(90 days)
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.
§ 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.