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The TRILLIUM Oval MRI System is an imaging device, and is intended to provide the physiological and clinical information, obtained non-invasively and without the use of ionizing radiation. The MR system produces transverse, coronal, sagittal, oblique, and curved cross-sectional images that display the internal structure of the head, body, or extremities. The images produced by the MR system reflect the spatial distribution of protons (hydrogen nuclei) exhibiting magnetic resonance. The NMR properties that determine the image appearance are proton density, spin-lattice relaxation time (T1), spin-spin relaxation time (T2), and flow. When interpreted by a trained physician, these images provide information that can be useful in diagnosis determination.

Anatomical Region: Head, Body, Spine, Extremities
Nucleus excited: Proton
Diagnostic uses: T1, T2, proton density weighted imaging, Diffusion weighted imaging, MR Angiography, Image processing, Spectroscopy, Whole Body

The TRILLIUM OVAL is a Magnetic Resonance Imaging System that utilizes a 2.9 Tesla superconducting magnet in a gantry design. The design was based on the ECHELON Oval MRI system. The TRILLIUM OVAL has been designed to enhance clinical utility as compared to the ECHELON Oval by taking advantage of the stronger magnetic field and stronger gradient field and slew rate.

The provided document is a 510(k) premarket notification for the "Trillium Oval MR System." It primarily focuses on demonstrating substantial equivalence to a predicate device and does not contain detailed information about acceptance criteria or a specific study proving the device meets those criteria in the context of diagnostic accuracy, particularly for AI/CADe systems.

This document describes a Magnetic Resonance Imaging (MRI) system, which is a diagnostic imaging device. The "acceptance criteria" discussed are largely related to safety and general performance standards for MRI systems, rather than specific diagnostic performance metrics (e.g., sensitivity, specificity) for a particular clinical application. The "study" refers to non-clinical and some clinical imaging tests to demonstrate that the device meets these engineering and safety standards.

Here's an analysis based on the provided text, addressing the requested points:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not present a table of specific acceptance criteria with corresponding performance metrics in the format typically used for evaluating diagnostic accuracy (e.g., sensitivity, specificity, AUC). Instead, it lists non-clinical test standards and mentions that the device was subjected to these tests. The implication is that the device met these standards.

Regarding the Absence of AI/CADe Specifics:

It's crucial to note that this submission is for a Magnetic Resonance Imaging System (hardware and core software), not an Artificial Intelligence (AI) or Computer-Assisted Detection/Diagnosis (CADe/CADx) software. Therefore, the questions related to AI performance metrics (like sample sizes for test/training sets, expert ground truth adjudication for AI, MRMC studies, standalone algorithm performance, etc.) are not applicable to this specific document. The "device" here is the MRI scanner itself.

Specific Answers to Your Questions (where applicable for an MRI system submission):

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

   • Test Set Sample Size: The document mentions "sample clinical imaging of the head, torso, and extremities using all anatomy coils." It does not specify the number of subjects or images used for this clinical imaging.
   • Data Provenance: Not specified in the document (e.g., country of origin). The document implies these were internally generated as part of the submission process, likely prospective.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

   • This is not applicable in the context of this 510(k) submission for an MRI system. The "ground truth" for the clinical imaging mentioned would be the visual assessment by "trained physicians" (as mentioned in the indications for use) to confirm diagnostic quality, but the number and qualifications of evaluators are not specified.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

   • Not applicable. This level of detail on ground truth adjudication is typically for AI/CADe performance studies, not for the submission of a core imaging device.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

   • No. This is not an AI/CADe device. Such a study was not performed or described.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

   • No. This is not an AI/CADe device. The device is an MRI system, which always requires human operation and interpretation.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

   • For the non-clinical tests (NEMA standards, SAR simulations), the "ground truth" is adherence to established engineering and safety specifications and theoretical models.
   • For the "sample clinical imaging," the implied ground truth is that the images generated are of sufficient diagnostic quality as determined by "trained physicians," comparable to the predicate device. This is a qualitative assessment of imaging capability rather than a definitive diagnosis of a specific condition against a gold standard like pathology.

8. The sample size for the training set

   • Not applicable. This is not an AI/CADe device that uses a "training set" in the machine learning sense.

9. How the ground truth for the training set was established

   • Not applicable.

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