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Respiratory Gating for Scanners (RGSC) is used to characterize the patient's respiratory patterns, providing the necessary information to diagnostic devices to acquire images synchronized with the breathing motion. RGSC can also be used to monitor the patient position during the image acquisition.

Respiratory Gating for Scanners (RGSC) is a respiratory motion monitoring device used in the breathing-synchronized acquisition of images on CT and/or PET CT Scanners. It first received FDA clearance in 2015 (K151533). The device consists of the RGSC cabinet (containing workstation unit & real-time unit for user control and interaction), a gating reflector block placed on the patient, a camera system which is used to monitor the reflector block and report the patient's respiratory motion to the workstation, and a visual coaching device. RGSC is operated primarily by radiologist technicians and/or radiotherapists with current licensure and/or certification as required by regional authority, in accordance with the prescription of radiologist or a radiation oncologist and under the general supervision of chief technologists and/or medical physicists, as required by regional authority.

The concepts in the operation of the device include:

• 1. Breathing-synchronized image acquisition
• 2. Breathing motion tracking and recording
• 3. Tracking, recording, and triggering with prospective and retrospective gating for diagnostic imaging

The infrared camera tracks the position and motion of the reflector block, which is placed on the patient's chest or abdomen during this process. This light, plastic block with four reflective markers which face the direction of the camera is in transitory contact with the patient's skin for a limited amount of time (

The provided document is a 510(k) summary for Varian Medical Systems' "Respiratory Gating for Scanners v2.0" (RGSC v2.0), seeking substantial equivalence to their predicate device, "Respiratory Gating for Scanners v1.0 MR1" (RGSC v1.0 MR1), cleared under K151533.

The key changes in RGSC v2.0 from the predicate device are:

1. SmartTrack algorithm change to improve detection and tracking of the Reflector Block: The improved algorithm addresses issues with x-ray scatter and pixel noise that sometimes led to invalid results in previous versions. The new method is designed to be more robust in detecting the Reflector Block's position.
2. Use of a new filtering method for noise reduction on the breathing amplitude signal: RGSC v2.0 uses a Kalman filtering method, which is presented as more robust against couch motions compared to the simple sliding averaging filter used in the predicate device.
3. Support for couch-mounted camera (in addition to previous wall- and ceiling-mounted camera): This expands the system's installation flexibility.

The document explicitly states: "No animal or clinical tests are being submitted to establish substantial equivalence with the predicate device." This means that the acceptance criteria and performance data for this device are based on non-clinical verification and validation testing, not on clinical studies involving human or animal subjects that directly measure diagnostic accuracy or clinical outcomes.

Therefore, the requested information regarding certain aspects of clinical studies, such as sample size for test sets, data provenance, expert consensus, adjudication methods, MRMC studies, standalone algorithm performance, and ground truth establishment for such studies, is not applicable to this submission as no clinical performance data was provided or required for the substantial equivalence determination.

The submission focuses on engineering validation to demonstrate that the changes do not negatively impact safety and effectiveness and that the device performs its intended use as designed, consistent with the predicate.

Here's a breakdown of the available information based on the prompt's request:

1. A table of acceptance criteria and the reported device performance:

Since no clinical accuracy data is presented, acceptance criteria are generally implied by conformance to design specifications, industry standards, and the successful completion of non-clinical verification and validation tests. The "reported device performance" is described qualitatively by the improvements made.

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

• Sample size: Not applicable/Not specified for clinical data, as no clinical tests were submitted. The V&V testing involved various non-clinical scenarios (simulated use, bench testing).
• Data provenance: Not applicable for clinical data. For non-clinical V&V, the testing was conducted by Varian Medical Systems. Specific country of origin for the non-clinical test data is not detailed, but Varian Medical Systems is based in Palo Alto, CA, USA.
• Retrospective or prospective: Not applicable, as no clinical studies were submitted.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not applicable, as no clinical studies with expert-adjudicated ground truth were submitted.

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

• Not applicable, as no clinical studies requiring ground truth adjudication were submitted.

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

• No, an MRMC comparative effectiveness study was not done or submitted. The device is a "Respiratory Gating for Scanners," which is an input device for diagnostic imaging, not an AI software intended for image interpretation or diagnosis that would typically involve human reader performance studies.

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

• No "standalone" performance study in the context of diagnostic accuracy was explicitly mentioned as having been performed or submitted. The device's function is to characterize respiratory patterns and provide information to diagnostic devices. Its performance is evaluated through its ability to accurately detect and track the reflector block and filter the breathing signal, which are functional aspects demonstrated by non-clinical V&V, not diagnostic output.

