(34 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 document is a 510(k) premarket notification summary for the Eclipse Treatment Planning System (Eclipse TPS). This device is a software tool used by trained medical professionals to design and simulate radiation therapy treatments.
However, the 510(k) summary (K071873) and the FDA letter do not contain information about acceptance criteria, performance studies with specific metrics, sample sizes for testing or training, methods for establishing ground truth, or details about human reader studies (MRMC or standalone AI performance).
The document primarily focuses on establishing substantial equivalence to a predicate device (Eclipse Treatment Planning System, K050296) and outlining the general indications for use and classification. This type of regulatory submission for a software device generally relies on verification and validation activities to ensure the software performs as intended, but the detailed results of these activities are typically not included in the public 510(k) summary.
Therefore, I cannot provide the requested information based on the provided text. To answer your questions, one would need access to the full 510(k) submission including the detailed validation documentation.
§ 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.