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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 intended use of the device is the control of accurate patient positioning with assistance of a 3D Tracking System in a radiotherapy environment.

The iGUIDE System is a powered radiation therapy support assembly which provides patient positioning control before radiotherapy treatment. The iGUIDE System consists of the following system components: iGUIDE Reference Frame with optical markers, iGUIDE Calibration Phantom (calibration phantom for KV-imaginq). NDI Polaris Tracking System, iGUIDE Workstation with iGUIDE software (control room) and iGUIDE Terminal (treatment room). The iGUIDE System is intended to be used together with the HexaPOD RT CouchTop (K041448), which is intended to be used together with the following radiation therapy systems: Elektra Precise Treatment System with Precise Table (K983678), Varian Trilogy Radiotherapy Delivery System (K033343), Clinac 2300 C/D with Exact Couch (K913119),and Siemens PRIMUS or ONCOR Linear Accelerator with Siemens ZXT Treatment Table (K910971)

The provided text does not contain information about acceptance criteria or a study that proves the device meets specific acceptance criteria.

The 510(k) summary explicitly states:

"No performance data is required for this Class II device nor requested by the Food and Drug Administration (Office of Device Evaluation)."

Therefore, I cannot provide the requested information, including:

1. A table of acceptance criteria and the reported device performance
2. Sample size used for the test set and the data provenance
3. Number of experts used to establish the ground truth for the test set and their qualifications
4. Adjudication method for the test set
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, or the effect size of human readers improving with AI vs without AI assistance
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
7. The type of ground truth used
8. The sample size for the training set
9. How the ground truth for the training set was established

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