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

• For the non-clinical verification and validation testing, the "ground truth" would be the engineering specifications, known physical parameters, simulated conditions, and expected system behavior, rather than clinical ground truth (e.g., pathology or patient outcomes).

8. The sample size for the training set

• Not applicable. The document does not describe the device as employing machine learning that would require a "training set" in the conventional sense for AI clinical performance. The changes involve algorithmic improvements (SmartTrack, Kalman filter) but these are described in terms of engineering solutions rather than data-driven machine learning models.

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

• Not applicable. See point 8.

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Respiratory Gating for Scanners (RGSC) is used to characterize the patient's respiratory patterns, providing the necessary information to diagnostic devices to acquire images synchronized with the breathing motion. RGSC can also be used to monitor the patient position during the image acquisition.

Respiratory Gating for Scanners (RGSC) consists of the RGSC Cabinet (Containing Workstation Unit & Real-Time Unit). Infrared Camera, Reflector Block, and Visual Coaching Device. RGSC is used in the breathing-synchronized acquisition of images on CT and/or PET CT Scanners. RGSC is an accessory to these systems. RGSC is operated primarily by radiologist technicians and/or radiotherapists, in accordance with the prescription of radiologist or a radiation oncologist and under the general supervision of a chief technologists and/or medical physicists.

The infrared camera tracks the position and motion of the reflector block, which is placed on the patient's chest or abdomen during this process. This light, plastic block has four reflective markers which face the direction of the reflector block is in transitory contact with the patient's skin for a limited amount of time (

The provided text describes a 510(k) premarket notification for the "Respiratory Gating For Scanners" (RGSC) device by Varian Medical Systems. While it details various non-clinical tests conducted, it explicitly states that no clinical tests were included in this submission. Therefore, it is not possible to provide acceptance criteria and a study proving the device meets those criteria from the given text.

The information below is based only on the provided document and highlights why a comprehensive answer to your request cannot be fully constructed from it:

1. Table of Acceptance Criteria and Reported Device Performance:

• Acceptance Criteria: Not explicitly stated in the provided text for device performance. The document focuses on regulatory compliance and substantial equivalence to a predicate device, rather than specific performance metrics and their acceptance thresholds.
• Reported Device Performance: No clinical performance metrics (e.g., accuracy, sensitivity, specificity, or improvement in image quality due to gating) are reported based on a clinical study in this document. The document states "The non-clinical data supports the safety of the device and the hardware and software verification and validation demonstrate that Respiratory Gating for Scanners should perform as intended in the specified use conditions." This is a general statement about meeting design intent, not specific performance against clinical acceptance criteria.

2. Sample Size Used for the Test Set and Data Provenance:

• Sample Size for Test Set: Not applicable, as no clinical test set was used for performance evaluation (stated "No clinical tests have been included in this submission").
• Data Provenance: Not applicable.

3. Number of Experts Used to Establish Ground Truth and Qualifications:

• Not applicable, as no clinical test set with ground truth established by experts was used.

4. Adjudication Method:

• Not applicable.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

• No MRMC comparative effectiveness study was done. The document explicitly states "No clinical tests have been included in this submission."

6. Standalone Performance Study:

• The document implies that standalone software verification and validation testing were conducted, but these were for functional correctness, not clinical performance. It does not describe a standalone clinical performance study of the algorithm without human-in-the-loop. The system is described as an accessory to diagnostic devices, indicating human operation.

7. Type of Ground Truth Used:

• Not applicable, as no clinical test set requiring ground truth was used. The verification and validation activities mentioned are typically against engineering specifications or pre-defined software requirements, not clinical ground truth.

8. Sample Size for the Training Set:

• Not applicable, as no clinical data-driven training of an AI/ML algorithm is described in this submission. The device description points to a system based on infrared tracking of a reflector block, not an AI model trained on a dataset.

9. How the Ground Truth for the Training Set Was Established:

• Not applicable.

Summary from the provided document:

The 510(k) submission for Varian Medical Systems' Respiratory Gating for Scanners (RGSC) did not include clinical tests to demonstrate its performance against specific clinical acceptance criteria. The approval was based on non-clinical data, including biocompatibility, electrical safety and EMC, software verification and validation, and mechanical testing. The argument for substantial equivalence relies on the device leveraging similar technological principles as its predicate (RPM Respiratory Gating System) for respiratory tracking and gating, with identified differences not extending or adding to the intended use or affecting safety and effectiveness. The document asserts that the non-clinical data supports the safety and intended performance of the device under specified use conditions.

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