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HFT150 is for spontaneously breathing adult and pediatric patients (10 kg and up) who would benefit from receiving high flow warmed and humidified respiratory gases. The flow may be from 2 - 60 L/min depending on the patient interface. HFT150 is used in hospital and professional healthcare environments.

The HFT150 is a heated humidifier with integrated flow source and a heated breathing tube to deliver warmed and humidified gas flow to a patient. The HFT150 includes an integrated oxygen module, delivering an oxygen range of 21% to 100% to the patients. The HFT150 humidifier is comprised of two connected functional units. One is a motorized blower assembly that provides air flow and the delivery of supplemental oxygen to patients via an integrated oxygen module. The blower speed is directly related to total delivered flow and is controlled by software with a flow sensor. The blower assembly output connects directly to an integrated humidification tub. The second functional unit of the HFT150 is a heated humidifier. The tub is integral to the HFT150. Software monitors ambient temperature, humidity, and flow to optimize the humidity delivery to the patient and minimize condensation in the patient circuit. The HFT150 is protected from contaminants and pathogens by an integral anti-bacterial filter. The nasal cannulas, heated tubes, and water tubs are disposable and are for single use only. The HFT150 may be operated by nurses, respiratory therapists, or doctors and water tubs are disposable and are for single use only. The HFT150 may be operated by nurses, respiratory therapists, or doctors.

This document is a 510(k) summary for the HFT150, a respiratory gas humidifier. It focuses on demonstrating substantial equivalence to a predicate device, the AIRVO 2 Series Humidifier, rather than detailing the acceptance criteria for a specific AI algorithm or its performance in a clinical study. Therefore, most of the requested information regarding AI device performance, sample sizes for test and training sets, expert qualifications, and ground truth establishment is not present in this document.

However, I can extract the general testing summary which outlines the types of evaluations performed on the HFT150 device to ensure its safety and performance, which are analogous to acceptance criteria in a broader sense.

Here's a breakdown of what information is available based on your request:

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

The document does not provide a table of specific numerical acceptance criteria for performance parameters (e.g., specific humidity levels or temperature accuracy) alongside reported device performance for the HFT150. Instead, it lists the standards to which the device was tested, implying that the acceptance criteria for these tests were meeting the requirements of those standards.

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

Not applicable. This document refers to device verification and validation testing against engineering standards rather than clinical studies with patient data.

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)

Not applicable. Ground truth establishment by experts is typically associated with AI/ML algorithm validation using clinical data, which is not the subject of this 510(k) summary.

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

Not applicable. Adjudication methods are used in clinical studies for establishing ground truth, which is not described here.

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 document does not describe an AI-assisted device or MRMC study.

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

Not applicable. This document does not describe an AI/ML algorithm.

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

Not applicable. The "ground truth" for the device, in this context, is its adherence to the performance and safety specifications outlined in the referenced standards (e.g., "electrical safety compliance," "biocompatibility material standards," "flow rate accuracy"). These are verified through engineering and laboratory testing.

8. The sample size for the training set

Not applicable. There is no mention of an AI algorithm or a training set.

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

Not applicable. There is no mention of an AI algorithm or a training set.

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