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The CyberKnife VSI™ Robotic Radiosurgery System is intended to provide treatment planning and image-guided stereotactic radiosurgery and precision radiotherapy for tumors, lesions and conditions anywhere in the body when radiation treatment is indicated.

The CyberKnife VSI Robotic Radiosurgery System is a computer controlled medical system for planning and performing minimally invasive stereotactic radiosurgery and precision radiotherapy using a treatment radiation generator, linear accelerator, manipulator (robot), and a target locating subsystem to accurately deliver radiation to the treatment target. The CyberKnife VSI uses skull tracking, fiducial tracking, Xsight® Spine Tracking, Xsight® Lung Tracking, and Synchrony® Respiratory Tracking for dynamic positioning and pointing of the linear accelerator.

The provided text describes a 510(k) summary for the CyberKnife VSI™ Robotic Radiosurgery System. However, it does not contain any information regarding specific acceptance criteria, a study proving device performance against those criteria, or details typically found in such a study (sample size, expert qualifications, ground truth methodology, MRMC study, or standalone performance results).

The document is a submission for substantial equivalence to a predicate device, focusing on the device's description, intended use, and substantial equivalence claim. It explicitly states: "The CyberKnife VSI is substantially equivalent to the predicate device. The intended use, principles of operation, technological characteristics and labeling are the same or equivalent."

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

To answer your request, I would need a different document that details the performance study conducted for the CyberKnife VSI™ Robotic Radiosurgery System, including the acceptance criteria and results.

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The CyberKnife® Robotic Radiosurgery System is intended to provide treatment planning and image-guided stereotactic radiosurgery and precision radiotherapy for tumors, lesions and conditions anywhere in the body when radiation treatment is indicated.

The CyberKnife Robotic Radiosurgery System is a computer controlled medical system for planning and performing minimally invasive stereotactic radiosurgery and precision radiotherapy using a treatment radiation generator, linear accelerator, manipulator (robot), and a target locating subsystem to accurately deliver radiation to the treatment target. The CyberKnife System uses skull tracking, fiducial tracking, Xsight™ Spine Tracking, Xsight" Lung Tracking, and Synchrony" Respiratory Tracking for dynamic positioning and pointing of the linear accelerator.

This 510(k) summary (K091146) from Accuray Incorporated for the CyberKnife® Robotic Radiosurgery System does not contain the detailed acceptance criteria and study information typically found in a clinical performance study. The provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than providing a new clinical study.

Therefore, for almost all of your requested information, the answer is that the document does not provide this information.

Here's a breakdown of what can and cannot be answered based on the provided text:

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

• Response: This information is not provided in the 510(k) summary. 510(k) submissions for substantial equivalence often rely on technical comparison and predicate device performance rather than new clinical trials with acceptance criteria.

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

• Response: This information is not provided. No specific test set or data provenance from a study proving performance against acceptance criteria is mentioned.

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)

• Response: This information is not provided. No test set requiring expert-established ground truth is described.

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

• Response: This information is not provided. There is no mention of a test set or adjudication process.

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

• Response: This information is not provided, and such a study would not typically be applicable to a robotic radiosurgery system like the CyberKnife, which is a treatment delivery device rather than an AI-assisted diagnostic tool for human readers.

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

• Response: This information is not provided. The CyberKnife is a system performing treatment delivery, not a standalone algorithm in the sense of an AI diagnostic tool. Its performance is inherent to its mechanical and software precision.

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

• Response: This information is not provided. If any "ground truth" were relevant, it would likely relate to the accuracy of radiation dose delivery and patient positioning, which are engineering and physics measurements, not typically clinical "ground truth" as you'd find in diagnostic imaging.

8. The sample size for the training set

• Response: This information is not provided. As this is not a machine learning diagnostic device, the concept of a "training set" for an algorithm in this context is not directly applicable in the way it would be for an AI-driven image analysis tool. The CyberKnife uses advanced algorithms for tracking and radiation delivery, but these are typically developed through engineering and physics principles rather than statistical training on a large dataset of "cases."

