(46 days)
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:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified in the document. | The document states: "Performance testing verified that the TBird VELA Ventilator meets it's performance requirements." No specific performance metrics or values are provided. |
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.
§ 868.5895 Continuous ventilator.
(a)
Identification. A continuous ventilator (respirator) is a device intended to mechanically control or assist patient breathing by delivering a predetermined percentage of oxygen in the breathing gas. Adult, pediatric, and neonatal ventilators are included in this generic type of device.(b)
Classification. Class II (performance standards).