Search Results

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.

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.

Ask a specific question about this device

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 be also used to monitor the patient position during the image acquisition, simulation and treatment.

The Varian RPM Respiratory Gating Device is an attachment to the Varian Clinac radiation therapy treatment systems, radiation therapy simulators, and image acquisition devices used for diagnostics and radiation therapy. The RPM system senses and records the respiratory motion and respiratory state of a patient using video tracking of an optical marker placed on the patient to a location indicated by the physician. Video camera is connected to a PC workstation is used for video tracking of markers.

I am sorry, but the provided text does not contain any information about acceptance criteria or a study that proves the device meets those criteria. The document is a 510(k) summary and an FDA clearance letter for the RPM Respiratory Gating System.

It describes the device, its intended use, and states that it is substantially equivalent to a predicate device based on a comparison of technological characteristics. However, it does not include:

• A table of acceptance criteria and reported device performance.
• Information about sample sizes, data provenance, or ground truth establishment for any test sets.
• Details on expert involvement, adjudication methods, or MRMC studies.
• Results of a standalone algorithm performance study.

The document primarily focuses on establishing substantial equivalence to a predicate device, which is the basis for 510(k) clearance, rather than presenting detailed performance study results against specific acceptance criteria.

Ask a specific question about this device

The Varian RPM Respiratory Gating device is an attachment to the radiation therapy simulator and Varian Clinac radiation therapy treatment system. It is to be used to characterize (in simulation) the patient's respiratory patterns and then, in treatment, 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 video-based RPM Respiratory Gating System provides a respiration gating signal to a Clinac radiation therapy machine to "hold" the beam during planned intervals of the respiration cycle. The system derives beam-hold signals from the patient chest motion, which it tracks using a video camera connected to a PC workstation. The computer includes real-time and multi-channel video digitization and display hardware controlled by digital image analysis and video tracking software that runs as a Windows NT application. The PC also includes a relay and I/O board that under software control opens and closes the Clinac gating switch for beam-hold control. The RPM Respiratory Gating System receives live video images from a monochrome CCD video camera equipped with an infrared ring illuminator. When used for planning, the RPM Respiratory Gating System receives images from both the camera and a simulator or fluoroscope. For treatment use, the RPM Respiratory Gating System receives images from the camera.

The provided text describes the RPM Respiratory Gating System and compares its characteristics to a predicate device, the NIMS Respitrace System. However, it does not include specific acceptance criteria, a study proving device performance against those criteria, or details regarding sample sizes, expert involvement, or ground truth establishment for such a study.

Therefore, many of the requested sections will be marked as "Not provided in the text."

Here's the breakdown of the information extracted from the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria: Not provided in the text.
Reported Device Performance: The text provides a comparison of technical specifications between the RPM Respiratory Gating System and the predicate device. These specifications, while indicative of performance, are not explicitly framed as "acceptance criteria" against which the device's performance was measured in a study.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not provided in the text. The document describes the system and compares its technical specifications to a predicate device, but does not detail a specific study with a test set of data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not provided in the text.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not provided in the text.

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 provided in the text. The RPM Respiratory Gating System appears to be an automated system for tracking respiratory patterns and controlling a radiation beam, rather than a diagnostic tool requiring human reader interpretation or augmented by AI in a traditional MRMC study context. The document does not mention any AI components or human reader studies.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

The device itself is described as a system that "derives beam-hold signals from the patient chest motion, which it tracks using a video camera connected to a PC workstation." and "the radiation beam is actively gated by the system, so that the beam is held (not irradiating) when the motion is outside the thresholds set in the planning session." This implies a standalone algorithm-driven function. However, the text does not provide details of a specific "standalone performance study" with metrics. The presented information focuses on technical specifications and functionality.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Not provided in the text. No study or ground truth establishment method is described. The comparison is based on technical parameters of the device itself and its predicate.

8. The sample size for the training set

Not provided in the text.

9. How the ground truth for the training set was established

Not provided in the text.

Ask a specific question about this device