(267 days)
The Scanditronix Medical RFA-300, LDA Utility is used to more effectively perform radiation therapy beam measurements including acceptance testing, trimming information, routine beam checks and quality assurance measurements and on-line data analyses using personal computer (PC) monitor. These uses are similar to those of the predicate identified in section (3) of this Summary.
The Scanditronix Medical RFA-300, LDA Utility is an extension to the RFA-300 system used to measure radiation therapy beam intensity. For use, a complete RFA-300 system is needed extended with the following equipment:
- Multichannel electrometers emX which provides 12 independent electrometer channels each or a DPD-510 which provides 10 independent electrometer channels.
- Linear Detector Array LDA-11 (11 detectors) or LDA-25 (25 detectors).
- PC-based software providing control, display, calibration and save functions.
This is a summary of the acceptance criteria and study details for the Scanditronix Medical RFA-300, LDA Utility:
Acceptance Criteria and Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Operational characteristics suitable for intended purpose (effectively performing radiation therapy beam measurements including acceptance testing, trimming information, routine beam checks, quality assurance measurements, and on-line data analyses). | Comparison of operational characteristics for the Scanditronix Medical RFA-300, LDA Utility and the predicate product showed similar results that are suitable for their intended purpose. |
| Minimization of potential electrical hazards | Scanditronix Medical adheres to recognized and established industry practice, and all devices are subject to final performance testing. The device is designed for conformance with IEC 601-1 standards for electrical isolation and meets electrical performance standards for CSA and UL certifications. |
| Meeting accelerator performance standards for measurement and data processing capabilities | IEC-601C standards for accelerator performance are used as minimum criteria of measurement and data processing capabilities of the Scanditronix Medical RFA-300, LDA. The device was tested and found to fulfill these requirements. |
| Electromagnetic compatibility (EMC) | The Scanditronix Medical RFA-300, LDA Utility has been tested and found to fulfill the requirements concerning electromagnetic compatibility according to the standard IEC 601-1-2 (see appendix XVII). |
| Safety (implied, as part of overall performance and meeting standards) | Testing of operational parameters for the Scanditronix Medical RFA-300, LDA Utility, indicates that the device is safe. |
| Appropriate verification and dose measurements of radiation beams (implied, as part of overall performance) | Testing indicates that the device provides appropriate verification and dose measurements of radiation beams. |
| Performance equivalent to or better than the legally marketed predicate device | Testing indicates that the device performs as well as or better than the legally marketed predicate device identified in section (3) of this summary (RFA-300, Wellhöfer WP600, Wellhöfer MDA). |
Study Details
- Sample Size used for the test set and the data provenance: Not applicable. The device is for radiation therapy beam measurements, not for patient data analysis. The testing involved comparing operational characteristics and adherence to engineering standards.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for this type of device (a measurement tool) is established through engineering standards, comparative performance against predicate devices, and adherence to regulatory compliance. No mention of human expert panel for ground truth assessment in the context of diagnostic interpretation.
- Adjudication method for the test set: Not applicable. This document describes testing against engineering standards and comparison with predicate device performance, not a diagnostic adjudication process.
- 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: Not applicable. This is not an AI-assisted diagnostic device. It's a measurement tool for radiation therapy.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: The device itself is standalone in its function for measuring radiation beams. The "human-in-the-loop" involves a technician operating the system and interpreting the measurements as part of a larger radiation therapy quality assurance process. The document primarily focuses on the device's technical specifications and performance against established benchmarks without human involvement in evaluating its output for a diagnostic decision.
- The type of ground truth used:
- Engineering Standards: IEC 601-1, CSA, UL certifications for electrical safety and performance.
- Accelerator Performance Standards: IEC-601C for measurement and data processing capabilities.
- Electromagnetic Compatibility Standards: IEC 601-1-2.
- Comparative Performance: Against identified predicate devices (RFA-300, Wellhöfer WP600, Wellhöfer MDA) regarding operational characteristics.
- The sample size for the training set: Not applicable. This device is a measurement instrument, not a machine learning or AI system that requires a "training set" in the conventional sense.
- How the ground truth for the training set was established: Not applicable, for the reason stated above.
§ 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.