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The AVEA is intended to provide continuous respiratory support in an institutional health care environment. It may be used on adult, pediatric, and neonatal patients. Properly trained clinical personnel, under the direction of a physician should only operate it.

The AVEA is a servo-controlled, software-driven ventilator. It has a dynamic range of breathing gas delivery that provides for neonatal through adult patients. Its user interface module provides maximum flexibility with simple operator interaction. It has a flat panel color LCD with real time charting and digital monitoring capabilities, a touch screen for interaction, membrane keys and a dial for changing settings and operating parameters. It also has an internal gas delivery system with servo controlled active inhalation and exhalation functions. The AVEA may be configured as a conventional ventilator or non-invasive positive pressure ventilator (NPPV). It has been designed to function using most commonly available accessories.

The provided text is a 510(k) summary for the AVEA Ventilator. It describes the device, its intended use, and states that performance testing and analysis verified the device meets its requirements and is substantially equivalent to legally marketed predicate devices. However, it does not contain the specific details required to complete your request: acceptance criteria, reported device performance metrics, and the specifics of a study proving those criteria were met.

Therefore, I cannot provide a table of acceptance criteria and reported device performance or details about the study, as that information is not present in the provided document.

Here's a breakdown of what can be extracted and what cannot:

A. Information NOT present in the document:

1. A table of acceptance criteria and the reported device performance: The document states "Performance testing and analysis will have verified that the AVEA Ventilator meets its performance requirements," but it does not list these specific requirements or the results.
2. Sample size used for the test set and the data provenance: Not mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as there's no mention of a diagnostic AI component requiring ground truth from experts. The device is a ventilator.
4. Adjudication method: Not applicable.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not mentioned, and generally not applicable for a device like a ventilator.
6. If a standalone study (i.e. algorithm only without human-in-the-loop performance) was done: Not mentioned, and not a typical study for a ventilator.
7. The type of ground truth used: Not applicable in the context of a ventilator's performance validation.
8. The sample size for the training set: Not applicable as no AI/algorithm training is explicitly described for a diagnostic purpose.
9. How the ground truth for the training set was established: Not applicable.

B. Information that can be inferred or stated from the document:

• Study type: The document generally refers to "Performance testing and analysis" and "Validation" which are typical for medical device clearance processes to ensure the device performs as intended and is safe and effective. It's not a diagnostic AI study.
• Purpose of the study: To demonstrate that the AVEA Ventilator meets its performance requirements and is substantially equivalent to predicate devices.
• Predicate Devices: A list of 7 predicate ventilators from Puritan Bennett, Drager, SIEMENS, Bear Medical Systems, Bird Products Corporation, and DATEX-OHMEDA is provided.

In summary, the provided 510(k) summary for the AVEA Ventilator does not contain the detailed study results, acceptance criteria, or methodological specifics typically found in a clinical study report for an AI/diagnostic device that would allow me to populate your request. It primarily focuses on the regulatory submission process and substantial equivalence to existing devices.

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