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Elekta Unity using Magnetic Resonance Imaging is indicated for radiation therapy treatments and stereotactic radiation treatments of malignant and benign diseases anywhere in the body as determined by a licensed medical practitioner in accordance with a defined treatment plan. Elekta Unity is intended for use with compatible Treatment Planning and Oncology Information Systems.

The Elekta Unity 1.5T MR scanner is a magnetic resonance imaging system that produces cross-sectional images in any orientation of the internal structure of the whole body before, during and after the radiotherapy treatment. Images provide information that may assist the therapy planning, patient positioning and treatment delivery related to radiation oncology.

Elekta Unity is a multifunctional digital linear accelerator designed to assist licensed medical practitioners in the delivery of ionizing radiation to defined volumes (e.g. malignant and benign tumors). Elekta Unity is capable of both intensity modulated radiation therapy (IMRT) and image guided radiation therapy (IGRT). Elekta Unity consists of a gantry-mounted 7MV linear accelerator sub-system which rotates around a 1.5T Magnetic Resonance Imaging (MRI) sub-system and a Patient Positioning Sub-system (PPS). It is controlled by dedicated system software, which incorporates patient positioning, imaging, and treatment delivery functions, and it is designed for use in conjunction with approved compatible Oncology Information and Treatment Planning systems. The Elekta Unity 1.5T MRI scanner is a magnetic resonance imaging sub-system that produces cross-sectional images in any orientation of the internal structure of the whole body before, during and after the radiotherapy treatment.

The provided text describes the Elekta Unity device, a medical charged-particle radiation therapy system. However, it does not contain specific acceptance criteria, reported device performance data, detailed information about study designs (like sample sizes for test or training sets, data provenance, expert adjudication, or MRMC studies), or how ground truth was established for the training set.

The document is a 510(k) premarket notification summary, which focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed clinical study report with performance metrics against predefined acceptance criteria.

Therefore, I cannot fulfill your request for a table of acceptance criteria and reported device performance, nor can I provide information regarding sample sizes, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth details.

The document states that:

• Non-clinical testing was performed to evaluate device performance and functionality against design and risk management requirements at sub-system, integration, and system levels.
• Software verification testing was conducted in accordance with FDA's "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices that pose a major level of concern (Class C per IEC 62304).
• Basic safety and essential performance have been satisfied through conformance with device-specific recognized consensus standards (listed in the table on page 7), as well as applicable general and collateral safety and essential performance standards for medical devices.
• Validation and usability testing of the integrated system was performed in accordance with FDA guidance on human factors and usability engineering under clinically representative conditions by competent and professionally qualified personnel.
• The results from verification testing demonstrate device conformance to stated design specifications and standards.

While these statements indicate that testing was done to ensure safety and performance, the specific data, acceptance criteria, and study details you've asked for are not present in this document.

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