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With radiotherapy equipment (Medical Linac, CT-Sim), it is used for patient positioning before treatment and continuous monitoring of patients during treatment, and can also be used to track patients' breathing mode (including DIBH, EEBH, 4DCT three breathing modes), in order to implement image acquisition synchronized with breathing and radiation therapy.

Klarity SGRT system offers a dedicated non-irradiating and non-invasive surface guided radiation therapy solution. SGRT system includes three main application modules: patient positioning, treatment (motion) monitoring and respiratory gating.

With the patient positioning module, the SGRT system continuously senses the 3D patient body surface and compares it with the prerecorded reference surface by 3D image registration: The calculated 6 degree-of-freedom positioning deviations are visualized and sent to the positioning couch, to ensure a consistent and efficient inter-session patient setup/positioning, both manually and automated.

With the treatment (motion) monitoring module, the SGRT system monitors the patient's surface in real-time throughout the treatment session. Once the body part surface exceeds the predefined tolerance, the system will automatically alert the therapist and turnoff the beam immediately.

With the respiratory gating module, the system keeps tracking the patient's respiratory movements in real-time. During the treatment delivery, this functionality is used to maximize the protection of organs-at-risk; And in CT room, this functionality is used to make the 4DCT imaging best adapt to the patient's breathing in order to minimize the 4DCT imaging artifacts caused by the respiratory motion.

Klarity SGRT system mainly consists of advanced software. PC workstation, one or three 3D cameras and calibration tools. SGRT system provides two models, ARSG-E1A and ARSG-E3A.

The Klarity SGRT System (ARSG-E1A, ARSG-E3A) is a surface-guided radiation therapy solution. The following table outlines its acceptance criteria and reported performance based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state the sample size used for the test set. It mentions "Non-clinical tests were conducted to verify that the Klarity SGRT System (ARSG-E1A, ARSG-E3A) meets all design specifications". The provenance of the data for these non-clinical tests is not specified in terms of country of origin or whether it was retrospective or prospective.

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

The document does not provide information on the number of experts used to establish ground truth or their qualifications. The studies mentioned are non-clinical performance and comparative tests, not expert-opinion based evaluations.

4. Adjudication Method for the Test Set

The document does not describe any specific adjudication method for a test set, as no clinical study involving human judgment is detailed.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

No MRMC comparative effectiveness study was done. The document explicitly states: "The clinical test is not applicable, there's no clinical data."

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Yes, numerous standalone performance tests were conducted. The document states: "Non-clinical tests were conducted to verify that the Klarity SGRT System (ARSG-E1A, ARSG-E3A) meets all design specifications...". This includes specific performance metrics like measurement accuracy, reproducibility, and respiratory gating accuracy. These tests inherently evaluate the algorithm's performance in a standalone manner, separate from human intervention in a clinical setting.

7. The Type of Ground Truth Used

For the non-clinical performance tests, the "ground truth" would be established by precise physical measurements and reference systems used during these engineering and performance verification tests. This is not derived from expert consensus, pathology, or outcomes data, but rather from direct physical measurement.

8. The Sample Size for the Training Set

The document does not provide information about the sample size for a training set. As the device is referred to as "advanced software" and performs tasks like 3D image registration and real-time motion monitoring, it likely involves algorithms that would require training data, but details are not disclosed.

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

The document does not provide information on how the ground truth for any potential training set was established.

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The system is intended for use in radiation therapy clinics together with diagnostic or treatment equipment and provides:

• accurate and reproducible patient positioning. .
• patient motion supervision with an audible and/or visual alarm whenever . the patient motion during treatment is outside of the specified tolerance values, while still allowing for normal breathing motion without triggering the alarm.
• a respiratory signal to be supplied to diagnostic imaging equipment . (primarily CTs) for prospectively and retrospectively (aka 4DCT) gated imaging and reconstruction.

The system cannot directly determine the location of the intended treatment target, since only the patient external surface is detected. The actual target position must therefore, whenever deemed necessary by qualified personnel, be verified using other systems such as CBCT or EPID.

The Sentinel system is intended for use in radiation therapy clinics to accurately position patients in a reproducible way, prior to treatment and to monitor the patient continuously during treatment. The system provides information about a patient's position and the adjustments required in order to position the patient as close as possible to a reference setup. During monitoring, the system reports deviations in the patient's position during treatment.

The system shall only be used by hospital personnel, qualified to work in radiation therapy or diagnostics departments.

