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Breathing system heaters are defined as a device that is intended to warm breathing gases before they enter a patient's airway.

The Airlife Heated Ventilator and Anesthesia Breathing Circuits are comprised of disposable connectors, tubing, and heating wire assemblies. The circuits are for infant, pediatric and adults.

The provided text is a 510(k) summary for the Airlife® Heated Ventilator and Anesthesia Breathing Circuits. It focuses on establishing substantial equivalence to a predicate device based on intended use and performance attributes. The document does not contain the detailed information required to describe acceptance criteria, a specific study proving device performance against those criteria, or the methodology for a clinical study involving human readers or ground truth establishment.

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

1. Table of acceptance criteria and the reported device performance:

• Acceptance Criteria: Not explicitly stated in terms of specific performance metrics with numerical thresholds. The summary mentions "performance attributes are similar" to the predicate, implying that the device should perform comparably, but no specific criteria or targets are reported.
• Reported Device Performance: Not detailed in the provided text. The document states:

  "All materials used in the fabrication of the Airlife® Heated Ventilator and Anesthesia Breathing Circuits were evaluated through biological qualification safety tests as outlined in ISO 10993 Part-1 "Biological Evaluation of Medical Devices". These materials also were tested in accordance with industry recognized test methods and were found to be acceptable for the intended use."
  This describes testing for materials and states they were found "acceptable," but it doesn't provide performance data for the device itself (e.g., heating efficiency, temperature control, flow resistance).

Therefore, a table cannot be constructed from the provided information.

2. Sample sized 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. The text describes material testing but does not mention a "test set" in the context of a clinical or performance study with a specific sample size 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 information is not provided. There is no mention of a "test set" requiring ground truth established by experts.

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

• This information is not provided. There is no mention of a "test set" or an adjudication process.

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 information is not provided. The device is a heated breathing circuit, not an AI-assisted diagnostic tool, so an MRMC study involving human readers and AI is not applicable here.

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

• This information is not provided. The device is a physical medical device, not an algorithm, so this type of study is not applicable.

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

• This information is not provided as there is no mention of a study requiring ground truth. The "testing" mentioned pertains to biological safety and industry-recognized methods for materials, not clinical outcomes or expert-adjudicated data.

8. The sample size for the training set:

• This information is not provided. There is no mention of a "training set" as this device is not a machine learning model.

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

• This information is not provided as there is no mention of a "training set" or ground truth for it.

In summary, the provided 510(k) summary focuses on demonstrating substantial equivalence based on intended use and material safety, not on specific performance criteria or clinical study results with detailed methodologies. The context is a medical device from 1999, which aligns with less extensive reporting requirements for performance studies at that time compared to modern AI/diagnostic device submissions.

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