(124 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 radiation (brachytherapy) treatments.
Eclipse provides software tools for planning the treatment of malignant or benign diseases with radiation. Eclipse 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.
Eclipse is used for planning external beam radiation therapy treatments employing photon energies between 1 and 50 MV, electron energies between 1 and 50 MeV, for proton energies between 50 and 300 MeV, and for planning internal radiation (brachytherapy) treatments with any clinically approved radioisotope. The treatment planning system utilizes a patient model or virtual patient derive from medical imaging techniques to simulate, calculate and optimize the radiation dose distribution inside the body during a treatment procedure in order to ensure effective treatment of the tumor but to minimize damage to surrounding tissue.
The provided document is a 510(k) premarket notification letter from the FDA regarding the Eclipse Treatment Planning System (18.1). It primarily addresses the substantial equivalence of the new version to a legally marketed predicate device (Eclipse Treatment Planning System 18.0).
Unfortunately, this document does not contain the detailed information required to describe acceptance criteria and a study proving the device meets those criteria, as requested in your prompt.
Here's why and what information is missing:
- No specific acceptance criteria table or performance metrics: The document states that "Test results demonstrate conformance to applicable requirements and specifications," but it does not list what those requirements or specifications are (the acceptance criteria), nor does it provide a table of reported device performance against those criteria.
- No information on clinical studies or human-in-the-loop performance: The document explicitly states, "No animal studies or clinical tests have been included in this pre-market submission." This immediately tells us that there was no MRMC study, no standalone performance study in a clinical context, and no ground truth established from patient outcomes or expert consensus for such a study.
- Focus on software V&V and equivalence to predicate: The "Summary of Performance Testing (Non-Clinical Testing)" section primarily references software verification and validation (V&V) activities (unit, integration, system testing) and measurement comparison tests using Gamma evaluation criteria and plan comparisons using clinical objectives and workflow testing to show comparability to the predicate. These are engineering and software quality assurance tests, not clinical performance studies with defined acceptance metrics for AI/algorithm performance.
- No mention of AI/algorithm specific performance: The document describes "RapidArc Dynamic" as an "improved optimization algorithm," but it does not treat it as a distinct AI algorithm requiring specific clinical performance validation against a ground truth as one might expect for a diagnostic or prognostic AI tool. The testing mentioned appears to be related to the accuracy and efficiency of the planning output compared to the predicate, rather than the performance of an AI model in a diagnostic or assistive capacity.
- No details on sample size, data provenance, expert ground truth, or adjudication: Because no clinical performance study was conducted or reported, all these details are consequently missing.
In summary, the provided document focuses on regulatory compliance, substantial equivalence to a predicate device, and general software V&V, rather than providing the detailed clinical performance study information you are asking for, which is typical for AI/ML-driven diagnostic or prognostic devices seeking regulatory clearance.
The "Eclipse Treatment Planning System" is a software tool used by trained medical professionals to design and simulate radiation therapy treatments. While it includes "optimization algorithms" (like RapidArc Dynamic), the FDA submission treats these changes as enhancements to an existing system, validated through engineering and software testing for comparability, rather than a novel AI/ML device requiring an independent clinical performance study as outlined in your prompt questions.
§ 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.