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The CyberKnife and CyberKnife VSI Systems are intended to provide treatment planning and image-quided stereotactic radiosurgery and precision radiotherapy for tumors, lesions and conditions anywhere in the body when radiation treatment is indicated. The CyberKnife Systems may be used to treat astrocytoma, glioma, skull base tumors, metastases (brain and bony), nasopharyngeal carcinoma, meningioma, acoustic neuroma, schwannoma, pituitary adenoma, hemangioblastoma, craniopharngioma, arteriovenous malformation, cavernous malformation, trigeminal neuralgia, and tumors of the neck, spine, pancreas, liver, lungs, ovary, prostate, and bladder. Patients should be examined by a team of physicians to determine if they are candidates for CyberKnife treatment.

The CyberKnife Robotic Radiosurgery System and CyberKnife VSI Robotic Radiosurgery System are computer controlled medical systems 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 target locating system provides X-rays of the treatment area taken by a diagnostic X-ray system that lets the user know the position of the target. The CyberKnife and CyberKnife VSI Systems use skull tracking, fiducial tracking, Xsight® Spine Tracking, Xsight® Lung Tracking, and Synchrony® Respiratory Tracking for dynamic positioning and pointing of the linear accelerator. The system uses a 6 MV linear accelerator to provide a dose rate up to 1000 MU/minute.

The provided 510(k) summary for the CyberKnife VSI™ Robotic Radiosurgery System primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed de novo clinical study with specific acceptance criteria and detailed performance metrics.

Therefore, the requested information, particularly regarding specific numerical acceptance criteria, detailed device performance for those criteria, sample sizes for test sets, expert-established ground truth, adjudication methods, MRMC studies, standalone performance, and training set details, is largely not present in this document.

However, I can extract the available relevant information and highlight what is missing based on your request.

Acceptance Criteria and Study for CyberKnife VSI™ Robotic Radiosurgery System

This device did not present a standalone study with explicit acceptance criteria and corresponding performance metrics in a table format in this 510(k) summary. Instead, it focused on demonstrating substantial equivalence to an existing predicate device (the CyberKnife System). The main acceptance criterion appears to be that the new tracking software performs equivalently to the predicate device's tracking systems.

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Sample Size: Not explicitly stated as a number. The document mentions "Archived images from CyberKnife patient lung treatments." This implies a set of patient data, but the quantity is not specified.
• Data Provenance: Retrospective, as it involved "Archived images from CyberKnife patient lung treatments." The country of origin is not specified, but given the applicant's address in Sunnyvale, California, USA, and FDA submission, it's likely US-based data.

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

• Not specified. The document does not describe a process for establishing ground truth via expert consensus for this specific equivalence testing. The "ground truth" for tracking performance would likely be derived from the inherent physical accuracy of the existing CyberKnife system's tracking mechanisms, which the new software was compared against.

4. Adjudication Method for the Test Set:

• Not specified. This detail is not relevant given the nature of the equivalence testing described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

• No, an MRMC study was not described. The submission focuses on the performance of the device's tracking software, not human reader performance with or without AI assistance.

6. If a Standalone (algorithm only without human-in-the-loop performance) was done:

• Yes, in spirit. The testing described involves "tracking software" performance and "regression testing to verify integrity of existing features." This typically refers to the algorithm's direct performance based on inputs (archived images) without active human interpretation as part of the core evaluation. The system itself is "computer controlled."

7. The Type of Ground Truth Used:

• Not explicitly defined in terms of expert consensus, pathology, or outcomes data for this specific testing. Given that it was "tracking performance" compared to a predicate, the ground truth would likely be established by the known, validated performance characteristics of the predicate CyberKnife system's tracking, which the new software aimed to match. This would involve internal validation metrics of positioning accuracy and dynamic targeting.

8. The Sample Size for the Training Set:

• Not specified. The document does not mention details about a training set for the tracking software. It's possible the software relies on established algorithms or models that were trained elsewhere, or that the "new" software is an update or refinement rather than a completely new AI model requiring a distinct training phase.

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

• Not applicable / Not specified. As no training set details were provided, the method for establishing its ground truth is also not elaborated upon.

Summary of Missing Information:

The 510(k) summary focuses on demonstrating substantial equivalence, which often means showing that the device performs "as well as" or "equivalently to" an existing device, rather than providing absolute performance metrics against predefined acceptance criteria for a novel functionality. Consequently, much of the detailed study design information requested (e.g., number of experts, specific sample sizes for test/training sets, detailed ground truth establishment for novel algorithms) is not present in this type of submission when the primary claim is equivalence via regression testing and performance matching a predicate.

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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.

Ask a specific question about this device

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.

