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The IMRIS iMRI 3T V is indicated for use as a magnetic resonance diagnostic device (MRDD) that produces transverse, sagittal, coronal and oblique cross sectional images, spectroscopic images and/or spectra, and that displays the internal structure and/or function of the head, body or extremities.

Other physical parameters derived from the images and/or spectra may also be produced. Depending on the region of interest, contrast agents may be used. These images and/or spectra and the physical parameters derived from the inages and/or spectra when interpreted by a trained physician yield information that may assist in diagnosis.

The IMRIS iMRI 3T V system may also be used for imaging during intra-operative and interventional procedures when performed with MR safe devices or MR conditional devices approved for use with the MR scanner.

The IMRIS iMRI 3T V MRI systems may also be used for imaging in a multi-room suite.

The IMRIS iMRI 3T V is a traditional MRI unit that has been suspended on an overhead rail system, and is designed to operate inside an RF shielded room to facilitate intra-operative and multi-room use. The magnet is normally situated in a Diagnostic Room (DR) until imaging is requested. The system retains all standard diagnostic features of an MRI system in the DR. The DR is separated from the intra-operative Operating Room (OR) by sliding doors that are part of the facility structure.

The IMRIS iMRI 3T V is a tool for radiologists and surgeons, used to acquire images for diagnostic, intraoperative, or interventional procedures. For OR purposes, high-resolution images can be obtained immediately prior to surgical incision, intraoperatively, and after wound closure. The IMRIS iMRI 3T V is based on the IMRIS iMRI 3T S cleared under 510(k) K133692 and the Siemens MAGNETOM Vida MRI system cleared under 510(k) K192924. The major components of the IMRIS iMRI 3T V system are: the Siemens MAGNETOM Vida MRI system with minor modifications, IMRIS Magnet Mover System, RF coils, Application platform, OR Table Assembly, Head fixation device, IMRISeye, and Horseshoe headrest.

Here's a summary of the acceptance criteria and the study information for the IMRIS iMRI 3T V system, based on the provided text:

Acceptance Criteria and Device Performance

The FDA clearance document for the IMRIS iMRI 3T V system does not explicitly detail a table of specific numerical acceptance criteria and corresponding reported device performance values in the way one might see for an AI algorithm's sensitivity/specificity. Instead, the "acceptance criteria" are implied by the successful completion of design verification and validation tests against established standards and the confirmation of "sufficient quality for diagnostic use" by radiologists.

Study Details

1. Sample sizes used for the test set and data provenance:

   • The document mentions "a number of V&V tests" and that images were produced and confirmed by radiologists, but it does not specify the sample size (number of images, cases, or patients) used for a distinct test set for image quality evaluation.
   • Data Provenance: Not specified. The document does not indicate the country of origin of the data or whether it was retrospective or prospective.

2. Number of experts used to establish the ground truth for the test set and their qualifications:

   • The document states, "Board certified Radiologist confirmation that images produced by the device are of sufficient quality for diagnostic use."
   • Number of Experts: Singular ("Radiologist") is used, implying at least one board-certified radiologist. The exact number is not provided.
   • Qualifications: "Board certified Radiologist". (No specific years of experience are mentioned).

3. Adjudication method for the test set:

   • Not specified. The document only mentions "Board certified Radiologist confirmation," but it does not detail a specific adjudication method like 2+1 or 3+1 if multiple radiologists were involved.

4. Multi Reader Multi Case (MRMC) comparative effectiveness study:

   • No, a MRMC comparative effectiveness study was not explicitly mentioned or described. The study focuses on demonstrating the substantial equivalence of the device to its predicate through compliance with standards and expert confirmation of image quality, rather than quantifying human reader improvement with/without AI assistance. The device is an MRI system, not an AI-powered diagnostic tool for interpretation.

5. Standalone (algorithm only without human-in-the-loop performance) study:

   • Yes, in the sense that the device's technical performance and image quality were evaluated independently. The "Board certified Radiologist confirmation" would be an assessment of the output (images) produced by the device itself, rather than an assessment of how well a human interprets those images with or without AI assistance. The device is a diagnostic imaging system, designed to produce images for human interpretation, not an AI algorithm for autonomous diagnosis.

6. Type of ground truth used:

   • Expert Consensus/Opinion: The ground truth for image quality was established by a "Board certified Radiologist confirmation" that images were of "sufficient quality for diagnostic use." This relies on expert interpretation and judgment. There's no mention of pathology or outcomes data being used for this specific evaluation.

7. Sample size for the training set:

   • Not applicable/Not specified. The IMRIS iMRI 3T V is a magnetic resonance diagnostic device (hardware system), not an AI algorithm that undergoes "training" on a dataset in the conventional machine learning sense for image interpretation. The "training" of the system would refer to its engineering, calibration, and adherence to established physical principles and specifications.

8. How the ground truth for the training set was established:

   • Not applicable. As above, this is a hardware device, not an AI algorithm model that learns from a labeled training set.

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