The Sentinel platform is based on advanced laser technology with multipurpose software modules covering different tasks in the treatment procedure. The c4D multi-application software supports all modes of operation in one integrated package. The software is user friendly and requires a minimum of user interaction in the daily clinical workflow, while providing the advanced user with sophisticated data management, analysis and reporting functionalities. The software is designed to integrate with existing systems at the clinic, such as CT, linacs and R&V systems, and with motorized couch tops.

The Sentinel system does not require any markers to be placed on the patient or the couch, and doesn't subject the patient to any additional radiation. This also means that the personnel can stay in the treatment room during the whole set up procedure.

Sentinel includes three application modules, cPosition for fast and accuracy patient positioning, cMotion for motion detection during the treatment delivery procedure and cRespiration for respiratory gating diagnostic CT imaging, so called 4D CT studies. Patient positioning before the actual treatment begins, together with subsequent motion detection, ensures that the patient's position is correct both before and during the whole treatment delivery.

The Sentinel hardware consists of a single scanner unit containing the laser and camera, mounted in the ceiling in front of the gantry. The scanner is connected to the PC running the c4D software.

During patient surface acquisition, a laser line is swept along the patient while the camera records a number of images. From the data acquired, a complete 3D surface of the patient can be reconstructed using laser line triangulation. For patient positioning, the acquired surface is captured in a few seconds and can contain several hundred contours. For motion detection the number of contours are typically lowered so that the desired frame rate is achieved. The system is capable of acquiring more than 50 contours per second.

The provided text does not contain detailed information about the acceptance criteria and a specific study that definitively proves the device meets those criteria in the format requested.

The document is a 510(k) Summary for the Sentinel device, primarily focused on demonstrating substantial equivalence to a predicate device. It briefly mentions "Verification and validation has been carried out according to the C-RAD quality management system" and refers to a "V&V report," but the details of this report, including specific acceptance criteria and study results, are not provided in this summary.

It does state: "For the functionality of sending data to the CT for gated imaging and/or reconstruction, non-clinical (phantom) tests have been performed in collaboration with three hospitals in Europe: Uppsala (Sweden), Malmö (Sweden), and Lisbon (Portugal)." However, the details of these phantom tests (e.g., specific metrics, acceptance thresholds, sample sizes, a table comparing expected vs. observed performance) are not included.

Therefore, I cannot directly extract the full requested information from the provided text.

Here's a breakdown of what can be inferred or what is missing based on the prompt's requirements:

1. A table of acceptance criteria and the reported device performance

• Acceptance Criteria: Not explicitly stated in a quantifiable, tabular format. The general intent is that the device provides "accurate and reproducible patient positioning" and "patient motion supervision with an audible and/or visual alarm whenever the patient motion during treatment is outside of the specified tolerance values, while still allowing for normal breathing motion without triggering the alarm" and provides "a respiratory signal to be supplied to diagnostic imaging equipment (primarily CTs) for prospectively and retrospectively (aka 4DCT) gated imaging and reconstruction." Specific numerical thresholds for accuracy, reproducibility, or alarm triggers are not provided.
• Reported Device Performance: Not presented in a quantifiable, tabular format. The document states that "non-clinical (phantom) tests have been performed" and concludes that "the non clinical tests demonstrates that the device is safe, as effective, and performs as well as the legally marketed device Sentinel (K082582)." No specific performance metrics or results from these tests are given.

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

• Sample Size (Test Set): Not specified. The "non-clinical (phantom) tests" were performed, implying inanimate objects were used, not human patients. The number of phantom tests or data points is not mentioned.
• Data Provenance: "non-clinical (phantom) tests have been performed in collaboration with three hospitals in Europe: Uppsala (Sweden), Malmö (Sweden), and Lisbon (Portugal)." This indicates a prospective testing approach on phantoms.

3. 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)

• Not applicable as the tests were "non-clinical (phantom) tests." Ground truth for phantom tests would typically involve precisely known physical properties or measurements rather than expert human interpretation of medical images.

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

• Not applicable/Not mentioned. Given it was non-clinical phantom testing, adjudication methods for human interpretation of medical data are not relevant.

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 MRMC comparative effectiveness study was done. This device is a positioning and monitoring system, not an AI-assisted diagnostic tool that requires human reader improvement studies. The document focuses on the device's ability to position and monitor, not interpret.

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

• The non-clinical phantom tests likely represent a standalone performance evaluation of the system's accuracy and functionality in controlling and monitoring without direct human intervention in the positioning process itself (though humans would set up the tests). The document doesn't explicitly describe these tests as "standalone" in the context of an AI-only performance evaluation, but rather as demonstrating the device's technical capabilities.

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

• For the non-clinical phantom tests, the ground truth would inherently be based on the known, precisely engineered properties of the phantoms and/or reference measurements established through highly accurate measurement tools. It's not expert consensus, pathology, or outcomes data.

