(56 days)
The e.IMRT Calculator is a simple, stand-alone software program provided on a CD-rom for use on an appropriately configured personal computer. It is intended to assist the oncologist or medical physicist in creating an optimum electron treatment plan based on the treatment objective for the patient.
Using previously established mathematical equations, the e.IMRT Calculator suggests several potential electron beam treatment energy solutions, within user selected parameters, by combining several discrete energies typically available on the linear accelerator(s). It uses previously user gathered or generated depth dose data sets for each electron energy available (4, 6, 9, 12, 15, 16, 18, 20 or 22 MeV) on the user's specific liner accelerator(s) as its primary input. Other inputs involve the identification of the facility, specific linear accelerator(s) and bolus used.
The output of the e.IMRT calculator is a hardcopy printout of the suggested electron beam treatment energies, in both numeric and graphical formats. The site, linear accelerator and bolus information are also provided on this printout are the site. The e.IMRT Calculator does not, however, electronically store any patient identification data or information. Inputs involving patient information are only used for hardcopy printouts.
Specific electron beam parameters are selected from the solution options provided by the e.IMRT Calculator for non-direct (manual) input into the user's radiation treatment planning system. The treatment planning system then creates a treatment plan based on the treatment objective for the patient, which is reviewed by the attending oncologist for acceptability prior to implementation with a linear accelerator.
The e IMRT Calculator is a simple, stand-alone software program provided on a CD-rom for use on an appropriately configured personal computer. It is intended to assist the oncologist or medical physicist in creating an optimum electron treatment plan based on the treatment objective for the patient.
Using previously established mathematical equations, the e.IMRT Calculator suggests several potential electron beam treatment energy solutions, within user selected parameters, by combining several discrete energies typically available on the linear accelerator(s). It uses previously user gathered or generated depth dose data sets for each electron energy available (4. 6, 9, 12, 15, 16, 18, 20 or 22 MeV) on the user's specific liner accelerator(s) as its primary input. Other inputs involve the identification of the facility, specific linear accelerator(s) and bolus used.
The output of the e.IMRT calculator is a hardcopy printout of the suggested electron beam The butput of the c.HAN's numeric and graphical formats. The site, linear accelerator and bolus information are also provided on this printout are the site. The e.IMRT Calculator does not, however, electronically store any patient identification data or information. Inputs involving patient information are only used for hardcopy printouts.
Specific electron beam parameters are selected from the solution options provided by the e. IMRT Calculator for non-direct (manual) input into the user's radiation treatment planning system. The treatment planning system then creates a treatment plan based on the treatment objective for the patient, which is reviewed by the attending oncologist for acceptability prior to implementation with a linear accelerator.
The Standard Imaging e.IMRT Calculator is a software program designed to assist oncologists or medical physicists in creating optimal electron beam treatment plans. The device suggests potential electron beam treatment energy solutions by combining discrete energies available on linear accelerators, using previously established mathematical equations and user-provided depth dose data.
Here's an analysis of the acceptance criteria and the study proving the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document describes a validation process rather than specific quantitative acceptance criteria with numerical targets. The acceptance criteria seem to be qualitative and related to the proper functioning and comparison against existing systems.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Algorithm transfer | Validated |
| Results presentation and graphing | Validated |
| Absolute dose depth measurements | Validated |
| Interface, compatibility, use and misuse | Validated |
| Treatment planning system comparison analysis | Validated |
| Compliance with IEC 60601-1-4 (Edition 1 2000-04) | Designed to comply |
| Meets predetermined design specifications, risk analysis, and validation objectives | Met |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state a specific "test set" with a defined sample size in terms of patient cases or data points. The validation involved various aspects listed above. The provenance of the data used for depth dose measurements (input to the calculator) is stated as "previously user gathered or generated depth dose data sets for each electron energy available... on the user's specific linear accelerator(s)." This indicates the data provenance is user-generated/user-specific, likely retrospective in the sense that this data would have been collected prior to using the e.IMRT Calculator. The document does not specify countries of origin.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document does not specify a number of experts used to establish ground truth for a test set. The validation process appears to be more focused on the computational aspects of the calculator and its comparison to existing systems and measured physical properties. While the e.IMRT Calculator is intended to assist oncologists or medical physicists, the document does not detail expert involvement in generating a ground truth for a validation study.
4. Adjudication Method for the Test Set
No adjudication method is described, as a formal test set requiring adjudication by multiple experts is not detailed for the validation process.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance
No MRMC comparative effectiveness study is mentioned. The device is a "calculator" to assist in treatment planning, not an AI for image interpretation that would typically require MRMC studies.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, the validation implicitly includes standalone performance. The "Algorithm transfer," "Results presentation and graphing," and "Absolute dose depth measurements" evaluations focused on the calculator's inherent performance and accuracy of its outputs based on its algorithms and inputs. The "Treatment planning system comparison analysis" also speaks to its standalone calculation capabilities being compared.
7. The Type of Ground Truth Used
The ground truth used for validation appears to be a combination of:
- Established mathematical equations: The device uses "previously established mathematical equations."
- User-generated/measured depth dose data: This data serves as the primary input and a basis for the calculations, presumably validated against physical measurements.
- Comparison to existing commercial systems: The device is "substantially equivalent to the electron portion of the ADAC Laboratories (Philips) Pinnacle 3 Radiation Therapy Planning Software," suggesting that Pinnacle 3's output might have served as a comparative ground truth or benchmark for the "treatment planning system comparison analysis."
- Empirical absolute dose depth measurements: These measurements would serve as a physical ground truth for calibrating and validating the dose calculation.
8. The Sample Size for the Training Set
The document does not describe a "training set" in the context of machine learning. The e.IMRT Calculator uses "previously established mathematical equations" and "user gathered or generated depth dose data sets." These depth dose data sets could be considered analogous to input data for its operations, but not a "training set" in a machine learning sense where the algorithm learns from the data.
9. How the Ground Truth for the Training Set Was Established
As no "training set" (in the machine learning sense) is explicitly mentioned, the establishment of ground truth for such a set is not applicable. The underlying principles are based on conventional physics-based calculations using established equations and physical measurements for depth dose data.
§ 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.