(54 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) (K071873) 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) Premarket Notification for the Varian Medical Systems, Inc. Eclipse Treatment Planning System (Eclipse TPS). It describes the device, its indications for use, and a comparison to a predicate device. However, this document does not contain any information about acceptance criteria, performance studies, sample sizes, ground truth establishment, or expert involvement as requested in the prompt.
The document is primarily focused on demonstrating substantial equivalence to a previously cleared device (Eclipse K071873) by comparing their indications for use, algorithm features, and other features.
Therefore, I cannot fulfill your request for:
- A table of acceptance criteria and reported device performance.
- Sample sizes for test sets or data provenance.
- Number and qualifications of experts for ground truth.
- Adjudication method.
- MRMC comparative effectiveness study results.
- Standalone algorithm performance studies.
- Type of ground truth used.
- Sample size for the training set.
- How ground truth for the training set was established.
This type of detailed study information is typically found in engineering reports or validation studies submitted as part of the 510(k) application, but it is not commonly included in the publicly available 510(k) summary document itself. The summary focuses on high-level comparisons for substantial equivalence.
§ 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.