(195 days)
The Hailie™ sensor is intended for single-patient use in the home environment as a medication reminder and electronic data capture accessory for recording actuations of prescribed inhaler usage. This may be used in the following applications:
- In clinical trials, where researchers need to know when a patient has actuated their trial inhaler medication.
• In clinical practice, where specialists, general practitioners, nurses, and educators need to know if a patient has actuated their prescribed inhaler medication.
• In self-management, where patients need to track their medication use as part of their management plan.
The Hailie™ sensor is compatible only with Bevespi Aerosphere® and is for use by adults. 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 used to provide a medication reminder and actuation recording function for use as an accessory to the inhaler specified on the device label. Under the current 510(k), the Hailie™ sensor is indicated for use only with the Bevespi Aerosphere®.
The Hailie™ sensor is a clip-on device that attaches externally around the housing of the inhaler. Optical and mechanical sensors are used to detect the presence and actuation of the inhaler. The Hailie™ sensor contains an electronic clock and calendar that are used to log the date and time of inhaler actuation.
The user interface consists of three control buttons and three LED indicators to check device status, initiate communications functions, and provide reminder features. The Hailie™ sensor has a Bluetooth interface to wirelessly exchange medication and reminder setting data with a paired communications device and compatible mobile software applications.
The provided text describes the Hailie™ Sensor, an accessory for inhalers, and its FDA 510(k) premarket notification. The document primarily focuses on demonstrating substantial equivalence to a predicate device through non-clinical testing. It explicitly states that clinical testing was not required for this determination. Therefore, the device performance and acceptance criteria are based on non-clinical, functional, and engineering tests rather than a multi-reader, multi-case (MRMC) comparative effectiveness study or a standalone AI algorithm performance study.
Here's the breakdown of the information requested, based on the provided document:
1. A table of acceptance criteria and the reported device performance
The document does not present a formal table of distinct acceptance criteria with corresponding performance metrics like a typical clinical trial. Instead, it describes various non-clinical tests and states that the device "meets design and performance functional requirements" and "complies" with relevant standards. The "performance" is generally described as "correct functionality and compatibility."
| Acceptance Criteria (Implied from Testing) | Reported Device Performance (Summary) |
|---|---|
| Biocompatibility: Complies with ISO 10993 standards. | Meets requirements from listed ISO 10993 standards. |
| Electrical Safety: Complies with ANSI/AAMI ES60601-1 and related IEC standards. | Complies with ANSI/AAMI ES60601-1:2005 +A1:2012, C1:2009, A2:2010 (general safety), IEC 60601-1-11:2015 (home-use safety), IEC 60601-1-2:2014 (electromagnetic compatibility). |
| Electromagnetic Compatibility (EMC): Complies with IEC 60601-1-2 and FCC regulations. | Complies with IEC 60601-1-2:2014 (electromagnetic compatibility) and ANSI C63.10:2013 / 47 CFR Part 15 (FCC regulations). |
| Software Functionality: Correct functionality and validation. | Software verification and validation testing conducted to ensure correct functionality; software functions are substantially equivalent to the predicate device. Documentation provided as per FDA guidance. |
| Optical Inhaler Presence Detection Sensor Performance: Correct functionality. | Performance testing carried out to establish correct functionality. |
| Pressure Inhaler Actuation Detection Sensor Performance: Correct functionality. | Performance testing carried out to establish correct functionality. |
| Bluetooth Data Transfer Communications Performance: Correct functionality. | Performance testing carried out to establish correct functionality. |
| General Performance: Shelf life, Bluetooth range. | Performance testing carried out to establish correct functionality. |
| Usability: Can be used successfully with the compatible inhaler. | Summative usability validation testing carried out; demonstrated that the Hailie™ sensor can be used successfully. |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
The document does not detail specific sample sizes for tests (e.g., how many devices were tested for electrical safety, how many users for usability). The performance tests appear to be laboratory-based and focused on device function rather than clinical data. Given that clinical testing was not required, there is no mention of patient data (retrospective or prospective) or country of origin for such data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
Not applicable. The ground truth for this device's performance is established through engineering and functional testing against defined technical specifications and regulatory standards, not through expert consensus on medical images or patient outcomes.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This type of adjudication method is relevant for studies involving human interpretation (e.g., reading medical images) where a consensus or majority opinion is needed to establish ground truth. For this device's non-clinical testing, the "ground truth" is determined by objective measurements and compliance with technical standards.
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 above." Therefore, no MRMC study or AI assistance evaluation was performed as part of this submission. The Hailie™ sensor is an electronic data capture accessory for an inhaler, not an AI-powered diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable in the context of an AI algorithm. The device has an "algorithm" in the sense of software processing, but its "standalone performance" refers to its ability to accurately detect inhaler presence and actuation, store data, and communicate via Bluetooth, as verified through performance testing, not as a diagnostic algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this device's non-clinical performance evaluation is based on:
- Compliance with recognized international and national standards (e.g., ISO 10993 for biocompatibility, IEC 60601 for electrical safety and EMC).
- Pre-defined engineering specifications and functional requirements for optical and mechanical sensor performance, data transfer, and user interface.
- Successful completion of usability tasks.
8. The sample size for the training set
Not applicable. This device is not an AI/machine learning model that requires a "training set" of data in the typical sense. Its functionality is based on direct sensor input and programmable logic.
9. How the ground truth for the training set was established
Not applicable, as no training set (for an AI model) was used.
§ 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).