(17 days)
The Eclipse Treatment Planning System (Eclipse TPS) is used to plan radiotherapy treatments 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 Eclipse Treatment Planning System (Eclipse TPS) is a computer-based software device used by trained medical professionals to design and simulate radiation therapy treatments. It is capable of planning treatments for external beam irradiation with photon, electron, and proton beams, as well as for internal irradiation (brachytherapy) treatments.
This document, a 510(k) premarket notification from Varian Medical Systems for their Eclipse Treatment Planning System, primarily focuses on demonstrating substantial equivalence to a predicate device. It does not contain the specific type of performance study data (e.g., clinical study results comparing AI-assisted vs. non-AI assisted performance, or standalone algorithm performance against ground truth) that would typically include acceptance criteria and detailed study results for an AI/ML powered device.
The document states: "No animal studies or clinical tests have been included with this pre-market submission." This explicitly means that the kind of study you are asking about, which involves evaluating the device's performance against detailed acceptance criteria using a test set, was not part of this submission. The "PERFORMANCE DATA" section (page 4) refers solely to "Software verification and validation."
Therefore, based on the provided text, I cannot extract the information requested in your prompt regarding acceptance criteria and performance data from a clinical study or a standalone algorithm evaluation. The acceptance criteria and performance data for this submission are focused on software verification and validation, as well as demonstrating substantial equivalence based on technological characteristics and intended use.
§ 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.