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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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The TBird VELA Ventilator is intended to provide continuous or intermittent mechanical ventilatory support for individuals who require mechanical ventilation. The ventilator is a restricted medical device intended for use by qualified, trained personnel under the direction of a physician. Specifically, the ventilator is applicable for adult and pediatric patients weighing at least 10 kg (22 lbs.), who require the following general types of ventilatory support, as prescribed by an attending physician:

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

The TBird VELA Ventilator employs a turbine gas delivery system along with microprocessor control to provide support for pediatric to adult patients. Capable of delivering clinically advanced modes of ventilation like Pressure Support with an internal battery or AC power the TBird VELA Ventilator has an extensive patient range.
The TBird VELA Ventilator ventilator pneumatic system is an electromechanical system comprised of four major subsystems, each containing several components. These systems include the flow delivery system, the exhalation system, the safety system and the inspiratory hold valve.
This electromechanical system controls all inspiratory flow to the patient. The exhalation system controls the flow of gas from the patient's lungs during the exhalation phase. The mechanical safety system ensures that the patient can breath spontaneously from room air and that the patient pressure is limited to a maximum value in the event of a ventilator malfunction. When activated, the inspiratory hold valve blocks flow between the flow delivery system and the patient.
The TBird VELA Ventilator ventilator electronic system is comprised of several subsystems, each containing numerous components. These subsystems include the Graphical User Interface System, the Power System, the Main Controller System, Exhalation, and Flow Delivery systems. The Display System is comprised of SVGA and Touchscreen. The Main Controller System is comprised of three Pressure Transducers, an Analog-to-Digital Converter, two Digital-to-Analog Converters, the Input-Output Processor, Solenoid Valves, and the Watchdog and Hardware Fault Monitors. The Power System conditions and controls energy from the AC input, the internal battery, and the option of external battery pack. The ventilator operates from this source, as well as recharging the internal battery.

The provided document, K032451, is for a medical device (TBird VELA Ventilator) and details modifications to an already cleared device. It primarily focuses on demonstrating substantial equivalence to predicate devices and verifying performance requirements.

Therefore, the requested information regarding acceptance criteria, study details, expert involvement, and specific ground truth methodologies for an AI device is not applicable to this submission. This document describes a ventilator, which is a hardware medical device, not an AI/ML-driven software device.

Specifically:

1. A table of acceptance criteria and the reported device performance: Not applicable. The document states "Performance testing verified that the TBird VELA Ventilator meets its performance requirements," but does not present a table of specific acceptance criteria or quantitative performance metrics in the way one would for an AI model. The verification is at a system level for a hardware device.
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 refers to a clinical study for an AI algorithm, not the engineering performance verification of a ventilator.
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. This pertains to AI model evaluation, not hardware device performance.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. This pertains to AI model evaluation.
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 pertains to AI model evaluation, specifically human-in-the-loop performance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This pertains to AI model evaluation.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable. This pertains to AI model evaluation.
8. The sample size for the training set: Not applicable. This pertains to AI model training.
9. How the ground truth for the training set was established: Not applicable. This pertains to AI model training.

The document indicates that "Performance testing verified that the TBird VELA Ventilator meets it's performance requirements and that this device is substantially equivalent to medical devices currently legally marketed in the United States." This implies that internal engineering and functional tests were conducted to ensure the device performs as intended and meets relevant safety and effectiveness standards for a ventilator, likely against established benchmarks for similar devices. However, the specific details of these performance requirements and test outcomes are not provided in this summary.

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The TBird VELA Ventilator is intended to provide continuous or intermittent mechanical ventilatory support for the care of individuals who require mechanical ventilation. The ventilator is a restricted medical device intended for use by qualified, trained personnel under the direction of a physician. Specifically, the ventilator is applicable for adult and pediatric patients weighing at least 10 kg (22 lbs.), who require the following general types of ventilatory support, as prescribed by an attending physician:

• Positive pressure ventilation .
• Assist/Control, SIMV, CPAP modes of ventilation .

The ventilator is suitable for use in institutional and transport settings. It is not intended for use as an emergency medical transport ventilator.

The TBird VELA Ventilator employs a turbine gas delivery system along with microprocessor control to provide support for pediatric to adult patients. Capable of delivering clinically advanced modes of ventilation like Pressure Support with an internal battery or AC power the TBird VELA Ventilator has an extensive patient range.

The TBird VELA Ventilator ventilator pneumatic system is an electromechanical system comprised of four major subsystems, each containing several components. These systems include the flow delivery system, the exhalation system, the safety system and the inspiratory hold valve.

This electromechanical system controls all inspiratory flow to the patient. The exhalation system controls the flow of gas from the patient's lungs during the exhalation phase. The mechanical safety system ensures that the patient can breath spontaneously from room air and that the patient pressure is limited to a maximum value in the event of a ventilator malfunction. When activated, the inspiratory hold valve blocks flow between the flow delivery system and the patient.

The TBird VELA Ventilator ventilator electronic system is comprised of several subsystems, each containing numerous components. These subsystems include the Graphical User Interface System, the Power System, the Main Controller System, Exhalation, and Flow Delivery systems. The Display System is comprised of three Alarm Setpoint Displays, seven Control Setpoint Displays, up to forty-eight Message Display characters, up to twentyfive Discrete Indicators, and a bargraph style Manometer. The Main Controller System is comprised of three Pressure Transducers, an Analog-to-Digital Converter, two Digital-to-Analog Converters, the Input-Output Processor, Solenoid Valves, and the Watchdog and Hardware Fault Monitors. The Power System conditions and controls energy from the AC line input, the internal battery, and the optional external battery pack. When energy is available from the AC line, the ventilator operates from this source, as well as recharging the internal battery.

The manufacturer states that "Performance testing verified that the TBird VELA Ventilator meets it's performance requirements and that this device is substantially equivalent to medical devices currently legally marketed in the United States."

However, this submission does not provide any specific acceptance criteria or detailed results of the performance testing. It only makes a general statement about meeting performance requirements and substantial equivalence.

Therefore, many of the requested details cannot be extracted from the provided text.

Here is a summary of what can and cannot be provided based on the given document:

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

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

• Sample Size for Test Set: Not specified.
• Data Provenance: Not specified (e.g., country of origin, retrospective/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):

• Number of Experts: Not specified.
• Qualifications of Experts: Not specified.

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

• Adjudication Method: Not specified.

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:

• MRMC Study: Not mentioned or implied. The device is a ventilator, not an AI-assisted diagnostic tool for human readers.

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

• This question is not entirely applicable in the context of a ventilator. The "performance testing" would likely refer to the device's functional performance in delivering ventilation according to its specifications, rather than an algorithm's diagnostic performance. No details are given about the methodology of this testing.

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

• Ground Truth: Not specified. For a ventilator, "ground truth" would generally refer to established engineering standards, physiological measurements, and clinical outcomes for evaluating its performance. However, no details on how "performance requirements" were assessed are provided.

8. The sample size for the training set:

• Sample Size for Training Set: Not applicable/not specified. Ventilators do not typically have "training sets" in the same way AI algorithms do. Their development involves engineering design, prototyping, and testing against specified performance criteria.

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

• Ground Truth for Training Set: Not applicable/not specified. (See point 8).

In summary, the provided document is a 510(k) summary for a ventilator, focusing on its description, intended use, and substantial equivalence to predicate devices. It states that performance testing was conducted to verify that the device meets its requirements, but it does not provide any specific details about the acceptance criteria, study design, sample sizes, or results of that testing.

Ask a specific question about this device