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The MRIdian Linac system, with magnetic resonance imaging capabilities, is intended to provide stereotactic radiosurgery and precision radiotherapy for lesions, tumors, and conditions anywhere in the body where radiation treatment is indicated.

The MRIdian Linac system is an image-quided radiation therapy (IGRT) system that uses a 6 MV linear accelerator radiotherapy system to deliver ionizing radiation while using a magnetic resonance imaging system for image guidance in real time. The MRIdian consists of the Treatment Planning and Delivery System (TPDS), Magnetic Resonance Imaging System (MRIS) and the Radiation Therapy Delivery System (RDS). These three subsystems are designed to operate concurrently for accurate targeted administration of radiation therapy.

The provided text is a 510(k) summary for the MRIdian Linac System. It outlines the device's technical specifications, intended use, and its comparison to a predicate device to establish substantial equivalence. However, it does not contain acceptance criteria, reported device performance figures, or details of a study (like sample size, data provenance, expert ground truth, adjudication methods, MRMC studies, or standalone performance) that would typically be used to prove a device meets specific acceptance criteria related to a new functionality or performance claim.

Instead, this document focuses on demonstrating that the modified MRIdian Linac System is substantially equivalent to its predicate device based on:

• Identical Intended Use and Indications for Use.
• Substantially equivalent technological characteristics, with minor differences that do not raise new questions of safety or effectiveness.
• Conformance to design specifications and satisfaction of intended users' needs, including risk mitigations.
• Compliance with various regulatory and recognized standards (e.g., medical electrical equipment safety, electromagnetic compatibility, software life cycle, usability, biocompatibility).

The document states: "Test results demonstrate that the device conforms to design specifications and meets the needs of the intended users, including assuring risk mitigations were implemented and functioned properly. Software testing was performed and documented as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices."" This implies that internal verification and validation testing was conducted, but the specific acceptance criteria and the detailed results of these tests are not provided in this public summary.

Therefore, I cannot extract the requested information regarding detailed acceptance criteria and a study proving those criteria are met from the provided text in the format you specified. The document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a performance study with explicit acceptance metrics for a novel AI or diagnostic functionality.

The closest information related to performance that is provided is in the "Summary of Technological Characteristics" table, which compares various physical and imaging parameters of the subject device to the predicate device. This table effectively shows that the characteristics are either "Same" or have minor, non-significant differences (e.g., spatial resolution for volume scans and cine scans).

If this were a submission for a new AI feature, the acceptance criteria would typically involve metrics like sensitivity, specificity, AUC, and the study details would describe how these were measured against a ground truth. None of that is present here.

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