(122 days)
Model 1216 Quality Reports is intended for quality assessment of radiotherapy treatment plans and the radiotherapy treatment planning process.
Model 1216 Quality Reports is a multi-functional information and data management software application intended to be used by trained clinicians who are familiar with radiation therapy, such as medical physicists, medical dosimetrists, and radiation oncologists.
Model 1216 Quality Reports receives DICOM data from Treatment Planning Systems (TPS) which are capable of providing such data. The data may include images, radiation therapy (RT) objects such as RT Plan, RT Structure Set and RT Dose. The user may also capture data through manual input.
The application allows the user to:
- Create reports and charts which may be sent to the institution's Electronic . Medical Record (EMR) system.
- Measure quality with standardized metrics that are based on the institution's ● chosen standards.
- Capture information from the clinical team during pre-treatment planning. ●
- Establish benchmark and progress data to demonstrate continuous improvement.
- Audit the Dose Volume Histogram (DVH) from the TPS.
- . Facilitate quantitative review of the estimated dose via a single DVH metric.
- Customize and save a library of non-dosimetric plan parameters and compare ● them against user defined constraints.
- . Track plan quality scores over time to assess performance and provide the basis for measuring continual improvement.
This document is a 510(k) premarket notification for the Model 1216 Quality Reports by Sun Nuclear Corporation. The information provided outlines the device's intended use and technical specifications, comparing it to predicate devices. However, it explicitly states that no clinical trials were performed for this device, and testing was limited to bench testing using simulated clinical workflows.
Therefore, it is not possible to provide acceptance criteria and a study proving the device meets those criteria based on the provided text, as such a study was not conducted. The document states:
"As with the predicate device, no clinical trials were performed for Model 1216 Quality Reports. Testing was limited to Bench testing using simulated clinical workflows." (Page 5)
Without clinical data or a formal study demonstrating performance against specific acceptance criteria, the detailed information requested below cannot be extracted from this document.
However, I can extract information related to the testing that was performed and the general claims made:
1. A table of acceptance criteria and the reported device performance
No specific acceptance criteria for clinical performance are provided in the document, nor is there reported clinical device performance, as no clinical trials were conducted. The document mentions:
- "Verification tests were written and executed to ensure that the system was working as designed."
- "Pass/fail criteria were used to verify requirements and to ensure that risk mitigations functioned as intended."
- "Regression tests were performed."
This indicates internal verification and validation testing, but not performance against clinical acceptance criteria.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
As no clinical trials were performed, there is no "test set" in the context of patient data. Testing was done with "simulated clinical workflows," meaning synthetic or representative data, but the sample size (number of cases or types of simulations) and data provenance (country, retrospective/prospective) are not specified.
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)
Not applicable, as no clinical test set with externally established ground truth was used.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as no clinical test set was used that would require adjudication.
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 study was performed. The device is a "multi-functional information and data management software application" for quality assessment, not an AI-assisted diagnostic tool for human readers in the traditional sense of improving interpretation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The device functions as a standalone software, but its performance was assessed through "bench testing using simulated clinical workflows" rather than a formal standalone clinical performance study using patient data and ground truth. The document states it is "intended to be used by trained clinicians who are familiar with radiation therapy, such as medical physicists, medical dosimetrists, and radiation oncologists," indicating human-in-the-loop operation for the overall process, even if the software itself runs independently.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the internal "verification tests" and "simulated clinical workflows," the ground truth would typically be defined by the expected behavior or output of the software according to its design specifications. It would not involve expert consensus, pathology, or outcomes data from real patients.
8. The sample size for the training set
Not applicable. The document does not describe an AI/machine learning model that requires a training set. This is a software application for data management and quality assessment, not a learning algorithm.
9. How the ground truth for the training set was established
Not applicable, as there is no training set mentioned or implied.
§ 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.