(90 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 actuation, inspiratory flow and inhaler shake 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 Ventolin, Advair, Flovent inhaler. 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 is intended for single-patient multiple use in the home environment as an electronic data capture accessory for monitoring and recording actuation, inspiratory flow and inhaler shake for prescribed inhaler usage.
This appears to be a 510(k) clearance letter from the FDA for the Hailie® Sensor. These letters typically grant market clearance based on substantial equivalence to a predicate device and do not usually include extensive details about the performance study that would generate acceptance criteria and detailed performance metrics as one might find in an AI/ML device submission.
Based on the provided text, there is no specific information regarding acceptance criteria and a study that proves the device meets those criteria in the way described in your request (e.g., performance metrics, sample sizes for test/training sets, expert adjudication methods, MRMC studies, or standalone performance).
The document primarily focuses on:
- Confirming the device's substantial equivalence to a predicate.
- Indications for Use of the Hailie® Sensor.
- Regulatory classifications and general controls.
Therefore, I cannot fulfill your request for the specific details listed because they are not present in the provided FDA clearance letter.
To fully answer your request, you would typically need access to the full 510(k) submission, which would contain the performance testing data and clinical study details (if any were required beyond basic functionality and safety testing for substantial equivalence).
§ 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).