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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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