth chip functionality. The system leverages smartphone technology to connect to and activate an ENDS device, ensuring only age-verified users can operate it.This study evaluates the system’s performance in simulated-use scenarios, addressing legal age connectivity, device activation, and deactivation protocols, including biometric authentication and idle-time deactivation.
A multi-center human factors validation study was conducted with a sample of 102 participants recruited from the general population.
Participants were 51% male and 49% female, aged 18 to 67 years (22% aged 18–20, 18% aged 21–24, 20% aged 25–44, 20% aged 45–64, and 20% aged 65 or older). Inclusion criteria required participants to be comfortable using smartphones and phone applications, as assessed by a 5-point Likert scale intake questionnaire (mean score ≥ 4.0).
Participants were tasked with using their own smartphones to work through a series of tasks designed to simulate real-world usage of the IKE BLE System. The study protocol involved three primary tasks: (1) downloading and installing the IKE application, (2) completing age verification using on-screen prompts, and (3) activating and deactivating a test ENDS device via Bluetooth connectivity.
Device activation was assessed by the ability to establish a stable Bluetooth connection, while deactivation was evaluated by the system’s ability to disconnect the device after 15 minutes of idle time or through biometric re-authentication (fingerprint or facial recognition). Observational data were collected on task completion rates, error occurrences, and user-reported ease of use. Participants rated their experience using a 5-point Likert scale (1 = Not Easy, 5 = Extremely Easy). Data were analyzed using descriptive statistics and qualitative thematic analysis of participant feedback.
Device activation was assessed by the ability to establish a stable Bluetooth connection, while deactivation was evaluated by the system’s ability to disconnect the device after 15 minutes of idle time or through biometric re-authentication (fingerprint or facial recognition). Observational data were collected on task completion rates, error occurrences, and user-reported ease of use. Participants rated their experience using a 5-point Likert scale (1 = Not Easy, 5 = Extremely Easy). Data were analyzed using descriptive statistics and qualitative thematic analysis of participant feedback.
Device activation was assessed by the ability to establish a stable Bluetooth connection, while deactivation was evaluated by the system’s ability to disconnect the device after 15 minutes of idle time or through biometric re-authentication (fingerprint or facial recognition). Observational data were collected on task completion rates, error occurrences, and user-reported ease of use. Participants rated their experience using a 5-point Likert scale (1 = Not Easy, 5 = Extremely Easy). Data were analyzed using descriptive statistics and qualitative thematic analysis of participant feedback.
Device activation was assessed by the ability to establish a stable Bluetooth connection, while deactivation was evaluated by the system’s ability to disconnect the device after 15 minutes of idle time or through biometric re-authentication (fingerprint or facial recognition). Observational data were collected on task completion rates, error occurrences, and user-reported ease of use. Participants rated their experience using a 5-point Likert scale (1 = Not Easy, 5 = Extremely Easy). Data were analyzed using descriptive statistics and qualitative thematic analysis of participant feedback.
Device activation was assessed by the ability to establish a stable Bluetooth connection, while deactivation was evaluated by the system’s ability to disconnect the device after 15 minutes of idle time or through biometric re-authentication (fingerprint or facial recognition). Observational data were collected on task completion rates, error occurrences, and user-reported ease of use. Participants rated their experience using a 5-point Likert scale (1 = Not Easy, 5 = Extremely Easy). Data were analyzed using descriptive statistics and qualitative thematic analysis of participant feedback.
Device activation was assessed by the ability to establish a stable Bluetooth connection, while deactivation was evaluated by the system’s ability to disconnect the device after 15 minutes of idle time or through biometric re-authentication (fingerprint or facial recognition). Observational data were collected on task completion rates, error occurrences, and user-reported ease of use. Participants rated their experience using a 5-point Likert scale (1 = Not Easy, 5 = Extremely Easy). Data were analyzed using descriptive statistics and qualitative thematic analysis of participant feedback.