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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 (< 24 hours). The Instructions for Use provides instruction on how to properly clean the block for re-use between patients. This component is not intended for sterilization.

Within the camera housing, an illuminator ring emits the infrared light which reflects off of the markers on the reflector block back to the camera. The camera is mounted either on the wall or ceiling along the central axis of the couch at a maximum distance of 4.0 meters from the block. The camera is directly connected to the RGSC Cabinet through the back panel. The housing also contains the class II laser used to calibrate the camera. This calibration is to be performed after installation and any time the camera's position has changed.

The RGSC Cabinet houses the Workstation Unit and Real-Time Unit. The Workstation contains the RGSC application which has functions for patient file creation and storage, calibration of the system, set up, recording, and review of a reference session. The Real-Time Unit contains software for the real-time image data processing, which is used in the dynamic tracking of the reflector block. The real-time unit controls the interface to the Wireless Access Point, Camera, and the 3d Party Diagnostic Imaging Scanner.

No biologics or drugs are in this device is not intended for single use. No parts of the system are provided sterile or are intended for sterilization.

The associated accessories include:

• . Keyboard and Mount for RGSC Workstation
• Monitor for RGSC Workstation ●
• VCD Couch Mounting Arm .
• VCD Battery Packs, Charging Station, and External DC Power Supply ●
• . Wireless Access Point

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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