(254 days)
This device is designed for use on patients unable to cough or clear secretions effectively due to reduced peak cough exspiratory flow, resulting from high spinal cord injuries, neuromuscular deficits or severe fatigue associated with intrinsic lung disease. It may be used either with a facemask, mouthpiece, or an adapter to a patient's endotrached tube or tracheostomy tube. For use in hospital, institutional setting, or at home. For use on adult patients 3 years old and up.
The BiWaze Cough is a device intended for clearing bronchopulmonary secretions. The therapy provided by BiWaze Cough mimics a cough and consists of three phases which mimic a cough; inhale, exhale, and pause phase. The inhale phase is positive airway pressure to expand the lungs. Then the exhale phase is a sudden shift to negative pressure to pull the air out of lungs. Finally, the pause phase provides positive pressure which keeps the airways open in between the therapy cycle. The Peak Inspiratory Flow can be selected on three different levels: High, Medium, Low. The device can be operated via a power supply and is also battery operated. Performance is controlled from a touch screen panel in manual or automatic modes. The device is controlled by software algorithms, and error messages are displayed in cases where the normal functioning doesn't occur. Advanced features include inspiratory trigger and oscillations.
The provided text does not contain information about acceptance criteria and the study proving a device meets these criteria in the context of an AI/Machine Learning device. Instead, it's a 510(k) summary for a medical device called "BiWaze Cough," which is a non-continuous ventilator.
The document discusses the device's substantial equivalence to predicate devices based on its technical characteristics, safety protocols, and performance data from bench testing and software code reviews, not from a clinical study involving human patients or ground truth established by experts.
Therefore, I cannot provide the requested information about acceptance criteria, test set sample size, expert ground truth, adjudication methods, MRMC studies, standalone performance, training set details, or how ground truth was established for a machine learning model, as this information is not present in the provided text for this specific device.
The "Performance Data" section explicitly states: "Performance testing was conducted on BiWaze Cough and the device was found substantially equivalent to the predicate device. Verification activities have been performed to verify that the device modifications did not affect the safety and effectiveness of the subject device. This included bench testing, software unit testing, and code reviews." This confirms that the evaluation was engineering-based for a physical device, not an AI/ML model.
§ 868.5905 Noncontinuous ventilator (IPPB).
(a)
Identification. A noncontinuous ventilator (intermittent positive pressure breathing-IPPB) is a device intended to deliver intermittently an aerosol to a patient's lungs or to assist a patient's breathing.(b)
Classification. Class II (performance standards).