(108 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) 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, a software device used for radiation therapy planning. It describes the device, its intended use, and compares it to a predicate device. However, it does not contain the detailed information requested regarding acceptance criteria and the study that proves the device meets those criteria.
Specifically, the document states:
"Verification and Validation were performed for all the new features and regression testing was performed against the existing features of Eclipse. System requirements created or affected by the changes can be traced to the test outcomes. The outcome was that the product conformed to the defined user needs and intended uses and that there were no DRs (discrepancy reports) remaining which had a priority of Safety Intolerable or Customer Intolerable."
This statement confirms that verification and validation were done and that the product conformed to user needs and intended uses, implying that acceptance criteria were met. However, it does not provide the specific metrics or details of these acceptance criteria, nor the methodology of the study.
Therefore, I cannot provide the requested information from the given text. The document does not include:
- A table of acceptance criteria and the reported device performance: This detailed information is not present. The document only states that the product "conformed to the defined user needs and intended uses."
- Sample size used for the test set and the data provenance: The document mentions "verification and validation" and "regression testing" but does not provide sample sizes or data provenance.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This information is not provided.
- Adjudication method for the test set: Not mentioned.
- If a multi reader multi case (MRMC) comparative effectiveness study was done, and the effect size: Not mentioned. This type of study seems irrelevant for a treatment planning system comparing features against a predicate device.
- If a standalone (i.e. algorithm only without human-in-the loop performance) was done: The evaluation performed is described as "Verification and Validation" and ensuring "conformed to the defined user needs and intended uses," which implies human judgment in the overall process of using the software. It does not detail a standalone algorithm performance test.
- The type of ground truth used: Not specified. It generally refers to conformance to "defined user needs and intended uses" and the absence of "discrepancy reports."
- The sample size for the training set: Not applicable for this type of software submission as it's not an AI/ML device in the modern sense of requiring extensive training data. It's a deterministic treatment planning system.
- How the ground truth for the training set was established: Not applicable for the same reason as above.
§ 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.