(30 days)
The Eclipse Helios Option is an inverse planning tool for creating a highly conformal radiation treatment plan using intensity modulated photon fields, and is an option to Eclipse (K010975). Helios creates in-field intensity modulated beam profiles that result in precisely shaped dose distributions inside the patient. Helios computes the in-field intensities based on user-specified clinical dose-volume constraints corresponding to the desired dose distribution inside target volumes and critical organs. Helios implements an inverse planning algorithm and supports dynamic MLC treatments for Intensity Modulated Radiation Therapy (IMRT). The Helios option is used to assist the clinician by shaping and modulating the field intensities according to the clinical constraints and patient anatomy.
The Varian Eclipse Helios Option software is used to inversely plan photon radiation therapy treatments employing linear accelerators and other similar teletherapy devices with x-ray energies from 1 -- 50 MV.
Eclipse Helios Option is an inverse planning software used to generate complicated radiation (megavoltage photon) therapy treatment plans for Linear accelerators having dynamic MLC capabilities. The physician defines the desired treatment outcome in terms of dose-volume constraints: Helios uses the dose-volume information to automatically optimize the dose distribution within the patient by modulating the radiation fluences for each treatment field. Helios requires a user interface in order to define the regions of interest within the patient and to add treatment fields to be used for the radiation therapy treatment. Helios 6.5 will use Varian's Eclipse device as the front-end interface to its optimization engine. Varian Eclipse is a computer-based device used for calculating and displaying prospective or verification treatment plans for particular patients undergoing a course of radiation therapy. The system consists of a computer with graphics display, and plotter output.
Eclipse Helios Option is an integral part of the Eclipse (K010975) treatment planning system.
The provided text is a Premarket Notification [510(k)] Summary for the Varian Eclipse, Helios Option. This document does not describe acceptance criteria for evaluating device performance in the way a clinical study would, nor does it present a study proving the device meets specific performance criteria against a ground truth.
Instead, this document is a regulatory submission for premarket clearance, primarily focused on demonstrating substantial equivalence to a legally marketed predicate device. The information provided is for regulatory review, not a detailed technical performance study.
Here's an analysis based on the provided text and why it doesn't contain the requested information:
- No Acceptance Criteria or Reported Device Performance: The document describes the device (an inverse planning software for radiation therapy) and its intended use. It does not contain a table of acceptance criteria (e.g., accuracy thresholds, precision values) or reported quantitative device performance metrics against such criteria.
- No Description of a Study for Performance: The text does not detail any study where the device's performance was measured against a ground truth. It focuses on the device's technological characteristics and its similarity to a predicate device. The phrase "Specification Comparison Chart" is mentioned, but the chart itself is not included, and it would likely compare technical specifications rather than clinical performance metrics.
- No Sample Sizes, Data Provenance, or Ground Truth Information: Since no performance study is described, there's no mention of sample sizes for test sets or training sets, data provenance, number or qualifications of experts, adjudication methods, MRMC studies, or standalone performance. The ground truth for such an inverse planning system would typically involve comparing generated dose distributions to established clinical standards or phantom measurements, none of which are detailed here.
In summary, the provided document is a regulatory submission (510(k)) for market clearance, not a clinical or technical performance study report. Therefore, it does not contain the specific information requested regarding acceptance criteria, device performance metrics, or details of a study proving those criteria were met.
The key components of the document are:
- Device Name: Eclipse, Helios Option
- Intended Use: Inverse planning tool for creating highly conformal radiation treatment plans using intensity modulated photon fields, assisting clinicians by shaping and modulating field intensities based on clinical constraints and patient anatomy.
- Predicate Device: CadPlan Helios Option Version 6.0, K9845432
- Regulatory Determination: The FDA found the device substantially equivalent to its predicate.
§ 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.