(88 days)
The RPM Respiratory Gating System is used to obtain tracking of the subject respiratory pattern for respiratory synchronized image acquisition and radiation therapy treatment. It can also be used to monitor the patient position during image acquisition, simulation and treatment.
The Varian RPM Respiratory Gating is an attachment to radiation therapy treatment systems such as conventional linear accelerators, proton therapy systems, radiation therapy simulators and image acquisition devices used for diagnostics and radiation therapy. The RPM device is to be used to characterize the patient's respiratory motion information to synchronize their operation with the respiratory motion. The imaging devices either trigger the image acquisition based on the signal received from RPM, or they use respiratory motion signal to trigger beam-hold and limit the beam-on time to those points in the respiratory cycle where the target volume is within acceptable motion limits. The RPM device can also be used to monitor the patient's position during the image acquisition and treatment therapy process.
The RPM Respiratory Gating System is an attachment to radiation treatment systems used to characterize a patient's respiratory motion for synchronized image acquisition and radiation therapy treatment, and to monitor patient position during these processes.
1. Acceptance Criteria and Reported Device Performance:
The provided document is a 510(k) summary for a substantial equivalence claim, not a detailed study report with specific acceptance criteria and performance data. The table below summarizes the features and specifications of the device, comparing the previously cleared predicate device with the current device. The implication is that the performance of these features meets acceptable standards for the intended use, as no changes were made to these core functional specifications.
| Feature and/or Specification of New/Modified Device | Cleared Device Feature/Specification | Device With Change |
|---|---|---|
| Intended Use | Tracking respiratory pattern for synchronized image acquisition and radiation therapy treatment; monitoring patient position during image acquisition, simulation, and treatment. | No change |
| Indications for Use | Tracking respiratory pattern for synchronized image acquisition and radiation therapy treatment; monitoring patient position during image acquisition, simulation, and treatment. | No change |
| Objects physically attached to patient | Light plastic block with retro-reflective markers (2 or 6 dots), typically on upper abdomen or chest. | No change |
| Wire connections made to patient | None | No change |
| Measured parameters | Vertical, lateral, and longitudinal position of the marker block. | No change |
| Maximum signal range | 32 cm vertical by 41 cm lateral at 380 cm working distance (50 mm lens); 29 cm vertical by 38 cm lateral at 180 cm working distance (25 mm lens). | No change |
| Measurement resolution (at 380 cm, 50 mm lens) | Vertical: 0.013 cm; Lateral: 0.023 cm; Longitudinal: 0.055 cm. | No change |
| Measurement resolution (at 180 cm, 25 mm lens) | Vertical: 0.004 cm; Lateral: 0.002 cm; Longitudinal: 0.018 cm. | No change |
| Measurement drift | None | No change |
| Distance to patient | 15 ft maximum patient-camera distance. | No change |
| Compatible with radiation therapy treatment devices | Yes (Varian accelerators) | Varian Linear Accelerators, Proton therapy Systems that are capable of being gated. |
| Compatible with radiation therapy simulators | Yes | No change |
| Compatible with Image acquisition systems | Yes (General interface); support for triggered/gated and 4D image acquisition. | No change |
| Supported patient coaching methods | Audio and/or visual | No change |
| Supported breathing methods | Free-breathing, voluntary breath-hold | No change |
| Patient position monitoring | Yes | No change |
| Recognition and management of periodicity changes | Yes | No change |
| Support for phase-based and amplitude-based gating | Both phase and amplitude based gating | No change |
2. Sample Size Used for the Test Set and Data Provenance:
The document states, "Results of verification and validation testing demonstrate that the RPM Respiratory Gating System satisfies the intended use as described above." However, this 510(k) summary does not provide specific details on:
- The sample size used for the test set.
- The country of origin of the data.
- Whether the data was retrospective or prospective.
Given that this is a 510(k) for a device with "No change" to most of its core features and specifications compared to a predicate device, it's highly probable that the "verification and validation testing" referred to was an internal engineering and performance evaluation, rather than a clinical study with human subjects.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
This information is not provided in the 510(k) summary. Given the absence of specific clinical study details, it's unlikely that "experts" were formally used to establish ground truth in the context of clinical accuracy for this type of device in this submission. The "ground truth" would more likely refer to established engineering benchmarks and measurements of physical parameters.
4. Adjudication Method for the Test Set:
This information is not provided in the 510(k) summary.
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:
This type of study is not applicable to the RPM Respiratory Gating System as described. This device is an attachment to radiation therapy systems for tracking respiratory patterns and monitoring patient position. It is not an AI-assisted diagnostic or interpretive tool that would involve human readers or affect their diagnostic performance.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done:
The device itself is a standalone system in the sense that it performs its function of tracking respiratory patterns and providing gating signals without direct human interpretation of the tracking data in real-time. The "verification and validation testing" mentioned would assess the standalone performance of its measurement accuracy, resolution, drift, and compatibility. However, the details of such standalone testing are not explicitly described in terms of methodology or specific results.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.):
The type of "ground truth" for this device would relate to the physical accuracy of its measurements (e.g., how accurately it measures the position of the marker block, its resolution, and drift). This would be established through engineering standards and calibrated measurement tools, not typically through expert consensus, pathology, or outcomes data, which are more relevant for diagnostic or prognostic devices.
8. The Sample Size for the Training Set:
This information is not provided and is likely not relevant for this device. The RPM Respiratory Gating System, as described, is a sensing and tracking system, not a machine learning or AI algorithm that requires a "training set" in the conventional sense. Its functionality is based on established optical tracking principles.
9. How the Ground Truth for the Training Set Was Established:
This information is not provided and is likely not relevant for this device, as it does not appear to use a training set in the machine learning context.
§ 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.