(11 days)
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.
§ 892.5050 Medical charged-particle radiation therapy system.
(a)
Identification. A medical charged-particle radiation therapy system is a device that produces by acceleration high energy charged particles (e.g., electrons and protons) intended for use in radiation therapy. This generic type of device may include signal analysis and display equipment, patient and equipment supports, treatment planning computer programs, component parts, and accessories.(b)
Classification. Class II. When intended for use as a quality control system, the film dosimetry system (film scanning system) included as an accessory to the device described in paragraph (a) of this section, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.