(134 days)
The Hailie@ sensor is intended for single patient, multiple use, in the home environment, as an electronic data capture accessory for monitoring and recording actuations, inspiratory flow, and inhaler orientation, for prescribed inhaler usage.
The Hailie@ sensor may be used in the following applications: in clinical trials, where specialists, general practitioners, nurses, and educators need to know if a patient has used their prescribed medication or assess inspiratory flow and inhaler technique; and in patient self-management including medication reminders.
The Hailie® sensor is compatible only with the following ELLIPTA® DPI inhalers: Breo™, Incruse™, Trelegy™ and Arnuity™. The Hailie@sensor is not intended to indicate remaining quantity of medication in an inhaler and does not include a dose counting function. The Hailie® sensor is not intended to provide spirometry measurements.
The Hailie® Sensor (Hailie® sensor) NF0106 model, is a modification to the Hailie® sensor NF0109 model, and is used to provide medication reminder, actuation monitoring, orientation and airflow recording functions, for use as an accessory to the inhaler specified on the device label. The Haili® sensor is indicated for use only with the following ELLIPTA® DPI inhalers: Breo™, Anoro™, Incruse™, Trelegy™ and Arnuity™.
The Hailie® sensor is a clip-on device that attaches externally around the housing of the inhaler. Optical sensors are used to detect the inhaler presence and monitor actuation. Motion and flow sensors are used to record inhaler usage technique parameters. The Hailie® sensor contains an electronic clock and calendar that are used to log the date and time of inhaler usage events.
The user interface consists of a single Status Button and a multi-color LED indicator to check device status, initiate communications functions, and provide reminder features. The Hailie® sensor has a Bluetooth interface to wirelessly exchange medication usage data and reminder setting data with a paired communications device and compatible mobile software applications.
This document, a 510(k) summary, describes the Hailie® Sensor NF0106, a medical device intended to monitor and record inhaler usage. The information provided heavily emphasizes equivalence to a predicate device (Hailie® Sensor NF0109) and reference devices rather than detailing a standalone acceptance criteria study with specific performance metrics and corresponding results for the NF0106 model itself.
Based on the provided text, a comprehensive table of acceptance criteria and reported device performance, as well as a detailed description of an MRMC or standalone study with specific performance metrics (like sensitivity, specificity, accuracy, etc.) for the detection of inhaler usage parameters, cannot be fully constructed or extracted. The document focuses on demonstrating that the modified Hailie® Sensor (NF0106) performs equivalently to prior cleared devices and meets general safety and performance requirements through a series of non-clinical testing.
Therefore, I will extract and synthesize the information that is available regarding testing and performance, and note where specific details for the requested categories are either not present or are presented in a comparative rather than quantitative manner.
Summary of Acceptance Criteria and Study to Prove Device Meets Them
Note: The provided text is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device through non-clinical testing. It does not present a standalone clinical performance study with explicit acceptance criteria for metrics like accuracy, sensitivity, or specificity of the device's core functions (actuation, inspiratory flow, orientation detection) in a quantitative, per-metric format. Instead, it describes general performance testing and states that the device offers "equivalent performance to the predicate" or "sufficient accuracy" without providing specific numerical targets or results for these equivalencies.
Due to the nature of this document (a 510(k) summary for a modified device), specific enumerated acceptance criteria with corresponding performance numbers for each function are not explicitly listed in a table format. The performance data section describes the types of tests conducted and their general conclusions of compliance or equivalence.
