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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 anywhere in the body.

The provided text does not contain information about specific acceptance criteria or a study proving the device meets those criteria.

The document is a 510(k) summary for the CyberKnife® System, focusing on establishing substantial equivalence to predicate devices. It states that the device's "intended use, principles of operation, and technological characteristics are the same" as the predicate devices, which is the basis for its clearance.

Therefore, I cannot populate the requested table or answer the specific questions about acceptance criteria, study details, sample sizes, ground truth establishment, or MRMC studies.

Here's why the information is missing from the provided text:

• 510(k) Substantial Equivalence: A 510(k) submission primarily demonstrates that a new device is as safe and effective as a legally marketed predicate device. It often relies on comparisons of technical specifications, performance data (if applicable and comparable), and intended use rather than requiring extensive de novo clinical studies with pre-defined acceptance criteria for the new device as would be seen for a PMA (Premarket Approval) application or a novel high-risk device.
• Focus on Description and Intended Use: The provided text mainly describes the device, its intended use, and the regulatory outcome (clearance based on substantial equivalence). It doesn't delve into detailed performance studies.

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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 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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