(97 days)
TrueBeam-TrueBeam STx-Edge: The TrueBeam ™ radiotherapy delivery system is intended to provide stereotactic radiosurgery and precision radiotherapy for lesions, tumors, and conditions anywhere in the body where radiation treatment is indicated.
VitalBeam: The VitalBeam system is intended to provide stereotactic radiosurgery and precision radiotherapy for lesions, tumors, and conditions anywhere in the body where radiation treatment is indicated.
The TrueBeam and VitalBeam Radiotherapy System is a medical linear accelerator that delivered therapeutic radiation to patient in accordance with the physician's prescription.
The system consists of two major components – a photon, electron and diagnostic kV X-ray radiation beam producing component that is installed in a radiation-shielded vault and a control console area located outside the treatment room.
The provided text does not contain information about an AI/ML device or its acceptance criteria. Instead, it is an FDA 510(k) clearance letter for the Varian Medical Systems TrueBeam, TrueBeam STx, EDGE, and VitalBeam (4.1) radiation therapy systems.
The document discusses:
- Device Name & Regulation: TrueBeam, TrueBeam STx, EDGE, and VitalBeam (4.1), regulated as a Medical Charged-Particle Radiation Therapy System (21 CFR 892.5050, Class II, Product Code: IYE).
- Intended Use & Indications for Use: The devices are intended for stereotactic radiosurgery and precision radiotherapy for various lesions, tumors, and conditions throughout the body in adult and pediatric patients. A key update in version 4.1 is the incorporation of changes to the CBCT image reconstruction algorithm to allow for the use of CBCT images in the simulation and planning for adaptive radiation therapy. However, it explicitly states that TrueBeam v4.1 cannot deliver adaptive dosimetry on a real-time, per-fraction basis, but supports off-line adaptive treatment planning or delivery.
- Predicate Device: TrueBeam / TrueBeam STx / Edge / VitalBeam (K231317), which is version 4.0.
- Technological Characteristics: The subject device (v4.1) and predicate device (v4.0) share the same medical linear accelerator, couch, integrated treatment and imaging consoles, multi-leaf collimators, and supported treatment techniques. The significant difference is the software change to the CBCT image reconstruction algorithm for adaptive radiation therapy planning.
- Performance Data: Verification and validation of the modified software and hardware were conducted to assess image quality and dose calculation accuracy against planning CT images for suitability in adaptive planning. Software was considered a "major" level of concern. Human factors validation study was conducted per IEC 62366. The system complies with various IEC and ISO standards related to safety, EMC, quality management, risk management, and biocompatibility.
- Clinical Testing: No animal or clinical tests were submitted to establish substantial equivalence.
Since the device described is a medical linear accelerator for radiation therapy and not an AI/ML device, the specific questions regarding AI/ML acceptance criteria, test set details (sample size, provenance, expert adjudication, MRMC studies, standalone performance), ground truth, and training set details are not applicable to the provided text. The document focuses on demonstrating substantial equivalence to a predicate device through non-clinical performance testing and compliance with regulatory standards for a radiation therapy system.
§ 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.