(259 days)
With radiotherapy equipment (Medical Linac, CT-Sim), it is used for patient positioning before treatment and continuous monitoring of patients during treatment, and can also be used to track patients' breathing mode (including DIBH, EEBH, 4DCT three breathing modes), in order to implement image acquisition synchronized with breathing and radiation therapy.
Klarity SGRT system offers a dedicated non-irradiating and non-invasive surface guided radiation therapy solution. SGRT system includes three main application modules: patient positioning, treatment (motion) monitoring and respiratory gating.
With the patient positioning module, the SGRT system continuously senses the 3D patient body surface and compares it with the prerecorded reference surface by 3D image registration: The calculated 6 degree-of-freedom positioning deviations are visualized and sent to the positioning couch, to ensure a consistent and efficient inter-session patient setup/positioning, both manually and automated.
With the treatment (motion) monitoring module, the SGRT system monitors the patient's surface in real-time throughout the treatment session. Once the body part surface exceeds the predefined tolerance, the system will automatically alert the therapist and turnoff the beam immediately.
With the respiratory gating module, the system keeps tracking the patient's respiratory movements in real-time. During the treatment delivery, this functionality is used to maximize the protection of organs-at-risk; And in CT room, this functionality is used to make the 4DCT imaging best adapt to the patient's breathing in order to minimize the 4DCT imaging artifacts caused by the respiratory motion.
Klarity SGRT system mainly consists of advanced software. PC workstation, one or three 3D cameras and calibration tools. SGRT system provides two models, ARSG-E1A and ARSG-E3A.
The Klarity SGRT System (ARSG-E1A, ARSG-E3A) is a surface-guided radiation therapy solution. The following table outlines its acceptance criteria and reported performance based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Metric | Acceptance Criteria (Subject Device) | Reported Device Performance (Subject Device) | Predicate Device (K113276) Performance | Reference Device (K082582) Performance |
|---|---|---|---|---|
| Measurement Accuracy | Better than 1mm | Better than 1mm | Better than 1mm | Better than 1mm |
| Measurement Reproducibility | Not greater than 0.5mm | Not greater than 0.5mm | 0.2mm | 0.2mm |
| Respiratory Gating Accuracy | ≤1mm | ≤1mm | Within 1mm for rigid body | Within 1mm for rigid body |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample size used for the test set. It mentions "Non-clinical tests were conducted to verify that the Klarity SGRT System (ARSG-E1A, ARSG-E3A) meets all design specifications". The provenance of the data for these non-clinical tests is not specified in terms of country of origin or whether it was retrospective or prospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
The document does not provide information on the number of experts used to establish ground truth or their qualifications. The studies mentioned are non-clinical performance and comparative tests, not expert-opinion based evaluations.
4. Adjudication Method for the Test Set
The document does not describe any specific adjudication method for a test set, as no clinical study involving human judgment is detailed.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
No MRMC comparative effectiveness study was done. The document explicitly states: "The clinical test is not applicable, there's no clinical data."
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
Yes, numerous standalone performance tests were conducted. The document states: "Non-clinical tests were conducted to verify that the Klarity SGRT System (ARSG-E1A, ARSG-E3A) meets all design specifications...". This includes specific performance metrics like measurement accuracy, reproducibility, and respiratory gating accuracy. These tests inherently evaluate the algorithm's performance in a standalone manner, separate from human intervention in a clinical setting.
7. The Type of Ground Truth Used
For the non-clinical performance tests, the "ground truth" would be established by precise physical measurements and reference systems used during these engineering and performance verification tests. This is not derived from expert consensus, pathology, or outcomes data, but rather from direct physical measurement.
8. The Sample Size for the Training Set
The document does not provide information about the sample size for a training set. As the device is referred to as "advanced software" and performs tasks like 3D image registration and real-time motion monitoring, it likely involves algorithms that would require training data, but details are not disclosed.
9. How the Ground Truth for the Training Set Was Established
The document does not provide information on how the ground truth for any potential training set was established.
§ 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.