1. Table of Acceptance Criteria and Reported Device Performance
| Feature/Test Category | Acceptance Criteria (Inferred from text) | Reported Device Performance (Summary from text) |
|---|---|---|
| Optical Inhaler Presence Detection | Accurate detection of installed ELLIPTA® DPI inhalers. | Determined optical calibration limits and confirmed accurate detection of the installed ELLIPTA® DPI inhalers, with equivalent performance to the predicate. |
| Airflow Detection Sensor (Inspiratory Flow) | Performance of flow detection during inhaler usage across potential inspiratory flow range, to record flow rate and duration related to inhaler actuation and detect inhalation appropriately for the purpose of monitoring use of a medication inhaler. | Confirmed performance of flow detection during inhaler usage across potential inspiratory flow range, to record flow rate and duration related to inhaler actuation and detect inhalation appropriately for the purpose of monitoring use of a medication inhaler. (Implicitly meeting criteria, no specific numbers given). Inhaler usage parameters are measured with sufficient accuracy for monitoring inhaler use equivalent to the reference devices. |
| Airflow Verification | Negligible effect of the Hailie® sensor on flow impedance in the airflow path with respect to required airflow through the inhaler. | Confirmed the effect of the Hailie® sensor on flow impedance in the airflow path is negligible with respect to required airflow through the inhaler. |
| Motion Detection Sensor (Inhaler Orientation) | Detect inhaler orientation according to requirements from the inhaler manufacturer, while not detecting normal handling of the inhaler. | Confirmed performance of orientation detection to monitor inhaler orientation, according to requirements from the inhaler manufacturer, while not detecting normal handling of the inhaler. (Implicitly meeting criteria, no specific numbers given). |
| General Performance (Battery-life, Shelf-life, Bluetooth Communications Range) | Acceptable performance over specified Battery-life, Shelf-life, and specified Bluetooth communications range. | Confirmed acceptable performance over the specified Battery-life, Shelf-life and specified Bluetooth communications range, with equivalent performance to the predicate. |
| User Interface Testing (Device Display, Buzzer) | Visibility of device display and audibility of device buzzer. | Confirmed visibility of device display and audibility of device buzzer, with equivalent performance to the predicate. |
| Biocompatibility | Meet requirements of ISO 10993 series for surface device contacting intact skin for limited duration ≤ 24 hours. | Evaluated and met requirements from ISO 10993-1:2018, ISO 10993-5:2009, ISO 10993-10:2010, and ISO 10993-12:2012. |
| Electrical Safety & EMC | Comply with specified electrical safety and EMC standards (ANSI/AAMI ES60601-1, IEC 60601-1-11, IEC 60601-1-2). | Complies with ANSI/AAMI ES60601-1:2005 +A1:2012, C1:2009, A2:2020 (general safety), IEC 60601-1-11:2020 (home-use safety), and IEC 60601-1-2:2020 (electromagnetic compatibility). |
| Software V&V | Ensure correct functionality for all software modules and comply with FDA guidance for software and cybersecurity. | Conducted to ensure correct functionality for all software modules. Documentation provided as recommended by FDA guidances. (Implicitly meeting criteria). Software verification demonstrates that the device should perform as intended. |
| Usability | Evaluate impact on critical tasks and establish validity of results from testing in accordance with FDA guidance. | Carried out to evaluate impact on critical tasks and established validity of results. The usability evaluation indicates no issues for successful use. |
| Overall Equivalence | Substantial equivalence to predicate device. | Information indicates the Hailie® sensor is substantially equivalent to the predicate device. |
2. Sample size used for the test set and the data provenance:
- Sample Size: The document does not specify exact sample sizes (e.g., number of devices or number of tests performed) for the performance testing. It states that "Non-clinical testing and evaluation of the Hailie® sensor has been carried out..."
- Data Provenance: The tests were non-clinical, conducted by "external laboratories" for electrical safety and EMC. No specific country of origin for the data or whether it was retrospective or prospective is mentioned beyond it being "non-clinical testing." This implies laboratory-based, controlled testing rather than patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- The document describes non-clinical testing. Therefore, there is no mention of experts establishing a "ground truth" for a test set in the clinical sense (e.g., radiologists reviewing images). The ground truth for performance testing would likely be based on controlled laboratory conditions and measurement equipment.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable as this was non-clinical performance testing, not a clinical study requiring adjudication of expert interpretations.
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:
- No. The document explicitly states: "Clinical testing was not required for a determination of substantial equivalence of the Hailie® sensor. The product functionality has been adequately assessed by non-clinical testing as outlined above." Therefore, no MRMC study was conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- The device itself is a standalone sensor that operates to detect and record events. The performance testing described (optical detection, airflow, motion, general performance) effectively serves as "standalone" performance evaluation of the device's core functions, as it does not involve a human in the loop for the actual detection mechanism of the device. The device's output (logged data) is what a human would then review.
- However, no specific quantitative metrics (e.g., "95% accuracy in detecting actuations") are provided from such a standalone assessment. Instead, the performance is described as "equivalent to the predicate" or "sufficient accuracy."
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- For the non-clinical performance testing, the ground truth would have been established through instrumentation, controlled experimental setups, and engineering specifications. For example, a known flow rate would be introduced to test the airflow sensor, or a known orientation change to test the motion sensor.
8. The sample size for the training set:
- This device is not an AI/ML algorithm that requires a "training set" in the conventional sense of machine learning model development. It's a sensor-based electronic device. Therefore, the concept of a "training set" for model development does not apply here.
9. How the ground truth for the training set was established:
- Not applicable, as there is no "training set" for an AI/ML model.
§ 868.5630 Nebulizer.
(a)
Identification. A nebulizer is a device intended to spray liquids in aerosol form into gases that are delivered directly to the patient for breathing. Heated, ultrasonic, gas, venturi, and refillable nebulizers are included in this generic type of device.(b)
Classification. Class II (performance standards).