(53 days)
The Explorer 4DTM Treatment Planning System software is intended for use in preparing treatment plans for patients who have intracranial diseases where neurological radio surgery has been prescribed.
The software is used to electronically import CT images to determine the precise location of the target, to define and visualize treatment beam locations, and to visualize dose to the target and other structures.
The Explorer 4D™ Treatment Planning System (TPS) provides individual treatment plans for patients undergoing gamma radiation therapy treatment. The TPS provides for the import of patient images and selecting a series of relevant patient images to create a treatment plan.
Precise calculation of the dose delivery parameters is supported by the registration of fiducial markers as a reference point between patient images. These images are then annotated with the region of interest (ROI) to be exposed to radiation. Several tools are provided to adjust the ROI based on the desired treatment area, within these regions "shots" (radiation sources) and associated treatment dose levels are defined as they related to a specified collimator size.
Here's a breakdown of the acceptance criteria and study information for the American Radiosurgery Explorer 4D104 Treatment Planning System, based on the provided text:
Acceptance Criteria and Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Spatial Accuracy of Treatment Planning System | 1 mm |
| Accuracy of Dose Delivery | 3% |
Study Information
The document refers to a "Performance Test Report (Attachment 10)" which provides data from ten separate performance tests. However, the provided text does not contain the detailed contents of this attachment. Therefore, much of the requested information cannot be definitively answered from the given excerpt.
Here's what can be inferred or explicitly stated:
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Sample size used for the test set and the data provenance:
- Sample Size: The document mentions "data from ten separate performance tests." It does not specify the number of cases or data points within these tests.
- Data Provenance: Not specified in the provided text (e.g., country of origin, retrospective or prospective).
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not specified in the provided text.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not specified in the provided text.
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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:
- A MRMC study is not indicated for this device. The Explorer 4D™ TPS is a treatment planning system, which assists in defining treatment parameters, not an AI or diagnostic tool for human readers to interpret. The stated performance metrics are for the system's accuracy in spatial planning and dose calculation, not for improving human diagnostic accuracy. There's no mention of human readers or AI assistance in the context of comparative effectiveness.
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If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- The performance metrics (1mm spatial accuracy, 3% dose delivery accuracy) appear to be for the standalone (algorithm only) performance of the Treatment Planning System. While the system provides tools for operators to adjust the ROI, the core performance measures cited are inherent to the system's calculations.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- The document implies that the ground truth for spatial accuracy and dose delivery would be based on physical measurements and validated dose calculation models. For example, phantoms are often used for calibration and testing in radiation therapy. The text mentions "phantom calibration" in the context of the predicate device, suggesting similar methods would be used for the Explorer 4D. However, the exact type of ground truth for each of the "ten separate performance tests" is not detailed.
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The sample size for the training set:
- Not specified in the provided text. This device is a treatment planning system, and while it involves algorithms, it's not described as a machine learning/AI diagnostic tool with a distinct "training set" in the conventional sense. Its development would involve software engineering and physics-based modeling rather than typical machine learning training on a large dataset of patient images.
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How the ground truth for the training set was established:
- Not applicable/specified, given the nature of the device as a treatment planning system rather than a machine learning model requiring a specific "training set" with established ground truth labels for classification/prediction tasks.
§ 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.