(288 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, and sagittal cross-sectional images that display the internal structure of 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 for breast imaging.
- . 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 Aurora MR Spectroscopy Package is intended for use as a noninvasive diagnostic device that provides information based on relative concentration of the Choline metabolite in breast tissues. The localized spectra reflect the NMR properties of proton density, spin-lattice relaxation time (T1), spin-spin relaxation time (T2), and chemical shift. When interpreted by a trained medical practitioner, these spectral data provide information that can be useful in diagnosis determination.
The modified AURORA is identical to the AURORA breast imaging system cleared by the FDA through K032082 except for the addition of the Spectroscopy pulse sequence protocol and its corresponding user interface software.
The provided text describes an FDA 510(k) submission for the "Spectroscopy Package for AURORA MRI System" (K073425). However, it does not contain explicit acceptance criteria and corresponding performance metrics for the device, nor does it detail a comprehensive study proving the device meets specific acceptance criteria in the manner requested.
The document primarily focuses on establishing substantial equivalence to a predicate device (Aurora MRI System K032082) for an added Spectroscopy Package. It states: "Testing was performed to validate the safety and performance of the AURORA with the new pulse sequence." but does not elaborate on the nature of this testing, the acceptance criteria, or the results.
Therefore, many of the requested details cannot be extracted directly from the provided text.
Here's what can be gathered and what remains unknown based on the input:
Description of Acceptance Criteria and Study (Derived Information and Gaps)
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Inferred/Assumed for MRI Spect.) | Reported Device Performance (Not explicitly stated in document) |
|---|---|
| Preamble: The document states the Spectroscopy Package is intended for use as a noninvasive diagnostic device that provides information based on relative concentration of the Choline metabolite in breast tissues. The localized spectra reflect NMR properties. When interpreted by a trained medical practitioner, these spectral data provide information useful in diagnosis. | Preamble: The document states "Testing was performed to validate the safety and performance of the AURORA with the new pulse sequence." However, no specific performance metrics like sensitivity, specificity, accuracy, or quantitative measures of choline concentration accuracy are provided in relation to any acceptance criteria. |
| Specific Performance Criteria: Not specified within the document. For the addition of a Spectroscopy Package, typical performance criteria might include: | No specific performance data is provided to correlate with these inferred criteria. |
| - Spectral quality/resolution: Ability to clearly identify and separate choline peaks. | |
| - Accuracy of metabolite quantification (e.g., choline concentration): How close measured values are to true values. | |
| - Reproducibility/Repeatability: Consistency of spectral data and quantification over multiple scans. | |
| - Consistency with established spectroscopy methods: Comparison to other validated spectroscopy devices or techniques. | |
| - Safety: Ensuring the new pulse sequence does not introduce new risks to the patient or operator. | (General safety validation is mentioned for the system as a whole.) |
| - Performance equivalent to predicate device for imaging: The core MRI system remains substantially equivalent to K032082. | (Implied through substantial equivalence claim for the core system.) |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size (Test Set): Not specified.
- Data Provenance: Not specified.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Number of Experts: Not specified.
- Qualifications of Experts: Not specified. The document only states that the spectral data provide information "When interpreted by a trained medical practitioner."
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Adjudication Method: Not specified.
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
- MRMC Study: Not mentioned or implied. This device is an MRI system with an added spectroscopy package, not explicitly described as an AI-assisted diagnostic tool in the document.
- Effect Size of Human Reader Improvement: Not applicable, as no MRMC study or AI assistance is detailed.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Standalone Performance: Not mentioned. The spectroscopy package provides "information based on relative concentration of the Choline metabolite" which is explicitly stated to be useful "When interpreted by a trained medical practitioner," indicating a human-in-the-loop scenario. No autonomous diagnostic capability is described.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Type of Ground Truth: Not specified. Given the nature of spectroscopy for metabolite concentration, ground truth for performance validation could involve phantom studies, ex vivo tissue analysis, or comparison with established in vivo methods (e.g., biopsy for pathology confirmation, though this is not directly related to spectroscopy performance metrics, but rather its clinical utility). However, the document does not elaborate.
8. The sample size for the training set
- Sample Size (Training Set): Not specified. The document does not describe a machine learning algorithm that would require a distinct "training set" in the modern sense. The "testing" mentioned is likely validation of the pulse sequence and software, rather than training of a classification algorithm.
9. How the ground truth for the training set was established
- Ground Truth Establishment (Training Set): Not applicable, as no training set for a machine learning model is described.
Summary of what is known:
- The device is an MRI system with an added Spectroscopy Package.
- The Spectroscopy Package is intended to provide information based on the relative concentration of the Choline metabolite in breast tissues.
- The output (spectral data) is meant to be interpreted by a trained medical practitioner.
- "Testing was performed to validate the safety and performance of the AURORA with the new pulse sequence."
- The submission claims substantial equivalence to a predicate MRI system (K032082) for its core function, acknowledging the new spectroscopy package as the modification.
Key Gaps in Information:
The document lacks critical details regarding the specific performance testing, acceptance criteria, study design (sample size, data provenance, expert involvement, ground truth methods), and results related to the spectroscopy package's diagnostic capabilities. The primary focus of this 510(k) summary is establishing substantial equivalence for the overall device due to the mere addition of a pulse sequence, rather than detailing a
comprehensive clinical performance study typical for novel diagnostic claims. For an addition to an already cleared system, often the focus for the 510(k) is demonstrating that the addition does not introduce new safety concerns and performs as expected technically, rather than a full clinical efficacy trial against specific diagnostic 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.