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The AURORA MR system is an imaging device, and is intended to provide the physician with physiological and clinical information, obtained non-invasively and without the use of ionizing radiation. The MR system produces transverse, coronal, sagittal, and oblique cross-sectional images that display the internal structure of the extremities (breast tissue, axilla, and chest wall local to the breast). 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 (TI), spin-spin relaxation time (12), and flow. When interpreted by a trained physician, these images provide information that can be useful in diagnosis determination.

The AURORA is a dedicated breast MRI system intended to be used as an adjunct to conventional breast screening methods.

The AURORA Magnetic Resonance Diagnostic Device is being enhanced by a "forklift upgrade" to increase the clinical utility of the AURORA in the stationary configuration. With the "forklift upgrade," the AURORA is available in a stand-alone configuration, and as an upgrade path to existing AURORA installations.

The "forklift upgrade" enhancement is an alternate main MRI magnet, operating at a nominal field strength of 0.5T, and improved RF-chain and gradient-chain subsystems. No changes in software or pulse sequences were necessary to support full functionality of these "forkliff upgrade" enhancements.

The provided document is a 510(k) premarket notification for the AURORA Magnetic Resonance Diagnostic Device. It largely focuses on establishing substantial equivalence to a predicate device and does not contain detailed information about specific acceptance criteria, performance studies with quantitative results, or specific expert evaluations beyond general statements of intended use and safety.

Here's an analysis based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not provide a specific table of acceptance criteria or quantitative reported device performance metrics in the way one would typically find for a new, substantially different device or software. The submission focuses on a "forklift upgrade" to an existing device (AURORA K003561) and claims substantial equivalence.

The "performance" described is in terms of its functional capabilities and imaging characteristics, which are implicitly considered 'acceptable' because they are identical to the predicate device.

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

The document does not specify a sample size for a test set or the data provenance (e.g., country of origin, retrospective/prospective). The submission states, "Laboratory and clinical testing to internationally-accepted standards were performed to support this claim of substantial equivalence," implying that such testing occurred, but no details are provided about the datasets used or their characteristics.

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

This information is not provided in the document. Given that the submission focuses on hardware upgrades and claims "identical" technological characteristics to a predicate device, it's possible that a formal ground truth establishment process with multiple experts for novel diagnostic performance was not deemed necessary for this specific 510(k) submission.

4. Adjudication Method for the Test Set

The document does not mention any adjudication method for a test set.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

This information is not applicable and not provided. The AURORA device described here is an MRI system, not an AI-powered diagnostic algorithm designed to assist human readers. Thus, an MRMC study comparing human readers with and without AI assistance would not be relevant to this submission.

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

This information is not applicable and not provided. The AURORA is a complete MRI system, not a standalone algorithm.

7. The Type of Ground Truth Used

The document does not specify the type of ground truth used for any performance evaluation. As noted, the submission emphasizes substantial equivalence based on the hardware upgrade and existing predicate device characteristics, rather than a novel diagnostic performance claim requiring extensive new clinical ground truth establishment.

8. The Sample Size for the Training Set

This information is not provided and is not applicable in the context of this submission. The AURORA is an MRI system; it is not an AI/ML algorithm that is "trained" in the conventional sense with a distinct training set. The "software or pulse sequences" are mentioned as being unchanged, implying they were developed and validated prior to this upgrade, but no training set details are given.

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

This information is not provided and is not applicable. As explained above, this submission is for an MRI hardware upgrade and does not involve an AI/ML algorithm with a training set and corresponding ground truth.

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