(20 days)
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.
§ 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.