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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.

When interpreted by a trained physician magnetic resonance images acquired before, during, and after the radiotherapy treatment yield information that can be useful in diagnosis and may assist 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).

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.

When interpreted by a trained physician the images acquired before, during, and after the radiotherapy treatment yield information that can be useful in diagnosis and may assist therapy planning, patient positioning and treatment delivery related to radiation oncology.

In addition to the MRI sequences cleared with the predicate device, the subject device Elekta Unity configuration has the ability to generate images using following techniques, before, during or after treatment:

Introduce 3D Vane
3D Vane XD is a free breathing acquisition method that can be used to compensate for respiratory motion and peristalsis in 3D/FFE and 3D/TFE body imaging.

Introduce CS-Sense - compressed images
Compressed SENSE is an acceleration technique that is less sensitive to noise allowing increased resolution and/or coverage without a scan time penalty.

Introduce Breath Hold (BH) .
Breath-hold is a technique where an image is acquired when a patient holds their breath in a defined phase of the breathing cycle.

The Elekta Unity device mentioned in the document is a medical charged-particle radiation therapy system. However, the provided document does not contain information about specific acceptance criteria or a dedicated study proving device performance against such criteria for AI/ML components.

The document primarily focuses on demonstrating substantial equivalence of the overall device (Elekta Unity with new imaging options) to a predicate device (Elekta Unity K192482). It lists performance testing for the overall system based on design verification, risk management, software verification, and conformance to recognized consensus standards.

Here's a breakdown of why the requested information cannot be fully provided based on the given text, and what information is available:

Missing Information (Specific to AI/ML acceptance criteria and performance study):

• No explicit acceptance criteria for an AI/ML component: The document introduces new imaging options (3D Vane XD, CS-Sense, Breath Hold) but does not frame these as AI/ML applications requiring specific performance metrics like sensitivity, specificity, or AUC against a ground truth. They are described as "additional imaging options" or "acceleration techniques."
• No dedicated study proving AI/ML device performance: There is no study described that evaluates the performance of any AI/ML algorithm within the Elekta Unity against a defined ground truth, nor are there details about sample size, expert readers, or adjudication methods for such a study.
• No MRMC comparative effectiveness study for AI assistance: The document does not describe any study where human readers' performance with and without AI assistance was compared.
• No standalone algorithm-only performance study: No study detailing the performance of an algorithm without human involvement is mentioned.
• No details on ground truth for AI/ML training or testing: Since no specific AI/ML component is detailed with its own performance study, there's no information about the ground truth used for training or testing such components.
• No sample size for training sets of AI/ML components: This information is not present.

What is available regarding overall device testing and compliance:

The document states broader performance testing was conducted for the Elekta Unity system, but these are general engineering and safety tests rather than AI/ML specific performance evaluations.

• Design verification and performance testing: Carried out in accordance with FDA's Quality System Regulation (21 CFR §820.30), ISO 13485, ISO 14971, and IEC 62304.
• Software verification testing: Conducted and documented in accordance with FDA guidance for devices that pose a major level of concern (Class C per IEC 62304).
• Basic safety and essential performance: Satisfied through conformance with device-specific recognized consensus standards (listed in a table).

However, none of this directly answers the AI/ML-specific questions in your prompt. The "new imaging options" are presented as new functionalities of the MR system rather than intelligent algorithms for interpretation or decision support.

Therefore, a table of acceptance criteria and reported device performance for an AI/ML component cannot be created from the provided text. The document focuses on demonstrating that the device as a whole with its new MR imaging sequences maintains safety and effectiveness comparable to its predicate, largely through non-clinical engineering and software testing and adherence to general medical device standards.

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