(78 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 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.
§ 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.