(265 days)
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:
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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.
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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.
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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.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- This is not applicable.
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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.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- This is not applicable.
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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.
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The sample size for the training set:
- This is not applicable as there is no AI component or a "training set" mentioned.
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How the ground truth for the training set was established:
- This is not applicable.
§ 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).