(26 days)
The AURORA MRI 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 (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.
The modified AURORA is identical to the AURORA breast imaging system cleared by FDA through K032082 except for the addition of the RODEO fat-suppression pulse sequence.
The provided text describes a 510(k) summary for the AURORA Magnetic Resonance Diagnostic Device. It states that "Testing was performed to validate the safety and performance of the AURORA with the new pulse sequence." However, no specific acceptance criteria or detailed study results demonstrating how the device meets those criteria are included in the provided text. The document focuses on establishing substantial equivalence to a predicate device based on similarities in intended use, design, and technological characteristics, particularly the addition of a new fat-suppression pulse sequence.
Therefore, the following information cannot be extracted from the given text:
- A table of acceptance criteria and the reported device performance: This information is not present.
- Sample sized used for the test set and the data provenance: Not mentioned.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not mentioned.
- Adjudication method for the test set: Not mentioned.
- 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 mentioned.
- If a standalone performance study was done: The document mentions "Testing was performed to validate the safety and performance," but doesn't detail the type of study or its results, making it impossible to confirm if standalone performance was specifically assessed and reported.
- The type of ground truth used: Not mentioned.
- The sample size for the training set: Not mentioned.
- How the ground truth for the training set was established: Not mentioned.
The document primarily serves as a regulatory submission (510(k)) to demonstrate substantial equivalence for a modification to an existing MRI system, focusing on the addition of a new fat-suppression pulse sequence, rather than a detailed report of clinical validation studies with specific performance metrics and acceptance criteria.
§ 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.