(150 days)
The Sensus IORT System is indicated for radiation therapy treatments. The Sensus IORT System is an electron linear accelerator with a beam-forming x-ray target used for low energy to treat lesions, tumors, and conditions in or on the body where radiation is indicated. Only Sensus TVM Balloon Applicators can be used with the Sensus IORT System.
The Sensus IORT System is a mobile robotically-guided low-energy intraoperative radiotherapy device for treating cancer lesions and tissue beds during and post-surgery. The Xray source with beam shaping Morpheus provides radiation emission in the low energy therapy ranges of 50, 60, and 70 kV (a total of 3 kV modes) and is held and moved in place by an IEC 60601 medical certified robotic-arm. The robotic-arm uses a 7-axis motion system and is designed for human-robot collaboration for optimized treatment delivery and dosimetry.
The robotic-arm and its control cabinet mounted in the base of the Sensus IORT System contains multiple sensory capabilities for safety and simple operator control that allows it to act as an assistant to the doctor. The robot's joint torque sensors allow it to touch the patient with enough sensitivity to move with respiratory tracking (dubbed Cybernetic Respiratory Motion Tracking, or CRMT) and allow hand-guided movement by the doctor to control and place the xray source into position to deliver therapy.
The X-ray source held by the robotic arm consists of a drift tube and electron acceleration stage. In general, kilovoltage x-ray sources produce x-rays by accelerating electrons onto a tungsten target, which is a high-Z material. The electrons decelerate in the target, and their energy is converted to x-ray radiation (referred to as Bremsstrahlung, literally "braking" radiation), which is emitted in a roughly isotropic radiation pattern.
The Morpheus x-ray gun enables the Sensus IORT System to deliver an optimal and effective therapy beam to the targeted tissue bed that requires localized treatment. The Morpheus x-ray gun is operated by the system's control circuits and software and it is being fed by the high voltage power supply (HVPS), which provides the high voltage through the HV Feedthrough to the Morpheus x-ray gun and the integrated cooling module, which circulates the cooling fluid in order to maintain the Morpheus x-ray gun at a stable and optimal thermodynamic condition. The currently available kV modes of the Morpheus x-ray gun are 50kV, 60kV, and 70kV (Gen 1.0). The high voltage potential from the HVPS is fed to the Cathode by the HV Feedthrough onto the Cathode Assy.
Once the electron beam hits the Diamond-Tungsten-Molybdenum (CW-Mo) target, x-ray photons are generated in an isospheric pattern that is emitted towards the front and back of the target. The x-ray photons have no attenuating barrier in the front of the target (the attached Cooling Jacket is x-ray translucent) and the x-ray photons that are emitted from the back side of the target are emitted out with no significant attenuation through the SiC Window Sleeve. This allows the x-ray photons to be effectively generated and emitted from both sides of the target, thus rendering an optimal geometric distribution and coverage of the generating x-ray beam to deliver therapy.
The system base unit is self-propelled with full battery backup, which allow the operators to move it between surgical suites and hospital facilities. It also features a 3KW back up UPS, which allows the operators to complete a full treatment, even if the hospital power grid goes off line.
The Sensus IORT System is a stand-alone system that incorporates its own cooling module, power supplies, and networking. It consists of five separate core components:
- Computer Control Console .
- . Beam Shaping Morpheus / X-Ray Source (to delivery X-ray radiation)
- Cybernetic Respiratory Motion Tracking (using the Robotic Arm) .
- Base Unit with Drive/Propulsion System (device cabinet with motor) .
- . Red-Diode laser for positioning
The Sensus IORT System X-ray source interacts with a sterile tissue volume management (TVM) Balloon Catheter to act as a barrier between the X-ray source and the patient.
The provided text describes a medical device, the Sensus IORT System, and its substantial equivalence to a predicate device. However, it does not describe acceptance criteria or a study proving the device meets those criteria in the context of an AI/algorithm performance study. The document focuses on the physical and operational characteristics of the radiation therapy system and its safety compliance.
Therefore, I cannot extract the information required for a table of acceptance criteria, sample sizes, expert involvement, or MRMC studies related to AI/algorithm performance. The information provided pertains to the device's safety and effectiveness as a radiation therapy system, not the performance of an AI or algorithm.
The document discusses:
- Safety Tests: Compliance with IEC 60601 series standards for electrical and mechanical safety, usability, and electromagnetic compatibility.
- Verification & Validation: General mention of V&V activities and reports, including "Cybernetic Respiratory Motion Tracking (CRMT) Testing Protocol" and "Sterile drape compatibility testing protocol." These appear to be functional tests of the device's features, not performance metrics of an AI in a diagnostic or predictive capacity.
- Substantial Equivalence: A comparison table showing the Sensus IORT System's characteristics against a predicate device (Xoft Axxent Brachytherapy System). This table highlights physical, operational, and regulatory similarities and differences. The differences discussed (e.g., kV range, target material, robotic arm) are hardware and functionality related, not AI performance.
In summary, this document does not contain information about an AI or algorithm acceptance criteria study. The "Cybernetic Respiratory Motion Tracking" feature mentioned appears to be a real-time motion tracking system, likely based on sensor feedback and control algorithms, but its performance is described in terms of general functionality ("allow it to touch the patient with enough sensitivity to move with respiratory tracking" and "optimizing the therapy delivery") rather than specific AI/algorithm performance metrics and study designs as requested.
§ 892.5900 X-ray radiation therapy system.
(a)
Identification. An x-ray radiation therapy system is a device intended to produce and control x-rays used for 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.