(159 days)
A-Model: The F&P Solo mask is intended to be used by adults weighing ≥661bs (30 kgs) who have been prescribed non-invasive positive airway pressure therapy such as CPAP or Bi-Level by a physician. The F&P Solo mask is intended for singlepatient use in the home.
SL A-Model: The F&P Solo mask is intended to be used by adults weighing ≥661bs (30 kgs) who have been prescribed non-invasive positive airway pressure therapy such as CPAP or Bi-Level by a physician. The F&P Solo mask is intended for singlepatient use in the home and for multiple patient use in the hospital or other proper disinfection of the device can occur between patient uses.
The Solo Mask, is a non-invasive patient interface with cushions that seal against the airway entrance of the nose. The mask is held on the face with a headqear and connects to a single breathing tube by a 22mm male swivel adaptor to receive pressurized air from a continuous Positive Airway Pressure device (CPAP or Bi-level). The exhaust bias holes on the frame of the mask allow exhaled air to be flushed out while the system is in operation. The F&P Solo Mask is a prescription only device, provided in a non-sterile state.
This document is a 510(k) Premarket Notification from the FDA regarding the F&P Solo Mask Range, a non-invasive patient interface for CPAP or Bi-Level therapy. The document asserts that the device is substantially equivalent to a predicate device, as required by FDA regulations.
Based on the provided information, the request appears to be asking for a description of acceptance criteria and the study that proves the device meets those criteria, specifically concerning an AI/ML medical device. However, this document is NOT about an AI/ML medical device. It's about a physical medical device (a CPAP mask).
Therefore, I cannot extract the information requested in points 1 through 9 because the provided text does not contain any information about AI/ML acceptance criteria, ground truth, expert adjudication, or MRMC studies.
The document primarily focuses on:
- Device Description: What the F&P Solo Mask is, its models (A-Model, SL A-Model), and its intended use (CPAP/Bi-Level therapy for adults).
- Predicate Device Comparison: A detailed table comparing the F&P Solo Mask with a legally marketed predicate device (F&P Evora™ Nasal Mask, K200089) based on design features, technical specifications (pressure range, resistance to flow, dead space, sound, shelf-life, operating conditions), and components.
- Non-Clinical Tests: A summary of various non-clinical tests performed on the device to demonstrate conformance to applicable standards (e.g., ISO 17510:2015 for CO2 rebreathing, pressure-flow curve, exhaust flow, resistance to flow, vibration and noise; ISO 10993 series for biological evaluation). These are physical and performance tests specific to a respiratory mask, not AI/ML performance metrics.
In summary, none of the requested AI/ML specific information (acceptance criteria for AI, data provenance, expert ground truth, MRMC studies, standalone AI performance data, training set details) is present in this 510(k) submission for a non-AI/ML 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).