(31 days)
The Respironics Monarch II Mini Mask is intended to provide an interface for application of Respironics CPAP or bi-level therapy to patients.
The Monarch II Mini Mask is a single-patient-use interface for adult patients (> 30 kg) receiving Respironics CPAP or bi-level therapy. The mask consists of a removable silicone skin-contacting cushion, a polycarbonate faceplate, and a polycarbonate elbow (to which 15 mm flexible tubing is attached). The elbow fits on the faceplate at a 90° angle and swivels 360° about faceplate.
The Monarch II Mask incorporates a thin mask cushion that folds inward, creating a flap to improve seal. The mask fits over the tip of the nose (rather than under the nares). This improves the stability of the mask and also accommodates patients with various nose sizes and facial shapes. The shape of the modified cushion is that of a typical nasal mask (triangular). The mask is available in two sizes, small and medium, and is available with or without headgear. The mask does not come in contact with the nasal bridge area.
The faceplate is round and has three slots for the corresponding headgear attachment tabs. One exhalation port is on the elbow. The headgear material is Neoprene encased in nylon/polyester, a common material used for apparel products. It is safe for "next-to-skin" applications. The headgear has three attachment tabs.
Mask tubing is reusable low-density polyethylene with EVA. Mask tubing is 6 inches long, 15 mm diameter at the mask, and gradually widens to 22 mm diameter at the opposing end. The 22mm end of the mask tubing has an "accessory swivel" used to attach a 6-foot patient circuit.
The provided text is a 510(k) summary for the Monarch II Mini Mask. It does not include details about acceptance criteria, specific device performance against those criteria, or details regarding a study to prove such performance.
The document primarily focuses on establishing substantial equivalence to a predicate device (Monarch Mini Mask K945938) based on similarities in:
- Indicated use
- Operating principle
- Skin-contacting mask cushion materials
- Technology
- Manufacturing process
It also describes the device and its intended use. There is no information about clinical studies, test sets, ground truth establishment, expert adjudication, or MRMC studies.
Therefore, I cannot fulfill your request for:
- A table of acceptance criteria and the reported device performance
- Sample sized used for the test set and the data provenance
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Adjudication method
- If a multi reader multi case (MRMC) comparative effectiveness study was done, and its effect size
- If a standalone performance study was done
- The type of ground truth used
- The sample size for the training set
- How the ground truth for the training set was established
This type of information is typically found in performance studies or clinical trial reports, which are not present in this 510(k) summary. The summary explicitly states that "Verification testing has shown the modified mask has the following similarities to the previously cleared predicate device," implying that the assessment was based on demonstrating equivalence rather than a full, standalone performance study with predefined acceptance criteria for a new device.
§ 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).