(50 days)
The Sun Nuclear Dose Calculator is a software product intended to compute a radiotherapy dose volume.
Model 1218028 Dose Calculator computes a dose volume for a user-specified treatment delivery device based on user-provided three dimensional volumetric imaging information (e.g., computed tomography) and beam intensity values. Both the imaging data and beam intensity values are specified in DICOM-RT format. The beam model for the specified treatment delivery device is provided with the software. The output of the SDC is a DICOM RT dose volume.
The Dose Calculator is for use with external beam photon radiation therapy calculations. Charged particle radiotherapy calculations (including electron, proton, and heavy ion therapy) are not indicated for use with this product.
The Dose Calculator software application is considered to be a software module that may be used by several Sun Nuclear Corporation products and/or 300 party applications.
The provided document is a 510(k) premarket notification for a medical device called the "Model 1218028 Dose Calculator." It does not contain the detailed study information typically found in a clinical trial report or a comprehensive validation study. The document primarily focuses on establishing substantial equivalence to a predicate device.
Therefore, many of the requested categories cannot be fully answered with the information available.
Here's an attempt to extract what is present and indicate what is missing:
1. A table of acceptance criteria and the reported device performance
The document states: "Test results of the modified device have demonstrated that the device performs within its design specifications and equivalently to the predicate device." However, specific acceptance criteria or quantitative performance metrics are not provided in this summary.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document mentions "appropriate bench testing methods" but does not specify the sample size of the test set, the provenance of the data, or whether it was retrospective or prospective.
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)
This information is not provided and is unlikely to be relevant for this type of device (a dose calculator) where "ground truth" would likely be established through physical measurements or established theoretical models, not expert consensus on images.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Adjudication methods are typically used for subjective assessments by experts. Since the device calculates dose volumes, and the "ground truth" establishment is not explicitly described, this information is not provided and likely not applicable in the traditional sense.
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
The document does not mention a multi-reader multi-case (MRMC) comparative effectiveness study. This device is a dose calculator, not an AI-assisted diagnostic tool that would typically involve human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The document describes the device as "a software product intended to compute a radiotherapy dose volume." This inherently implies a standalone performance of the algorithm in its primary function, as it computes the dose volume based on inputs. The statement "Test results of the modified device have demonstrated that the device performs within its design specifications" suggests standalone testing, but explicit details of "standalone performance" metrics are not provided.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The document does not explicitly state the type of "ground truth" used. For a dose calculator, the ground truth would likely be derived from:
- Physical measurements: Using phantoms and dosimeters to measure actual dose distribution.
- Established reference calculations/models: Comparing the device's output to results from validated and widely accepted dose calculation algorithms or commercial treatment planning systems.
- Theoretical physics principles: Ensuring calculations adhere to fundamental physics.
Given the context of "bench testing," it's highly probable that physical measurements or comparisons to established reference systems were used, but this is not explicitly stated.
8. The sample size for the training set
The document does not mention a training set sample size. This type of device, which computes dose volumes based on physical models and inputs, is generally not "trained" on a dataset in the way a machine learning algorithm for image recognition would be. Its "knowledge" is embedded in its beam model and calculation algorithms.
9. How the ground truth for the training set was established
As there is no mention of a traditional "training set" for machine learning, this information is not applicable/provided. The "ground truth" for the device's underlying models (like beam models) would be established through extensive calibration and measurement using dosimetric equipment and physical phantoms, but this process is not detailed here.
§ 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.