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510(k) Data Aggregation
(259 days)
The Radixact Treatment Delivery System is indicated for the delivery of radiation therapy stereotactic body radiotherapy (SBRT), or stereotactic radiosurgery (SRS) to tumors or other targeted tissues anywhere in the body under the direction of a licensed medical practitioner. The megavoltage x-ray radiation is delivered using rotational, intensitymodulated (IMRT), or non-modulated (non-INRT/three-dimensional conformal) treatment techniques and using imageguided (IGRT) or non-image-guided workflows in accordance with the physician-approved plan. The Radixact Treatment Delivery System integrates Surface Guided Radiation Therapy (SGRT) for patient position and motion monitoring, and breath-hold gating.
The predicate and modified Radixact Treatment Delivery Systems are radiation therapy delivery systems, that provide megavoltage CT imaging capabilities coupled with x-ray radiation delivery. The system achieves delivery using rotational, intensity modulated (IMRT), or non-modulated (non-IMRT/three-dimensional conformal) radiation therapy treatment techniques utilizing image-guided (IGRT) or non-image-guided workflows, to tumors or other targeted tissues anywhere in the body, in accordance with the physician-approved plan.
The additional feature update: VitalHold incorporates an external optical monitoring system (EMS), which is integrated with the Radixact system to enable Surface Guided Radiotherapy (SGRT) for patient setup, patient position and motion monitoring, and breath-hold gating.
Neither the predicate Radixact Treatment Delivery System nor the modified Radixact Treatment Delivery System diagnose disease or quantify treatment effectiveness. Accordingly, they are not intended for diagnostic use.
The provided text describes a 510(k) premarket notification for the Radixact Treatment Delivery System, which is a medical device for radiation therapy. The submission focuses on the substantial equivalence of the modified device to a legally marketed predicate device.
It's crucial to understand that this document does not describe a study involving AI-driven diagnostic or treatment planning software that requires complex acceptance criteria based on human expert review, high-volume datasets, or MRMC studies. Instead, it describes a hardware and software update to an existing radiation therapy delivery system, primarily the integration of a Surface Guided Radiotherapy (SGRT) system for patient positioning and motion monitoring, and breath-hold gating.
Therefore, many of the requested elements regarding acceptance criteria for AI performance (like sensitivity, specificity, MRMC studies, large training/test sets for AI, expert readers for ground truth, and adjudication methods) are not applicable to this type of device submission as described in the provided text.
The "Performance Data" section primarily addresses engineering verification and validation, compliance with electrical safety and EMC standards, and risk management. The "Non-Clinical Data" section focuses on testing the functionality of the SGRT integration with the core Radixact system, not AI performance. It states "No animal or clinical tests are being submitted to establish substantial equivalence with the predicate device."
Here's a breakdown of the requested information based on the provided text, indicating where information is present and where it is not applicable or not detailed for this type of device:
Acceptance Criteria and Study for Radixact Treatment Delivery System (K223159)
This submission is for a modification to an existing radiation therapy delivery system, primarily focusing on the integration of a Surface Guided Radiotherapy (SGRT) system for patient positioning and motion monitoring, and breath-hold gating. The "study" described is primarily engineering verification and validation testing to demonstrate the device's functionality, safety, and effectiveness, not a clinical trial or an AI performance study as typically understood for diagnostic support systems.
1. A table of acceptance criteria and the reported device performance
The document lists "Key system performance attributes" related to the SGRT integration and states that "The Verification results show that the design goals and objectives had been met." However, it does not provide a quantitative table of specific acceptance criteria values and reported performance values beyond stating that the tests demonstrated conformity to design specifications and met user needs. The performance attributes mentioned are functional:
| Acceptance Criteria (Functional) | Reported Device Performance (as stated) |
|---|---|
| 1. Track a moving surrogate | "Verification results show that the design goals and objectives had been met." "Data within this submission... include data, discussion, and results." (Implying successful tracking) |
| 2. Deliver treatment beam to the surrogate | "Verification results show that the design goals and objectives had been met." (Implying successful beam delivery in relation to the surrogate) |
| 3. Pause the treatment beam when the surrogate has moved out of a defined threshold, i.e., gating window | "Verification results show that the design goals and objectives had been met." (Implying successful pausing when out of threshold) |
| 4. Inform the user to resume the treatment beam when the surrogate moves within the defined threshold | "Verification results show that the design goals and objectives had been met." (Implying successful user notification for resumption) |
| Overall Safety and Effectiveness | "The modified Radixact Treatment Delivery System meets the safety and performance criteria and is substantially equivalent with reference to safety and effectiveness to the predicate Radixact Treatment Delivery System." "The enhanced ability to turn the MV beam on in under one second." |
| Compliance with Standards | Conforms to listed electrical safety, EMC, radiation protection, and usability standards (e.g., ANSI AAMI ES60601-1, IEC 60601-1-2 Ed 4.1, IEC 60601-2-1 Ed 3.1) and regulatory references (21 CFR §820, ISO 13485, ISO 14971). |
2. Sample size used for the test set and the data provenance
- Test Set Sample Size: Not specified in terms of patient cases or images for performance testing. The "Non-Clinical Data" section refers to "testing outlined above" (functional tests with a "moving surrogate"), which are likely engineering tests rather than patient studies.
