(146 days)
EDOSE is indicated to be used as an independent quality assurance (QA) tool for the treatment planning system, to verify that the treatment plan is in fact successfully delivered to the patient. EDOSE is used by oncologist, radiotherapy physicist and/or radiotherapy dosimetrist to check the accuracy of the delivery by high energy linear accelerator that are planned to be applied or have been applied to a patient. By using the specific measuring device, the product can output the dose distribution of the patient or phantom based on treatment field image data and theoretical calculation. The product can calculate and check the dose distribution to be or has been delivered. In addition, the product may be used to display the dose distribution on other fused image sets which could provide additional clinical information to the radiation oncologist regarding the treatment.
EDOSE is a three-dimensional dose verification system making IMRT verification becomes accurate, efficient and fast. This system fully supports Varian and Elekta accelerators; it can verify conventional IMRT, IMRT and VMAT. With Collapsed Cone convolution algorithm, it realizes the reconstruction of the three-dimensional dose and combined with the CT image, making the three-dimensional distribution of the dose at a glance. By using CUDA parallel algorithms, EDOSE quickly and efficiently provide the entire program as well as the calculation results of individual GAMMA radiation field, and visually display GAMMA distribution. Meanwhile, EDOSE provides automatic correction of absolute dose and EPID position to support DVH comparison chart and the move of isodose curve. Through a series of powerful functions, the accelerator quality assurance has become so easy.
The provided text is a 510(k) summary for the EDOSE device, detailing its substantial equivalence to a predicate device, Dosimetry Check with Exit Dose. While it discusses the device's intended use and general characteristics, it does not contain a detailed study with acceptance criteria and reported device performance, nor does it provide information on sample sizes, ground truth establishment, or multi-reader studies.
The document only states the following regarding performance: "Review of ID 3 - Performance, both are the same, so the SE is not affected." This implies that the performance is considered substantially equivalent to the predicate device, but no specific performance metrics or acceptance criteria for EDOSE are presented.
Therefore, many of the requested details cannot be extracted from the provided text.
Here's an attempt to answer the questions based only on the provided text, with clear indications where the information is not available:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not Available | Not Available |
| (No specific acceptance criteria or performance metrics for EDOSE are mentioned in the provided text. The document only states that the performance of EDOSE is considered "the same" as the predicate device, Dosimetry Check with Exit Dose, implying substantial equivalence without specific data.) |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not Available
- Data Provenance (Country of Origin): Not Available
- Data Provenance (Retrospective/Prospective): Not Available
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of Experts: Not Available
- Qualifications of Experts: Not Available
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Adjudication Method: Not Available
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
- MRMC Study Conducted?: No (Not mentioned or implied in the text. The device is described as an "independent quality assurance (QA) tool," not a reader assistance tool.)
- Effect Size: Not Applicable (as no such study was mentioned)
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Standalone Performance Study Conducted?: Not explicitly stated, however, the device is described as an "independent quality assurance (QA) tool" that "can calculate and check the dose distribution." This strongly suggests standalone functionality, but no specific study or metrics are provided. The text mentions "the software system test and the product design verification are performed as the same single testing activity. During the system test period, all of the product level and software requirements have been tested and verified," which broadly refers to software testing rather than a clinical performance study.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Type of Ground Truth: Not Available (The device "verifies that the treatment plan is in fact successfully delivered" and "checks the dose distribution to be or has been delivered," implying comparison against a planned or measured dose, but the specific nature of the ground truth for validation is not detailed.)
8. The sample size for the training set
- Sample Size for Training Set: Not Available (No mention of a training set or machine learning model training.)
9. How the ground truth for the training set was established
- Ground Truth Establishment for Training Set: Not Applicable (No training set or machine learning model is mentioned.)
§ 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.