(442 days)
The Trilogy Evo ventilator provides continuous or intermittent positive pressure ventilation for the care of individuals who require mechanical ventilation. Trilogy Evo is intended for pediatric through adult patients weighing at least 2.5 kg. The ventilator can measure, display, record, and alarm SpO2, FiO2, CO2, and Pulse Rate data when integrated with the appropriate accessories. The ventilator is suitable for use in institutional, home, and non-emergency transport settings for example wheelchair or personal vehicle. It may be used for both invasive and non-invasive ventilation.
The Trilogy Evo ventilator is a microprocessor controlled blower based pressure control or volume controlled ventilator intended for the care of individuals who require mechanical ventilation. The ventilator is intended to provide continuous or intermittent ventilatory support. The ventilator is suitable for use in institutional, home, and non-emergency transport settings for example wheelchair or personal vehicle. It is applicable for adults and pediatric patients weighing at least 2.5 kg who require the following types of ventilatory support: Control Modes (A/C-PC, A/C-VC), Spontaneous modes (CPAP, PSV), Mixed modes (S/T, SIMV-PC, SIMV-VC), AVAPS-AE modes (AVAPS-AE with PC Breath enabled, with auto backup; AVAPS-AE with PC Breath enabled, without auto backup; AVAPS-AE with PC Breath disabled, with auto backup; AVAPS-AE with PC Breath disabled, without auto backup). In addition to the therapy modes, the Trilogy Evo provides the following major functions: Therapy Features, Power Manaqement, Physiological alarms, Graphical User Interface using a touch screen display, status LEDs and dedicated keys for user input, Bluetooth and USB Communications, Compatibility with various patient interfaces and multiple circuit types, Remote alarm and nurse call capability, Connectivity with hospital monitors, Capability to connect, display and alarm SpO2, FiO2 and ETCO2 monitors, Ventilation with supplemental low flow oxygen or oxygen blender.
The provided text describes the 510(k) premarket notification for the Trilogy Evo Ventilator, demonstrating its substantial equivalence to previously marketed predicate devices. However, the document does not contain information about studies involving AI or machine learning algorithms, human readers, or the establishment of ground truth by expert consensus that would typically be associated with AI/ML device performance evaluation as per your prompt.
Therefore, I cannot extract the specific details requested regarding acceptance criteria, study methodologies for AI performance, sample sizes, expert involvement, or MRMC studies, as these aspects are not present in the provided text, which focuses on the regulatory submission for a traditional mechanical ventilator.
The performance data section details non-clinical tests such as:
- Software verification and validation
- Biocompatibility testing
- General safety, electrical safety, and electromagnetic compatibility (EMC)
- Human factors testing
It explicitly states: "Clinical tests were not required to demonstrate the safety and effectiveness of the Trilogy Evo ventilator. Product functionality has been adequately assessed by non-clinical tests."
This indicates that the performance evaluation for this device did not involve clinical studies with human subjects or methods, like MRMC studies, often used to assess devices that employ AI/ML impacting diagnostic or clinical decision-making.
If you have a document about an AI/ML-based medical device, please provide that, and I would be happy to help describe its acceptance criteria and supporting studies as per your detailed request.
§ 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).