- Data Provenance: Not applicable in the context of patient data for a test set. The validation is primarily technical/engineering.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable. This submission does not involve AI-driven diagnosis or analysis requiring expert interpretation of medical images to establish ground truth for a test set. The "ground truth" for the functional tests would be the controlled movement of the surrogate and the expected system response, not expert consensus on clinical data.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not Applicable. There are no medical image interpretations requiring adjudication for this device's submission as 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
- No Multi-Reader Multi-Case (MRMC) study was done. The document explicitly states: "No animal or clinical tests are being submitted to establish substantial equivalence with the predicate device." This device is a treatment delivery system, not a diagnostic AI system intended to assist human readers in interpretation.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- The performance evaluation focused on the integrated system's functional capabilities (tracking, beam delivery, pausing, informing user). While the SGRT system itself performs some automated actions (e.g., gating the beam), the evaluation is of its function within the treatment delivery workflow, not as a standalone AI algorithm producing outputs for human review. The document does not describe "algorithm only" performance as a separate study element in the context of an AI-driven system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Type of Ground Truth: For the "Key system performance attributes" related to the SGRT, the ground truth would be the controlled and known physical parameters of the moving surrogate (e.g., its position, movement beyond/within thresholds) and the expected system response according to design specifications. This is typical for engineering verification and validation of a mechanical/software system, not clinical ground truth from patient data like pathology or expert consensus.
8. The sample size for the training set
- Not Applicable. This document does not describe the development of a machine learning (AI) model with a "training set" in the context of diagnostic or predictive AI. The submission is for a hardware and software update to a radiation therapy delivery system.
9. How the ground truth for the training set was established
- Not Applicable. As there is no described training set for an AI model, this question is not relevant to the provided text.
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(116 days)
The kVCT Imaging Feature is an option within the indications for use of the Radixact Treatment Delivery System. The Radixact Treatment Delivery System is indicated for the delivery of radiation therapy, stereotactic radiotherapy or stereotactic radiosurgery to tumors or other targeted tissues anywhere in the body under the direction of a licensed medical practitioner.
The kVCT Imaging Feature is designed for use with the predicate Radixact Treatment Delivery System last cleared on K161146. The primary functions of the kVCT Imaging Feature are: 1) acquisition of kV x-ray images according to input protocols in concert with other subsystems, 2) correcting 2D images and 3) returning reconstructed 3D images.
The Radixact Treatment Delivery System is a radiation therapy delivery system that provides Image Guided Radiation Therapy (IGRT) using integral megavoltage CT imaging capabilities and delivers helical (rotational) and fixed-angle (non-rotational) radiation therapy to tumors and other targeted tissues.
The provided text describes the 510(k) summary for the Accuray kVCT Imaging Feature for the Radixact Treatment Delivery System. However, it does not contain the specific details of acceptance criteria for diagnostic imaging performance or the results of a study proving the device meets these criteria in the way typically found for AI/CADe devices.
Instead, this document focuses on establishing substantial equivalence to a predicate device (Radixact Treatment Delivery System, K161146) and a reference device (Motion Tracking And Compensation Feature For The Radixact Treatment Delivery System, K182687) by comparing technological characteristics and ensuring safety and performance are equivalent or better. It emphasizes that the kVCT imaging offers improved intrinsic tissue contrast and image quality characteristics compared to that of MVCT imaging (from the predicate).
Therefore, I cannot populate the table and answer all questions in the requested format for acceptance criteria and a study proving performance, as that information is not present. The document explicitly states: "No animal or clinical tests are being submitted to establish substantial equivalence with the predicate device."
However, I can extract the comparative performance specifications between the MVCT Imaging (predicate) and kVCT Imaging (subject device), which are presented as characteristics rather than formal acceptance criteria and study results.
