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The Aurora-RT, with magnetic resonance imaging capabilities, is intended to provide precision radiotherapy for lesions, tumors, and conditions anywhere in the body where radiation treatment is indicated.

Aurora-RT is a medical device for image-guided radiation therapy (IGRT) that combines magnetic resonance imaging (MRI) with radiotherapy technology. It combines a 6 MV medical linear accelerator (Linac) and 0.5 T cryogenless superconducting MRI system mounted in a rotating gantry frame. The MR imaging capability is utilized for positioning the patient at the start of radiation therapy in place of computed tomography (CT) imaging that is commonly used in radiation therapy. MR imaging offers superior soft tissue contrast compared to CT and does not utilize ionizing radiation as with CT images.

This document is a 510(k) Premarket Notification from MagnetTx Oncology Solutions Ltd. for their Aurora-RT device. It describes the device, its intended use, and argues for its substantial equivalence to a predicate device (ViewRay MRIdian Linac System). The document focuses on regulatory compliance and technical specifications rather than clinical study data for device performance against specific acceptance criteria.

Therefore, the provided text does not contain the detailed information necessary to fully answer the request regarding acceptance criteria and the study that proves the device meets them. Specifically, the prompt asks for a table of acceptance criteria and reported device performance, sample sizes for test and training sets, data provenance, expert ground truth establishment, adjudication methods, MRMC studies, standalone performance, and ground truth types. This information is typically found in a clinical study report or a more detailed performance evaluation section of a 510(k) submission, which is not present in this summary document.

The document does mention "Summary of Performance Testing" (Section 5.9), stating that:

• "Comprehensive performance testing has shown that the few differences in technological characteristics between Aurora-RT and the predicate device do not affectiveness of Aurora-RT for its intended use."
• "Design control procedures applied to the development of Aurora-RT, including verification and validation testing, are in compliance with 21 CFR 820 FDA Quality System Regulation, ISO 13485 Medical devices – Quality management systems – Requirements for requlatory purposes, and ISO 14971 Medical devices – Application of risk management to medical devices."
• "The performed testing demonstrated conformance to design requirements and recognized consensus standards and ensured all identified risks and hazards were mitigated."
• "Software verification testing was conducted and documented in accordance with the FDA's 'Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices' for devices that pose a major level of concern."
• "Basic safety and essential performance have been satisfied through conformance with device-specific recognised consensus standards, as well as applicable general and collateral safety and essential performance standards for medical devices."

However, these statements are high-level summaries of compliance with general medical device regulations and standards (IEC 60601 series, IEC 61217, IEC 62304, IEC 62366-1) rather than a detailed breakdown of specific performance acceptance criteria and results for the device's clinical claims (e.g., precision radiotherapy for lesions, tumors).

Based on the provided text, the following information can be inferred or explicitly stated, but much of the requested detail is missing:

1. A table of acceptance criteria and the reported device performance:
   • No specific clinical acceptance criteria for "precision radiotherapy" are provided in the context of device performance data.
   • The document primarily compares technological characteristics (Max Dose Rate, Static Dose Accuracy, MLC characteristics, Isocenter Accuracy, MRI Field Strength, Field Homogeneity, Geometric Accuracy, SNR) between the proposed device (Aurora-RT) and the predicate device (ViewRay MRIdian Linac System). These are design specifications and technical performance parameters, not necessarily clinical 'acceptance criteria' tied to patient outcomes or a specific clinical study evaluation described in the way the prompt asks.
   • For example:
     • Static Dose Accuracy for Linac:
       • Acceptance Criteria/Target (Aurora-RT): 90% of the points evaluated in a treatment volume pass a gamma criteria of 3%/3mm.
       • Reported Performance: Implied to meet this target, as the document states "The performed testing demonstrated conformance to design requirements and recognized consensus standards."
       • (Predicate Device: 90% of points pass relative gamma 3%/3mm AND high dose, low gradient absolute point measurement within 5% of planned dose.)
     • Isocenter Accuracy:
       • Acceptance Criteria/Target (Aurora-RT): 1 mm diameter
       • Reported Performance: Implied to meet this target.
     • Geometric Accuracy (MRI):
       • Acceptance Criteria/Target (Aurora-RT):

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