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The Trilogy ™ System with RapidArc is intended to provide stereotactic radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere in the body when radiation treatment is indicated.

The Trilogy ™ System with RapidArc is indicated for stereotactic radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere in the body when radiation treatment is indicated.

The Trilogy System modifications enable the delivery a RapidArc treatment fields that simultaneously vary the intensity of radiation and gantry rotation speed.

All other features of the Trilogy System and remain as cleared by K061140, K033343, and K070094.

The provided text is a 510(k) summary for Varian Medical Systems' Trilogy System with RapidArc. It describes the device, its intended use, and substantial equivalence to a predicate device. However, it does not contain any information about acceptance criteria or a study proving the device meets those criteria, nor any specific performance data.

Therefore, I cannot fulfill your request for:

• A table of acceptance criteria and reported device performance.
• Sample size used for the test set and data provenance.
• Number of experts used to establish ground truth and their qualifications.
• Adjudication method.
• MRMC comparative effectiveness study results or effect size.
• Standalone performance study.
• Type of ground truth used.
• Sample size for the training set.
• How ground truth for the training set was established.

This document focuses on regulatory approval based on demonstrating substantial equivalence to a previously cleared device, not on presenting detailed performance studies against specific acceptance criteria.

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