(90 days)
OmniDos is used to accurately analyse and handle the measured dose distribution in quality assurance purposes, for calibration of radiation devices, as input data to Treatment Planning Systems, for acceptance testing, beam tuning and in research.
The Scanditronix & Wellhöfer OmniDos is a General Dosimetry System similar to Wellhöfer Dosimetrie: WP700, FDA K945321/S1, 1995, 29th of March. Scanditronix Medical: RFA-300, FDA K934303/S1, 510(k) Aug 1994, Scanditronix Medical: RFA-300, LDA Utility, FDA K961400: Jan. 1997. OmniDos and the marketed predicated products are radiotherapy quality assurance measuring devices designed to measure dose distribution. Using appropriate detectors and servo/scanners, the dose distribution can be accurately measured to provide acceptance testing, beam tuning, routine beam verifications, isodose tracking and linear scans. These devices are designed to function in conjunction with a PC, which controls the relative position of the detectors while measuring and storing dose information of the radiotherapy beam. Each device is designed to provide two or more channels from electrometers which have their results converted into digital information for storage, display, or transfer to other systems for radiation therapy treatment planning using data formats suitable for the other system. Depending on configuration the devices offer several options for use of the detector system, including film scanning, TMR measurements, and other options.
The provided text describes the Scanditronix Medical AB OmniDos General Dosimetry System, a device for measuring radiation dose distribution in radiotherapy quality assurance.
Here's an analysis of the acceptance criteria and study information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state quantitative acceptance criteria or specific performance metrics in a tabular format. Instead, it relies on demonstrating equivalence to predicate devices and adherence to relevant standards.
| Acceptance Criterion (Described Conceptually) | Reported Device Performance |
|---|---|
| Operational Characteristics | "Comparison of operational characteristics for the Scanditronix Medical OmniDos General Dosimetry System and the predicate product show similar results that are suitable for their intended purpose." |
| Electrical Safety (IEC 601-1) | "The Scanditronix Medical OmniDos General Dosimetry System is designed for conformance with IEC 601-1 standards for electrical isolation and leakage current and meets electrical performance standards for CSA and UL." |
| Electromagnetic Compatibility (IEC 601-1-2) | "The electrometers of Scanditronix Medical and its sister company Wellhöfer Dosimetrie GmbH for OmniDos, General Dosimetry System has been tested and found to fulfil the requirements concerning electromagnetic compatibility according to the standard IEC 601-1-2." |
| Safety | "Testing of operational parameters indicates that the Scanditronix Medical OmniDos General Dosimetry System is safe..." |
| Intended Use Fulfillment | "...it fulfils the intended use..." |
| Performance Equivalence | "...and performs as well as or better than the previously released product RFA-300plus." (Implies meeting or exceeding the performance of the predicate device. The predicate devices are listed as WP700 (FDA K945321/S1), RFA-300 (FDA K934303/S1), and RFA-300 LDA Utility (FDA K961400), with the RFA-300plus likely being an updated version of one of these.) |
2. Sample Size Used for the Test Set and Data Provenance
The document refers to "final tests" performed on the "whole system consisting of software and hardware." However, it does not specify the sample size for these tests (e.g., number of measurements, number of devices tested).
- Sample Size: Not specified.
- Data Provenance: The tests are described as "Non-Clinical tests" and performed by the manufacturer ("Scanditronix Medical and its sister company Wellhöfer Dosimetrie GmbH"). The origin of the data (country) is not explicitly stated beyond the company's location in Sweden. It is presumably prospective testing conducted by the manufacturer for regulatory submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable as the device is for quality assurance measurement, not diagnostic interpretation. The testing involved comparing operational characteristics and adherence to technical standards, not expert-derived ground truth for diagnostic accuracy.
4. Adjudication Method for the Test Set
This is not applicable as the testing did not involve human interpretation or subjective assessments requiring adjudication. The performance was assessed against objective characteristics and technical standards.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
A multi-reader multi-case (MRMC) comparative effectiveness study was not performed or mentioned. The device is a measurement system, not an AI-assisted diagnostic tool for human readers.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
The evaluation described is essentially a standalone performance assessment of the system (software + hardware) against its intended function and established technical standards. There isn't an "algorithm only" component separate from the hardware in the context of this dosimetry system. The "Non-Clinical tests" section details this standalone evaluation of the system's operational characteristics, electrical safety, and electromagnetic compatibility.
7. Type of Ground Truth Used
The "ground truth" for this device's evaluation was based on:
- Predicate device performance: The OmniDos system was compared to and declared "similar" or "as well as or better than" previously released predicate devices (WP700, RFA-300, RFA-300 with LDA Utility).
- Established industry practice and standards: Adherence to "recognized and established industry practice" for electrical hazards, and conformance with IEC 601-1 (electrical isolation, leakage current), CSA, UL (electrical performance), and IEC 601-1-2 (electromagnetic compatibility) standards.
- Intended use fulfillment: The device's ability to accurately measure dose distribution for quality assurance, calibration, input to treatment planning systems, acceptance testing, beam tuning, and research.
8. Sample Size for the Training Set
This is not applicable. The OmniDos is a dosimetry system, not an AI/machine learning model that requires a training set in the conventional sense. Its "training" would be inherent in its design and engineering based on physics and metrology principles, rather than data-driven machine learning.
9. How the Ground Truth for the Training Set Was Established
This is not applicable for the same reasons as #8. The "ground truth" for its development would be the fundamental principles of radiation dosimetry and engineering standards, not a labeled dataset for a machine learning algorithm.
§ 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.