(43 days)
Magnetic resonance imaging (MRI) and magnetic resonance angiography (MRA) of the musculoskeletal structures, soft tissue and vascular structures within the anatomic regions from the chest to the pelvic region.
Model 554HI-12 RAPID Body Coil. Compatible with Hitachi AIRIS-Elite MR Systems.
The provided document is a 510(k) Summary of Safety and Effectiveness for the "Model 554HI-12 RAPID Body Coil." This document is part of a premarket notification for a medical device and thus focuses on demonstrating substantial equivalence to a predicate device, rather than presenting a performance study with detailed acceptance criteria and a comprehensive study report for a novel AI/software device.
Therefore, much of the requested information regarding acceptance criteria, specific performance metrics, sample sizes, ground truth establishment, expert adjudication, and MRMC studies, cannot be found in this document because it pertains to the regulatory review process for a hardware component (an MRI coil) based on substantial equivalence, not a software or AI device's clinical performance study.
However, I can extract the information that is present and explain why other details are absent based on the nature of this document.
Here's a breakdown of the available and unavailable information:
1. A table of acceptance criteria and the reported device performance
The document defines acceptance criteria by stating that the new device has "No change" in specific safety and imaging performance parameters compared to the predicate device. This implies that "no change" is the acceptance criterion for equivalence.
| Acceptance Criteria (Implied) | Reported Device Performance (Compared to Predicate) |
|---|---|
| Maximum Static Magnetic Field: No change | No change due to coil |
| Rate of Magnetic Field Strength Change: No change | No change due to coil |
| RF Power Deposition: No change | No change |
| Acoustic Noise Levels: No change | No change due to coil |
| Biocompatibility: No change | No change |
| Specification Volume: No change | No change |
| Signal-to-Noise Ratio: No change | No change |
| Image Uniformity: No change | No change |
| Geometric Distortion: No change | No change |
| Slice Thickness and Gap: No change | No change |
| High Contrast Spatial Resolution: No change | No change |
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 for Test Set: Not applicable/not provided. This document describes a new MRI coil seeking clearance through the 510(k) pathway, which relies on demonstrating substantial equivalence to a legally marketed predicate device rather than conducting a new clinical study with a "test set" in the context of an AI/software device. The "testing" would involve demonstrating the new coil functions within the safety and performance limits when paired with a compatible MRI system, and that these parameters are equivalent to those of the predicate.
- Data Provenance: Not applicable/not provided.
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 applicable/not provided.
- Qualifications of Experts: Not applicable/not provided.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Adjudication Method: Not applicable/not provided.
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: No, this type of study was not performed. The device is an MRI body coil, not an AI-assisted diagnostic tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Performance: Not applicable. The device is a hardware component (an MRI coil), not a standalone algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Type of Ground Truth: Not applicable in the context of a clinical performance study with "ground truth" as typically defined for AI/software. The "ground truth" for this device's assessment would be established engineering and safety standards for MRI coils and comparison to the predicate device's established performance specifications. The "ground truth" for the claims of "no change" would be derived from technical measurements and comparisons.
8. The sample size for the training set
- Sample Size for Training Set: Not applicable. This is not an AI/machine learning device.
9. How the ground truth for the training set was established
- Ground Truth for Training Set Establishment: Not applicable. This is not an AI/machine learning device.
Summary of Device and Regulatory Context for Understanding:
This document is a 510(k) submission for an MRI coil, which is a hardware accessory for an MRI system. The primary goal of a 510(k) submission is to demonstrate that the new device is "substantially equivalent" to a legally marketed predicate device. This typically involves showing that the new device has:
- The same intended use as the predicate device.
- The same technological characteristics as the predicate device, or
- Different technological characteristics that do not raise new questions of safety and effectiveness, and performance data that demonstrates the device is as safe and effective as the predicate device.
In this specific case, the manufacturer is demonstrating that its Model 554HI-12 RAPID Body Coil, when used with the Hitachi AIRIS-Elite 0.3T MRI system, is substantially equivalent to a GE Signa 0.5T system operated with a legally marketed predicate device. The "study" described is a comparison of critical safety and imaging performance parameters, where the finding that there is "no change" in these parameters due to the new coil is the basis for demonstrating equivalence and meeting regulatory requirements. It is not a clinical performance study measuring diagnostic accuracy or reader improvement for a software algorithm.
§ 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.