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

• Response: This information is not provided, as a training set in the typical AI sense is not described.

Summary of the CyberKnife System as per the 510(k) Summary:

• Trade Name: CyberKnife® Robotic Radiosurgery System
• Device Description: Computer-controlled medical system for planning and performing minimally invasive stereotactic radiosurgery and precision radiotherapy. It uses a linear accelerator, manipulator (robot), and a target locating subsystem (including skull tracking, fiducial tracking, Xsight™ Spine Tracking, Xsight™ Lung Tracking, and Synchrony™ Respiratory Tracking) to accurately deliver radiation.
• Intended Use: To provide treatment planning and image-guided stereotactic radiosurgery and precision radiotherapy for tumors, lesions, and conditions anywhere in the body when radiation treatment is indicated.
• Substantial Equivalence: The document states the device is substantially equivalent to a predicate device, with the same or equivalent intended use, principles of operation, technological characteristics, and labeling. This implies that the safety and effectiveness are established by comparison to an already cleared device, rather than through a new, detailed clinical performance study with acceptance criteria.

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The CyberKnife® Robotic Radiosurgery System is intended to provide treatment planning and image-guided stereotactic radiosurgery and precision radiotherapy for tumors, lesions and conditions anywhere in the body when radiation treatment is indicated.

The CyberKnife® Robotic Radiosurgery System is indicated for treatment planning and image guided stereotactic radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere in the body when radiation treatment is indicated.

The CyberKnife Robotic Radiosurgery System is a computer controlled medical system for planning and performing minimally invasive stereotactic radiosurgery and precision radiotherapy using a treatment radiation generator, linear accelerator, manipulator (robot), and a target locating subsystem to accurately deliver radiation to the treatment target. The CyberKnife System uses skull tracking, fiducial tracking, Xsight™ spine tracking, Synchrony" Respiratory Tracking and Lung Tumor Tracking for dynamic positioning and pointing of the linear accelerator.

The provided text is a 510(k) summary for the CyberKnife® Robotic Radiosurgery System. However, it does not contain the detailed acceptance criteria or the study results that prove the device meets these criteria. The document focuses on the device description, intended use, and substantial equivalence to a predicate device, which are standard components of a 510(k) summary for regulatory approval.

Specifically, the excerpt is missing information regarding:

• Quantitative acceptance criteria (e.g., accuracy, precision targets).
• Details of any specific performance studies, including sample sizes, data provenance, expert ground truth, or statistical results.
• Information on MRMC studies or standalone algorithm performance.

Therefore, I cannot populate the table or answer the specific questions based solely on the text provided. The document states that "The CyberKnife Robotic Radiosurgery System with the Lung Tumor Tracking algorithm is substantially equivalent to the predicate device. The intended use, principles of operation, technological characteristics and labeling are the same or equivalent." This statement implies that the device is deemed acceptable because it performs similarly to an already approved device, rather than by meeting a specific set of new, quantitative acceptance criteria outlined in this summary.

To answer your request, I would need a different document that details the performance studies and their results.

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The CyberKnife System for Stereotactic Radiosurgery/Radiotherapy is intended to provide treatment planning and image-guided stereotactic radiosurgery and precision radiotherapy for lesions, turnors and conditions anywhere in the body when radiation treatment is indicated.

The CyberKnife System is a computer-controlled medical system for planning and performing minimally invasive stereotactic radiosurgery and precision radiotherapy using a treatment radiation generator, linear accelerator, manipulator (robot), and a target locating subsystem to accurately deliver radiation to the treatment target anywhere in the body.

The provided text is a 510(k) summary for the CyberKnife® System for Stereotactic Radiosurgery/Radiotherapy. It describes the device, its intended use, and its substantial equivalence to predicate devices. However, it does not contain information regarding detailed acceptance criteria, specific performance studies (like multi-reader multi-case studies or standalone performance), sample sizes for test or training sets, ground truth establishment, or expert qualifications as typically found in clinical validation studies for AI/software devices.

