(87 days)
The TomoTherapy Treatment System is intended to be used as an integrated system for the planning and precise delivery of radiation therapy, stereotactic radiotherapy, or stereotactic radiosurgery to tumors or other targeted tissues while minimizing the delivery of radiation to vital healthy tissue. The megavoltage x-ray radiation is delivered in a rotational, non-rotational, modulated (IMRT), or non-modulated (non-IMRT/three dimensional conformal) format in accordance with the physician prescribed and approved plan.
The TomoTherapy Treatment System is a radiation therapy system that integrates planning, dose calculation, megavoltage CT imaging for IGRT functionality, and helical (rotational) and fixed beam (non-rotational) radiation therapy treatment capabilities into a single comprehensive system. The TomoTherapy Treatment System is a prescription device. It delivers radiation in accordance with a physician approved plan. The device does not diagnose disease, recommend treatment regimens, or quantify treatment effectiveness. The megavoltage CT imaging functionality is not intended for diagnostic use. The TomoTherapy Treatment System with Fast Optimizer is a modification that allows for increased efficiency and speed during the treatment planning process through the use of modified hardware and software.
The provided text describes a 510(k) premarket notification for the "TomoTherapy Treatment System Next Generation Fast Optimizer." This filing is for a modification to an existing device, the TomoTherapy Hi-Art System (K082005), to increase efficiency and speed during the treatment planning process. The key takeaway is that the modification primarily involves new hardware (Graphics Processing Unit (GPU)) and revised software to accommodate it, while maintaining unchanged dose accuracy constraints and not affecting the radiation delivery system.
Therefore, the performance data presented focuses on demonstrating that these modifications do not degrade performance and that the updated system remains as safe and effective as the predicate device.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Conformance to applicable recognized consensus standards for medical devices. | "The TomoTherapy Treatment System Next Generation Fast Optimizer was tested and it was demonstrated that there are no changes to the conformance to the requirements of applicable recognized consensus standards for medical devices." |
| Performance within design specifications. | "Results of verification and validation tests confirm the TomoTherapy Treatment System Next Generation Fast Optimizer performance is within design specifications." |
| Dose accuracy constraints maintained (unchanged from predicate). | "As the modification is limited to faster operation of the Planning sub-system with unchanged dose accuracy constraints..." (This implies the performance met these existing constraints, as no new questions of safety or effectiveness regarding dose accuracy were raised by the modification). |
| Safety and effectiveness (comparable to predicate device). | "These performance data demonstrate the TomoTherapy Treatment System Next Generation Fast Optimizer is as safe, as effective, and performs as well as the predicate device." |
2. Sample Size Used for the Test Set and Data Provenance
The document does not provide specific details about the sample size used for the test set or the data provenance (e.g., country of origin, retrospective/prospective). It generally refers to "verification and validation tests." Given the nature of the modification (software/hardware for faster optimization), it's highly likely these tests would involve in silico simulations and phantom measurements rather than patient data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
The document does not mention the involvement of experts in establishing ground truth for the test set. Given that the focus is on a technical upgrade to a simulation and planning system, ground truth would likely be established through physical dosimetry measurements (phantoms) and computational models (physics-based simulations) rather than expert clinical review.
4. Adjudication Method for the Test Set
The document does not describe any adjudication method. This is consistent with a technical performance evaluation where quantitative measurements and computational comparisons are the primary means of verification.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. The document explicitly states: "No clinical tests were required to establish substantial equivalence." This type of study would involve human readers and clinical cases.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, implicitly, a standalone evaluation of the algorithm's performance (specifically the "Fast Optimizer" component) was done. The performance data section refers to "verification and validation tests" that confirmed performance within design specifications and conformance to standards. These tests would evaluate the algorithm's output (e.g., dose calculations, plan optimization speed) directly, without human intervention in the loop of measuring that performance itself. However, it's important to note that the device is a "prescription device" and intended to be used with a physician-approved plan, meaning a human is always in the loop for the end-to-end clinical process. The standalone performance here refers to the technical accuracy and speed of the planning system's calculations.
7. The Type of Ground Truth Used
The ground truth for this device's performance evaluation would primarily be derived from:
- Physics-based models and calculations: For dose accuracy and optimization.
- Physical phantom measurements: For verifying radiation dose delivery and distribution against the planned dose.
- Industry standards and regulatory requirements: For demonstrating conformance.
8. The Sample Size for the Training Set
The document does not provide any information about a training set size. This modification focuses on optimizing the speed and efficiency of an existing planning algorithm, rather than developing a new AI model that requires a large training dataset in the conventional sense. The "Fast Optimizer" component likely involves algorithmic improvements and hardware acceleration rather than a machine learning model trained on a data set.
9. How the Ground Truth for the Training Set Was Established
As no specific training set is mentioned in the context of conventional machine learning, this question is not directly applicable. If "training" refers to the development and refinement of the optimization algorithms, the "ground truth" would have been established through a combination of physics principles, engineering specifications, and iterative testing against known or simulated scenarios to ensure the algorithm generates accurate and clinically acceptable treatment plans while achieving the desired speed improvements.
§ 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.