(249 days)
Hudson RCI® Comfort Flo nasal cannulas are intended to be used in conjunction with the Comfort Flo Humidification System to provide a continuous flow of heated and humidified air/oxygen mixtures to spontaneously breathing patients.
It is indicated for single use by adult and pediatic (2 years and above) patients in professional healthcare environments.
Hudson RCI® Comfort Flo® Plus cannulas are intended to be used in conjunction with the Humidification System to provide a continuous flow of heated and humidified air/oxygen mixtures to spontaneously breathing patients.
It is indicated for single use by adult and pediative (12 years and above) patients in professional healthcare environments.
Hudson RCI® Comfort Flo Nasal Cannulas:
Comfort Flo nasal cannulas are intended to be used in conjunction with the Comfort Flo Humidification System to provide a continuous flow of heated humidified air to spontaneously breathing patients. Sizes available include adult and pediatric.
Hudson RCI® Comfort Flo Plus Cannulas:
Cannula tube is assembled with other components to create a product named Comfort Flo® Plus Cannula with/ without Chin Strap. The Comfort Flo Plus cannulas are intended to be used in conjunction with the Humidification system intended to provide a continuous flow of heated and humidified air/oxygen mixtures to spontaneously breathing patients. It allows for the safe and effective delivery of heated, humidified oxygen therapy to the patients.
The Comfort Flo Plus Cannulas are available in small, medium and large configurations. The chin strap is also offered individually.
Hudson RCI® Comfort Flo Plus Cannulas:
Comfort Flo Soft Plus cannulas are the same as Comfort Flo Plus cannulas except for head strap. These have a soft/cushioned head strap for patient comfort.
It is used as an alternative to oxygen face mask and allows the patient to continue to talk, eat and drink while receiving the therapy.
Hudson RCI® Tracheostomy Adaptor:
The Hudson RCI® Tracheostomy Adapters are intended to be used in conjunction with tracheostomies in order to provide a secure connection to spontaneously breathing tracheostomy patients for oxygen therapy. It allows for the safe and effective delivery of oxygen therapy to the patient's trachea.
The Tracheostomy Adaptor consists of 15mm (female) connector with cap deflector which enables it to be attached to 15M conical connector of tracheostomy tube/ patient connector port and swivel connector (15F/22M) at another end in order to connect with breathing circuit/ humidification system.
It is indicated for single use by adult and pediatric (12 years and above) patients in professional healthcare environments.
The provided text is related to a 510(k) premarket notification for a medical device (nasal cannulas) and does NOT contain information about acceptance criteria or a study proving that the device meets specific performance criteria, especially not in the context of an AI/ML-driven medical device.
The document describes the device, its intended use, comparison to predicate devices, and a summary of non-clinical (bench) performance testing and biocompatibility testing. However, it explicitly states "This section does not apply. No animal testing was performed" and "This section does not apply. No clinical testing was performed" under "Performance Testing (Animal)" and "Performance Testing (Clinical)" respectively.
Therefore, I cannot extract the requested information regarding acceptance criteria, device performance from a test set, sample sizes for test/training sets, data provenance, expert numbers/qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment relevant to an AI/ML device.
The document discusses tests like:
- Post aging Visual Inspection
- Relevant Humidity Output testing
- Thermal Overshoot testing
- Gas path and headgear joint and connection strength testing
- Flow Leak Test/ Gas path leak testing
- Head Gear Testing
- Shelf Life Testing
- Useful Life Testing
- Transportation simulation
- ISO gauging
These are all bench tests for a mechanical/physical device (nasal cannula), not studies that would involve AI/ML performance metrics like sensitivity, specificity, AUC, or the involvement of human readers/experts for ground truth.
In summary, the provided document does not contain the information required to answer your request about acceptance criteria and study details for an AI/ML medical device.
§ 868.5450 Respiratory gas humidifier.
(a)
Identification. A respiratory gas humidifier is a device that is intended to add moisture to, and sometimes to warm, the breathing gases for administration to a patient. Cascade, gas, heated, and prefilled humidifiers are included in this generic type of device.(b)
Classification. Class II (performance standards).