(114 days)
The Varian High Energy Linear Accelerator is intended to provide stereotactic radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere in the body when radiation treatment is indicated.
The Varian High Energy Linear Accelerator models provide various selections among the features, specifications, and accessories that have been most recently cleared as the Varian High Energy Linear Accelerator, K112839.
The High Energy Linear Accelerator is a radiotherapy treatment unit. The equipment consists of a gantry, couch, stand and control console. The device is permanently installed. The radiotherapy treatment beam is generated by a linear accelerator assembly consisting of an electron gun, waveguide and collimator.
An extensive system of interlocks is designed to prevent or terminate beam-on unless essential treatment parameters are in place and system operating conditions relevant to safe operation are correct.
The changes to the Varian High Energy Linear Accelerator establish motion zone rules, which limit the motions of couch and gantry that can be initiated or directed from outside the treatment room. The purpose of the zone rules is to increase patient safety by reducing the possibility of collision between the gantry and the patient.
All other features and technological characteristics of the Varian High Energy Linear Accelerator models remain as cleared by K112839.
The provided text describes a 510(k) Summary for the Varian High Energy Linear Accelerator. This document focuses on demonstrating substantial equivalence to a predicate device and safety and effectiveness based on verification and validation activities. It does not contain information about acceptance criteria and a study proving a device meets those criteria in the context of AI/algorithm performance.
Specifically, the document discusses:
- The device (Varian High Energy Linear Accelerator) and its predicate device (K112839).
- The intended use and indications for use, which remain unchanged from the predicate device.
- Changes made to the device, primarily establishing "motion zone rules" to limit couch and gantry movements, thereby increasing patient safety by reducing collision risk.
- The fact that "design control procedures applied to the development of the Varian High Energy Linear Accelerator and its modifications include requirements reviews, risk analysis, and verification and validation testing. The results of verification and validation activities demonstrate that the acceptance criteria have been met." This statement is very general and does not provide specific acceptance criteria or details of the validation study.
- A comparison table illustrating feature and specification equivalence, including software version and specific dose rates and field sizes, all of which are either unchanged or relate to the new "zone rules" feature.
Therefore, I cannot populate the requested information (table of acceptance criteria, sample size, ground truth, MRMC study, standalone performance, etc.) because the provided text does not contain this type of information. The document is a regulatory submission for a physical medical device (a linear accelerator used for radiation therapy) and its software update related to mechanical movement restrictions, not an AI or algorithmic diagnostic device.
§ 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.