(88 days)
The Varian Eclipse device is used to plan photon and electron radiation therapy treatments employing linear accelerators and other similar radiotherapy devices with xray energies from 1 -- 50MV, as well as Cobalt-60 and electron energies from 1 -- 50MeV. Eclipse will plan the 3D radiotherapy treatment approaches to combined modality plans, coplanar and non-coplanar fields, static and ARC fields, beam modifiers and beam intensity modulators.
Eclipse includes also tools for treatment preparation (diagnostic image analysis, contouring and segmentation) and plan review.
As part of the VARiS Vision System, Eclipse integrates the treatment planning in overall therapy process, while taking advantage of the Varian Vision database.
The Varian Eclipse is a computer-based device used for calculating and displaying prospective or verification treatment plans for particular patient undergoing a course of radiation therapy. The system consists of a computer with graphics display, plotter output, film scanner and backlit digitizer input.
Eclipse provides the capabilities diagnostic image analysis, contouring and segmentation and dosimetric plan review. In addition Eclipse provides tools for photon and electron dose calculation and photon dose compensation. Dose distribution from external beam, intracavitary and interstitial plans (created in BrachyVision [K992762], which can be sold as an option with Eclipse) can be combined together.
Eclipse integrates treatment planning with Varian Vision applications.
This document is a 510(k) premarket notification for the Varian Eclipse radiation therapy treatment planning system. It compares the new device named "Eclipse" to its predicate device, "Eclipse 6.5, K010975". The focus of the submission is on demonstrating substantial equivalence to the predicate device.
Here's an analysis based on the provided text:
Key Takeaway: This 510(k) submission does not contain information about specific acceptance criteria, device performance metrics, or a study that rigorously "proves" the device meets acceptance criteria in the way new, novel medical devices undergo such testing. Instead, the submission relies on demonstrating substantial equivalence to a previously cleared predicate device.
The tables in the document are comparison charts of features and functionalities between the new Eclipse and the predicate Eclipse 6.5. This is a common approach in 510(k) submissions, where the new device is shown to have the same intended use and similar technological characteristics as a legally marketed device, thus not raising new questions of safety and effectiveness.
Therefore, many of the requested items (acceptance criteria, specific performance metrics, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types of study, training set information) are not applicable or not explicitly detailed in this type of substantial equivalence document for a rebranded/updated version of an existing device.
However, I will extract relevant information where possible, and explicitly state when information is not present.
Acceptance Criteria and Device Performance Study Information
1. A table of acceptance criteria and the reported device performance:
This document does not present a table of quantitative "acceptance criteria" and "reported device performance" in the typical sense of a novel device undergoing clinical validation against predefined metrics. Instead, the main "acceptance criterion" for a 510(k) is demonstrating substantial equivalence to a predicate device. The performance is implied to be equivalent to the predicate.
The tables provided are a Specification Comparison Chart between the predicate and new device, showing identical features across the board. This implies the "performance" of the new device is expected to be the same as the predicate given the identical technical specifications and intended use.
| Acceptance Criterion (Implied: Substantial Equivalence to Predicate) | Reported Device Performance (Implied: Identical to Predicate) |
|---|---|
| Intended Use: The Varian Eclipse device is a treatment planning system used for diagnostic image analysis, contouring & segmentation, geometrical planning, photon and electron dose calculation and plan review. | The Varian Eclipse device is a treatment planning system used for diagnostic image analysis, contouring & segmentation, geometrical planning, photon and electron dose calculation and plan review. (Identical as per "Specification Comparison Chart") |
| Technological Characteristics: All listed features and functionalities (General Software, Contouring Tools, Display, Geometric Planning, Visualization, Calculation Algorithms, Import/Export Features, Plan Review, Plan Output - Hardcopy) must be identical to or not raise new questions of safety and effectiveness compared to the predicate device. | All listed features and functionalities are identical to the predicate device as per the "Specification Comparison Chart". For example, "Coplanar and Non-coplanar Photon Beams" are listed for both, "Energy range: 1MV – 50MV Single Pencil Beam Convolution Model MU Calculations" are listed for both, etc. The primary change highlighted is the addition of "Electron Monte Carlo dose calculation model (based on Macro Monte Carlo algorithm)" to the Electrons calculation. This would have been considered to improve or at least be equivalent to the previous model and not raise new questions of safety/effectiveness. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
This information is not provided in the document. As this is a 510(k) for an updated planning system, it likely relies on internal validation and verification activities rather than formal clinical studies with "test sets" in the context of diagnostic accuracy. If any testing was done, it would likely be engineering or software validation rather than patient data-driven performance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
This information is not provided in the document. Given the nature of a treatment planning system update, "ground truth" as it relates to expert clinical review of specific cases is not typically part of a 510(k) for this type of device unless new diagnostic capabilities were introduced.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This information is not provided in the document.
5. 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:
This is not applicable and not provided. The Eclipse device is a treatment planning system, not an AI-powered diagnostic tool for human readers. It provides tools for calculation and display.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
The document describes the device as a "computer-based device used for calculating and displaying prospective or verification treatment plans." It is inherently a tool that supports human planning, not a standalone diagnostic or therapeutic algorithm operating without human input or review. Thus, a "standalone algorithm only" performance study in the context of AI is not applicable and not provided. The performance of its calculation algorithms (e.g., dose calculation) would have been validated against established physics models and benchmarks, but this is not detailed here.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
Given that this is a treatment planning system, the "ground truth" for its core functions (like dose calculation) would be based on established physics principles, verified phantom measurements, and potentially comparisons to other validated treatment planning systems. However, the specific methodology for establishing such ground truth for validation is not detailed in this 510(k) summary. For image analysis features like contouring, the "ground truth" would be expert anatomical delineation, but again, no specific studies proving this are detailed in this summary.
8. The sample size for the training set:
This information is not provided in the document. Treatment planning systems are typically developed based on physics models, algorithms, and established medical imaging and dosimetry data, rather than being "trained" on a large "training set" like many AI/ML devices.
9. How the ground truth for the training set was established:
This information is not provided as a formal "training set" in the context of AI/ML is not explicitly discussed. The underlying principles for the calculations (e.g., photon and electron dose calculation models) would be based on validated scientific and medical physics principles.
§ 892.1000 Magnetic resonance diagnostic device.
(a)
Identification. A magnetic resonance diagnostic device is intended for general diagnostic use to present images which reflect the spatial distribution and/or magnetic resonance spectra which reflect frequency and distribution of nuclei exhibiting nuclear magnetic resonance. Other physical parameters derived from the images and/or spectra may also be produced. The device includes hydrogen-1 (proton) imaging, sodium-23 imaging, hydrogen-1 spectroscopy, phosphorus-31 spectroscopy, and chemical shift imaging (preserving simultaneous frequency and spatial information).(b)
Classification. Class II (special controls). A magnetic resonance imaging disposable kit intended for use with a magnetic resonance diagnostic device only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.