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

The External System Gating Interface is indicated for use in exporting beam information to external gating devices.

The Trilogy System modifications enable the export of beam information to external gating devices.

All other features of the Trilogy System and remain as cleared by K033343, K061140, K070094 and 072916.

This 510(k) submission (K081188) for "Trilogy™ with External System Gating Interface" is for modifications to an existing radiotherapy delivery system. It primarily focuses on the ability to export beam information to external gating devices. As such, the concept of "acceptance criteria" and "device performance" in relation to clinical efficacy or diagnostic accuracy, as one might find for an AI-powered diagnostic device, is not directly applicable here.

This submission is about confirming that the modification (the external system gating interface) performs its intended function without compromising the safety and efficacy of the already cleared base device (Trilogy™ Radiotherapy Delivery System). The "study" here is more akin to verification and validation testing of the new interface rather than a full-scale clinical trial proving primary clinical effectiveness.

Therefore, many of the requested categories (like sample size for test/training sets, experts for ground truth, adjudication methods, MRMC studies, standalone performance) are not provided in the document because they are not relevant to this type of device modification submission. Device modifications typically refer to verification and validation data to show that the modification performs as intended and does not negatively impact existing functionalities.

Let's break down what information is available and how it aligns with your questions, and where there are gaps due to the nature of the submission:

Acceptance Criteria and Device Performance (Not Applicable in the traditional sense for this submission)

This submission is about a modification to an existing device (Trilogy Radiotherapy Delivery System) to enable the export of beam information to external gating devices. The "acceptance criteria" for such a modification would generally revolve around:

• Functionality: Does the interface correctly export the specified beam information?
• Accuracy: Is the exported information (e.g., beam status, timing) accurate and synchronized?
• Safety: Does the interface introduce any new hazards or compromise the safety of the overall system?
• Compatibility: Is the interface compatible with intended external gating devices (though specific devices are not named here)?
• Reliability: Does the interface consistently perform over time?

The provided document mentions the modification enables the export of beam information, but it does not detail the specific acceptance criteria or the test results (device performance data) used to demonstrate this. The FDA's substantial equivalence determination implies these tests were reviewed and deemed satisfactory, but the document itself is a summary, not the full submission.

Table of Acceptance Criteria and Reported Device Performance:

1. Sample Size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size: Not specified in the provided summary.
• Data Provenance: Not specified in the provided summary. This type of submission would typically involve internal engineering verification and validation testing, not clinical data in the traditional sense for the modification itself.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Number of Experts & Qualifications: Not applicable and not specified. For device modifications in radiotherapy, "ground truth" establishment usually refers to engineering specifications, performance against known good systems, or simulated scenarios, not clinical expert consensus on diagnostic images.

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

• Adjudication Method: Not applicable and not specified. This is relevant for studies involving human interpretation or clinical outcomes, not for functional verification of a software/hardware interface.

4. 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

• MRMC Study: No, an MRMC study was not done. This device is not an AI-powered diagnostic tool, but a modification to a radiotherapy delivery system.

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

• Standalone Performance: Not applicable in the context of an "algorithm." The device itself is a standalone radiotherapy delivery system. The modification is an interface that likely functions autonomously once configured, but this is not an "algorithm-only" performance evaluation as seen in AI submissions. The performance would be assessed through engineering tests.

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

• Type of Ground Truth: Not explicitly stated, but for this type of modification, the "ground truth" would be the engineering specifications for the beam information to be exported (e.g., "beam on/off status should be X," "timing signal should be Y"). Verification would confirm the interface accurately transmits data that matches these predefined specifications.

7. The sample size for the training set

• Sample Size for Training Set: Not applicable. This device modification does not involve a "training set" in the machine learning sense.

8. How the ground truth for the training set was established

• Ground Truth for Training Set Establishment: Not applicable. This device modification does not involve a "training set" in the machine learning sense.

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

The 3rd Party Couch Top Support is designed to position and support patients for radiotherapy. The Varian Exact ® Couch is designed for use with non-Varian aftermarket table tops.

The Trilogy Tx Delivery System is being modified to include 3rd Party Couch Top Support.

