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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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