The document is a regulatory submission for a medical device that delivers radiation therapy, not an AI/software as a medical device (SaMD) that provides diagnostic or prognostic information. Therefore, the typical "acceptance criteria" and "study types" requested for SaMDs are not present in this document.

Based on the provided text, I cannot complete the table or answer the specific questions about acceptance criteria and study details. The document focuses on regulatory approval based on substantial equivalence, which primarily considers:

• Intended Use: The CyberKnife System is indicated for treatment planning and image-guided stereotactic radiosurgery and precision radiotherapy for lesions, tumors, and conditions anywhere in the body when radiation treatment is indicated.
• Principles of Operation: The device is a computer-controlled system for planning and performing minimally invasive stereotactic radiosurgery and precision radiotherapy using a treatment radiation generator, linear accelerator, manipulator (robot), and a target locating subsystem to accurately deliver radiation.
• Technological Characteristics: The subject modifications are stated to have the same characteristics as predicate devices.

The approval states that the device is "substantially equivalent" to predicate devices, implying that its performance is considered comparable to existing, legally marketed devices. However, the exact performance metrics or a detailed clinical validation study as might be conducted for an AI diagnostic device are not provided in this specific 510(k) summary.

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The CyberKnife System for Stereotactic Radiosurgery/Radiotherapy is intended to provide treatment planning and image-guided stereotactic radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere in the body when radiation treatment is indicated.

The CyberKnife System is a computer controlled medical system for planning and performing minimally invasive stereotactic radiosurgery and precision radiotherapy using a treatment radiation generator, linear accelerator, manipulator (robot), and a target locating subsystem to accurately deliver radiation to the treatment target. The CyberKnife System uses skull tracking, fiducial tracking and skeletal structure tracking for dynamic positioning and pointing of the linear accelerator.

The provided text describes the CyberKnife® System for Stereotactic Radiosurgery/Radiotherapy and its 510(k) submission, focusing on its intended use and substantial equivalence to a predicate device. However, it does not contain the specific information requested regarding acceptance criteria, study details, sample sizes, ground truth establishment, expert qualifications, or comparative effectiveness with human readers.

Therefore, I cannot fulfill your request for the detailed table and study information based solely on the provided text. The document primarily acts as a summary for the K041315 510(k) submission, stating that the device is substantially equivalent to a predicate device and is intended for treatment planning and image-guided stereotactic radiosurgery and precision radiotherapy.

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The CyberKnife System for Stereotactic Radiosurgery/Radiotherapy is intended to provide treatment planning and image guided stereotactic radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere in the body when radiation treatment is indicated.

The CyberKnife System is a computer controlled medical system for planning and performing minimally invasive stereotactic radiosurgery and precision radiotherapy using a treatment radiation generator, linear accelerator, manipulator (robot), and a sophisticated target locating subsystem to accurately deliver radiation to the treatment target. The CyberKnife System uses skull tracking and tracking of implanted fiducials for dynamic positioning and pointing of the linear accelerator.

The provided text is a 510(k) summary from 2003 for the CyberKnife® System, along with the FDA's clearance letter. This document focuses on demonstrating substantial equivalence to a predicate device rather than detailing specific performance criteria, studies, or acceptance criteria in the modern sense of algorithm evaluation.

Therefore, the requested information regarding acceptance criteria, device performance, sample sizes for test/training sets, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies for an AI/algorithm-driven device cannot be found in this document. The CyberKnife System, as described in this 2003 submission, is a medical linear accelerator system for stereotactic radiosurgery/radiotherapy, which uses image guidance and a FAST algorithm for targeting. The submission does not detail the performance of the "FAST algorithm" in terms of diagnostic accuracy or clinical decision support, but rather focuses on the safety and effectiveness of the overall system for delivering radiation treatment.

Explanation for Missing Information:

This 510(k) submission predates the widespread use and specific FDA guidance for evaluating AI/ML-driven medical devices, especially those focused on diagnostic performance or AI-assisted interpretation. The document primarily focuses on the device's intended use, technological characteristics, and comparison to a predicate device as required for a 510(k) clearance in 2003.

