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The AVEA is intended to provide continuous respiratory support in an institutional health care environment (e.g. hospitals). It may be used on neonatal through adult patients. It should only be operated by properly trained clinical personnel, under the direction of a physician.

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 graphical user interface module (UIM) has a flat panel color LCD with real time charting and digital monitoring capabilities, a touch screen for interaction, membrane kevs 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. Using internal batteries this provides inter-hospital transport as well as back up capability due to loss of AC power. The AVEA may be configured as a conventional ventilator or non-invasive positive pressure ventilator (NPPV). It has been designed to function using commonly available accessories.

The provided document is a 510(k) summary for the AVEA Ventilator, focusing on modifications for Volume Guarantee and Nasal Intermittent Positive Pressure Ventilation. It states that "Performance testing verified that the AVEA Ventilator meets its performance requirements and that this device is substantially equivalent to medical devices currently legally marketed in the United States." However, it does not provide specific details about the acceptance criteria or the study that proves the device meets those criteria, as requested in the prompt.

Therefore, I cannot provide a complete answer to your request based on the provided text. The document confirms that performance testing was done, but it omits the actual results and methodology of that testing.

Here's what I can extract and what is missing based on your request:

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

• Missing from the document. The document states that performance testing "verified that the AVEA Ventilator meets its performance requirements," but it does not list these requirements (i.e., acceptance criteria) or the specific reported device performance against them.

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

• Missing from the document. The document mentions "Performance testing" but does not specify the sample size, data provenance, or whether it was retrospective or prospective.

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 / Missing from the document. This type of information is typically relevant for AI/ML-based diagnostic devices where a "ground truth" needs to be established, often by human experts reviewing medical images or patient data. The AVEA Ventilator is a mechanical ventilator, and its performance testing would likely involve engineering and physiological measurements rather than expert review for "ground truth." Therefore, this information is not relevant in the context of this device or is completely absent.

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

• Not applicable / Missing from the document. Similar to point 3, adjudication methods are usually for resolving discrepancies in expert interpretations, which is not relevant for a mechanical ventilator's performance testing.

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 / Missing from the document. An MRMC study is relevant for diagnostic AI tools involving human readers. This is not applicable to a mechanical ventilator like the AVEA Ventilator.

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

• Not applicable / Missing from the document. This question is also focused on AI/ML algorithms. The AVEA Ventilator has software that implements Volume Guarantee and Nasal Intermittent Mandatory Ventilation, which are automated functions. The document states "software implement Volume Guarantee which is the automated requlation of inspiratory pressure," implying standalone algorithmic function within the device. However, the performance study details for these automated functions are not provided.

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

• Not applicable / Missing from the document. As mentioned in point 3, the concept of "ground truth" in the context of expert review is unlikely to apply to the performance testing of a mechanical ventilator. The ground truth for such a device would typically be derived from engineering specifications, established physiological parameters, and direct measurement against those standards. The specific methods are not detailed.

8. The sample size for the training set:

• Not applicable / Missing from the document. A "training set" typically refers to data used to train an AI/ML model. While the ventilator has "software-driven" functions, the document does not suggest an AI/ML model that would require a distinct training set in the conventional sense. The "training" would be more akin to software development and verification/validation against specifications.

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

• Not applicable / Missing from the document. For the reasons stated in points 7 and 8, this information is not provided and likely not relevant in the AI/ML context.

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The VELA Ventilator is intended to provide continuous or intermittent respiratory support in an institutional health care environment (e.g. hospitals) for individuals who require mechanical ventilation. The ventilator is a restricted medical device intended for use only by qualified trained personnel under the direction of a physician. It may be used on adult and pediatric patients. Specifically, the ventilator is applicable for adult and pediatric patients weighting at least 5 kg (11lb), who require the following types of ventilation support, as prescribed by an attending physician.

• Positive pressure ventilation
• Assist / control, SIMV, or CPAP modes of ventilation
  The ventilator is suitable for use in institutional and transport settings. It is not intended of use in an emergency medical transport ventilator or for home care applications.

A VELA with the CO2 monitoring option is intended to monitor the effectiveness of ventilation. It may be used on adult and pediatric patients. It is suitable for use in a hospital critical care environment, and is a restricted medical device intend for use by qualified trained personnel under the direction of a physician.

The VELA Series Ventilator is a modified Tbird Ventilator and like its predecessor, is an easy to use, self-contained, servo-controlled, software-driven ventilator. It has a dynamic range of breathing gas delivery that provides for pediatric through adult patients. Its revolutionary 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 easy interaction, membrane keys and a dial for changing settings and operating parameters. A precision gas delivery turbine with servo controlled active inhalation and exhalation improves performance over previous generations.

The VELA Series Ventilator may be configured as a conventional ventilator or non-invasive positive pressure ventilator (NPPV). It is easy to clean and its design does not allow liquids to pool on the casing, reducing the likelihood of fluid leakage into the body of the ventilator.

The VELA Series Ventilator base model comes with comprehensive features for the critical care environment. Optional features can be added at time of purchase or at a later date.

The provided text describes the VELA Ventilator and its intended use, but it does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria in terms of accuracy or clinical effectiveness.

The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices rather than proving a device meets specific quantitative performance targets against a defined acceptance criterion.

Here's what can and cannot be extracted from the provided text according to your request:

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

• Not Available: The document does not specify any quantitative acceptance criteria or reported device performance metrics in the way you've outlined (e.g., sensitivity, specificity, accuracy against a gold standard). The "Summary of Testing and Validation" states, "In Summary Performance testing verified that the VELA Ventilator meets it's performance requirements and that this device is substantially equivalent to predicate medical devices currently legally marketed in the United States." This is a general statement and does not provide specific criteria or results.

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

• Not Available: The document does not describe a clinical test set, its sample size, or data provenance. The validation seems to be based on performance testing to ensure it meets requirements for substantial equivalence, not a clinical study with a "test set" in the context of AI/diagnostic device performance.

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/Not Available: Since there is no described test set or study involving "ground truth" establishment by experts (as would be for an AI or diagnostic device), this information is not provided.

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

• Not Applicable/Not Available: As above, no such adjudication method is mentioned.

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/Not Available: The VELA Ventilator is a mechanical ventilator, not an AI-assisted diagnostic or imaging device. Therefore, an MRMC study or assessment of human reader improvement with AI assistance is not relevant or included.

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

• Not Applicable/Not Available: The device is a ventilator, a mechanical medical device, not an algorithm.

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

• Not Applicable/Not Available: Ground truth as typically defined for diagnostic or AI devices is not relevant to the information provided about this mechanical ventilator. The "ground truth" in this context would likely be the accurate delivery of ventilation parameters as measured by engineering tests.

8. The sample size for the training set

• Not Applicable/Not Available: As a mechanical device, there is no "training set" in the machine learning sense.

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

• Not Applicable/Not Available: As above, there is no training set mentioned.

In summary: The provided document is a 510(k) summary for a ventilator, focusing on demonstrating substantial equivalence to existing predicate devices. It describes the device, its intended use, and indicates that performance testing was conducted to verify it meets its requirements. However, it does not detail specific acceptance criteria, study methodologies, or performance metrics in the format typically required for diagnostic or AI-based devices.

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