(84 days)
To provide an option to the CyberKnife System which will enable dynamic image guided stereotactic radiosurgery and precision radiotherapy of lesions, tumors and conditions that move under the influence of respiration.
Presently, irradiation of lesions that move during breathing, such as those located in the lung or near the diaphragm, would typically be performed during patient breath-holds. The Motion Tracking System option to the CyberKnife® System is designed to treat lesions while they are moving during the respiratory cycle. This offers the ability to reduce normal tissue exposure by using smaller irradiation margins, shorten treatments, increase accuracy and provide more comfort for the patient.
During motion tracking operation, a correspondence between surface (e.g. thorax/abdomen) movements and movement of the target lesion is developed prior to the start of treatment and is regularly updated during treatment each time the CyberKnife system acquires a new pair of x-ray images. This correspondence is then used to estimate lesion position in real time by monitoring surface movement during treatment.
Motion Tracking provides the CyberKnife system with the capability to monitor the patient's respiration and command the robot manipulator to compensate for the treatment target motion within the body, in real-time, while the radiation is being delivered.
The Motion Tracking System includes a sensor assembly, tracking targets, a cable junction box, and a controller.
The provided text does not contain detailed information about the acceptance criteria and the study that proves the device meets those criteria. The document is a 510(k) summary for a "Motion Tracking System", focusing on its intended use, device description, and a letter of substantial equivalence from the FDA.
Therefore, I cannot populate the table or provide the requested details about the study, sample sizes, ground truth, or expert involvement as this information is not present in the provided text.
Based on the information provided, here's what can be extracted and what is missing:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified | Not specified |
Missing Information: The document heavily focuses on the regulatory aspects and technical description of the device's function, but it does not detail specific acceptance criteria (e.g., accuracy thresholds, precision targets, latency limits) or the quantitative results of performance testing against such criteria.
2. Sample size used for the test set and the data provenance:
- Sample Size for Test Set: Not specified.
- Data Provenance (e.g., country of origin of the data, retrospective or prospective): Not specified.
Missing Information: There is no mention of a test set, its size, or the nature/origin of data used for any performance evaluation.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of Experts: Not specified.
- Qualifications of Experts: Not specified.
Missing Information: The document doesn't describe any expert-established ground truth or the involvement of experts in evaluating the device's performance.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Adjudication Method: Not specified.
Missing Information: No details on adjudication methods are provided.
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:
- MRMC Study: Not mentioned or implied.
Missing Information: The device is a "Motion Tracking System" for radiation therapy, which implies it's a technical accessory for precise delivery, not a diagnostic AI tool that would typically involve human readers. Therefore, an MRMC study comparing human reader performance with/without AI assistance would likely not be applicable or expected for this type of device.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Standalone Performance: While the description implies the system operates in real-time to compensate for motion, the document does not explicitly detail a standalone performance study with specific metrics. It describes the functionality of estimating lesion position and commanding the robot, rather than reporting on a formal standalone performance evaluation.
Missing Information: Specific studies dedicated to standalone performance with quantitative results are not mentioned.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Type of Ground Truth: Not specified.
Missing Information: There is no description of how ground truth was established for any performance evaluation.
8. The sample size for the training set:
- Sample Size for Training Set: Not specified.
Missing Information: No mention of a training set or its size.
9. How the ground truth for the training set was established:
- Ground Truth for Training Set: Not specified.
Missing Information: No details on how ground truth was established for a training set.
Summary of what is available from the text:
- Device Name: Motion Tracking System (option to the CyberKnife® System)
- Intended Use: To enable dynamic image-guided stereotactic radiosurgery and precision radiotherapy of lesions, tumors, and conditions that move under the influence of respiration.
- Mechanism: Develops a correspondence between surface movements and target lesion movement, estimates lesion position in real-time by monitoring surface movement, and commands the robot manipulator to compensate for target motion.
- Regulatory Status: Received 510(k) clearance (K020294) indicating substantial equivalence to predicate devices (Accuray CyberKnife® System, K011024 and Varian Medical Systems RPM Respiratory Gating System, K983629).
The provided text serves primarily as a regulatory submission summary, detailing the device's purpose and regulatory pathway rather than a detailed scientific study report.
§ 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.