Ask a specific question about this device

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, Xsight" Lung Tracking, and Synchrony" Respiratory Tracking for dynamic positioning and pointing of the linear accelerator.

I am sorry, but the provided text does not contain information about acceptance criteria, device performance, or any studies with sample sizes, expert qualifications, or ground truth establishment. The document is a 510(k) summary and an FDA clearance letter for the CyberKnife® Robotic Radiosurgery System, primarily focusing on its intended use and substantial equivalence to a predicate device, rather than detailed performance study results.

Ask a specific question about this device

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 stereotactic radiosurgery and precision radiotherapy using a 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.

1. Acceptance Criteria and Reported Device Performance

The provided 510(k) summary (K071531) for the CyberKnife® Robotic Radiosurgery System does not explicitly list specific acceptance criteria or quantitative performance metrics within the document itself. Instead, it states that the device is "substantially equivalent" to a predicate device, implying that its performance is implicitly accepted as meeting the same standards as the predicate.

The summary highlights the system's capabilities, which implicitly define its expected performance:

• 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."
• Key Technological Features for Performance: "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."

Therefore, based on the provided document, a table of explicit acceptance criteria and corresponding reported device performance cannot be generated. The acceptance is based on substantial equivalence to a predicate device, meaning its performance characteristics are presumed to be comparable.

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

The provided 510(k) summary does not contain information regarding a specific test set, its sample size, or its data provenance (e.g., country of origin, retrospective/prospective). This document focuses on the general description of the device and its intended use, and the declaration of substantial equivalence. Typically, detailed study information, including test set specifics, would be found in the full 510(k) submission, not necessarily in the publicly available summary.

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

The provided 510(k) summary does not mention any clinical studies involving expert observers to establish ground truth for a test set. As such, the number and qualifications of experts are not specified.

4. Adjudication Method for the Test Set

Since no specific test set or clinical study involving ground truth establishment by experts is detailed in the provided summary, there is no information about any adjudication method.

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

The provided 510(k) summary does not mention a Multi-Reader Multi-Case (MRMC) comparative effectiveness study, nor does it discuss human reader improvement with or without AI assistance. The CyberKnife system is a robotic radiosurgery system, not an AI-assisted diagnostic or interpretation tool for human readers in the traditional sense of MRMC studies. Its "AI" functionality, if any, would be embedded in its autonomous tracking and positioning capabilities.

6. Standalone Performance Study

The 510(k) summary does not detail a standalone performance study in terms of specific quantitative outcomes. The declaration of "substantial equivalence" implies that the device's standalone performance is comparable to an existing, legally marketed predicate device. The functional description of its tracking capabilities (skull tracking, fiducial tracking, Xsight™ Spine Tracking, Xsight™ Lung Tracking, and Synchrony™ Respiratory Tracking) highlights the system's autonomous operation to achieve precise radiation delivery.

7. Type of Ground Truth Used

The provided 510(k) summary does not specify the type of ground truth used for performance validation. Given that it is a radiosurgery system, the "ground truth" for its accuracy and efficacy would typically involve phantoms and/or clinical outcomes data, rather than expert consensus on diagnostic images or pathology. However, this level of detail is not present in the summary.

8. Sample Size for the Training Set

The provided 510(k) summary does not mention any training set or its sample size. The description indicates a mature, computer-controlled medical system, suggesting engineering and validation processes rather than a machine learning model that requires a "training set" in the common sense of AI development.

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

Since no training set is mentioned, there is no information on how its ground truth was established.

Ask a specific question about this device

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.

Ask a specific question about this device

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 and skeletal structure tracking for dynamic positioning and pointing of the linear accelerator.

The provided 510(k) summary (K062514) for the CyberKnife® Robotic Radiosurgery System does not contain the detailed information required for a comprehensive description of acceptance criteria and the study proving device performance.

This document is a 510(k) Summary, which is a high-level overview submitted to the FDA to demonstrate substantial equivalence to a predicate device. It typically focuses on the device's intended use, technological characteristics, and comparison to the predicate, rather than detailed performance studies and acceptance criteria.

Therefore, I cannot provide a table of acceptance criteria, reported device performance, sample sizes, expert qualifications, adjudication methods, details about MRMC or standalone studies, or ground truth information based solely on the provided text.

The document states: "The CyberKnife Robotic Radiosurgery System with the modified Fiducial 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 modifications to the fiducial tracking algorithm were deemed to not raise new questions of safety and effectiveness, and therefore, extensive new clinical performance studies might not have been required for this specific submission as part of proving substantial equivalence.

To answer your request thoroughly, I would need access to the full 510(k) submission or supporting technical documentation referenced within it, which would typically contain the details of validation studies.

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