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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 (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 Nivairo™ RT047 Vented Hospital Full Face Mask, Anti-Asphyxiation Valve Version (referred as RT047) is a vented hospital full face mask with an anti-asphyxiation valve for use with single limb circuits. The RT047 is a single use device intended for use as an accessory to deliver non-invasive positive pressure ventilation (NPPV) to a patient as passively vented non-invasive ventilation system. The RT047 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 Nivairo™ RT047 Vented Hospital Full Face Mask, Anti-Asphyxiation Valve Version. It does not contain information about a study that tests the device's performance against acceptance criteria in the context of an AI/human reader study.

Instead, the document focuses on demonstrating substantial equivalence of the RT047 mask to a previously cleared predicate device (RT045) based on non-clinical performance data and technological characteristics.

Therefore, I cannot provide the requested information regarding acceptance criteria and a study that proves the device meets those criteria for an AI-related context because this document pertains to a medical device that is not an AI/ML-enabled product. The device is a full face mask, an accessory to ventilators.

The document explicitly states:

• "Clinical performance testing was not required to demonstrate substantial equivalence for the RT047." (Page 5)

It also does not mention any AI component, human readers, ground truth establishment by experts, or MRMC studies.

Here's an analysis of the provided information from the perspective of the document's content:

1. A table of acceptance criteria and the reported device performance:

   • The document lists several non-clinical tests performed (e.g., Dead Space Testing, Pressure Drop and Resistance to Flow Testing, CO2 Testing, Venting Leak Rate, Biocompatibility testing). However, it does not explicitly provide a "table of acceptance criteria" with specific numerical targets and the device's reported performance against each. It states that these tests demonstrate "substantial equivalence" and that "device design changes, compared to the predicate do not raise new questions of safety or effectiveness." This implies the device met the expected performance within these tests, likely by being comparable to the predicate or within established safety limits, but the specific criteria and results are not detailed in this summary.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

   • This information is not provided in the document. The non-clinical tests are described generically without details on sample sizes or data provenance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

   • This is not applicable as the document does not describe a study involving expert establishment of ground truth.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

   • This is not applicable.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

   • This is not applicable. The device is a physical medical mask, not an AI system.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

   • This is not applicable.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

   • This is not applicable. The document refers to non-clinical performance data for substantial equivalence, not ground truth for an AI task.

8. The sample size for the training set:

   • This is not applicable as there is no AI component or a "training set" mentioned.

9. How the ground truth for the training set was established:

   • This is not applicable.

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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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The Fisher & Paykel Healthcare single patient use masks are intended for use as an accessory to ventilators to enable noninvasive 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 Nivairo™ RT045 Non-Vented Hospital Full Face Mask Anti-Asphyxiation Valve (herein referred to as RT045) is a non-vented hospital full face mask with anti-asphyxiation valve for use with single limb circuits. The RT045 is a single use device intended to deliver noninvasive positive pressure ventilation (NPPV) to a patient as part of a passively vented noninvasive ventilation system.

The RT045 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 single 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 RT045 mask is a prescription only device, provided in a non-sterile state.

I am sorry, but the provided text is a 510(k) premarket notification for a medical device (Nivairo™ RT045 Non-Vented Hospital Full Face Mask Anti-Asphyxiation Valve). This document primarily focuses on establishing substantial equivalence to a predicate device based on technological characteristics and non-clinical performance data.

The document states: "Clinical performance testing was not required to demonstrate substantial equivalence for the RT045."

Therefore, I cannot provide information on:

• Acceptance criteria and device performance based on a study of the device's effectiveness in clinical use. The document does not describe such a study.
• Sample size used for the test set and data provenance.
• Number of experts used to establish ground truth and their qualifications.
• Adjudication method.
• Multi-reader multi-case (MRMC) comparative effectiveness study results.
• Standalone (algorithm-only) performance.
• Type of ground truth used (expert consensus, pathology, outcomes data, etc.).
• Sample size for the training set.
• How the ground truth for the training set was established.

The document does mention that non-clinical performance data was conducted to demonstrate substantial equivalence. It refers to:

• Performance testing of the RT045 compared to the RT040 (predicate device).
• Evaluations against standards:
  • ISO 5356-1:2004 Anaesthetic and respiratory equipment- Conical connectors: Part 1: Cones and sockets.
  • ISO 10993-1:2009 Biological Evaluation of medical devices - Part 1: Evaluation and testing within a risk management process.
  • Clauses 5.3 and 5.5 of ISO 17510-2:2007 Sleep Apnoea Breathing Therapy- Part 2: Masks and Application Accessories.

However, the specific "acceptance criteria" and "reported device performance" in relation to these non-clinical tests are not detailed in the provided text in a way that would allow for a table similar to what you requested for clinical studies. The document only states that "These data demonstrates substantial equivalence of the RT045 to the RT040. The results of the comparative bench testing do not raise any new questions regarding safety or effectiveness for the RT045."

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