(78 days)
The speciality coils are indicated for use in conjunction with the 1.5T MAGNETOM ESSENZA, a magnetic resonance diagnostic device (MRDD) that produces transverse, sagittal, coronal and oblique cross sectional images, and that displays the internal structure and/or function of the body. These images when interpreted by a trained physician yield information that may assist in diagnosis.
The Speciality Coils are intended to be used in conjunction with the MAGNETOM ESSENZA, a Magnetic Resonance Diagnostic Device. These coils will be used to present images which reflect the spatial distribution and the other physical parameters derived from the images may also be produced. The Speciality Coils will include: 8-Channel Wrist Coil, 4-Channel Special-Purpose Coil, 8-Channel Foot-Ankle Coil, and the Focus Shoulder Array Coil, Small for the existing 1.5T MAGNETOM ESSENZA Magnetic Resonance System.
Here's a breakdown of the acceptance criteria and the study information based on the provided text:
Acceptance Criteria and Device Performance
The provided document describes the modification of existing coils and the introduction of new specialty coils for an MRI system. The key acceptance criteria revolve around safety and performance parameters, particularly Signal-to-Noise Ratio (SNR) and Image Uniformity, compared to predicate devices.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Safety Parameters: | |
| Maximum Static Field | Unaffected by modifications (implied to meet existing standards) |
| Rate of Change of Magnetic Field | Unaffected by modifications (implied to meet existing standards) |
| RF Power Deposition | Unaffected by modifications (implied to meet existing standards) |
| Acoustic Noise Level | Unaffected by modifications (implied to meet existing standards) |
| Biocompatibility | No new materials were used for the new specialty coils compared to their predicate device, therefore no new biocompatibility tests were performed. (Implied to meet existing biocompatibility standards of predicate devices) |
| Performance Parameters: | |
| Geometric Distortion | Unaffected by modifications (implied to meet existing standards) |
| Slice Profile, Thickness and Gap | Unaffected by modifications (implied to meet existing standards) |
| High Contrast Spatial Resolution | Unaffected by modifications (implied to meet existing standards) |
| Signal to Noise Ratio (SNR) | "Signal to Noise Ratio (SNR) and image uniformity tests were performed for the new speciality coils and the results presented in this submission show that they are equivalent with the predicate devices." (Specific quantitative values for performance or acceptance thresholds are not provided in the summary, but equivalence to predicate devices is claimed.) |
| Image Uniformity | "Signal to Noise Ratio (SNR) and image uniformity tests were performed for the new speciality coils and the results presented in this submission show that they are equivalent with the predicate devices." (Specific quantitative values for performance or acceptance thresholds are not provided in the summary, but equivalence to predicate devices is claimed.) |
Study Details
The provided document describes a bench testing approach to demonstrate substantial equivalence, rather than a clinical study involving human subjects or artificial intelligence performance evaluation.
-
Sample size used for the test set and the data provenance: Not applicable. The "test set" in this context refers to the specialty coils themselves, which were tested in a laboratory setting. No patient data or images are referenced as a "test set" in the context of an AI/human performance study. The testing was conducted in a laboratory, so the data provenance would be "in-house laboratory testing."
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for image quality metrics like SNR and uniformity is established through physical measurements and phantom studies, not typically through human expert consensus, especially for hardware (coils) evaluation.
-
Adjudication method for the test set: Not applicable. The assessment was based on objective physical measurements of the coils' performance.
-
If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No, an MRMC study was not done. This submission is for MRI hardware (specialty coils), not an AI algorithm or diagnostic software that would typically undergo such a study. The focus is on the physical performance and safety of the coils themselves.
-
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: No, a standalone algorithm performance study was not done. This submission is for hardware.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The ground truth for the performance parameters (SNR, Image Uniformity) would be based on objective physical measurements using phantoms and established MR safety and performance measurement protocols. This is a technical validation of hardware, not a diagnostic accuracy study.
-
The sample size for the training set: Not applicable. The device is a set of MRI coils, not an AI algorithm that requires a training set.
-
How the ground truth for the training set was established: Not applicable, as there is no training set for this hardware submission.
§ 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.