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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 vield 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 motion monitoring with manual interrupt previously cleared with predicate Unity devices, the subject device Elekta Unity has added the following motion management strategies:

• · Anatomic Position Monitoring (APM) with Manual interrupt (also referred to as True Tracking as it 'tracks' in 3D and enables the system to gate using the 3D position of the anatomy's motion)
• · APM with Anatomic Tolerance Check (ATC)
• Adaptive Therapy with optional Baseline Shift (BLS) Recovery.

These modifications are not contained solely within the Elekta Unity Device, as the full clinical benefit is achieved with interoperability of Unity, Monaco RTP, and MOSAIQ OIS.

The provided text is a 510(k) summary for the Elekta Unity MR Linac and describes updates to an existing device rather than a new standalone AI/ML device with a clinical performance study. Therefore, a direct answer to all points regarding "acceptance criteria and the study that proves the device meets the acceptance criteria" in the context of an AI/ML algorithm's clinical performance cannot be fully provided from this document.

Specifically, the document states: "No animal or clinical tests were performed to establish substantial equivalence with the predicate device." This indicates that a human-in-the-loop (MRMC) or standalone (algorithm only) clinical performance study as typically understood for AI/ML diagnostic or treatment planning algorithms was not conducted for this 510(k) submission. The clearance is based on substantial equivalence by demonstrating that the new motion management strategies do not change the fundamental scientific technology or raise different questions of safety or effectiveness.

However, I can extract the information relevant to the device's technical specifications and the non-clinical testing performed to establish substantial equivalence.

Here's a breakdown of the available information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not present "acceptance criteria" in the traditional sense of a clinical performance study against a ground truth. Instead, it provides a comparison of "Technological Characteristics" between the subject device (Elekta Unity with new features) and its predicate device (Elekta Unity K212114). The "acceptance" here relates to demonstrating that the new features do not negatively impact the established performance and safety characteristics, or that they meet expected performance defined by engineering specifications.

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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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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 the 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 current Elekta Unity configuration has the ability to generate images using following techniques, before, during or after treatment for Off-line review:

• Single-shot EPI diffusion imaging (DWI) with 3 diffusion directions and up to 16 b-values.
• . Diffusion imaging processing with automatic generation of the ADC and/or eADC maps.

Here's a breakdown of the acceptance criteria and the study details for the Elekta Unity device, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

• The document does not specify a numerical sample size for the "test set" used in the image validation study. It only mentions "anonymized images" from Elekta Unity.
• Data Provenance: The images were "obtained on Elekta Unity," implying they were internally generated or acquired from the device itself. Given the context of a 510(k) summary, it's highly likely these were retrospective images produced during internal testing or early clinical use for device characterization, rather than a prospective, formal diagnostic study with patient consent for external use. The country of origin is not specified, but the submission is from Elekta Limited in the UK.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

• Number of Experts: More than one expert, specified as "US Board Certificated Diagnostic Radiologists." The exact number is not provided, but it implies a panel.
• Qualifications of Experts: "US Board Certificated Diagnostic Radiologists." No specific experience level (e.g., 10 years) is given.

4. Adjudication Method for the Test Set

• The adjudication method was consensus. The document states, "There was consensus among the expert reviewers that imaging with Elekta Unity met the clinical criteria for diagnostic MRI."

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

• No, an MRMC comparative effectiveness study was not explicitly stated or described. The study focused on the standalone performance and image quality of the Elekta Unity's MR imaging capabilities. It did not compare human readers with and without AI assistance; rather, it evaluated the diagnostic quality of the images generated by the device itself.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done

• Yes, a standalone performance evaluation of the imaging component was done. The image validation study assessed the quality of images produced by the Elekta Unity's MR scanner, interpreted by radiologists without any indication of AI assistance in the interpretation loop for the purpose of validating the device's inherent imaging capabilities. The main purpose of this 510(k) is the device itself (hardware and core software), not an AI diagnostic algorithm. The new features for diffusion imaging (DWI and ADC/eADC maps) are outputs of the device's imaging capabilities, which are then evaluated for their standalone image quality.

7. The Type of Ground Truth Used

• Expert Consensus. For the image validation, the ground truth was established by the "consensus among the expert reviewers that imaging with Elekta Unity met the clinical criteria for diagnostic MRI." For the device's overall safety and performance, the ground truth was established through conformance with recognized consensus standards and internal design and risk management requirements.

8. The Sample Size for the Training Set

• The document does not provide any information regarding a training set size. This submission is for the Elekta Unity hardware and its associated imaging capabilities, not primarily an AI/ML algorithm that would typically have a separate training set. The mention of "Diffusion imaging processing with automatic generation of the ADC and/or eADC maps" implies some algorithmic processing, but no details on training data for this specific processing are given.

9. How the Ground Truth for the Training Set Was Established

• As no training set is mentioned for the direct evaluation described, no information is provided on how its ground truth would have been established.

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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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