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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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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.

The 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 OIS.

The provided submission does not contain specific acceptance criteria with quantifiable metrics or a detailed study proving the device meets these criteria in the typical sense of a clinical trial for diagnostic or predictive AI. This 510(k) summary is for a Varian Medical Systems' 4D Integrated Treatment Console (4DITC) and focuses on changes and equivalence to a predicate device. The "study" described is verification and validation testing, which is a standard engineering and software testing process to ensure that a device performs as designed and meets its specified requirements.

Here's an analysis based on the provided text, addressing your points where possible:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not provide a table of specific acceptance criteria with quantifiable performance metrics (e.g., accuracy, sensitivity, specificity, or error rates) and corresponding reported performance values for these criteria.

Instead, the "acceptance criteria" are implied by the statement: "Verification testing was performed to demonstrate that the performance and functionality of the new and existing features met the design input requirements." The "reported device performance" is summarized as: "Results from Verification and Validation testing demonstrate that the product met defined user needs and defined design input requirements. Varian, therefore, considers 4DITC to be safe and effective and to perform at least as well as the predicate device."

The focus of this submission is on demonstrating that the modified 4DITC (v13) is substantially equivalent to the predicate device (v8.8) and that the new features function as intended, not on proving clinical efficacy or diagnostic accuracy through a traditional clinical study with defined performance metrics.

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify a "test set" in the context of patient data or clinical cases. The testing appears to be on the device itself (software and hardware integration).

• Sample Size: Not applicable in the context of clinical data. The testing was performed on a "production equivalent device."
• Data Provenance: Not applicable as no patient data test set is mentioned.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

This information is not provided. Since the testing described is primarily for software and system functionality rather than a diagnostic or predictive task requiring expert ground truth in a clinical sense, this information would likely not be relevant to this type of 510(k) submission. "Qualified personnel" performed the validation, but their specific expertise or number for establishing "ground truth" is not detailed.

4. Adjudication Method for the Test Set

Not applicable. There is no mention of a test set requiring adjudication by experts.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The document does not describe any study involving human readers or comparing performance with and without AI assistance. This device is an integrated treatment console, not an AI-driven image analysis or diagnostic tool.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

The device is a "4D Integrated Treatment Console," implying it's an interface and control system for radiation therapy, inherently designed to be used by humans (operators/clinicians) to manage treatment plans and delivery. It's not a standalone algorithm in the sense of an AI performing a task independently. The validation involved a "production equivalent device" under "clinically representative conditions," suggesting human-in-the-loop interaction for its intended use.

7. The Type of Ground Truth Used

The concept of "ground truth" as typically applied to AI or diagnostic devices (e.g., pathology, outcomes data) is not directly applicable here. For this type of system, "ground truth" refers to the expected behavior and compliance with design specifications and regulatory requirements. Therefore, the "ground truth" for the verification and validation testing would be the design input requirements and predefined functional specifications for the device’s features and operations.

8. The Sample Size for the Training Set

Not applicable. This device is a software and hardware system for managing radiation therapy, not an AI system that undergoes "training" on a dataset in the way a machine learning model would.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no "training set" for this type of device.

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The 4DITC function is designed to assist the operator of a radiation therapy device in providing accurate treatment setups for each patient by monitoring setup parameters and preventing the radiation therapy device from commencing irradiation when any parameter is out of conformance with the treatment plan.

The 4D Integrated Console provides the user with:

• A treatment verification function to assist the operator of a radiation therapy device in providing accurate treatment set-ups for each patient by monitoring set-up parameters
• Treatment safety by preventing the radiation therapy device from commencing irradiation when a linear accelerator. MLC, or MV imager parameter is out of conformance with the treatment plan
• The ability to select patients from a queue provided by the schedule
• The ability to retrieve plans from an information system for the selected patient
• The ability to evaluate a selected treatment plan to determine whether redefined dose limits will be exceeded
• The ability to acquire and edit positional data from radiation therapy devices
• The ability to override specific treatment parameters based on individual user rights
• The ability to send treatment records to an information system
• The ability to interact with the user controls of the PortalVision, the multi-leaf collimator system, the Patient Accessory Verification System, and the treatment verification function at a single workstation
• Provides access to the following:
  • Linear Accelerator
  • On-Board Imager
  • Trilogy RapidArc
    The 4D Integrated Treatment Console has been modified to include additional accessory support, treatment tasks and import/export interfaces.

The provided text is a 510(k) summary for the "4D Integrated Treatment Console." This document describes a medical device, its intended use, and its substantial equivalence to previously cleared devices. It is a regulatory submission, not a study report.

Therefore, the input does not contain information about:

• Acceptance criteria for device performance.
• A study proving the device meets acceptance criteria.
• Sample sizes for test or training sets.
• Data provenance.
• Number or qualifications of experts for ground truth.
• Adjudication methods.
• Multi-reader multi-case (MRMC) comparative effectiveness studies.
• Standalone algorithm performance studies.
• Type of ground truth used.
• How ground truth for the training set was established.

