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The Fisher & Paykel Healthcare RT019 Inspiratory/Expiratory Filter is intended for use between a ventilator and a breathing circuit. Its function is to remove microbiological and particulate matter from gases entering and/or exiting a breathing circuit. The RT019 is intended to be connected to the ventilator inspiratory and/or expiratory ports. It is not directional in terms of flow and is a single use device.

The Fisher & Paykel Healthcare RT019 Inspiratory/Expiratory Filter is classified as a The Fisher & Tayker Ticannoure N1009-12-1 CFR §868.5260. It is intended to be Blaced at the machine end of a ventilator breathing circuit, to remove microbiological and particulate matter from the gases in a breathing circuit. The RT019 filter has a dual-walled translucent thermoplastic enclosure with aligned connector ports and perpendicular filter media. Its total length is 78 mm (3.1 in) with a maximum cross section diameter of 67 mm (2.6 in), and a mass of 23 g (0.81 oz). It has maximuli Cross scetton Giameer of 07 mm (1:40 conical tapers. The filter uses an electrostatic, hydrophobic, depth-type filter media.

The provided text does not describe the acceptance criteria and the study that proves a device meets them in the way requested. Instead, it is a 510(k) summary for a medical device (Fisher & Paykel Healthcare RT019 Inspiratory/Expiratory Filter), which focuses on demonstrating substantial equivalence to a predicate device rather than presenting detailed performance acceptance criteria and a study to meet them.

Here's an analysis of why the requested information cannot be extracted from the provided text:

• No detailed acceptance criteria or performance data: The document states, "No additional tests were performed on the RT019 filter as it is identical to the predicate device (RT020). A change in the indications for use does not affect the filter's safety, efficacy or performance." This means there's no specific study for the RT019 presented, nor are there explicit acceptance criteria for its performance.
• Focus on substantial equivalence: The core argument is that the RT019 is "identical to the predicate device in every physical aspect" and therefore shares "the same technological characteristics" and "safety, effectiveness and performance."
• Lack of AI/algorithm specific information: The device described is a physical filter, not an AI or algorithm-based system. Therefore, questions related to test sets, data provenance, ground truth, experts, adjudication methods, MRMC studies, standalone performance, or training sets are not applicable to this document.

In summary, the provided text does not contain the information necessary to fulfill the request as it describes a physical medical device asserting substantial equivalence to a predicate device, rather than an AI/algorithm-driven device with performance studies against acceptance criteria.

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