(51 days)
The TRILLIUM OVAL Head Coil 32 is a 32 channel recieve-only multiple array device used with the Hitachi TRILLIUM OVAL 3.0 Tesla systems for imaging of the head region that can be interpreted by a trained physician.
The TRILLIUM OVAL Head Coil 32 is a receive-only device that detects the MR signal used to produce transverse, coronal, sagittal, oblique, and/or curved cross-sectional images that display the internal structure of the head. The images produced by the MR system reflect the spatial distribution of protons (hydrogen nuclei) exhibiting magnetic resonance. When interpreted by a trained physician, these images provide information that can be useful in diagnosis determination.
The provided document is a 510(k) premarket notification for the "TRILLIUM OVAL Head Coil 32". This document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study to prove a device meets specific acceptance criteria for diagnostic performance. Therefore, many of the requested elements for a diagnostic AI study are not applicable or not present in this type of submission.
Here's a breakdown of the available information with respect to your request:
1. A table of acceptance criteria and the reported device performance
The document does not specify "acceptance criteria" in the context of diagnostic performance metrics like sensitivity, specificity, or AUC, as it's a device component (MRI coil) and not an AI diagnostic algorithm. Instead, it refers to performance characteristics related to hardware and safety.
| Parameter | Acceptance Criteria (Predicate Performance) | Reported Device Performance (Subject Device) |
|---|---|---|
| NEMA MS 1 Method 4 | 145 +/- 20% | 245 +/- 20% |
| Electrical Safety | UL-60601-1, Class II | UL-60601-1, Class II |
| Heat Testing | (Implicit: safe operating temperatures) | Conducted (implied acceptable) |
2. Sample size used for the test set and the data provenance
Not applicable. This device is an MRI head coil, and the evaluation focuses on its technical performance and safety, not its diagnostic accuracy on a dataset of patient scans. The "clinical images of the head were provided to support the effectiveness of the subject device," but this is not a diagnostic test set with labeled outcomes.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. Ground truth for diagnostic outcomes is not established for this type of device submission. The images are interpreted by a "trained physician," which is a statement about the intended use of the images, not a ground truth assessment for a study.
4. Adjudication method for the test set
Not applicable. There is no diagnostic test set requiring adjudication in this submission.
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
Not applicable. This is not an AI diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI diagnostic algorithm.
7. The type of ground truth used
Not applicable. No ground truth for diagnostic outcomes was used as this is a device component, not a diagnostic algorithm. Performance evaluation focuses on engineering standards and safety.
8. The sample size for the training set
Not applicable. This is a hardware device; there is no training set in the context of machine learning.
9. How the ground truth for the training set was established
Not applicable. See above.
Summary of the Study Proving Device Meets Acceptance Criteria (Based on the provided document):
The "study" conducted for the TRILLIUM OVAL Head Coil 32 was primarily a series of non-clinical tests and comparisons to demonstrate substantial equivalence to a legally marketed predicate device (TRILLIUM OVAL WIT Posterior Head/Neck coil and WIT Anterior Head attachment - K142734).
The acceptance criteria are implicitly defined by compliance with recognized standards and a comparison of technological characteristics and performance to the predicate device.
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Tests Conducted:
- NEMA MS 1 (Determination of Signal-to-noise Ratio (SNR)): This standard quantitatively assesses the signal quality of MRI systems. The subject device reported an SNR of 245 +/- 20%, compared to the predicate's 145 +/- 20%. The higher SNR for the subject device indicates improved signal quality.
- NEMA MS 3 (Determination of Image Uniformity): This standard assesses the consistency of the signal across the image.
- AAMI / ANSI ES60601-1 (Medical Electrical Equipment - Basic Safety and Essential Performance): This evaluates overall electrical safety.
- IEC 60601-1-2 (Electromagnetic Compatibility): This ensures the device operates correctly without interference and doesn't cause interference.
- IEC 60601-2-33 (Particular Requirements for Basic Safety and Essential Performance of Magnetic Resonance Equipment): This is a specific safety standard for MRI equipment.
- Heat testing: Performed on the new coil to ensure it operates within safe temperature limits.
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Methodology:
The evaluation focused on comparing the intended use, hardware specifications (e.g., coil dimensions, coil type, number of elements, decoupling method), and performance (SNR, electrical safety) of the subject device to the predicate device. The conclusion of substantial equivalence was reached based on the analysis that:- The subject device has the same intended use.
- Any differences in specifications (e.g., increased number of channels from 19 to 32, improved SNR) do not constitute a new intended use and do not raise new questions of safety or effectiveness. In fact, the higher SNR for the subject device is generally considered an improvement in performance.
- Compliance with recognized safety and performance standards was demonstrated.
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Clinical Data: No formal clinical trials for diagnostic accuracy were conducted. However, "clinical images of the head were provided to support the effectiveness of the subject device." This is typically to visually demonstrate the image quality produced by the new coil.
In essence, the "study" was a regulatory submission that leveraged engineering tests and comparative analysis against an already approved predicate device to demonstrate that the new head coil is as safe and effective, and in some aspects, technologically improved, without introducing new risks.
§ 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.