(7 days)
The MR Instruments TEM 3000G Head Coil is designed to provide Magnetic Resonance Images of the brain, soft tissues and vasculature of the head. The TEM 3000G Head Coil is designed for use with the GE Signa 3.0T Excite MR System manufactured by GE.
The TEM 3000G Head Coil is a 15-element, quadrature transmit/receive coil. The coil elements and associated circuitry are enclosed in a rigid housing to prevent rne exposure to patient or environment. The coil housing employs a large open any order on the top. The coil design facilitates the scanning of patients with different head sizes and maximizes patient comfort and ease of use.
The provided text describes a 510(k) premarket notification for the TEM 3000G Head Coil. It primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting detailed acceptance criteria and a comprehensive study proving specific performance metrics against those criteria.
However, based on the information provided, we can infer some aspects and construct a response:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly list quantitative acceptance criteria with numerical targets. Instead, it states that "Performance testing was completed to verify the design specifications necessary for the designed for use with the GE Healthcare Signa® 3.0T MR System necessary for the user-ability of the GE based Head Coil." This implies the acceptance criteria were related to the coil's ability to produce Magnetic Resonance Images (MRIs) of the brain, soft tissues, and vasculature of the head when used with the specified GE MR system, and that these images should be comparable in quality to those produced by the predicate device.
| Acceptance Criteria (Inferred) | Reported Device Performance |
|---|---|
| Ability to provide Magnetic Resonance Images of the brain, soft tissues, and vasculature of the head. | "Performance testing was completed to verify the design specifications necessary for the designed for use with the GE Healthcare Signa® 3.0T MR System necessary for the user-ability of the GE based Head Coil. Test results modified.com and performance of the TEM 3000G Head Coil for its intended use." (This implies successful imaging of the specified anatomical regions.) |
| Compatibility and functional performance with the GE Signa 3.0T Excite MR System. | "The TEM 3000G Head Coil is designed for use with the GE Signa 3.0T Excite MR System manufactured by GE." and "Performance testing was completed to verify the design specifications necessary for the designed for use with the GE Healthcare Signa® 3.0T MR System..." (This indicates successful integration and operation with the specified MR system.) |
| Similar imaging quality and utility to the predicate device (GE Signa 3.0T Excite MR System Split Head Coil Assembly for G3). | "The data and information provided in this submission supports a substantial equivalence determination, and, therefore, 510(k) premarket notification clearance of the TEM 300G Head Coil." and "The similarities between the two devices is that they are both quadrature transmit and receive RF coils designed to work with the GE Signa 3.0T Excite transmit and the similar in size, shape and construction." (This implies performance is comparable enough to be considered substantially equivalent.) |
2. Sample Size Used for the Test Set and Data Provenance
The document does not provide details on the sample size used for the performance testing. It also does not specify the provenance of the data (e.g., country of origin, retrospective or prospective).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document does not mention the involvement of experts to establish ground truth or their qualifications. The testing appears to be focused on technical performance and compatibility rather than diagnostic accuracy requiring expert interpretation of images.
4. Adjudication Method for the Test Set
No adjudication method is described, as the testing focuses on technical performance rather than diagnostic interpretation.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the effect size of how much human readers improve with AI vs without AI assistance
No such study was conducted or mentioned. This device is an MRI head coil, a hardware component for image acquisition, not an AI-powered diagnostic tool requiring human reader studies.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is not applicable. The device is hardware (an MRI coil), not an algorithm.
7. The Type of Ground Truth Used
The ground truth for this type of device would likely be the technical specifications and image quality metrics (e.g., signal-to-noise ratio, image homogeneity, artifact levels) achieved with the coil, compared to the expected performance characteristics of a head coil for the specified MR system and the performance of the predicate device. It is inferred that these technical specifications and image quality were assessed, although the specific metrics and results are not detailed in this summary.
8. The Sample Size for the Training Set
This question is not applicable as the TEM 3000G Head Coil is a hardware device, not a machine learning algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
This question is not applicable for the same reason as above; there is no training set for a hardware device.
§ 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.