This 510(k) submission focuses on demonstrating substantial equivalence to existing devices based on technological characteristics and intended use, rather than presenting a performance study with acceptance criteria in the manner typically seen for diagnostic AI/ML device clearances.

Conclusion:

Based on the provided document, it is not possible to complete the requested table and answer the questions regarding acceptance criteria and a study proving device performance. The information provided is a regulatory filing for a medical device that assists in radiation therapy treatment setup, not a clinical performance study.

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The 4DITC function is designed to assist the operator of a radiation therapy device in providing accurate treatment setups for each patient by monitoring setup parameters and preventing the radiation therapy device from commencing irradiation when any parameter is out of conformance with the treatment plan.

The 4D Integrated Treatment Console (4DITC) has been modified to add a new capability called Patient Accessory Verification System (PAVS). PAVS is a feature set of 4D ITC that enhances treatment safety. This feature allows users to identify accessories (not connected to the linac) for patients and interlock the radiation beam until these devices have been acknowledged by the end-user. Also, PAVS allows patient verification between the patient on the treatment schedule with the patient in the treatment room. This is accomplished using a hand-held bar code scanner used in conjunction with software by trained clinical staff. Staff defines which accessories require a bar code label to be scanned. Clinical staff creates the labels for the accessories using label creation software in Practice Management and a label printer. Staff scans the appropriate accessories for each patient's treatment field for accessory selection verification.

The provided text is a 510(k) summary for a medical device (4D Integrated Treatment Console with Patient Accessory Verification System - PAVS). However, it does not contain the information requested regarding acceptance criteria and a study proving the device meets those criteria.

This document primarily focuses on:

• Device identification: Proprietary name, classification name, common name, predicate device.
• Device description: An explanation of the 4D Integrated Treatment Console (4DITC) and its new feature, Patient Accessory Verification System (PAVS), which enhances treatment safety by verifying patient accessories and patient identity using a bar code scanner.
• Indications for Use: Describes the purpose of the 4DITC in assisting radiation therapy operators with accurate treatment setups by monitoring parameters and preventing irradiation if parameters are out of conformance.
• Regulatory information: Mentions the FDA's review and determination of substantial equivalence to a predicate device, regulatory class, and general controls.

Therefore, I cannot provide the requested information in the table format or answer the specific questions about acceptance criteria, study details, sample sizes, ground truth establishment, or multi-reader multi-case studies because this data is not present in the provided text.

The text states "Refer to the Substantial Equivalence Comparison Chart" under the "Technological Characteristics" section, but this chart is not included in the provided document. Such a chart or other sections of the 510(k) submission would typically contain performance data and acceptance criteria.

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The 4D Integrated Treatment Console is designed to assist the operator of a radiation therapy device in providing accurate treatment set-ups for each patient by monitoring set up parameters and preventing the radiation therapy device from commencing irradiation while any parameter is out of conformance with the treatment plan.

The 4D Integrated Treatment Console provides the user with:

• a treatment verification function to assist the operator of a radiation . therapy device in providing accurate treatment setups for each patient by monitoring set up parameters and to prevent the radiation therapy device from commencing irradiation while any parameter is out of conformance with the treatment plan.
• the ability to select patients from a queue provided by the schedule .
• the ability to retrieve plans from the information system for the selected . patient
• the ability to evaluate a selected treatment plan to determine whether . redefined dose limits will be exceeded
• the ability to acquire and edit positional data from radiation therapy . devices
• the ability to override treatment parameters based on user rights .
• the ability to send treatment records to an information system i .
• the ability to interact with the user controls of the Portalvision, the multi-. the ability to microom and the treatment verification function on a single workstation.
• Provides access to the linear accelerator and the On-Board Imager. .

This document (K050479) is a 510(k) summary for the "4D Integrated Treatment Console." It's a premarket notification to the FDA to demonstrate substantial equivalence to a predicate device, not a study report proving specific device performance criteria with clinical data.

Therefore, the requested information regarding acceptance criteria, reported device performance, sample sizes, expert qualifications, ground truth establishment, or clinical study specifics (MRMC, standalone performance) for the device's functionality is not available in the provided text.

The 510(k) summary focuses on:

• Device Description: What the device does (e.g., treatment verification, patient and plan management, interaction with other Varian systems).
• Intended Use Statement: The purpose of the device (to assist in accurate treatment setups by monitoring parameters and preventing irradiation when parameters are out of conformance).
• Technological Characteristics: Claims of substantial equivalence to its predicate device (Varian Medical Systems' Varis 1.4g, K001643), which are detailed in a separate "Substantial Equivalence Comparison Chart" (not provided in the input).

The FDA's letter (within the provided text) confirms that they have reviewed the 510(k) premarket notification and determined the device is substantially equivalent to legally marketed predicate devices for the stated indications for use. This means the FDA found that the new device is as safe and effective as a legally marketed device and does not require a Premarket Approval (PMA).

In summary, the provided document does not contain the specific performance study details requested. Such details would typically be found in a separate validation or clinical study report, which is not part of this 510(k) summary.

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