(149 days)
The SOYALA Full Face Mask is intended for adult patients (>30kg) prescribed continuous positive airway pressure (CPAP) or bi-level therapy for multiplepatient use in a hospital or clinic environment after high-level disinfection and for single-patient use in a home environment.
The SOYALA Full Face Mask is a molded plastic face mask covering the patient's nose and mouth and including an exhalation system, for the delivery of CPAP or Bi-level Positive Pressure therapy. It consists of a mask cushion, mask frame, forehead cushion, coarse adjustment component, fine adjustment component, forehead support, headgear, headgear clip, ports for pressure measurement, port cap, rotating sleeve, elbow with anti asphyxia valve, and retaining ring. The mask provides a swivel and securely attached elbow connection for simple and secure handling of the tubing between the mask and the therapy device. The Weinmann SOYALA Full Face Mask comes in three sizes, small, medium and large. It has a removable mask cushion. An anti-asphyxia valve is integrated into the elbow of the mask. It functions as a safety mechanism, which allows the patient to breathe fresh air if the therapy device ceases operation. SOYALA Full Face Mask is secured to the patient's head with a 4-point headgear called the SOYALAstrap. An alternate headgear model is also available.
The provided text is a 510(k) summary for the Weinmann SOYALA Full Face Mask. It describes the device, its intended use, and claims substantial equivalence to predicate devices. However, the document does not contain the detailed acceptance criteria and study information typically found for AI/ML device evaluations.
Instead, the document states:
- "Bench testing was performed to ensure that the SOYALA Full Face Mask met its specifications. All tests were verified to meet acceptance criteria."
- "Biocompatibility testing was performed to verify the equivalent safety of the materials that are used."
This indicates that acceptance criteria and testing were done, but the specifics are not provided in this regulatory submission. This type of submission (510(k) in 2006) for a physical medical device like a face mask typically relies on engineering and biocompatibility testing against established standards, rather than complex clinical studies with AI/ML systems.
Therefore, I cannot provide the requested information regarding acceptance criteria, reported performance, sample sizes, expert ground truth, MRMC studies, standalone performance, or training set details because these specific elements are not present in the provided text, as it describes a hardware device not an AI/ML diagnostic system.
§ 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).