Here's the information that can be extracted, acknowledging the limitations mentioned above:
1. A table of (comparative) performance characteristics:
| Characteristic | Predicate MVCT Imaging (K161146) | Subject kVCT Imaging Feature (K202412) | Analysis/Comment |
|---|---|---|---|
| Imaging Dose | 0.5 - 3.0 cGy (near center of Tomo-Phantom) | 0.6 - 4.3 cGy (CTDIvol, Head) | |
| 0.4 - 2.3 cGy (CTDIvol, Body) | For MVCT Imaging, "Identical. Differences shown are due to additional detail provided and dose characterized in CTDIvol." For kVCT, this feature was "Feature not present" in the predicate, so it's a new capability. Note: The text implies the kVCT energy range offers improved intrinsic tissue contrast and image quality characteristics compared to MVCT, suggesting this imaging dose provides better clinical information. | ||
| Acquisition Trajectory | Helical (for MVCT) | Helical (for kVCT) | For MVCT, "Identical". For kVCT, "Feature not present" in predicate. |
| Slice Spacing | MVCT: 1, 2, 3, 4 and 6 mm reconstruction Intervals | kVCT: 1.2, 1.8, 3.6 mm | For MVCT, "Identical". For kVCT, "Substantially equivalent. The kV Imaging subsystem provides three-dimensional CT images with equivalent or better performance than the predicate device (MVCT)." |
| Spatial Resolution | MVCT: 1.6 mm | kVCT: 1.0 mm (at 2.0 mm intervals) | For MVCT, "Substantially equivalent". For kVCT, "Substantially equivalent. The kV Imaging subsystem provides three-dimensional CT images with equivalent or better performance than the predicate device (MVCT)." (1.0 mm is better than 1.6 mm). |
| Image Size | MVCT: 512 x 512 pixels | kVCT: 512 x 512 pixels | For MVCT, "Identical". For kVCT, "Feature not present" in predicate. |
| Scan Length | MVCT: 135 cm | kVCT: Up to 135 cm | For MVCT, "Identical". For kVCT, "Feature not present" in predicate. |
| Field of View (FOV) | MVCT: 39 cm diameter | kVCT: 25 - 50 cm | For MVCT, "Identical". For kVCT, "Feature not present" in predicate. |
| Image Uniformity | MVCT: Within 25 HU | kVCT: Within 15 HU (Head) | |
| Within 25 HU (Body) | For MVCT, "Identical". For kVCT, "Feature not present" in predicate. The kVCT performance for Head (15 HU) is better than the MVCT (25 HU). | ||
| Image Noise | MVCT: Less than 43 HU | kVCT: Less than 10 HU (Head) | |
| Less than 20 HU (Body) | For MVCT, "Substantially equivalent". For kVCT, "Feature not present" in predicate. The kVCT performance is significantly better (lower HU indicates less noise) than MVCT. | ||
| Contrast Resolution | MVCT: 3% contrast for 30 mm object | kVCT: 1% contrast for 10 mm object (Head) | |
| 2% contrast for 15 mm object (Body) | For MVCT, "Substantially equivalent". For kVCT, "Feature not present" in predicate. The kVCT contrast resolution is significantly better (lower contrast percentage for smaller objects indicates better resolution) than MVCT. | ||
| kV Detector Pixel Pitch | Reference (K182687): 0.4 mm pitch | Subject: 0.15 mm pitch | "Substantially equivalent. The subject device provides the same or better active area with the same or better pixel resolution as compared to the reference device." (0.15 mm is better resolution than 0.4 mm). |
2. Sample size used for the test set and the data provenance:
- The document explicitly states: "No animal or clinical tests are being submitted to establish substantial equivalence with the predicate device."
- Therefore, there is no test set of clinical images described in this document for evaluating diagnostic imaging performance against acceptance criteria. The data provenance is not applicable in this context.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable as no clinical test set with ground truth established by experts is mentioned.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable as no clinical test set is mentioned.
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:
- No MRMC study is mentioned. This device is an imaging feature, not an AI/CADe device designed to assist human readers in interpretation.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- The performance data cited ("Results of verification and validation testing confirm that the use of the kVCT Imaging Feature on the Radixact Treatment Delivery System conforms to design specifications and meets the needs of the intended users") refers to the engineering and technical performance of the imaging system itself, such as spatial resolution, image noise, contrast resolution, uniformity, and radiation dose, as shown in the table. These are intrinsic performance characteristics of the imaging modality, not a "standalone algorithm" performance in the context of an AI/CADe device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the technical performance characteristics listed (e.g., spatial resolution, image noise), the ground truth is typically established through phantom studies and metrology, comparing measured values against engineering specifications rather than clinical ground truth like pathology or expert consensus.
8. The sample size for the training set:
- Not applicable as this document does not describe an AI/CADe device that uses a training set of images.
9. How the ground truth for the training set was established:
- Not applicable.
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