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The Trilogy ™ Delivery System and Trilogy Tx Delivery System are intended to provide stereotactic radiosurgery and precision radiotherapy for lesions, turnors and conditions anywhere in the body when radiation treatment is indicated.

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

The changes to the Trilogy Radiotherapy Delivery System and Trilogy Tx Delivery System provide a modified software algorithm that implements gradual acceleration and deceleration of gantry rotation with direct drive.

All other features of the Trilogy Radiotherapy Delivery System and Trilogy Tx Delivery System remain as cleared by K061140 and K033343, respectively.

This is a 510(k) summary for Modifications to the Trilogy™ Delivery System and Trilogy Tx Delivery System, which are medical charged-particle radiation therapy systems. The provided documents focus on regulatory clearance and do not contain information about acceptance criteria or a study that proves the device meets specific performance criteria.

The submission states: "The changes to the Trilogy Radiotherapy Delivery System and Trilogy Tx Delivery System provide a modified software algorithm that implements gradual acceleration and deceleration of gantry rotation with direct drive." It also explicitly mentions that "All other features of the Trilogy Radiotherapy Delivery System and Trilogy Tx Delivery System remain as cleared by K061140 and K033343, respectively." This suggests that the modifications are software-related for gantry movement control, and the core functional performance criteria would likely have been established and tested during the original clearances (K061140 and K033343).

Therefore, based on the provided text:

1. A table of acceptance criteria and the reported device performance: This information is not present in the provided 510(k) summary. The summary is focused on demonstrating substantial equivalence to predicate devices for a software modification, not on detailed performance specifications or test results for new criteria.
2. Sample size used for the test set and the data provenance: This information is not present in the provided 510(k) summary.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This information is not present in the provided 510(k) summary. Given the nature of the device (radiation therapy system) and the described change (software for gantry control), "ground truth" in the typical medical imaging/AI sense is not applicable here. Performance would be assessed through engineering tests, phantom studies, and potentially clinical validation.
4. Adjudication method for the test set: Not applicable and not present in the provided 510(k) summary.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This device is a radiation therapy delivery system, not an AI-assisted diagnostic or image analysis tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: The device's modification is a software algorithm for gantry control. Its performance would be evaluated within the context of the overall system, likely through engineering tests, and would be considered "standalone" in the sense that the algorithm itself controls the gantry movement. However, the exact performance metrics and testing details are not provided.
7. The type of ground truth used: For a radiation therapy delivery system, ground truth would typically come from physical measurements (e.g., dosimetric measurements with phantoms, mechanical accuracy tests) against established engineering specifications. The exact type is not specified in this document.
8. The sample size for the training set: Not applicable to the information provided. The "training set" concept is usually associated with machine learning or AI models developed from data, which isn't explicitly detailed as part of this software modification.
9. How the ground truth for the training set was established: Not applicable, as no training set is described.

In summary, the provided 510(k) document is a regulatory submission for a software modification to an existing radiation delivery system. It attests to substantial equivalence based on the nature of the change and references prior clearances, rather than presenting detailed performance studies against specific acceptance criteria for the new software feature.

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