(30 days)
The Varian High Energy Linear Accelerator is indicated for stereotactic radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere in the body when radiation treatment is indicated.
The UNIQUE is indicated for stereotactic radiosurgery and precision radiotherapy for lesions, turnors and conditions anywhere in the body when radiation treatment is indicated.
The Varian Multileaf Collimator is intended to assist the clinician in the delivery of external beam radiation to defined target volumes during radiosurgery and radiotherapy while sparing surrounding normal tissue and critical organs from excess radiation.
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.
The UNIQUE 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.
The Varian Multileaf Collimator (MLC) is an accessory X-ray collimator designed to be mounted on a Varian radiotherapy linear accelerator. The MLC head is mounted on a Varian Linear Accelerator, where it shapes the radiation beam before it is delivered to the patient. The MLC head is permanently bolted onto the casting that holds the X-Jaws and Y-Jaws of the Varian Linear Accelerator gantry.
This document is a 510(k) premarket notification for a Varian Medical Systems linear accelerator and multileaf collimator. It explicitly states that no animal studies or clinical tests were included in this pre-market submission.
Therefore, based on the provided text, there is no information available to describe the acceptance criteria and the study that proves the device meets the acceptance criteria in the manner requested by the prompt. The submission focuses on demonstrating substantial equivalence to predicate devices through non-clinical tests, software verification and validation, and regression testing, rather than clinical performance data.
Specifically, the document states:
- "No animal studies or clinical tests have been included in this pre-market submission."
- "Verification testing was performed to demonstrate that the performance and functionality of the new C-Series operating system and MLC controller existing features met the design input requirements for CCMC."
- "Regression testing was performed to verify the integrity of any changes."
- "Validation testing was performed on production equivalent devices, under clinically representative conditions by qualified personnel."
As such, I cannot provide the requested information about:
- A table of acceptance criteria and reported device performance (in a clinical context).
- Sample size for test set and data provenance.
- Number of experts, qualifications, and ground truth establishment for a test set.
- Adjudication method.
- MRMC comparative effectiveness study parameters or effect size.
- Standalone algorithm performance.
- Type of ground truth used (clinical ground truth, specifically).
- Sample size for training set.
- How ground truth for the training set 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.