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The Varian ProtonVision device is a treatment planning system used for diagnostic image analysis, contouring & segmentation, proton energy range estimation and dose compensation, proton dose calculation and plan review.

The Varian ProtonVision device is used to plan proton radiation therapy treatments employing proton accelerators with energies from 70 to 235 MeV. ProtonVision will plan the 3D radiotherapy proton treatment approaches to rectangle and circular fields, and regular and irregular fields using customized blocking and compensators. ProtonVision includes also tools for treatment preparation (diagnostic image analysis, contouring & segmentation) and plan review.

As part of the Varis Vision System, ProtonVision integrates proton treatment planning in overall therapy process, while taking advantage of the Varian Vision database.

The Varian ProtonVision is a computer based device used for calculating and displaying prospective or verification treatment plans for particular patients undergoing a course of proton therapy. The system consists of a computer with graphics display and plotter outp As a Soma Vision (K992751) option, Proton Vision provides the capabilities of diagnostic image analysis, contouring and segmentation. In addition to SomaVision, ProtonVision e and the protone energy range estimation and dose compensation, proton dose calculation and dosimerice plan review. Proton Vision integrates proton treatment planning with

The provided document is a 510(k) Premarket Notification summary for the Varian ProtonVision 7.0 device from August 30, 2000. This type of document is a regulatory submission for medical devices to demonstrate substantial equivalence to a legally marketed predicate device.

Unfortunately, the provided text does not contain the detailed information required to fill out the requested table and study characteristics.

Here's why and what's missing:

• No acceptance criteria or device performance metrics are explicitly stated. The document focuses on regulatory compliance (510(k) submission, substantial equivalence) and a general description of the device's function. It does not include performance data such as accuracy, precision, sensitivity, specificity, or any specific quantitative metrics that would be part of an acceptance criterion.
• No specific study details are provided. The document refers to the device being substantially equivalent to its predicate (ProtonVision 7.0, K000922) and lists its intended use and technological characteristics (referencing an attached "Specification Comparison Chart, Tab F," which is not included). A 510(k) submission typically relies on a comparison to a predicate device rather than presenting new, detailed performance studies with sample sizes, ground truth establishment, or expert adjudication.

Therefore, many of the requested fields cannot be answered from the provided text.

Here's a breakdown of what can be inferred or what is explicitly missing:

1. A table of acceptance criteria and the reported device performance

Explanation: The document does not define specific performance metrics or acceptance criteria for the ProtonVision 7.0. It primarily asserts substantial equivalence to a predicate device (ProtonVision 7.0, K000922), implying that its performance is comparable, but no quantitative performance data is provided.

2. Sample size used for the test set and the data provenance

• Sample size: Not specified.
• Data provenance: Not specified. This type of submission (510(k) in 2000) for a software update often did not require extensive new clinical studies or detailed test set information beyond demonstrating functional equivalence.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Number of experts: Not specified.
• Qualifications of experts: Not specified.

4. Adjudication method for the test set

• Adjudication method: Not specified.

5. If a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance

• No, an MRMC study is not mentioned or implied. The device is a treatment planning system and not an AI-assisted diagnostic tool that would typically undergo such a study.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

• Not specified. Given the device's function as a "treatment planning system" for calculating and displaying plans, its performance is inherently in conjunction with human use (planning by a clinician). Standalone performance in the sense of a diagnostic algorithm is not applicable here.

7. The type of ground truth used

• Not specified. For a treatment planning system, ground truth would typically refer to the accuracy of dose calculations against physical measurements or validated models, or the accuracy of segmentation against expert contours. This level of detail is not in the summary.

8. The sample size for the training set

• Not applicable/Not specified. This device pre-dates modern "AI" in the sense of deep learning or machine learning requiring large training sets. Its functionality is described as "calculating and displaying" based on established physics models and algorithms, not "trained" on data.

9. How the ground truth for the training set was established

• Not applicable/Not specified. (See point 8).

In summary, the provided 510(k) document is a regulatory submission focused on demonstrating substantial equivalence to a predicate device for a treatment planning system rather than presenting detailed performance studies with quantitative acceptance criteria, test sets, or ground truth establishment typically found for novel diagnostic AI devices.

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