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The Trilogy Series of Ventilators (with or without the oximetry interface kit) are intended to provide continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation with or without air/oxygen blending. Trilogy is intended for pediatric through adult patients weighing at least 5 kg (111bs). The Oximetry Interface kit is intended to measure functional oxygen saturation of arterial hemoglobin (%SpO2) and pulse rate.

The device is intended to be used in the home, hospitals and institutions, and portable applications such as wheelchairs and gurneys. It may be used for both invasive and noninvasive ventilation. It is not intended to be used as a transport ventilator.

The Respironics Trilogy Series Ventilators are mixed (dual) mode ventilators in that they provide both pressure support and volume modes of therapy. They are intended to provide therapy for a patient as he progresses through his disease state from non-invasive bi-level to invasive bi-level ventilation with an assured tidal volume. The Trilogy Series of Ventilators consist of three separate model configurations: Trilogy 100, Trilogy 200, and Trilogy 202 (O2). The Trilogy Oximetry Interface Kit can be used with the Masimo Oximetry Module and the Respironics Trilogy Ventilators to measure functional oxygen saturation of arterial hemoglobin (%SpO2) and pulse rate. The kit consists of the Masimo High Performance/Low Power Oximetry Module, Masimo LNCS Series PULSE Oximeter Sensors, Trilogy Oximetry Interface Cable, and Trilogy Oximetry Interface Kit Instructions for Use. Data from the oximeter is transferred to the Trilogy Series Ventilator Support System via the Cable and displayed on the monitor panel and stored on the SD card.

The provided text describes a 510(k) premarket notification for device modifications, specifically adding an Oximetry Accessory to the Philips Respironics Trilogy Series Ventilators. While it details the device, its intended use, and compatibility, it does not include specific acceptance criteria or performance results from a study proving the device meets those criteria.

The document states that "The Respironics Trilogy Series Ventilator With Oximetry (i.e. the Trilogy Oximetry Interface Kit) met the required performance criteria and functioned as intended" (Section 8), and "the results of testing demonstrates the device to be substantially equivalent to the predicate devices in terms of meeting performance criteria and functioning as intended" (Section 10). However, it does not explicitly define what those performance criteria are or present the actual test results.

Therefore, the requested details about acceptance criteria, device performance, sample sizes, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone algorithms, and ground truth for training are not available in the provided text.

The document lists several standards (e.g., ISO 9919 for pulse oximeter equipment, IEC 60601 series for medical electrical equipment) that the device complies with, implying that performance criteria related to these standards were met. However, the exact thresholds and measured performance are not presented.

Summary of what cannot be provided from the text:

1. Table of acceptance criteria and reported device performance: Not explicitly stated.
2. Sample size used for the test set and data provenance: Not provided.
3. Number of experts used to establish the ground truth for the test set and their qualifications: Not provided.
4. Adjudication method for the test set: Not provided.
5. Multi-reader multi-case (MRMC) comparative effectiveness study information: Not mentioned. The device is an oximetry accessory, not an AI-assisted diagnostic tool for which MRMC studies are typically performed.
6. Standalone (i.e., algorithm only without human-in-the-loop performance) study information: Not applicable to this type of device, which is an oximetry module.
7. Type of ground truth used: Not provided.
8. Sample size for the training set: Not provided.
9. How the ground truth for the training set was established: Not provided.

The document focuses on substantiating equivalence to predicate devices and adherence to relevant standards for safety and effectiveness, rather than detailing the specific performance metrics and studies as one might find for a machine learning or diagnostic imaging device.

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