(28 days)
The Onrad™ Treatment System is intended to be used as an integrated system for the planning and precise delivery of radiation therapy, stereotactic radiotherapy, or stereotactic radiosurgery to tumors or other targeted tissues while minimizing the delivery of radiation to vital healthy tissue. The megavoltage x-ray radiation is delivered in a non-rotational, modulated (IMRT), or non-modulated (non-IMRT/three dimensional conformal) format in accordance with the physician approved plan.
The Onrad™ Treatment System is a radiation therapy system that integrates planning, dose calculation, megavoltage CT imaging for IGRT functionality, and fixed beam (non-rotational) radiation therapy treatment capabilities into a single comprehensive system.
The Onrad™ Treatment System is a prescription device. It delivers radiation in accordance with a physician approved plan. The device does not diagnose disease, recommend treatment regimens, or quantify treatment effectiveness. The megavoltage CT imaging functionality is not intended for diagnostic use.
I am sorry, but the provided text does not contain the detailed information necessary to answer the questions about acceptance criteria and a study proving device performance in the format requested. The document is an FDA 510(k) clearance letter for a medical device (Onrad™ Treatment System) and its accompanying 510(k) Summary.
Here's what the document does say regarding performance, and why it doesn't meet your request:
- Performance Data Section (Page 4): "The Onrad™ Treatment System was tested and shown to be in compliance with the requirements of applicable recognized consensus safety standards for medical devices. Results of verification and validation testing confirm the Onrad™ Treatment System conforms to design specifications and meets the needs of the intended users. No clinical tests were required to establish substantial equivalence. The performance data demonstrate the Onrad Treatment System is as safe, as effective, and performs as well as the predicate device."
This statement indicates that performance data exists and demonstrates compliance with safety standards and design specifications, and that no clinical trials were required for substantial equivalence. However, it does not provide specific acceptance criteria, reported device performance metrics, sample sizes, data provenance, expert details, adjudication methods, details on MRMC studies, standalone performance, ground truth types, or training set information. These details would typically be found in the V&V (Verification and Validation) report referenced, but not included or summarized in this FDA letter.
Therefore, I cannot populate the table or answer the specific questions about the study that proves the device meets acceptance criteria based on the provided input.
§ 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.