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510(k) Data Aggregation
(88 days)
Anatomical Region: Head, Body, Extremity, Spine, Neck, TMJ, and Heart
Nuclei excited: Hydrogen
Diagnostic Use: 2D/3D Imaging, MR Angiography
The Software Version 12.0/12.1 Upgrade for the MRT-50A/MRT-150A adds new sequences and software enhancements to the existing MRT-50A/150A software version. Version 12.1 also adds a new hardware to increase the number of slices available for FastSE sequences.
The provided 510(k) summary describes a software upgrade for an MRI device and focuses on establishing substantial equivalence to a previously cleared version. It does not contain a typical "study" in the sense of a clinical trial with acceptance criteria for diagnostic performance metrics (e.g., sensitivity, specificity, AUC). Instead, the performance is demonstrated by showing that safety and imaging parameters are either unchanged, improved, or remain within acceptable limits.
Here's an analysis of the provided information based on your requested categories:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state "acceptance criteria" for diagnostic performance in the way newer medical device submissions might. Instead, it demonstrates that the device's technical characteristics and imaging performance either meet or exceed those of the predicate device (V11.9) or established NEMA guidelines.
| Category | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Safety Parameters | ||
| Maximum static field strength | B0 unchanged from predicate device. | MRT-50A: 0.5T (No change) |
| MRT-150A: 1.5T (No change) | ||
| Rate of change of magnetic field | dB/dt unchanged from predicate device. | 7.5T/sec, τ = 1000ms (No change for both models) |
| Radio frequency power deposition | SAR remains below cleared levels of predicate device. | 0.3W/kg max SAR (MRT-50A) |
| 0.8W/kg max SAR (MRT-150A) | ||
| SAR remains below the cleared levels. | ||
| Acoustic Noise levels | Measured in accordance with NEMA guidelines. | MRT-50A: 80 dB |
| MRT-150A: 105 dB worst case, 85 - 100 dB typical | ||
| Imaging Performance Parameters | ||
| Specification volume | Comparable to predicate device. | MRT-50A: Head: 14cmX14cmX14cm, Body: 125mm diameter cross section X 250mm long |
| MRT-150A: 10cm dsv, 20cm dsv (No change implicitly, standard specs) | ||
| Signal to noise ratio | Phantom images and clinical images presented for new sequences must show acceptable SNR. | Sample phantom images and clinical images were presented for all new sequences. Signal-to-noise ratios for each phantom image were given. Clinical studies were presented for all new sequences. (Implies acceptable SNR was demonstrated though specific values are not provided in the summary) |
| Uniformity in three orthogonal planes | Unchanged from predicate device. | Unchanged |
| Slice Profile in three orthogonal planes | Unchanged from predicate device. | Unchanged |
| Geometric Distortion in three orthogonal planes | Unchanged from predicate device (due to no change in gradient system). | Unchanged (V12.0 and V12.1 do not change the gradient system, affecting linearity and thus geometric distortion). |
| Slice Thickness | Not applicable / Unchanged if applicable. | Not Applicable (It implies no direct change to slice thickness capabilities from the V11.9, only new sequences utilizing previous thickness capabilities). |
| Inter-slice Cross-talk | Not applicable / Unchanged if applicable. | Not Applicable (presumably similar reasoning as slice thickness). |
| Overall Equivalence | Substantially equivalent to predicate device. | "All safety and effectiveness attributes remain essentially unchanged." and "Version 12.0/12.1 Upgrade for the MRT-50A/150A is substantially equivalent to the V11.9 Software release for the MRT-50A/150A." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify a "test set sample size" in the context of a clinical performance study. The performance is evaluated based on:
- Phantom images: These are standardized tests using physical phantoms, not patient data.
- Clinical images: The document states "Clinical studies were presented for all new sequences," but does not provide details on the number of cases, patient demographics, data provenance (country of origin), or whether they were retrospective or prospective. Given the era (1996), these would likely have been internal validation cases rather than large, multi-center trials with detailed reporting.
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)
This information is not provided in the summary. The "clinical images" presented were likely evaluated by internal radiologists or medical experts to confirm image quality and diagnostic utility, but no details on their number or qualifications are given.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided as there is no formal clinical trial or reader study described.
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
A MRMC comparative effectiveness study was not conducted. This submission is for MRI software and hardware upgrades, not an AI or CAD (Computer-Aided Detection) system. Therefore, there is no AI assistance component or associated effect size reported.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
This is not applicable as the device is an MRI system, which inherently requires human operation and interpretation. It is not an algorithm designed for standalone performance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the safety and performance parameters listed:
- Safety parameters (static field, dB/dt, SAR): Ground truth is based on physical measurements and engineering specifications, often against established standards or internal benchmarks.
- Acoustic Noise: Measured in accordance with NEMA guidelines.
- Imaging Performance Parameters (SNR, Uniformity, etc.): Ground truth is established through physical phantom measurements and subjective assessment of clinical images by imaging experts (implied). There is no mention of pathology or outcomes data for performance evaluation in this summary.
8. The sample size for the training set
This information is not applicable/not provided. The software upgrade does not describe a machine learning or AI component that would require a "training set" in the modern sense. The software development and optimization would have involved iterative testing and refinement, but not a distinct "training set" as understood for AI models today.
9. How the ground truth for the training set was established
This information is not applicable/not provided for the reasons stated in point 8.
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