(73 days)
The Catalyst+ system and accessories are intended for use in radiation therapy clinics with treatment, to provide:
- · Interactive guidance for setup and positioning of patients for radiation therapy
- · Intra-fraction motion detection during radiation therapy
- · Respiratory gating during radiation therapy
The device is not intended for use in MR-linac systems.
The system shall only be used by hospital personnel, qualified to work in radiation therapy departments. Training on the use of the system will be given to users at the time of installation.
The Catalyst product consists of projector unit hardware and Windows based software. The product is intended to be used in radiation therapy clinics for patient positioning, patient monitoring and respiratory gating.
A 3D image of the patient surface can be acquired and compared to a reference image that was either imported from e.g. a treatment planning system, or acquired by surface scanning earlier. The Catalyst system computes the optimal couch correction as well as errors in the patient's posture.
Measurements are done continuously using near UV light (405 nm). The detected errors are in parallel projected using visible light (red and green) in real-time e.g. as a distance map directly on the patient's surface to indicate which body parts that need to be adjusted and how. The rigid-body couch correction is projected numerically and can be sent to the couch control system to enable auto-setup of the couch.
Once that patient is in the correct position, the Catalyst system will continue to monitor the patient during treatment delivery to ensure that it doesn't move out of position. If a large movement is detected, a warning can be issued for the personnel to react on, and/or an interlock can be triggered automatically to shut off the beam.
For optimal coverage of the patient and to support couch kicks, two additional units (Catalyst* system without back projection) can be installed in an angle from the main unit. The configuration is called Catalyst+ HD/PT.
The following application modules are provided:
- cPosition - is the application module that provides a reproducible way of accurately positioning patients. It compares the current patient position with a reference setup bv using surface matching software for calculating adjustments in the patient's position.
- cMotion - is the application module for supervising patient motion during treatment. During treatment the system shall record the patient's position continuously and signal or interrupt treatment when the patient is moving outside specified tolerance intervals.
- cRespiration is the application module for respiratory tracking and gating. ● During treatment the module is able to give a warning or to turn the beam on or off depending on the acquired respiratory signal and on the gating parameters established in the treatment plan. The cRespiration in Catalyst* is based on reference data created in the CT room.
The C-Rad Catalyst+ system and its variations (Catalyst+ HD, Catalyst, Catalyst HD, Catalyst Tomo, Catalyst PT) are intended for use in radiation therapy clinics for interactive guidance during patient setup and positioning, intra-fraction motion detection, and respiratory gating.
Acceptance Criteria and Device Performance (Implicit from the document - no explicit table provided)
The document does not provide a table of explicit acceptance criteria and corresponding device performance metrics. Rather, it states that "Performance data has been submitted to show that the Catalyst system achieves its intended use and that the hardware and software updates raise no new issues of safety or efficacy." The device's substantial equivalence to its predicate device (Catalyst K113276) is also a key aspect of its acceptance.
The document implicitly suggests that the device meets the performance of its predicate, which was already cleared by the FDA for similar functions. The "Technological comparison" section highlights that the core technology (optical 3D scanning, structured light) and principle of the scanner remain unchanged despite hardware and software updates.
Study Details:
The provided document is a 510(k) clearance letter from the FDA, along with the 510(k) Summary for the C-Rad Catalyst device. It describes the device and its intended use, and states that performance data was submitted, but it does not include the actual study details, methodology, or results. Therefore, most of the requested information regarding sample size, data provenance, ground truth establishment, expert qualifications, and MRMC studies cannot be extracted directly from this document.
However, based on the information provided, we can deduce the following:
- Sample size used for the test set and data provenance: Not specified in the provided document.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not specified in the provided document.
- Adjudication method for the test set: Not specified in the provided document.
- 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 specified in the provided document. The device primarily functions as a patient positioning and monitoring system, not for diagnostic interpretation that would typically involve human readers in the same way an imaging AI would.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: The device is described as providing "interactive guidance" and signaling for personnel, implying a human-in-the-loop system. Standalone performance for the core functionalities (e.g., accuracy of position detection) would have been assessed as part of the performance data submission, but the details are not included here.
- The type of ground truth used: Not specified in the provided document. For a positioning system, ground truth would likely involve highly accurate physical measurements by independent devices or methods.
- The sample size for the training set: Not specified in the provided document.
- How the ground truth for the training set was established: Not specified in the provided document.
§ 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.