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The VeriSuite patient position verification and correction of the patient's position during a radiotherapy treatment with external beams or charged particles. It is based on stereoscopic X-ray images and DRRs calculated from a CT image series of the treatment region of the patient and information from the treatment planning.

VeriSuite is an image processing system for verification and correction of the patient position during a radiation therapy treatment. The verification or correction is performed by a comparison of X-ray images that are acquired during the treatment with DRRs (digital reconstructed radiographs) calculated from a CT image series of the patient and information from the radiation therapy planning. The correction can also be based on fiducial, radio-opaque markers that are implanted in the patient.

With the fluoroscopy extension it is possible to observe the position of the patient and the treatment area during the treatment. Mainly the movements of the patient caused by breathing are in the focus. This information can be used to interrupt the treatment by the user.

VeriSuite is a system of devices consisting of the VeriSuite software and a number of hardware devices.

The provided text is a 510(k) Summary for a medical device (VeriSuite) and primarily focuses on regulatory approval and substantial equivalence to predicate devices, rather than detailed performance studies or specific acceptance criteria. Therefore, much of the requested information regarding acceptance criteria, study design, and performance metrics is not explicitly present in this document.

However, I can extract what is available and indicate what is missing.

1. Table of Acceptance Criteria and Reported Device Performance

This information is not provided in the document. The submission focuses on functional equivalence to predicate devices and software verification/validation, but not specific quantitative performance acceptance criteria or results of such tests in a clinical setting.

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

This information is not provided in the document. The document mentions "Non-clinical verification and validation software tests" but does not detail the size or nature of the test set used for these tests, nor the provenance of any data used.

3. Number of Experts Used to Establish Ground Truth and Qualifications

This information is not provided in the document.

4. Adjudication Method for the Test Set

This information is not provided in the document.

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

This information is not provided in the document. There is no mention of a comparative effectiveness study involving human readers with and without AI assistance.

6. Standalone (Algorithm Only) Performance Study

The document mentions "Non-clinical verification and validation software tests were conducted to confirm that VeriSuite 1.8 with fluoroscopy meets its intended use and is safe and effective." This implies foundational testing of the algorithm itself. However, specific standalone performance metrics (e.g., accuracy, precision) in a clinical context are not reported in this summary. The device's function is a "patient position verification system" and "calculation of a correction vector," which, by its nature, involves algorithm-only operation to produce outputs for human review.

7. Type of Ground Truth Used

This information is not provided in the document. For the "Non-clinical verification and validation software tests," the nature of the ground truth would depend on the specific tests conducted (e.g., simulated data with known positions, comparison to known anatomical landmarks in a phantom). Explicit details are missing.

8. Sample Size for the Training Set

This information is not provided in the document. As a "patient position verification system" that calculates DRRs from CT data and identifies correction vectors, the system's core functionality likely relies on computational geometry and image processing rather than a "training set" in the machine learning sense for image recognition. If there were any machine learning components, the training set size is not disclosed.

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

This information is not provided in the document, and likely less relevant given the description of the device's function.

Summary of available information from the document:

• Device Function: VeriSuite is an image processing system for verification and correction of patient position during radiation therapy. It compares X-ray images with DRRs calculated from CT series and can also use fiducial markers. The fluoroscopy extension allows observation of patient movement (e.g., breathing) to interrupt treatment.
• Safety and Effectiveness: "Non-clinical verification and validation software tests were conducted to confirm that VeriSuite 1.8 with fluoroscopy meets its intended use and is safe and effective."
• Substantial Equivalence: The submission concludes that the device is "as safe and effective and substantially equivalent to the predicate devices described herein." This is the primary "proof" offered in a 510(k) summary for new features.
• Predicate Devices:
  • VeriSuite 1.8 (K092653) for the core system.
  • EXACTRAC 5.5 / ExacTrac X-RAY 6D (K072506) for the fluoroscopy functionality.
• Differences from Predicate (EXACTRAC 5.5): VeriSuite does not support optical prepositioning or internal respiratory gating signal display. Minor differences in hardware (higher resolution flat panels, X-ray image, and pixel size for VeriSuite).

In essence, this 510(k) summary acts as a declaration of substantial equivalence based on the stated intended use, technological comparison, and internal verification/validation, rather than a detailed report of a clinical efficacy study with specific statistical acceptance criteria. For such details, one would typically need to review the full 510(k) submission, which is not provided here.

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