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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.

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The Fisher & Paykel Healthcare single patient use masks are intended for use as an accessory to ventilators to enable noninvasive positive pressure ventilation (NPV) therapy (CPAP or bi-level) to be delivered to spontaneously breathing adult patients (>30kg) 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 Nivairo™ RT046 Non-Vented Hospital Full Face Mask, Standard Elbow Version (herein referred to as RT046) is a non-vented hospital full face mask with a standard elbow for use with dual limb circuits. The RT046 is a single use device intended for use as an accessory to deliver non-invasive positive pressure ventilation (NPPV) to a patient as part of a passively vented non-invasive ventilation system.

The RT046 is an oronasal full face mask intended to be used in a hospital/institutional environment by trained medical staff with patient monitoring systems in place. It connects to a dual limb breathing circuit via a 22mm female swivel adaptor to receive pressurized breathing gases from an external flow source or ventilator (CPAP or Bi-Level).

The RT046 mask is a prescription only device, provided in a non-sterile state.

The provided document is a 510(k) premarket notification summary for the F&P Nivairo™ RT046 Non-Vented Full Face Mask. It details the device, its intended use, and its comparison to a predicate device, focusing on non-clinical performance data.

Here's an analysis based on your request:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of "acceptance criteria" in the format of a typical performance study with specific device metrics and target values. Instead, it describes general performance testing conducted to demonstrate "substantial equivalence" to a predicate device (RT041). The "reported device performance" is essentially that the RT046's performance was compared to the RT041's and found to be "substantially equivalent," raising no new safety or effectiveness concerns.

However, it does mention the standards the device was evaluated against, which can be seen as implicit acceptance criteria for certain aspects:

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify a "sample size" in terms of number of patients or measurement instances for the non-clinical performance tests. These are typically bench tests. The data provenance is Fisher & Paykel Healthcare Limited, New Zealand. The tests are "non-clinical," implying they were conducted in a lab/bench setting, not on human subjects.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

Not applicable. This is a medical device for respiratory support, and the performance data presented are non-clinical (bench testing) and not related to diagnostic accuracy or human interpretation. Therefore, there's no "ground truth" to be established by experts in this context.

4. Adjudication Method for the Test Set

Not applicable, as there is no expert ground truth or ambiguity to adjudicate for these non-clinical performance tests.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No. The document explicitly states: "Clinical performance testing was not required to demonstrate substantial equivalence for the RT046." This indicates that no MRMC study, or any clinical study involving human readers/users, was performed.

6. Standalone Performance (Algorithm Only Without Human-in-the-Loop Performance)

Yes, in the sense that the performance testing described is focused on the device itself (its mechanical properties, biocompatibility) rather than its interaction with a human user in a clinical effectiveness study. The tests are purely "algorithm only" in that they evaluate the device's inherent characteristics against standards and a predicate, without human variability in effectiveness being a primary measurement.

7. Type of Ground Truth Used

For the non-clinical performance data, the "ground truth" is established by:

• Standards Compliance: Meeting the requirements of international standards like ISO 5356-1, ISO 10993-1, and ISO 17510-2.
• Predicate Device Performance: The performance characteristics of the legally marketed predicate device (RT041) serve as a benchmark for substantial equivalence.

8. Sample Size for the Training Set

Not applicable. There is no mention of a "training set" as this is not an AI/machine learning device. The document describes performance testing of a physical medical device.

9. How the Ground Truth for the Training Set Was Established

Not applicable, for the same reason as point 8.

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