(133 days)
The Eclipse Treatment Planning System (Eclipse TPS) is used to plan radiotherapy treatments for patients with malignant or benign diseases. Eclipse TPS is used to plan external beam irradiation with photon, electron and proton beams, as well as for internal irradiation (brachytherapy) treatments. In addition, the Eclipse Proton Eye algorithm is specifically indicated for planning proton treatment of neoplasms of the eye.
The Varian Eclipse™ Treatment Planning System (Eclipse TPS) (K050296) provides software tools for planning the treatment of malignant or benign diseases with radiation. Eclipse TPS is a computer-based software device used by trained medical professionals to design and simulate radiation therapy treatments. Eclipse TPS is capable of planning treatments for external beam irradiation with photon, electron, and proton beams, as well as for internal irradiation, (brachytherapy) treatments.
The provided text is a 510(k) summary for the Varian Eclipse Treatment Planning System (Eclipse TPS). It does not contain the detailed study information required to fill out the requested table and answer the specific questions about acceptance criteria, device performance, sample sizes, ground truth establishment, or comparative effectiveness studies.
The document primarily focuses on the regulatory aspects of the device, such as:
- Submitter's information
- Proprietary and common device names
- Classification and predicate devices
- Device description and indications for use
- FDA's substantial equivalence determination letter
Therefore, I cannot extract the information required for your request from this document. To answer your questions, I would need a different type of document, such as a clinical study report, a validation study, or a more detailed technical submission that includes performance data and methodology.
§ 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.