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510(k) Data Aggregation
(58 days)
The Motion Tracking and Compensation 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 Motion Tracking and Compensation Feature is designed for use with the predicate Radixact Treatment Delivery System last cleared on K161146. The Motion Tracking and Compensation Feature measures tumor location and motion using images provided by a kV imaging subsystem and predicts tumor location based upon a respiration amplitude measurement device. The Radixact Treatment Delivery System then compensates for tumor motion by making real-time adjustments.
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 a 510(k) premarket notification for a new feature (Motion Tracking and Compensation Feature) for an existing device (Radixact Treatment Delivery System). The core of the submission is to demonstrate substantial equivalence to the predicate device, not necessarily to provide specific performance metrics against pre-defined acceptance criteria in the way one might for a diagnostic AI device.
Therefore, the response below will focus on what is available in the text regarding "acceptance criteria" (more accurately, the claims of substantial equivalence) and the "study" (the verification and validation testing) that supports these claims, rather than a typical AI performance table.
1. A table of acceptance criteria and the reported device performance
For a substantial equivalence submission, the "acceptance criteria" are typically demonstrating that the new device feature does not raise new questions of safety or effectiveness compared to a predicate device, and performs as well as the predicate for its intended use. The table below summarizes the claims of substantial equivalence for various characteristics.
| Device Characteristic | Predicate Device Performance (Radixact K161146) | Reported Device Performance (Radixact with Motion Tracking and Compensation) | Acceptance Criteria Met? (Analysis) |
|---|---|---|---|
| Intended Use | Delivery of radiation therapy, stereotactic radiotherapy or stereotactic radiosurgery to tumors or other targeted tissues. | Option within the intended use of the Radixact Treatment Delivery System. Intended for delivery of radiation therapy, stereotactic radiotherapy or stereotactic radiosurgery to tumors or other targeted tissues. | Identical: The device's intended use fits within and is identical to the predicate's. |
| Indications for Use | 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. | Option within the indications for use of the Radixact Treatment Delivery System. Indicated for 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. | Identical: The device's indications for use fit within and are identical to the predicate's, with the addition of an introductory sentence for the feature. |
| System Configuration | Stand-alone radiation delivery system. | Stand-alone radiation delivery system with kV imaging and motion tracking and compensation added. | Substantially Equivalent: Introduction of Motion Tracking and Compensation Feature does not raise different issues of safety or effectiveness. |
| Physical Dimensions | Minimum Room Dimensions: 274 x 462 x 602 cm; Device Dimensions: 255 x 280 x 473 cm; Device Mass: 6580 kg. | Minimum Room Dimensions: 274.3 x 463 x 602 cm; Device Dimensions: 255 x 280 x 470.5 cm; Device Mass: 6580 kg plus 235 kg for kV subsystem components. | Substantially Equivalent: Minor differences are negligible or the added weight/components do not result in different questions of safety or effectiveness. |
| Basic Operation Parameters (Electrical, Environmental, Gantry) | Line Voltage: 380-480 V ac; Ambient Temp: 20-24 °C; Humidity: 30-60%; Bore Diameter: 85 cm; Gantry Rotation Continuous (1-5 RPM treatment, 10 RPM imaging); Couch Support in Bore: Provided. | Same as predicate. | Identical. |
| Radiation Delivery Modes | Helical, Direct. | Same as predicate. | Identical. |
| Photon Beam (Accelerator Type, RF Source, Energy, Field Size, Dose Rate) | Standing wave, Magnetron, 6 MV, Fixed/Dynamic Field Sizes, Dose Rate: 850 cGy/min standard, 1000 cGy/min optional. | Same as predicate. | Identical. |
| Collimation | Primary collimation, jaws and multi-leaf collimator. | Primary collimation, jaws and multi-leaf collimator. | Substantially Equivalent: Jaws have a new dynamic behavior for motion managed plans, continually adjusted to repoint the beam at the moving target while maintaining the same field size. This difference does not raise different questions of safety or effectiveness. |
| MVCT Imaging | Source: MVCT; FOV: 39 cm diameter; Dose: 0.5-3.0 cGy; Slice Spacing: 1, 2, 3, 4, 6 mm; Spatial Resolution: 1.6 mm. | Same as predicate. | Identical. |
| kV Imaging | Feature not present. | 50-150 kV Radiography Class I (60601-2-28) X-ray tube assembly; FOV: 20 cm x 20 cm; Spatial Resolution: < 1 mm; Approx Dose: 0.08-0.20 mGy; Small Focal Spot: 0.6 mm x 0.6 mm; Large Focus Spot: 1.0 mm x 1.0 mm; Current Range: 5-500 mA. | Substantially Equivalent: New feature provides two-dimensional low-dose radiographic images for patient alignment and tumor motion measurement. Functionality provided by hardware and driver software, meeting safety requirements (IEC 60601 series). No new questions of safety or effectiveness. |
