(152 days)
Delivery Analysis is indicated for making:
- Quantitative comparisons of planned and measured MLC fluence sinograms
- Quantitative comparisons of the planned dose distribution to the dose distribution calculated based upon the measured MLC fluence sinogram
- Quantitative comparisons of the delivered detector sinograms from one fraction to another
Delivery Analysis is a software tool that runs on a standalone workstation used to compare radiation therapy pre-treatment and measured in-treatment data with information describing the planned radiation treatment delivery. The pretreatment assessment tools provide a means to confirm whether the multi-leaf collimator (MLC) has performed according to the treatment plan and evaluate any differences in MLC performance that may affect the treatment delivery. The intreatment assessment tools allow comparison of the current radiation treatment fraction as delivered with previous fractions to evaluate the consistency of the treatment delivery with particular sensitivity to variations in patient setup and anatomy.
Delivery Analysis is a computer-based analysis tool for viewing plan and treatment delivery system data, making quantitative comparisons among data sets, trending specific metrics associated with deliveries, and calculating the dose implications for some measured quantities from the treatment delivery system. Delivery Analysis is designed for use with the TomoTherapy Treatment System last cleared under 510(k) number K121934. Delivery Analysis uses the radiation fields that are measured with the TomoTherapy fan-line detector array to provide both theoretical calculations and direct comparisons of raw data on a fraction per fraction basis.
This document (K143269) is a 510(k) summary for a device called "Delivery Analysis" by Accuray Incorporated. It describes the device, its intended use, indications for use, and a comparison to a predicate device. However, it does not provide specific acceptance criteria or an in-depth study detailing quantitative performance metrics as requested.
The document indicates that "Results of verification and validation testing confirm that Delivery Analysis conforms to design specifications and meets the needs of the intended users. No clinical tests were required to establish substantial equivalence. The performance data demonstrate that Delivery Analysis is as safe and effective, and performs as well as the predicate device." This suggests that internal testing was conducted, but the specifics of those tests, including detailed acceptance criteria and reported performance, are not included in this summary.
Therefore, I cannot fulfill your request for a table of acceptance criteria and reported device performance using the provided text.
Based on the provided text, the following information is not available:
- A table of acceptance criteria and the reported device performance
- Sample sizes used for the test set
- Data provenance for the test set
- Number of experts used to establish ground truth for the test set
- Qualifications of those experts
- Adjudication method for the test set
- Whether a multi-reader multi-case (MRMC) comparative effectiveness study was done
- Effect size of human readers improving with AI vs. without AI assistance
- Whether a standalone (algorithm only) performance study was done
- Type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Sample size for the training set
- How the ground truth for the training set was established
§ 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.