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Servo-air Lite Ventilator System is an assist ventilation in spontaneously breathing patients who require mechanical ventilation due to respiratory failure or chronic respiratory insufficiency. It offers noninvasive ventilation, invasive ventilation, and respiratory monitoring.

Servo-air Lite Ventilator System is intended for adult and pediatric patients weighing 15 kg and above.

Servo-air Lite Ventilator System is to be used only by healthcare professionals.

Servo-air Lite Ventilator System is to be used only in professional health care facilities and for transport within these facilities. It is not intended for transport between health care facilities.

The Servo-air Lite Ventilator System consists of a Patient Unit where gases are mixed and administered, and a User Interface where the settings are made and ventilation is monitored.

The Servo-air Lite Ventilator System is based on the cleared reference device Servo-air Ventilator System (K192604), with additions based on reference device Servo-u Ventilator System (K201874).

The ventilator delivers controlled or supported breaths to the patient, with constant pressure, using a set oxygen concentration. The ventilator can also deliver High Flow therapy with a constant flow.

Servo-air Lite contains a dedicated controller circuit for the Aerogen Solo nebulizer (included as standard).

Accessories for CO2 monitoring are available as options.

The Servo-air Lite Ventilator System will produce visual and audible alarms if any parameter varies beyond pre-set or default limits and log alarm recordings.

The system contains provisions for battery modules to supply the system in the case of mains power failure or during intra-hospital transport.

The provided text describes a 510(k) submission for the Servo-air Lite Ventilator System, which is a medical device and not an AI/ML-based device. Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, and training set information is not applicable in the context of an AI/ML device.

The document discusses non-clinical testing and performance for the ventilator system, focusing on:

• Software: Code review, static code analysis, unit tests, and integration tests.
• Performance: System testing, regression testing, free user testing, and waveform testing.
• Biocompatibility: Volatile Organic Compounds, Particulate Testing, Leachable testing.
• Human Factors Validation Testing.
• Compliance with various product standards (e.g., ANSI/AAMI ES 60601-1, IEC 60601-1-2) and biocompatibility standards (AAMI/ANSI/ISO 10993-1).

The conclusion states that the device is substantially equivalent to the predicate device (Respironics V60 K102985) based on equivalent indications for use and that no new questions of safety and effectiveness are raised. They have conducted risk analysis and performed necessary verification and validation activities to demonstrate that the design output meets the design input requirements and appropriate product standards.

However, the document does not provide specific acceptance criteria in a table or detailed results of these tests that would typically be presented for an AI/ML device's performance metrics like sensitivity, specificity, or AUC.

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