(17 days)
The USA Instruments 1.5T 12 Channel Body Array is intended to be used in the abdomen, pelvis and chest regions for 2D and 3D Magnetic Resonance imaging and Parallel body imaging.
The USA Instruments 1.5T 12 Channel Torso Coil is a 12- element coil with integrated preamplifiers that provides optimized geometry for parallel imaging. The coil is designed to provide imaging of the abdomen, pelvis and chest regions. This coil designed for use with the 1.5T Signa Excite MRI scanner, manufactured by General Electric Healthcare. The coil will be available with different connector configurations depending on the configuration of the scanner it will be used with.
The provided text describes a medical device, a Magnetic Resonance Imaging Accessory (1.5T 12 Channel Body Array), and its 510(k) premarket notification. However, the document does not contain detailed information about the specific acceptance criteria or the study that proves the device meets those criteria in the way typically expected for performance claims of AI/ML-based medical devices.
Here's an analysis based on the information provided, highlighting what's present and what's missing:
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Specific performance metrics (e.g., sensitivity, specificity, accuracy, image quality scores for specific conditions) | Not explicitly stated. The document only mentions "Testing was performed to demonstrate that the design modifications to the 1.5T 12 Channel Body Array meet predetermined acceptance criteria." These criteria are not detailed. |
| Safety (e.g., no new significant hazards) | "Usage of the USA Instruments 1.5T 12 Channel Body Array does not result in any new potential hazards." |
| Substantial Equivalence to Predicate Device | "It is the opinion of USA Instruments that the 1.5T 12 Channel Body Array is substantially equivalent to the GE Healthcare 1.5T 8 Channel Torso Coil (K031209)." |
Study Information (Based on available text)
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Sample size used for the test set and the data provenance:
- Not specified. The document mentions "Testing was performed," but provides no details about the size or nature of the test set, nor its provenance (country of origin, retrospective/prospective). This device is a hardware component (MRI coil), not an AI/ML algorithm that processes images, so a traditional "test set" with "ground truth" labels for diagnostic performance might not be applicable in the same way. The testing would likely focus on engineering performance, image quality, signal-to-noise ratio, safety, and compatibility.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable/Not specified. Given that this is a hardware device (MRI coil) and not an AI-based diagnostic tool, traditional "ground truth" and expert consensus for diagnostic accuracy are not the primary focus of the performance evaluation described. The "acceptance criteria" likely relate to physical and electrical performance, image quality metrics, and safety.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable/Not specified. As there's no mention of a diagnostic performance study requiring expert review and adjudication for ground truth, this information is not provided.
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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:
- No. This device is an MRI coil, not an AI-assisted diagnostic tool. Therefore, an MRMC study comparing human reader performance with and without AI assistance is not relevant or described. The comparison is between the new 12-channel coil and an existing 8-channel coil.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a hardware device (MRI coil), not an algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not applicable/Not specified in a diagnostic sense. For a hardware device like an MRI coil, the "ground truth" for its performance evaluation would typically involve objective measurements of signal-to-noise ratio, uniformity, coverage, artifact levels, safety parameters (e.g., SAR, heating), and image quality assessments against established engineering standards or industry benchmarks. These are not explicitly detailed in the summary.
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The sample size for the training set:
- Not applicable. There is no "training set" in the context of this hardware device.
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How the ground truth for the training set was established:
- Not applicable. There is no "training set" for this hardware device.
Summary of the device's "study" per the provided text:
The "Summary of Studies" section (item 11) states: "Testing was performed to demonstrate that the design modifications to the 1.5T 12 Channel Body Array meet predetermined acceptance criteria." The device is considered "substantially equivalent" to a predicate device (GE Healthcare 1.5T 8 Channel Torso Coil, K031209), primarily due to modifications in the number of elements (12 vs. 8) and coil connector design. The conclusion explicitly states that "Usage of the USA Instruments 1.5T 12 Channel Body Array does not result in any new potential hazards." This strongly suggests that the evaluation focused on engineering performance, safety, and compatibility, rather than a diagnostic accuracy study typically associated with AI/ML devices.
§ 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.