(22 days)
The CyberKnife System for Stereotactic Radiosurgery/Radiotherapy is intended to provide treatment planning and image-guided stereotactic radiosurgery and precision radiotherapy for lesions, turnors 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 is a 510(k) summary for the CyberKnife® System for Stereotactic Radiosurgery/Radiotherapy. It describes the device, its intended use, and its substantial equivalence to predicate devices. However, it does not contain information regarding detailed acceptance criteria, specific performance studies (like multi-reader multi-case studies or standalone performance), sample sizes for test or training sets, ground truth establishment, or expert qualifications as typically found in clinical validation studies for AI/software devices.
The document is a regulatory submission for a medical device that delivers radiation therapy, not an AI/software as a medical device (SaMD) that provides diagnostic or prognostic information. Therefore, the typical "acceptance criteria" and "study types" requested for SaMDs are not present in this document.
Based on the provided text, I cannot complete the table or answer the specific questions about acceptance criteria and study details. The document focuses on regulatory approval based on substantial equivalence, which primarily considers:
- Intended Use: The CyberKnife System is indicated for treatment planning and image-guided stereotactic radiosurgery and precision radiotherapy for lesions, tumors, and conditions anywhere in the body when radiation treatment is indicated.
- Principles of Operation: The device is a computer-controlled 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.
- Technological Characteristics: The subject modifications are stated to have the same characteristics as predicate devices.
The approval states that the device is "substantially equivalent" to predicate devices, implying that its performance is considered comparable to existing, legally marketed devices. However, the exact performance metrics or a detailed clinical validation study as might be conducted for an AI diagnostic device are not provided in this specific 510(k) summary.
§ 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.