(76 days)
For use with ventilators, anaesthesia machines and open flow systems where filtration of inspired and expired gases is required. The filter may be located at the machine end of expiratory and/or inspiratory limb of the circuit or at the patient end of the circuit Single patient use up to 24 hours.
Breathing Filters Bacterial
This describes a 510(k) premarket notification for a breathing filter. The document indicates that the device has been found substantially equivalent to legally marketed predicate devices. However, this type of regulatory submission (510(k)) and the provided text do not contain the kind of detailed study information you are asking for (acceptance criteria, specific performance metrics, sample sizes for test/training, expert adjudication, MRMC studies, standalone performance, or ground truth details).
510(k) submissions typically demonstrate substantial equivalence through comparison to an existing device, and while performance data is often included, it's not structured in the way you've outlined for an AI/ML medical device. The document is a clearance letter and an "Indications for Use" statement, not a scientific study report.
Therefore, for your request, I must state that the provided text does not contain the information requested for acceptance criteria, study details, sample sizes, expert involvement, or AI/ML specific performance metrics. This is a traditional medical device clearance, not an AI/ML driven device submission.
§ 868.5260 Breathing circuit bacterial filter.
(a)
Identification. A breathing circuit bacterial filter is a device that is intended to remove microbiological and particulate matter from the gases in the breathing circuit.(b)
Classification. Class II (performance standards).