(12 days)
The Edge™ Detector is a device that is designed for use as a radiation scanning detector in any water tank scanning system that is used to measure beam data in radiotherapy departments for dose modeling in the treatment planning computer.
The Edge™ detector is a radiation hardened silicon diode. The diode is encapsulated in a rectangular housing made of thin brass sheet. The active dimension of The Edge™ detector is 0.8 x 0.8 mm2. The diode die plane is parallel with the long axis of the detector housing with the center of the die marked by the cross on the top surface. The detector is mounted such that its top surface is parallel to the water surface and perpendicular to the incident radiation beam axis. The Edge™ detector is water-proof.
The Edge™ detector is designed to measure the radiation distribution in a water phantom. Because of its very small active dimension, The Edge™ detector can measure small field beam parameters, such as penumbra and flatness, more accurately than the conventional ionization chamber with larger active dimensions. Therefore, The Edge™ detector is especially useful for beam modeling in radiation therapy techniques involving small field sizes, such as IMRT (Intensity Modulation Radiation Therapy).
The provided document is a 510(k) Premarket Notification Summary for "The Edge™ - Scanning Diode Detector." It describes the device, its intended use, similarities and differences with marketed predicate devices, and a safety summary. However, it does not contain a detailed study proving the device meets specific acceptance criteria with performance metrics, sample sizes, ground truth establishment, or comparative effectiveness studies typically associated with AI/ML-based medical devices.
The document is a regulatory submission demonstrating substantial equivalence to predicate devices, focusing on safety and effectiveness for its intended use, rather than a performance study report for predefined acceptance criteria.
Therefore, I cannot provide the requested information in the format specified because the document does not contain it. The content is primarily a descriptive submission for regulatory clearance.
§ 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.