(87 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 irradiation with photon, electron and proton beams, as well as for internal radiation (brachytherapy) treatments.
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 consists of different applications, each used for specific purposes at a different phase of treatment planning. 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 FDA 510(k) summary for the Eclipse Treatment Planning System (v18.0) does not include acceptance criteria or the specific details of a study that proves the device meets acceptance criteria in the format requested.
The document states that "Software verification and validation was conducted and documentation was provided," and that "Test results demonstrate conformance to applicable requirements and specifications." However, it does not provide a table of acceptance criteria or reported device performance metrics. It also explicitly states: "No animal studies or clinical tests have been included in this pre-market submission."
Therefore, for the specific questions requested, the direct answer from the provided text is that the information is not available.
Here's a breakdown of the requested information that cannot be sourced from the provided text:
- A table of acceptance criteria and the reported device performance: Not provided. The document generally states conformance to requirements and specifications but doesn't list specific performance metrics or their acceptance thresholds.
- Sample size used for the test set and the data provenance: Not provided. The nature of the "test set" for software verification and validation is not detailed, nor is the origin of any data used. Given the statement "No animal studies or clinical tests," it's highly likely this refers to internal software testing data.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not provided. There is no mention of expert involvement in establishing ground truth for any test set.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not provided.
- If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not provided. The device is a "Treatment Planning System" and the focus is on its software functionality, not on AI assistance for human readers in diagnostic interpretation.
- If a standalone (i.e. algorithm only without human-in-the loop performance) was done: The document describes "Software Verification and Validation Testing" but does not distinguish between standalone and human-in-the-loop performance, nor does it provide performance metrics. The nature of a "treatment planning system" inherently involves a human user in the loop.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not provided.
- The sample size for the training set: Not applicable/Not provided. As a traditional software update for a treatment planning system, it's unlikely to involve a "training set" in the machine learning sense. The changes described are primarily related to dose calculation algorithms, UI support, and brachytherapy controls.
- How the ground truth for the training set was established: Not applicable/Not provided.
Summary of what is present:
- Device Name: Eclipse Treatment Planning System (v18.0)
- Predicate Device: Eclipse Treatment Planning System v16.1 (K201607)
- Indications for Use: To plan radiotherapy treatments for patients with malignant or benign diseases, using photon, electron, proton, and brachytherapy beams.
- Performance Data: "Software verification and validation was conducted and documentation was provided... Test results demonstrate conformance to applicable requirements and specifications."
- No Clinical/Animal Studies: Explicitly stated that "No animal studies or clinical tests have been included in this pre-market submission."
- Software Level of Concern: "Major."
- Standards Conformance: A list of IEC, ISO, and EN ISO standards is provided (e.g., IEC 62304, IEC 62366-1, IEC 82304-1, IEC 62083, IEC 61217, ISO 15223-1, ISO 20417, ISO 14971, EN ISO 13485).
- Conclusion: The device is considered "safe and effective and perform at least as well as the predicate device" based on non-clinical data, verification, and validation.
§ 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.