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The 4D Integrated Treatment Console provides assistance for accurate treatment delivery for each patient by monitoring linear accelerator parameters and by preventing the radiation therapy device from commencing irradiation when any parameter is out of conformance with the treatment plan.

4D Integrated Treatment Console (4DITC) allows the user to retrieve treatment plans and images from the Oncology Information System (OIS) and send the plan and images to the Treatment Console System (TCS). The planned treatment parameters from the OIS are verified against the TCS delivery parameters for accuracy. All treatment parameters on the TCS must match the treatment parameters on the 4DITC before treatment can be delivered. After the treatment has been completed for the session, the user closes the session and treatment history is sent to the OIS to be recorded. The recorded treatment history can then be displayed and reviewed in the Oll.

This document describes the 510(k) summary for Varian Medical Systems, Inc.'s 4D Integrated Treatment Console v13.0 MR4. However, the provided text does not contain the specific details required to answer all parts of your request regarding acceptance criteria and a study proving the device meets those criteria.

The document primarily focuses on explaining the device's function, comparing it to a predicate device (v13.0), and listing software changes. It mentions "Software Verification and Validation Testing" and "Test results demonstrate conformance to applicable requirements and specifications" but does not provide any quantitative performance data, specific acceptance criteria, or details of a study with a test set, ground truth, or expert involvement.

Therefore, I can only address parts of your request based on the information not present in the provided text.

Here's what can be extracted and what is missing:

Acceptance Criteria and Device Performance Study

The provided text does not include a table of acceptance criteria or reported device performance metrics in a quantitative manner. It states that "Test results demonstrate conformance to applicable requirements and specifications" and that the device "should perform as intended," but no specific numerical targets or results are given.

Missing Information & Assumptions Based on Typical Device Submissions (Not from provided text):

Given the nature of this device (a software-controlled system for radiation therapy treatment delivery), performance testing would typically involve:

• Functional Testing: Verifying that the software correctly manages and displays treatment parameters, prevents irradiation when parameters are out of conformance, handles data transfer, etc.
• Accuracy/Precision Testing: Confirming that the system accurately verifies parameters against the treatment plan. This might involve simulated scenarios or phantoms.
• Safety Testing: Demonstrating that the risk control measures (like blocking QA plans for clinical treatment) function as intended to prevent patient harm.
• Cybersecurity Testing: As mentioned, enhancements were made, so testing would confirm the effectiveness of these measures.

Here's a breakdown of the specific points you requested, indicating what's present and what's missing:

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

• Missing: The document states "Test results demonstrate conformance to applicable requirements and specifications" but provides no specific table, quantitative acceptance criteria, or performance data.

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

• Missing: No information on sample size or data provenance (e.g., country of origin, retrospective/prospective) for any test set is provided. The document explicitly states: "No animal studies or clinical tests have been included in this pre-market submission." This strongly suggests the testing was predominantly non-clinical (software verification and validation, perhaps hardware-in-the-loop testing, but not involving human patient data in a "study" sense).

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

• Missing: No ground truth establishment method involving experts is described, as there's no mention of a clinical or data-driven study that would require such a ground truth.

4. Adjudication method for the test set

• Missing: Not applicable, as no multi-expert ground truth establishment or test set adjudication method is described.

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

• Missing: No MRMC study was done, nor is there any mention of AI assistance for human readers. This device is described as assisting "accurate treatment delivery by monitoring linear accelerator parameters and by preventing the radiation therapy device from commencing irradiation when any parameter is out of conformance with the treatment plan." It's a control and verification system, not an AI-assisted diagnostic or interpretation tool.

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

• Missing: While the device's core function is software-driven ("algorithm only" in that sense), the document doesn't detail performance metrics for this standalone function. It implies the entire system (software and hardware interaction) was verified, but not in a way that provides isolated algorithm performance data. The device's purpose is inherently "human-in-the-loop" as it assists users in treatment delivery and prevents errors.

7. The type of ground truth used

• Missing in detail: Given the nature of a radiation therapy control system, "ground truth" would likely be established by:
  • Specification Compliance: Confirming that system outputs match predefined engineering specifications and design documents.
  • Expected System Behavior: Verifying that the system behaves as expected under various input conditions (e.g., correctly identifies out-of-conformance parameters, accurately blocks treatment when conditions are not met).
  • Manual Verification/Simulation: Using phantoms or simulated data to ensure the system's parameter monitoring and interlock functions are accurate.
• Not explicitly stated: The document does not specify "expert consensus," "pathology," or "outcomes data" as ground truth, as those typically apply to diagnostic or prognostic AI/image analysis systems, which this device is not.

8. The sample size for the training set

• Missing: Not applicable. This device is a software control system; it's not described as using machine learning that would require a "training set" in the typical sense for a predictive model or image analysis algorithm. The V&V testing is for verifying the correctness and robustness of its programmed logic and functions.

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

• Missing: Not applicable, as there's no mention of a training set or machine learning components.

Summary:

The provided K203766 FDA 510(k) summary for Varian's 4D Integrated Treatment Console v13.0 MR4 details software changes and asserts that "Software verification and validation were conducted," and "Test results demonstrate conformance to applicable requirements and specifications." However, it does not provide the specific quantitative performance data, acceptance criteria, study methodologies (e.g., sample sizes, ground truth establishment, expert involvement), or clinical study details that your request asks for. This is common for 510(k) submissions of iterative software updates to established predicate devices, where the focus is typically on non-clinical V&V demonstrating that the changes do not adversely affect safety or effectiveness and that the updated device performs as intended in alignment with its predicate.

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