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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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The Trilogy™ Radiotherapy Delivery System and Trilogy Tx Delivery System are intended to provide stereotactic radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere in the body when radiation treatment is indicated.
The Trilogy™ Radiotherapy 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 Trilogy TM Radiotherapy Delivery System, K033343, is a dual-energy, high dose rate medical linear accelerator optimized for 3D conformal radiation therapy, intensity-modulated radiation therapy and stereotactic applications. The Trilogy system allows for stereotactic treatments that may be intracranial or extracranial and consist of single-session or multisession ("fractionated") treatment delivery.

The provided text is a 510(k) Summary for the Varian Medical Systems' Trilogy Radiotherapy Delivery System. It primarily focuses on demonstrating substantial equivalence to predicate devices rather than providing a detailed study description with acceptance criteria and performance metrics for the new device itself.

Therefore, many of the requested sections (e.g., sample size for test set, number of experts for ground truth, adjudication method, MRMC study, training set details) are not explicitly available in this document.

However, I can extract information related to the acceptance criteria for specific technical specifications.

Here's the breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The device demonstrates performance equivalent to its predicate device, the Varian Medical Systems' Trilogy Radiotherapy Delivery System (K033343), and the CyberKnife (K041315) for its intended use and indications. The acceptance criteria can be inferred from the specifications listed in the "Substantial Equivalence Comparison" table.

Study Description and Specifics (Based on Available Information):

The document does not detail a specific new study to demonstrate device performance in terms of clinical outcomes or complex image analysis. Instead, it relies on demonstrating substantial equivalence to previously cleared devices (predicates). This means the "study" is primarily a comparison of technical specifications and intended use against the predicates.

2. Sample size used for the test set and the data provenance:

• Not applicable / Not explicitly stated. The document is a 510(k) summary focused on substantial equivalence by comparing technical specifications. It does not describe a clinical performance study with a "test set" in the context of image analysis or diagnostic accuracy. Data provenance would relate to the predicate devices' prior approvals.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not applicable / Not explicitly stated. No expert panel or ground truth establishment is described for a clinical test set in this document.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

• Not applicable / Not explicitly stated. As there is no clinical test set described in the context of diagnostic or treatment efficacy, there is no adjudication method detailed.

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:

• No. This document is for a radiotherapy delivery system, not an AI-assisted diagnostic or treatment planning software requiring MRMC studies for human reader performance.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:

• No. This document does not describe an AI algorithm or a standalone algorithmic performance study. It's for a medical linear accelerator.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

• Not applicable / Not explicitly stated. The "ground truth" in this context is the established safety and effectiveness of the predicate devices and their technical specifications, to which the new device is compared. For technical specifications like "Isocenter

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The Trilogy™ Radiotherapy Delivery System is a radiation therapy accelerator intended deliver megavoltage x-ray treatments for conventional radiotherapy (three dimensional conformal radiotherapy and intensity modulated radiotherapy) and stereotactic radiosurgery and radiotherapy. Stereotactic treatments are intended for therapy of lesions, e.g., arteriovenous malformations, primary tumors and metastases. Stereotactic treatments may be intracranial or extracranial and consist of single-session or fractionated delivery.

The modified 2300C/D, which will now be called the Trilogy™ Radiotherapy Delivery System, will include stereotactic functionality and remote couch motions as new features. The Trilogy™ Radiotherapy Delivery System is an image-guided, dual-energy, high-dose medical linear accelerator optimized for 3D conformal radiation therapy, intensity-modulated radiation therapy and stereotactic applications. The stereotactic applications include single-session radiosurgery, fractionated stereotactic radiation therapy and intensity modulated radiosurgery. The Trilogy™ system delivers megavoltage x-ray mountated fucilobargery. The treatment of cancer. The Treatment of cancer. The Trilogy™ system includes a dynamic multileaf collimator (Millennium™ MLC with Dynamic MLC software), electronic portal imaging device (AS1000™), asymmetric jaws, enhanced dynamic wedge, a stereotactic treatment delivery mode (6MV, 1000 MU/min, maximum field size of 15cm x 15cm) and remote couch motion. There will be a 0.75mm radius isocenter for all three rotational axes, which include the gantry, collimator and table axes. The Trilogy™ system will allow for stereotactic treatments that may be intracranial or extracranial and consist of single-session or fractionated delivery. Stereotactic treatments are intended for therapy of lesions, e.g., arteriovenous malformations, primary turnors and metastases.

The provided text is a 510(k) Summary for the Varian Medical Systems Trilogy Radiotherapy Delivery System. This document focuses on demonstrating substantial equivalence to predicate devices and describes the device's features and intended use. It does not contain information about acceptance criteria or specific studies proving the device meets those criteria in the way a clinical performance study for a diagnostic AI device would.

The Trilogy Radiotherapy Delivery System is a medical linear accelerator for radiation therapy, not a diagnostic AI device that generates a "reported device performance" against "acceptance criteria" through a traditional clinical study with a test set, ground truth, and expert adjudication in the manner typically associated with AI/ML medical devices.

Therefore, I cannot populate the requested table and sections. The 510(k) pathway for this device, approved in 2003, predates the typical framework for evaluating AI/ML medical devices. The "study" referenced in K03343 refers to engineering and performance testing to ensure the device operates as intended and meets safety standards, not a clinical study to establish diagnostic performance.

Key reasons for not being able to fulfill the request as specified:

• Type of Device: The Trilogy system is a treatment delivery device (a linear accelerator), not a diagnostic AI device. Its regulatory submission focuses on engineering specifications, safety, and substantial equivalence to existing similar devices (predicates).
• Approval Year: The K03343 submission was approved in 2003, well before specific regulatory guidance and common practices for AI/ML device evaluation were established, especially regarding clinical performance metrics like sensitivity, specificity, or reader improvement.
• Lack of Performance Data: The provided 510(k) summary does not include data like sensitivity, specificity, AUC, or other performance metrics typically associated with AI/ML diagnostic tools. Instead, it describes technical features (e.g., isocenter radius, maximum field size, dose rates) and clinical applications (types of radiation therapy and lesions).
• No "Ground Truth" for Performance: For a treatment delivery device, "ground truth" isn't established in the same way as for a diagnostic device (e.g., pathology for a cancer detection AI). Validation focuses on accurate and precise delivery of radiation according to planned parameters.
• No "Test Set" of Patients/Images: The concept of a "test set" and "training set" with expert-adjudicated ground truth, as posed in the prompt, does not apply to this type of device according to the provided documentation.

In summary, the provided document describes a traditional medical device (radiation therapy accelerator) and its 510(k) clearance process, which does not involve the specific types of performance studies, acceptance criteria, or ground truth methodologies requested for an AI/ML device.

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