8. The sample size for the training set

• Not applicable/Not mentioned. The document describes the system as "based on advanced laser technology with multipurpose software modules." It does not indicate the use of a machine learning model that would require a "training set" in the conventional sense. The software functions based on "advanced surface registration algorithms" and laser line triangulation.

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

• Not applicable, as no training set for a machine learning model is indicated.

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The Catalyst system is intended for use in radiation therapy clinics to accurately set-up and position patients in a reproducible way prior to treatment, and to monitor the patient continuously during treatment. The system provides, information about a patient's position and the adjustments required in order to position the patient as close as possible to a reference setup. During monitoring, the system reports deviations in the patient's position during treatment and disables the treatment beam in case of large detected movements. The system can also track the patient's respiratory motion for supporting synchronized image acquisition or treatment delivery.

The Catalyst system is a further development of the Sentinel system and is using the same software platform but contains a new hardware device which enables overall higher performance and the possibility to run multiple applications in parallel.

Catalyst is an advanced system based on optical surface tracking for patient monitoring during the radiotherapy treatment process. The Catalyst platform is based on advanced structured light measurements with multipurpose software modules covering different tasks in the treatment procedure. The c4D multi-application software supports all modes of operation in one integrated package. The software is user friendly and requires a minimum of user interaction in the daily clinical workflow, while providing the advanced user with sophisticated data management, analysis and reporting functionalities. The software is designed to integrate with existing systems at the clinic, such as CT, linacs and R&V systems, and with motorized couch tops.

Catalyst includes three application modules, cPosition for fast and accuracy patient positioning, cMotion for motion detection during the treatment delivery procedure, and cRespiration for detecting respiratory motion and generating a gating signal for synchronized imaging or gated treatment delivery.

The Catalyst hardware consists of a single scanner unit containing the projector and camera, mounted in the celling in front of the gantry. The scanner is connected to the PC running the c4D software.

During patient surface acquisition, a sequence of structured light patterns is illuminating the patient while the camera records a number of images. From the data acquired, a complete 3D surface of the patient can be reconstructed using the principles of optical triangulation. Information from the system is shown on a PC monitor in the treatment room as well as the control area. The system can also project a high resolution multi-color light field onto the patient surface, thus avoiding the need for the personnel to look at the PC monitor when setting up the patient. The system optionally records data which can be used for further analysis of actual patient motion during each treatment session.

Here's an analysis of the acceptance criteria and study information for the C-RAD Catalyst device, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state the numerical sample size used for the test set. It mentions "The validation performed at Varian Medical Systems, UAS and Malmö shows that the Catalyst application for patient positioning, monitoring and respiratory gating is functioning according to its intended use." This suggests prospective in-clinic testing at multiple sites (Varian Medical Systems, UAS, Malmö), implying that the data provenance is from clinical environments in those locations. The document does not specify the country beyond naming these sites.

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

The document does not specify the number of experts used or their qualifications for establishing ground truth for the test set. It states the system "shall only be used by hospital personnel, qualified to work in radiation therapy or diagnostic imaging departments," which implies that the validation would involve such qualified personnel, but doesn't detail their role in ground truth establishment.

4. Adjudication Method for the Test Set

The document does not describe the specific adjudication method used for the test set.

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

No multi-reader multi-case (MRMC) comparative effectiveness study is mentioned that assesses human readers' improvement with or without AI assistance. The device is a positioning and monitoring system, not and AI-assisted diagnostic tool for human readers.

6. Standalone (Algorithm Only) Performance Study

Yes, a standalone performance study was conducted. The "Performance data" section explicitly states, "The measurement accuracy is better than 1 mm for Catalyst and its predicates. The performance test results are presented in the application." This refers to the algorithm's direct measurement capability independently of human interpretation.

7. Type of Ground Truth Used

The type of ground truth used is implied to be a combination of:

• Physical measurement/reference: For "measurement accuracy better than 1 mm," the ground truth would likely be established through highly accurate physical measurement systems or phantoms.
• Clinical observation/intended function: For "functioning according to its intended use" for patient positioning, monitoring, and respiratory gating, the ground truth would be based on the established clinical procedures and expected behavior in a real-world scenario.

8. Sample Size for the Training Set

The document does not provide information about a specific "training set" or its size. As a surface tracking and positioning system, it might rely on pre-programmed algorithms and physical principles rather than a large, labeled training dataset in the way a modern AI image classification model would. If machine learning was used, the training data details are not disclosed.

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

Since no specific training set is mentioned (see point 8), the method for establishing its ground truth is not described.

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