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The Respironics Trilogy 202 system provides continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation with or without air/oxygen blending. Trilogy 202 is intended for pediatric through adult patients weighing at least 5 kg (11 lbs.).

The device is intended to be used in hospitals and institutions, and for portable applications such as wheelchairs and gurneys only when in an institutional setting. It may be used for both invasive and non-invasive ventilation. It is not intended to be used as a transport ventilator.

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The provided text is a 510(k) premarket notification letter for the Trilogy 202 Ventilator. This document is a regulatory approval letter from the FDA. It does not contain information about:

• Acceptance criteria table or reported device performance for a specific study.
• Sample sizes, data provenance, number of experts for ground truth, or adjudication methods for a test set.
• Whether a multi-reader multi-case (MRMC) comparative effectiveness study was done, or its effect size.
• Whether a standalone algorithm performance study was done.
• The type of ground truth used for performance evaluation.
• The sample size for a training set or how its ground truth was established.

This document primarily states that the device has been reviewed and determined to be substantially equivalent to legally marketed predicate devices, and outlines regulatory compliance requirements. It does not delve into the specific studies or data used to demonstrate performance against acceptance criteria.

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