(94 days)
The intended use of the OmniPro I'mRT system is to:
• verify the treatment plan and delivered dose of intensity modulated or static beams prior to treatment
• verify the intensity maps during IMRT delivery prior to treatment
• verify the absolute dose in given points for IMRT fields.
The Scanditronix & Wellhöfer OmniPro I'mRT system is a system similar to Radiological Imaging Technology: RIT113 Film Analysis System FDA K935928 12/13/1993
The OmniPro I'mRT system and the marketed predicated product are radiotherapy quality assurance systems designed to measure dose, doseor intensity-distributions, to analyse these data and to compare the measurement data with calculated dose- or intensity-distributions, especially in the field of Intensity Modulated Radiotherapy.
The OmniPro I'mRT system can consist of
- software (herafter called OmniPro I'mRT) .
- hardware supported by OmniPro I'mRT (like detector arrays, . filmscanning devices, single detectors, bodyphantoms for positioning and pacing of film and/or detectors or detector arrays).
The provided document is a 510(k) Pre-market Notification for the OmniPro I'mRT System, dated August 29, 2003. It's a submission to the FDA to demonstrate substantial equivalence to a legally marketed predicate device, the RIT113 Film Analysis System (K935928).
Based on the document, here's an analysis of the acceptance criteria and the study that proves the device meets them:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly present a table of quantitative acceptance criteria with reported performance values in the way one might see for a diagnostic device (e.g., sensitivity, specificity thresholds). Instead, the "acceptance criteria" are implied by the demonstration of substantive equivalence to the predicate device in terms of intended use, technological characteristics, and performance. The performance is assessed through a qualitative comparison, not a quantitative one against predefined metrics.
However, we can infer "performance" in the context of this submission as the ability of the OmniPro I'mRT system to perform the same functions as the predicate device (RIT113) effectively and safely.
| Acceptance Criteria (Implied by Equivalence) | Reported Device Performance (OmniPro I'mRT) |
|---|---|
| Intended Use Equivalence | Meets Intended Use: The OmniPro I'mRT system's intended use is identical to or encompasses the predicate: to verify treatment plans and delivered dose of intensity modulated or static beams prior to treatment, verify intensity maps during IMRT delivery prior to treatment, and verify absolute dose in given points for IMRT fields. This is explicitly stated as being fulfilled. |
| Technological Equivalence | Substantially Equivalent Technologies: Both systems are described as analyzing and measuring software supporting hardware (film scanners, detector arrays). The document details minor differences but concludes "There are no principal differences between the systems, neither regarding support of measured data, import of data or tools for comparing or analysing of data." |
| Performance Equivalence | Equivalent Performance: The document argues that performance differences are minor and do not limit intended use. For example: |
- Data Import: OmniPro I'mRT supports DICOM/RTOG; RIT113 supports more vendor-specific formats, but standards are gaining traction.
- Film Scanners: OmniPro I'mRT supports additional scanners (Vidar VXR-16, Lumisys) not supported by RIT113, with similar specifications.
- Calibration: OmniPro I'mRT uses a two-step (signal to OD, OD to dose) calibration, providing an advantage in independent checking, but achieving the same goal.
- Body Phantom Support: Both support almost all market phantoms; OmniPro I'mRT does not support the Gammex 469, but this "does not limitate the intended use."
- Detector Array Support: RIT113 supports import from portal imaging systems; OmniPro I'mRT supports the "whole measurement process" of a dedicated detector array (I'mRT QA). Both achieve the goal of comparing intensity maps.
- Single Detector Support: OmniPro I'mRT supports single detector measurements (e.g., Dose 1) to verify absolute dose, which is one of its stated intended uses.
- Analyzing Tools: OmniPro I'mRT includes all tools of RIT113 (film alignment, subtraction, isodose comparison) and adds multiplication and the gamma method, offering enhanced analysis capabilities. |
| Safety and Electrical Standards | Meets Safety Standards: The device adheres to recognized industry practices. All electrical devices conform to national and international standards (e.g., IEC 61010, CSA 22.2-601.1, EN 60-601, EN 55022, FCC Class B). Quality assurance system is certified to DIN EN ISO 9001 and DIN EN 46001. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document explicitly states: "Due to the fact that the system is a quality assurance device in radiation treatment not directly involved in the delivery of the treatment radiation, no clinical testing was performed."
However, it also states: "However, the device was tested in clinical environment by medical physicists to evaluate the overal performance (indication for use) of the system."
This indicates that a formal "test set" with a defined sample size, data provenance, and retrospective/prospective design in the sense of a clinical trial for diagnostic or therapeutic devices, was not conducted or reported. The evaluation in a "clinical environment" by medical physicists seems to be more of a usability and general performance assessment rather than a structured quantitative study with a specific test set. No specific sample size for this hands-on evaluation is provided.
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)
Given that no formal clinical "test set" and ground truth establishment study was described, this information is not provided. The assessment appears to rely on the expertise of "medical physicists" in the general clinical environment.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Since no formal test set and ground truth establishment study was described, there is no adjudication method reported.
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
No MRMC comparative effectiveness study was done or reported. The device is a "Dosimetry System for Quality Assurance" and not an AI-assisted diagnostic tool that would typically undergo such a study. The comparison is between the new device (OmniPro I'mRT) and a predicate device (RIT113), not between human readers with and without AI.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The document describes the OmniPro I'mRT as a "system" consisting of "software (herafter called OmniPro I'mRT)" and "hardware supported by OmniPro I'mRT". The workflow clearly indicates "human-in-the-loop" involvement (e.g., physicists placing films, developing films, importing data, analyzing data, comparing data). As a quality assurance system for radiotherapy, it inherently requires human input and interpretation.
Therefore, a standalone (algorithm only) performance assessment was not performed or is not applicable in the context of this device's intended use and design.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
As this is a quality assurance device, the "ground truth" for the system's function is the accurate measurement and comparison of planned vs. delivered radiation dose/intensity distributions. The system itself produces data that is then compared. The accuracy of these measurements is relative to the physical reality of the radiation field, not a clinical diagnosis. The "testing in clinical environment by medical physicists" likely involved verifying that the system accurately processed input data and produced expected output comparisons, consistent with established physics principles and clinical practice standards for radiation dosimetry. This is implicitly the "ground truth" for a QA device.
8. The sample size for the training set
No training set is mentioned or applicable in the context of this 2003 submission for a dosimetry QA system. The device does not appear to employ machine learning or AI that would require a distinct training set. Its functionality is based on algorithms that process acquired physical data according to known physical laws and calibration curves.
9. How the ground truth for the training set was established
Since no training set is indicated, the method of establishing ground truth for a training set is not applicable.
§ 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.