The Exact couch patient positioning and support within the Trilogy Tx cleared device is partially accomplished by the motorized control of longitudinal, lateral, vertical and angular positions. The Exact couch top, also known as the couch stretcher top or the treatment table top is fastened to the Exact couch and is the primary portion of the couch for positioning and support. An Exact couch interface specification is available to non-Varian aftermarket couch top manufacturers for use in designing couch tops that are used on the Exact couch instead of the Varian Exact couch top.

3rd Party Couch Top Support (also known as Aftermarket "non-Varian" Couch Top Attachment) enables third party couch tops to be installed upon the Exact Couch base, replacing the original Varian Exact Couch Top. The replacement is implemented following a published Interface Specification. Physical installation is completed and qualified by Varian representatives at customer locations. following proprietary internal procedures to ensure safety and effectiveness equivalent to that of the original Exact Couch Top.

This 510(k) summary describes a modification to an existing device, the Varian Trilogy Tx Delivery System, to include support for 3rd Party Couch Top Support. As such, the submission focuses on demonstrating that the modified device, when used with third-party couch tops, maintains the safety and effectiveness of the original system. This means the acceptance criteria and the study design are primarily concerned with the physical and functional integrity of the couch top interface and overall system, rather than clinical performance metrics in terms of disease diagnosis or treatment efficacy.

Here's an analysis of the provided text in relation to your requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The provided 510(k) summary does not explicitly state specific pass/fail acceptance criteria or quantitative performance metrics in a direct table format for the 3rd Party Couch Top Support. Instead, the "performance" discussed is centered on demonstrating substantial equivalence to the predicate device and ensuring safety and effectiveness equivalent to that of the original Exact Couch Top.

However, by inferring from the description of the device and the nature of the modification, the implicit acceptance criteria would revolve around:

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify a sample size for a "test set" in the traditional sense of a clinical or image-based diagnostic study. This submission is for a mechanical/functional modification. The "testing" or "qualification" likely involved:

• Physical evaluation and testing of various 3rd party couch tops to ensure they fit the interface specifications and could be securely installed.
• Functional tests (e.g., movement, patient load testing) with these couch tops on the Trilogy Tx system.

The data provenance is not explicitly stated as retrospective or prospective, or country of origin for such mechanical testing. However, given it's a device modification and qualification by the manufacturer (Varian Medical Systems, Palo Alto, CA, USA), the "data" would be internal engineering and quality assurance test results, most likely conducted prospectively during the development and validation phase.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This type of information is not relevant or present in this 510(k) submission. "Ground truth" in this context would typically refer to clinical or diagnostic accuracy. For a couch top modification, the "ground truth" is simply whether the couch can be securely attached, properly positioned, and can support a patient without failure, which is determined by engineering specifications and safety standards, not expert clinical consensus on a disease. The "experts" involved would be Varian's internal engineers and quality assurance personnel rather than radiologists or medical specialists establishing "ground truth" for a medical condition.

4. Adjudication Method for the Test Set

Again, an "adjudication method" as typically described for clinical studies (e.g., 2+1, 3+1) is not applicable here. The "adjudication" for this type of device modification would involve engineering review, compliance checks against specifications, and safety assessments by Varian's internal teams and ultimately, the FDA's review for substantial equivalence.

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, an MRMC comparative effectiveness study was not done, nor would it be relevant for this device modification. This submission is about a mechanical couch top interface, not an AI diagnostic or therapeutic aid affecting human reader performance.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done

No, a standalone algorithm performance test was not done. This device is a component of a radiation therapy system, not an AI algorithm.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc)

As discussed, the concept of "ground truth" in the clinical sense (e.g., pathology, outcomes data) does not apply to this 510(k) submission. The "ground truth" is the engineering specification for the couch interface, successful physical integration, and the demonstrated ability to maintain safety and functional performance equivalent to the original device. These are verified through engineering tests and physical validation, not clinical outcomes or expert consensus on medical conditions.

8. The Sample Size for the Training Set

This submission does not involve a "training set" in the context of machine learning or AI models. This is a modification to a physical medical device.

9. How the Ground Truth for the Training Set Was Established

Since there is no "training set," this question is not applicable.

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