(70 days)
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.
| Acceptance Criteria Category | Reported Device Performance (as described in the document) |
|---|---|
| Functional Equivalence | The "forklift upgrade" is an alternate main MRI magnet. No changes in software or pulse sequences were necessary to support full functionality. Device technological characteristics are identical to the predicate device. |
| Intended Use | Provides physiological and clinical information non-invasively, produces images of internal structure of extremities (breast tissue, axilla, chest wall local to breast). Adjunct to conventional breast screening. |
| Imaging Capabilities | 2D, 3D T1-/T2-weighted imaging, T1, T2, proton density measurements, image processing, 2D Spin Echo (SE), 2D/3D Gradient Echo (GRE), Fat Suppression, Image Subtraction, Image Filtering. Same as predicate. |
| Safety Standards | Laboratory and clinical testing to internationally-accepted standards (IEN/EC 60601-2-3.1) were performed. Claims no new potential hazards. |
| Contraindications | Same contraindications as all MRI Systems (pacemakers, aneurysm clips, etc.). |
| Cautions | Same cautions as all MRI Systems (implanted surgical clips, ferromagnetic materials, neonates/infants, permanent tattoos, compromised thermoregulatory systems, metallic implants, pregnancy). |
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.
§ 892.1000 Magnetic resonance diagnostic device.
(a)
Identification. A magnetic resonance diagnostic device is intended for general diagnostic use to present images which reflect the spatial distribution and/or magnetic resonance spectra which reflect frequency and distribution of nuclei exhibiting nuclear magnetic resonance. Other physical parameters derived from the images and/or spectra may also be produced. The device includes hydrogen-1 (proton) imaging, sodium-23 imaging, hydrogen-1 spectroscopy, phosphorus-31 spectroscopy, and chemical shift imaging (preserving simultaneous frequency and spatial information).(b)
Classification. Class II (special controls). A magnetic resonance imaging disposable kit intended for use with a magnetic resonance diagnostic device only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.