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The RT380/RT385 'Adult Evaqua 2' dual-heated breathing circuits are intended to deliver humidified breathing gases for administration to an adult patient. The RT385 differs only from the RT380 in that the RT385 is supplied with a ventilator pressure line and connector port. Gases available for medical use do not contain sufficient moisture and may damage or irritate the respiratory tract, or desiccate secretions of patients whose supraglottic airways have been bypassed. Thus humidified gases via a heated breathing circuit may be indicated for patients requiring mechanical ventilation, positive pressure breathing assistance, or general medical gases. These gases may be delivered by facemask or through bypassing the upper airways via an endotracheal tube.

The RT380 and RT385 'Adult Evaqua 2' dual-heated breathing circuits are intended as conduits of breathing gas for ventilation of adult patients, and to maintain the temperature of humidified inspired gas.

The RT380/RT385 'Adult Evaqua 2' dual heated breathing circuits are classified as 'Breathing System Heater' according to 21 CFR §868.5270.

The RT380/RT385 breathing circuits form part of a respiratory humidification system in which the inspiratory limb delivers humidified gas to the patient and the expiratory limb carries the expired gas away from the patient. Heater wires in the inspiratory and expiratory limbs minimise the formation of condensate.

The new adult breathing circuits (RT380/RT385) have been developed based on the cleared RT265/RT266 infant breathing circuit device. The RT380/RT385 are dual-heated adult breathing circuits that, like the predicate device (RT265/RT266), utilize corrugated polymer tubing, with a heater wire in both the inspiratory and expiratory limb.

The RT380 and RT385 have a water vapor permeable expiratory limb. Permeability allows water vapor to pass into the environment, minimizing the amount of condensate that might form within the expiratory limb and also minimizing the amount of humidity delivered to a ventilator.

The inspiratory and expiratory limbs of the RT380/RT385 are made using a foaming technique that creates tiny air bubbles in the tube wall. In the case of the inspiratory limb the air bubbles improve the limb thermal insulation properties and thus reduce condensate formation. In the case of the expiratory limb, the air bubbles allow a thick tube wall for robustness against physical damage without compromising the water vapor permeability.

The RT380 and RT385 use the same expiratory limb technology and construction ('Evaqua 2') as the RT265/RT266 expiratory limb, but in an adult sized circuit.

Duration of use for the RT380/RT385 has been verified and labeled for 14 days continuous use, compared with 7 days for the predicate device.

Both the RT380/RT385 and the RT265/RT266 predicate device have been verified and labeled for a shelf life of 5 years.

The provided text describes verification tests that were performed to establish the safety and efficacy of the RT380 and RT385 breathing circuits. However, it does not explicitly state acceptance criteria or provide specific numerical performance results in a way that can be directly presented in a table as requested.

The document uses the phrase "Testing was performed to the same standards as used for the predicate device," implying that the acceptance criteria for the new devices are aligned with those previously established for the predicate device (RT265/RT266). Without access to the predicate device's specific acceptance criteria and detailed test results, a precise table cannot be generated.

Therefore, many sections of your request cannot be fully answered with the information provided in the input text.

Here's a breakdown of what can be inferred or directly stated, and what cannot:

1. Table of Acceptance Criteria and Reported Device Performance:

• Acceptance Criteria: Not explicitly stated with numerical values. The text only mentions "Testing was performed to the same standards as used for the predicate device."
• Reported Device Performance: No specific numerical performance metrics are provided. The document generally states that "Verification tests were performed to establish the safety and efficacy" and "The RT380 and RT385 are considered to be substantially equivalent to the RT265/RT266 breathing circuit."

Therefore, a table cannot be accurately constructed based on the provided text. An example of how it would look if the data were present is shown below, but it would contain "N/A" for direct values from this document.

2. Sample size used for the test set and the data provenance:

• Sample Size for Test Set: Not specified. The document states "Verification tests were performed," but no sample sizes (e.g., number of circuits tested) are given for any of the listed tests.
• Data Provenance: Not specified. No country of origin is mentioned for the testing data, nor is it explicitly stated whether the study was retrospective or prospective. It is implied prospective, as they are "verification tests" for a new device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• This question is not applicable to this type of device (heated breathing circuits). "Ground truth" and "experts" are typically relevant for diagnostic AI/software devices where human interpretation is involved. For a physical medical device like this, performance is established through engineering and biological testing against predefined specifications.

4. Adjudication method for the test set:

• Not applicable for the same reasons as #3.

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:

• Not applicable. This study pertains to a physical medical device, not an AI/software diagnostic tool.

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

• Not applicable. This is a physical medical device, not an algorithm.

7. The type of ground truth used:

• Not applicable in the conventional sense of expert consensus, pathology, or outcomes data for imaging/diagnostic devices. For this device, the "ground truth" for each test category (e.g., condensate performance, humidity performance) would be established by engineering specifications, regulatory standards, and established physical/chemical measurement methods. For instance, "condensate performance" would likely involve measuring the amount of condensate formed under controlled conditions against a predetermined maximum allowable amount.

8. The sample size for the training set:

• Not applicable. This refers to a physical medical device and not a machine learning model that would require a training set.

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

• Not applicable for the same reason as #8.

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