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ExacTrac Dynamic is intended to position patients at an accurately defined point within the treatment beam of a medical accelerator for stereotactic radiosurgery or radiotherapy procedures, to monitor the patient position and to provide a beam hold signal in case of a deviation in order to treat lesions, tumors and conditions anywhere in the body when radiation treatment is indicated.

ExacTrac Dynamic (ETD) is a patient positioning and monitoring device used in a radiotherapy environment as an add-on system to standard linear accelerators (linacs). It uses radiotherapy treatment plans and the associated computed tomography (CT) data to determine the patient's planned position and compares it via oblique X-ray images to the actual patient position. The calculated correction shift will then be transferred to the treatment machine to align the patient correctly at the machine's treatment position. During treatment, the patient is monitored with a thermal-surface camera and X-ray imaging to ensure that there is no misalignment due to patient movement. Positioning and monitoring are also possible in combination with implanted markers. By defining the marker positions, ExacTrac Dynamic can position the patient by using X-rays and thereafter monitor the position during treatment.

Additionally, ExacTrac Dynamic features a breath-hold (BH) functionality to serve as a tool to assist respiratory motion management. This functionality includes special features and workflows to correctly position the patient at a BH level and thereafter monitor this position using surface tracking. Regardless of the treatment indication, a correlation between the patient's surface and internal anatomy must be evaluated with Image-Guided Radiation Therapy. The manually acquired X-ray images support a visual inspection of organs at risk (OARs). The aim of this technique is to treat the patient only during breath hold phases where the treatment target is at a certain position to reduce respiratory-induced tumor motion and to ensure a certain planned distance to OARs such as the heart. In addition to the X-ray based positioning technique, the system can also monitor the patient after external devices such as Cone-Beam CT (CBCT has been used to position the patient).

The ExacTrac Dynamic Surface (ETDS) is a camera-only platform without the X-ray system and is available as a configuration which enables surface-based patient monitoring. This system includes an identical thermal-surface camera, workstation, and interconnection hardware to the linac as the ETD system. The workflows supported by ETDS are surface based only and must be combined with an external IGRT device (e.g., CBCT).

The FDA 510(k) summary for Brainlab AG's ExacTrac Dynamic (2.0) and ExacTrac Dynamic Surface provides information regarding its performance testing to demonstrate substantial equivalence to its predicate device, ExacTrac Dynamic 1.1 (K220338).

Here is a breakdown of the requested information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state a table of "acceptance criteria" side-by-side with "reported device performance" values for all aspects of the device. However, it does reference the AAPM Task Group 1472 guidelines as a reference for the accuracy of surface-based monitoring and indicates that specific tests aimed to verify that accuracy specifications were not negatively affected. From the "Bench Tests" section, we can infer the objectives of the tests and how performance was evaluated.

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

• Sample Size for Test Set: The document mentions the use of an "in-house phantom" for the Rigid Body Surface Monitoring Accuracy Test and "phantom treatment" for the Workflow & Accuracy Test. It does not provide specific numerical sample sizes (e.g., number of phantom instances, number of trials).
• Data Provenance: All testing appears to be retrospective (bench tests, phantom studies) and conducted internally (in-house phantom). There is no mention of data from human subjects or specific countries of origin.

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

This information is not provided in the document. The testing described focuses on device performance against physical standards (e.g., phantom, previous system performance) and referenced guidelines (AAPM Task Group 1472), rather than expert-established ground truth on clinical images.

4. Adjudication Method for the Test Set

This information is not provided in the document. Given the nature of the bench and phantom tests, an adjudication method by experts is not described as it would be for clinical image interpretation studies.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, an MRMC comparative effectiveness study was not reported. The document states, "No clinical testing was required for the subject device." The testing described focuses on the device's physical performance, accuracy, and workflow.

6. Standalone Performance (Algorithm Only without Human-in-the-Loop)

The described tests, specifically the "Rigid Body Surface Monitoring Accuracy Test," "Workflow & Accuracy Test ExacTrac Dynamic," "Response Time Measurement," and "Verification of the Radiation Isocenter Calibration," appear to evaluate the device's inherent performance characteristics, often in a controlled phantom environment. This implies a focus on the standalone capabilities of the system, even though its ultimate use is in assisting human operators in a radiotherapy setting. The "Beam-off signal" in response to movement is an automated system response, indicating standalone algorithmic functioning.

7. Type of Ground Truth Used

The ground truth for the performance tests appears to be:

• Physical Phantoms: An "in-house phantom" for surface monitoring accuracy and "phantom treatment" for workflow and accuracy.
• Established Reference System Performance: Comparison to the "previous, well-established Radiation Isocenter Calibration in ETD 1.1."
• Industry Guidelines: Reference to "quality assurance guidelines for non-radiographic radiotherapy localization and positioning systems, that were defined by AAPM Task Group 1472."
• Expected System Behavior: Verification of expected responses (e.g., "Beam-off signal") to phantom movement.

8. Sample Size for the Training Set

This information is not provided in the document. The 510(k) summary focuses on verification and validation testing, not the development or training of specific algorithms that would require a "training set" in the context of machine learning.

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

As no training set is mentioned (see point 8), this information is not applicable/provided.

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