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The iMRI 1.5T A and 3T S are 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 images and/or spectra when interpreted by a trained physician yield information that may assist in diagnosis.

The iMRI 1.5T A and 3T S systems 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 iMRI 1.5T A and 3T S MRI systems may also be used for imaging in a multi-room suite.

The IMRIS Intraoperative MRI systems (iMRI 1.5T A and iMRI 3T S) are 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 until imaging is requested. For Diagnostic room purposes, the system retains the standard diagnostic features of an MRI system. The diagnostic room is separated from the intra-operative suite by sliding doors that are part of the facility structure.

The iMRI system (1.5T A/3T S) is a tool for radiologists and surgeons, used to acquire images for diagnostic, intra-operative or interventional procedures. For OR purposes, high-resolution images can be obtained immediately prior to surgical incision, intraoperative and after wound closure. The iMRI 1.5T A is based on the IMRIS Neuro II-SE predicate cleared under 510(k) K071099 and the Siemens MAGNETOM Aera/Skyra MRI system cleared under 510(k) K101347. The iMRI 3T S is based on the IMRIS Neuro III-SV cleared under 510(k) K083137 and the Siemens MAGNETOM Aera/Skyra MRI system cleared under 510(k) K101347. The major components of the iMRI systems are: the Siemens MAGNETOM MRI system with minor modifications; IMRIS Magnet Mover System, OR Table, RF coils and 3-pin head fixation device.

The provided text is a 510(k) Premarket Notification for the IMRIS iMRI 1.5T A and 3T S systems, which are Magnetic Resonance Diagnostic Devices (MRDD). This document focuses on demonstrating substantial equivalence to predicate devices and adherence to relevant safety and performance standards. It does not describe a study involving specific acceptance criteria for diagnostic performance outcomes (like sensitivity, specificity, accuracy) using a clinical dataset and expert review, as would be typical for an AI-powered diagnostic device.

Instead, the "study" described is a verification and validation process primarily focused on demonstrating safety, effectiveness, and substantial equivalence to existing MRI systems.

Here's an analysis 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 describe a "test set" in the context of clinical image data for diagnostic performance evaluation, nor does it mention data provenance (country of origin, retrospective/prospective). The "Sample clinical images" mentioned under "Design Verification and Validation Test (Bench Testing)" are likely for qualitative visual assessment and system validation, not for quantitative diagnostic performance metrics.

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

Not applicable. The filing does not detail a study involving expert-established ground truth for a test set of patient cases. The evaluation is focused on engineering and system performance standards, and comparison to predicate devices, rather than the diagnostic interpretive accuracy of the images by human readers.

4. Adjudication Method for the Test Set

Not applicable, as there is no specific test set requiring expert adjudication for establishing ground truth on diagnostic findings.

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

Not applicable. This 510(k) pertains to an MRI system itself, not an AI-powered diagnostic algorithm designed to assist human readers. Therefore, an MRMC study comparing human reader performance with and without AI assistance was not conducted or reported.

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

Not applicable. This device is a diagnostic imaging system, not an algorithm.

7. The Type of Ground Truth Used

For the safety and performance evaluations, the "ground truth" used is adherence to established engineering and medical device standards (IEC 60601 series, IEC 62304), and comparison against the technical specifications and performance characteristics of predicate and reference MRI devices for substantial equivalence. "Sample clinical images" were part of the V&V, implying visual assessment against expected image quality, but not a formally established clinical ground truth from pathology or outcomes.

8. The Sample Size for the Training Set

Not applicable. This is not an AI algorithm requiring a training set.

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

Not applicable.

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