Summary of what can be inferred from the provided text, despite not directly answering the query:

• Device Name: CyberKnife® System for Stereotactic Radiosurgery/Radiotherapy
• Intended Use: Treatment planning and image-guided stereotactic radiosurgery and precision radiotherapy for lesions, tumors, and conditions anywhere in the body when radiation treatment is indicated.
• Key Technology Mentioned: The CyberKnife System uses "skull tracking and tracking of implanted fiducials for dynamic positioning and pointing of the linear accelerator." It also mentions "The CyberKnife System with the FAST algorithm."
• Regulatory Pathway: 510(k) premarket notification, indicating substantial equivalence to a predicate device. This pathway generally relies on demonstrating that the new device is as safe and effective as a legally marketed device, rather than requiring extensive clinical trials to establish new performance criteria.
• Date of Submission/Clearance: July 29, 2003 (submission) / September 3, 2003 (clearance).

To answer the questions as requested, one would typically need a more recent regulatory submission or a detailed clinical study report specifically evaluating the "FAST algorithm" or similar components in a way that aligns with current AI/ML performance evaluation standards.

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To provide an option to the CyberKnife System which will enable dynamic image guided stereotactic radiosurgery and precision radiotherapy of lesions, tumors and conditions that move under the influence of respiration.

Presently, irradiation of lesions that move during breathing, such as those located in the lung or near the diaphragm, would typically be performed during patient breath-holds. The Motion Tracking System option to the CyberKnife® System is designed to treat lesions while they are moving during the respiratory cycle. This offers the ability to reduce normal tissue exposure by using smaller irradiation margins, shorten treatments, increase accuracy and provide more comfort for the patient.

During motion tracking operation, a correspondence between surface (e.g. thorax/abdomen) movements and movement of the target lesion is developed prior to the start of treatment and is regularly updated during treatment each time the CyberKnife system acquires a new pair of x-ray images. This correspondence is then used to estimate lesion position in real time by monitoring surface movement during treatment.

Motion Tracking provides the CyberKnife system with the capability to monitor the patient's respiration and command the robot manipulator to compensate for the treatment target motion within the body, in real-time, while the radiation is being delivered.

The Motion Tracking System includes a sensor assembly, tracking targets, a cable junction box, and a controller.

The provided text does not contain detailed information about the acceptance criteria and the study that proves the device meets those criteria. The document is a 510(k) summary for a "Motion Tracking System", focusing on its intended use, device description, and a letter of substantial equivalence from the FDA.

Therefore, I cannot populate the table or provide the requested details about the study, sample sizes, ground truth, or expert involvement as this information is not present in the provided text.

Based on the information provided, here's what can be extracted and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance:

Missing Information: The document heavily focuses on the regulatory aspects and technical description of the device's function, but it does not detail specific acceptance criteria (e.g., accuracy thresholds, precision targets, latency limits) or the quantitative results of performance testing against such criteria.

2. Sample size used for the test set and the data provenance:

• Sample Size for Test Set: Not specified.
• Data Provenance (e.g., country of origin of the data, retrospective or prospective): Not specified.

Missing Information: There is no mention of a test set, its size, or the nature/origin of data used for any performance evaluation.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Number of Experts: Not specified.
• Qualifications of Experts: Not specified.

Missing Information: The document doesn't describe any expert-established ground truth or the involvement of experts in evaluating the device's performance.

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

• Adjudication Method: Not specified.

Missing Information: No details on adjudication methods are provided.

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:

• MRMC Study: Not mentioned or implied.

Missing Information: The device is a "Motion Tracking System" for radiation therapy, which implies it's a technical accessory for precise delivery, not a diagnostic AI tool that would typically involve human readers. Therefore, an MRMC study comparing human reader performance with/without AI assistance would likely not be applicable or expected for this type of device.

