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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 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 provided text describes the Accuray TomoTherapy Treatment System (K121934), a radiation therapy system. It is a 510(k) submission, indicating that the device is seeking clearance based on its substantial equivalence to a predicate device.

Here's an analysis of the acceptance criteria and study information provided (or lacking thereof, as is common in 510(k)s for certain types of devices):

1. Table of Acceptance Criteria and Reported Device Performance

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

The submission states, "No clinical tests were required to establish substantial equivalence." This implies that the performance data primarily relied on non-clinical testing (bench testing, verification, and validation) rather than testing on patient data sets. Therefore, there is no specific sample size for a test set (e.g., patient images or clinical cases) detailed in this submission. The data provenance would be related to the internal testing environment rather than patient data.

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

Given that "No clinical tests were required," there is no mention of experts establishing ground truth for a clinical test set. The substantial equivalence is based on engineering and performance validation against internal specifications and consensus standards, rather than expert-adjudicated clinical outcomes or interpretations.

4. Adjudication Method for the Test Set

As there was no clinical test set requiring expert interpretation, no adjudication method is described.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC comparative effectiveness study was mentioned. The device is a radiation therapy system, not a diagnostic imaging device that typically undergoes MRMC studies to evaluate human reader performance with or without AI assistance. The focus here is on the system's ability to plan and deliver radiation accurately and safely, comparable to its predicate.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

The document describes the "TomoTherapy Treatment System" as an integrated system, highlighting its planning, dose calculation, and delivery capabilities. Its functions include IGRT (image-guided radiation therapy), which inherently involves a human (e.g., physician, dosimetrist, radiation therapist) in planning and overseeing the treatment. While the software has algorithmic components, the system itself is not purely "standalone" in the AI sense, as it requires human input and clinical judgment for its intended use. The performance data presented refers to the system's compliance with safety standards and design specifications, which would include the performance of its software algorithms within the integrated system, but it's not a "standalone algorithm-only" study in the context of diagnostic AI.

7. Type of Ground Truth Used

For a radiation therapy delivery system, the "ground truth" for non-clinical performance studies would likely be:

• Engineering specifications and design requirements: The system's output (e.g., radiation dose, beam shape, image acquisition parameters) must match predetermined, validated specifications.
• Physical measurements: Using phantoms and dosimeters to verify the accuracy of dose delivery and image quality.
• Compliance with recognized consensus safety standards: Demonstrating adherence to established industry-wide safety and performance metrics (e.g., IEC standards for medical electrical equipment, specific standards for radiation therapy devices).

8. Sample Size for the Training Set

The document does not provide information on a training set sample size. This type of device relies on physics-based models and validated algorithms rather than machine learning models trained on large datasets in the way typical AI/ML devices might. The software enhancements mentioned (asymmetric positions and dynamic motion of the primary beam limiting device) are likely based on deterministic algorithms and physical principles, thoroughly verified, rather than deep learning models requiring extensive training data.

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

As there's no mention of a training set for machine learning, this information is not applicable or provided. The "ground truth" for the development and verification of the system's physics-based algorithms and control software would be derived from fundamental principles of radiation physics, medical imaging, and robust engineering validation processes.

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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

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.

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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.

Here's a breakdown of the acceptance criteria and study information for the TomoTherapy Treatment System, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text does not explicitly state specific numerical acceptance criteria (e.g., minimum accuracy percentages, maximum deviation values). Instead, it refers to general conformity to standards and design specifications. Therefore, the table below reflects the qualitative statements made in the document regarding performance.

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

• Sample Size: The document does not specify a numerical sample size for the test set. It mentions "verification and validation tests, including extensive tests of imaging and radiation delivery functionality."
• Data Provenance: The document does not provide information on the country of origin of the data or whether the study was retrospective or prospective. It is a premarket notification for a medical device (510(k)), typically relying on engineering and bench tests for this type of submission rather than large-scale clinical studies.

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

The document does not mention the use of experts to establish "ground truth" in the context of diagnostic interpretation for the tests performed. The tests described are primarily focused on the engineering and physical performance of the radiation delivery system and imaging functionality, not on diagnostic accuracy requiring expert interpretation of images or patient outcomes.

4. Adjudication Method for the Test Set

As the tests described are technical performance evaluations rather than clinical assessments requiring human interpretation or decision-making, an adjudication method (like 2+1 or 3+1) is not applicable and therefore not mentioned in the document.

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

No, an MRMC comparative effectiveness study was not done. The document explicitly states: "No clinical tests were required to establish substantial equivalence." The focus was on demonstrating substantial equivalence to a predicate device through technical performance data.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Yes, in essence, standalone performance was assessed. The "verification and validation tests" for imaging and radiation delivery functionality would constitute evaluations of the system's performance without human intervention in the primary operational loop being tested (e.g., how accurately the system delivers radiation according to a plan, or how consistently the dose rate is maintained). The device's primary function is radiation delivery, not diagnostic interpretation by an AI algorithm.

7. The Type of Ground Truth Used

The "ground truth" for the tests performed would be established by engineering specifications, physical measurements, and recognized consensus standards. For example, the ground truth for dose consistency would be the expected dose output based on the physics of the system and calibration, measured against actual output. Similarly, imaging functionality would be assessed against expected image quality and resolution for megavoltage CT. There is no mention of pathology, outcomes data, or expert consensus related to diagnostic accuracy as the "ground truth" for these tests, as the device is not a diagnostic tool.

8. The Sample Size for the Training Set

The document does not specify a "training set" sample size. This type of device classification (510(k) for a radiation therapy system) generally does not involve machine learning algorithms that require a distinct training set in the way a diagnostic AI would. The performance data comes from verification and validation of the hardware and software systems.

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

As no specific "training set" for an AI algorithm is indicated, the concept of establishing ground truth for it is not applicable or mentioned in this document. The system's operation is based on pre-defined physics models and engineering designs, not learned patterns from a training dataset like a typical AI diagnostic tool.

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