| Motion Management | Not present (Tracking Algorithm, Compensation Algorithm, Synchrony Camera). | Tracking Algorithm: Radixact Motion Tracking; Compensation Algorithm: Radixact Motion Compensation; Synchrony Camera: Radixact Synchrony Motion Tracking. | Substantially Equivalent: Tracking algorithm based on K120233 (Synchrony Respiratory Tracking System). Compensation algorithm uses jaws and MLC effectively, similar to K120233. Synchrony camera has been in use for over ten years (K120233). Do not result in different questions of safety or effectiveness. |
| Laser System | Stationary (Green lasers for virtual/actual isocenter); Moveable (Red lasers for offset from virtual isocenter). | Substantially equivalent. | Substantially Equivalent: Minor differences are negligible and do not result in different questions of safety or effectiveness. |
| Patient Couch | Motion: Independent of each of the other axes. | Same as predicate. | Identical. |
| Biocompatibility | Couch Top: Carbon-fiber top; Synchrony Vest: Not used. | Couch Top: Carbon-fiber top; Synchrony Vest: Same vest cleared under K120233. | Identical/No new biocompatibility issues: Couch top is identical. The Synchrony Vest is a previously cleared component, introducing no new biocompatibility concerns. |
| Power Distribution | Isolation Transformer: Provided; UPS for Data Back-up: Provided. | Same as predicate. | Substantially Equivalent: Introduction of Motion Tracking and Compensation Feature did not introduce changes to this subsystem. |
| Operator Station & Machine Control Software | User interface to system functions; Controls radiation delivery and positioning systems; Provides measurements and status. | Same as predicate. | Identical. |
| Database | External database for gathering operational data and storage of procedure data. | Same as predicate. | Identical. |
| Safety Features | Interlock Subsystems: Present; Data integrity checking: Present. | Interlock Subsystems: Present; Data integrity checking: Present. | Substantially Equivalent: kV subsystem integrated into safety interlocks; no new issues. Motion Tracking and Compensation Feature does not modify data integrity checking design. |
2. Sample size used for the test set and the data provenance
The document states: "No animal or clinical tests were required to establish substantial equivalence with the predicate device." This indicates that the evaluations were likely based on bench testing, engineering verification, and validation activities rather than clinical data with patient samples. Therefore, there is no "test set" in the sense of a patient data set for an AI/diagnostic device.
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 tests were required, experts to establish ground truth for a test set of patient data were not used. The ground truth for engineering tests would be established by physical measurements and adherence to engineering specifications and recognized consensus standards.
4. Adjudication method for the test set
Not applicable. No clinical test set requiring adjudication was used.
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
Not applicable. This device is a radiation therapy delivery system with a motion tracking and compensation feature, not a diagnostic AI device requiring human reader interpretation, nor an AI-assisted diagnostic tool. No MRMC study was mentioned or performed.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
While the Motion Tracking and Compensation feature includes algorithms, the performance evaluation described as "verification and validation testing" would pertain to the proper functioning of these algorithms within the integrated system, and their impact on the overall system's ability to deliver radiation accurately despite motion. The submission relies on demonstrating that these new components adhere to established safety standards and maintain the device's original performance specifications, not necessarily on a "standalone" algorithmic performance study in isolation from the machine. The document states that the "Motion Tracking and Compensation Feature measures tumor location and motion... and predicts tumor location... [and] compensates for tumor motion by making real-time adjustments," implying that its performance is inherently tied to the system's function.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Given the nature of the device (radiation therapy delivery system) and the type of submission (substantial equivalence with waiver of clinical data), the "ground truth" for the device's performance would be:
- Engineering specifications and design requirements: The device's ability to accurately track and compensate for motion according to predefined engineering tolerances.
- Compliance with recognized consensus standards: The device passed tests against relevant IEC and other standards for radiation therapy equipment and medical electrical equipment (e.g., IEC 60601 series).
- Comparison to predicate device's established performance: The analysis repeatedly states that the new features are "substantially equivalent" and do not introduce new safety or effectiveness concerns compared to the already cleared predicate device.
8. The sample size for the training set
Not applicable. This is not an AI/machine learning model in the sense of needing a separate "training set" of patient data for a diagnostic task. The description of the tracking and compensation algorithms suggests they are deterministic or traditional control algorithms, rather than machine learning models requiring extensive training data.
9. How the ground truth for the training set was established
Not applicable, as there is no mention of a training set as would be understood for an AI/ML model for diagnostic purposes.
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