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The AURORA MRI system is an imaging device, and is intended to provide the physician with physiological and clinical information obtained noninvasively 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 (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.

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

• . Anatomical region: Breast tissue, axilla, and chest wall local to the breast
• . Nucleus excited: Proton
• Diagnostic uses: 2D, 3D T1-/T2-weighted imaging .

T1, T2, proton density measurements Image processing

• . Imaging Capabilities: 2D Spin Echo (SE) 2D/3D Gradient Echo (GRE) Fat Suppression
• . Imaging Processing: Image Subtraction Image Filtering

The modified AURORA is identical to the AURORA breast imaging system cleared by the FDA through K032082 except for the addition of the RODEO Spiral 3D pulse sequence.

The provided 510(k) summary for the AURORA Magnetic Resonance Diagnostic Device (K052698) describes modifications to an existing MRI system. However, it does not contain the detailed information necessary to fully answer all aspects of your request, particularly regarding specific acceptance criteria, a study proving performance against those criteria, or the use of AI.

The document primarily focuses on demonstrating substantial equivalence to a predicate device (K032082) after adding a new pulse sequence (RODEO Spiral 3D). It states that "Testing was performed to validate the safety and performance of the AURORA with the new pulse sequence," but it does not elaborate on the nature of this testing, the acceptance criteria, or the results.

Here's an analysis based on the provided text, highlighting what is present and what is missing:

Acceptance Criteria and Device Performance:

The document does not explicitly state quantitative acceptance criteria or a direct comparison of device performance against such criteria. The testing was focused on validating the safety and performance of the new pulse sequence.

Missing Information: A table of acceptance criteria and reported device performance is not provided in the summary. The summary is primarily a regulatory filing for substantial equivalence based on a new pulse sequence, not a detailed clinical or performance study report.

Sample Size and Data Provenance:

The document states "Testing was performed to validate the safety and performance of the AURORA with the new pulse sequence."
Missing Information: The summary does not specify the sample size used for any test set or the data provenance (e.g., country of origin, retrospective/prospective).

Number and Qualifications of Experts for Ground Truth:

Missing Information: There is no mention of experts used to establish ground truth for a test set, as this level of detail is not typically included in a 510(k) summary that focuses on validating a pulse sequence addition.

Adjudication Method:

Missing Information: No adjudication method is mentioned, as the summary does not detail any studies involving multiple readers or the establishment of ground truth in that way.

Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

Missing Information: A multi-reader multi-case (MRMC) comparative effectiveness study is not mentioned. The document does not describe any human reader studies, either with or without AI assistance. The device is an MRI system, not an AI-powered diagnostic tool.

Standalone (Algorithm Only) Performance Study:

Missing Information: A standalone performance study for an algorithm is not described. This device is a magnetic resonance imaging device, and the submission is about a new pulse sequence for image acquisition, not an AI algorithm for image interpretation.

Type of Ground Truth Used:

Missing Information: The summary does not describe the type of ground truth used, as it doesn't detail any studies requiring such a ground truth for diagnostic accuracy. The testing mentioned is for the "safety and performance" of a new MRI pulse sequence, which would typically involve image quality assessments or phantom studies, rather than clinical ground truth like pathology or outcomes data.

Sample Size for Training Set:

Missing Information: There is no mention of a training set sample size. This is consistent with the nature of the device being an MRI system with a new pulse sequence, rather than an AI or machine learning algorithm that requires a training set.

How Ground Truth for Training Set was Established:

Missing Information: As no training set is mentioned, there is no information on how its ground truth might have been established.

In summary, the provided 510(k) summary is a regulatory document focused on demonstrating substantial equivalence for a hardware/software modification (addition of a pulse sequence) to an existing MRI device. It does not contain the detailed performance study information, including acceptance criteria, sample sizes, expert involvement, or AI-specific data, that your request outlines.

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