(142 days)
The Fisher & Paykel Healthcare Visairo masks are single patient use masks intended for use as an accessory to ventilators to enable non-invasive positive pressure ventilation (NPPV) therapy (CPAP or bi-level) to be delivered to spontaneously breathing adult patients (> 30 kg) with respiratory insufficiency or respiratory failure who have been prescribed NPPV. The masks are to be fitted and therapy maintained by trained medical practitioners in a hospital/institutional environment with patient monitoring in place.
The F&P Visairo™ NIV Masks ("Visairo Masks") are oro-nasal full face masks that are intended for use as an accessory to deliver non-invasive positive pressure ventilation (NPPV) to a patient as part of a non-invasive ventilation system. The Visairo Masks are prescription only, provided in a non-sterile state.
The provided text discusses the F&P Visairo NIV Masks and their substantial equivalence to a predicate device, primarily focusing on regulatory aspects and comparisons of technical characteristics. It does not contain information about acceptance criteria for a device's performance that would typically be measured through a study assessing algorithm or human reader performance (e.g., sensitivity, specificity, or reader improvement with AI).
Instead, the "Performance Data" section (VII) mentions that the masks have been tested to applicable requirements of several ISO standards, which relate to:
- ISO 17510:2020 Sleep apnoea breathing therapy - Masks and application accessories
- ISO 5356-1:2015 Anaesthetic and respiratory equipment - Conical connectors: Part 1: Cones and sockets
- ISO 10993-1:2018 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
- ISO 18562-1:2017 Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 1: Evaluation and testing within a risk management process
These standards relate to device safety, functionality, and biocompatibility, not to the kind of performance metrics typically reported for diagnostic algorithms or AI-assisted diagnostic tools.
Therefore, I cannot provide a table of acceptance criteria and reported device performance, nor details about sample sizes, ground truth establishment, or multi-reader multi-case studies, as this information is not present in the provided document. The document describes a medical device in the context of a 510(k) premarket notification, which emphasizes substantial equivalence to a predicate device based on shared characteristics and compliance with general safety and performance standards.
§ 868.5895 Continuous ventilator.
(a)
Identification. A continuous ventilator (respirator) is a device intended to mechanically control or assist patient breathing by delivering a predetermined percentage of oxygen in the breathing gas. Adult, pediatric, and neonatal ventilators are included in this generic type of device.(b)
Classification. Class II (performance standards).