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

• Standalone Performance: While the description implies the system operates in real-time to compensate for motion, the document does not explicitly detail a standalone performance study with specific metrics. It describes the functionality of estimating lesion position and commanding the robot, rather than reporting on a formal standalone performance evaluation.

Missing Information: Specific studies dedicated to standalone performance with quantitative results are not mentioned.

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

• Type of Ground Truth: Not specified.

Missing Information: There is no description of how ground truth was established for any performance evaluation.

8. The sample size for the training set:

• Sample Size for Training Set: Not specified.

Missing Information: No mention of a training set or its size.

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

• Ground Truth for Training Set: Not specified.

Missing Information: No details on how ground truth was established for a training set.

Summary of what is available from the text:

• Device Name: Motion Tracking System (option to the CyberKnife® System)
• Intended Use: To enable dynamic image-guided stereotactic radiosurgery and precision radiotherapy of lesions, tumors, and conditions that move under the influence of respiration.
• Mechanism: Develops a correspondence between surface movements and target lesion movement, estimates lesion position in real-time by monitoring surface movement, and commands the robot manipulator to compensate for target motion.
• Regulatory Status: Received 510(k) clearance (K020294) indicating substantial equivalence to predicate devices (Accuray CyberKnife® System, K011024 and Varian Medical Systems RPM Respiratory Gating System, K983629).

The provided text serves primarily as a regulatory submission summary, detailing the device's purpose and regulatory pathway rather than a detailed scientific study report.

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To provide treatment planning and image-guided stereotactic radiosurgery and precision radiotherapy for lesions (e.g. arteriovenous malformations), tumors and conditions of the brain, base of skull (BOS), cervico-thoracic spine (CTS), head and neck.

The CyberKnife® System for Stereotactic Radiosurgery/Radiotherapy is a treatment planning, imaging, and treatment delivery system for image-guided stereotactic radiosurgery and precision radiotherapy. The treatment planning system provides 3-dimensional viewing of the patient anatomy with appropriate dose calculation of the target volume and surrounding tissue structures. The imaging system provides real-time, orthogonal x-ray images of the patient in the treatment position to verify treatment position and accuracy and provides information suitable for dynamically positioning and pointing a linear accelerator. The treatment delivery system consists of a linear accelerator which provides 6 MV x-rays. A six-access manipulator provides automated positioning and pointing of the linear accelerator. The treatment couch provides positioning of the patient.

The provided document is a 510(k) summary for the CyberKnife™ System, a medical device for stereotactic radiosurgery/radiotherapy. It focuses on the substantial equivalence to a predicate device and does not contain detailed information on acceptance criteria or a study proving that the device meets specific performance criteria.

Therefore, I cannot provide the requested information from the given text.

The document does not describe:

1. A table of acceptance criteria and the reported device performance: The "Feature Comparison Chart" compares technological characteristics between the CyberKnife and a predicate device (Varian Clinac 600SR), but these are not presented as acceptance criteria for a new device's performance validation. For example, "Mechanical Isocenter Accuracy" is listed as "≥ 0.05 cm RMS for all treatment nodes" for the CyberKnife, which could be an acceptance criterion, but the context does not explicitly state it as such for a validation study. There is no accompanying "reported device performance" against such a criterion in the document.
2. Sample size used for the test set and the data provenance: No information on any test set or data provenance is provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: No information on experts or ground truth establishment for a test set is provided.
4. Adjudication method for the test set: No information on an adjudication method is provided.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size: No information on an MRMC study is provided.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: The CyberKnife is a treatment delivery system, not an algorithm in the typical sense this question implies for AI/diagnostic devices. The document does not describe standalone performance testing for software components.
7. The type of ground truth used: No information on the type of ground truth for any study is provided.
8. The sample size for the training set: The document describes a medical device, not a machine learning model, so there is no concept of a "training set" in this context.
9. How the ground truth for the training set was established: Not applicable as there is no training set.

The document primarily focuses on establishing substantial equivalence in terms of technological characteristics and intended use compared to a predicate device, as required for 510(k) clearance by the FDA, rather than presenting a performance study with detailed acceptance criteria.

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