(119 days)
8ch Foot Ankle Coil manufactured by RFT is a receive-only RF surface coil designed for use with GE 3.0T MRI systems. 8ch Foot Ankle Coil is indicated to use for foot and ankle imaging. The nucleus excited is hydrogen.
The 8ch Foot Ankle Coil is a surface coil used for Magnetic Resonance Imaging. It's tuned to image Proton nuclei in a receive-only configuration. It is comprised of 8 individual Phased Array coil elements which receive the signal from patient's foot or ankle. Preamplifiers are integrated in the coil. The geometry is optimized for use with parallel imaging techniques.
The 8ch Foot Ankle Coil receives foot or ankle signal through 8-element phased array under 3T static magnetic field and presents the foot or ankle images based on the above mentioned theory.
The 8ch Foot Ankle Coil comprises the coil and the base plate. The coil conforms to patients' anatomy, accommodating various foot contours while minimizing patient discomfort. The base plate separated from the coil part is used to place the patients' anatomy on the table.
The associated accessories include:
- 1 cable
- 1 baseplate,
- 1 ankle pad,
- 1 foot pad,
- 1 ramp pad,
- 1 knee pad support,
- 1 strap.
Based on the provided document, the device in question is an 8ch Foot Ankle Coil, which is an RF surface coil designed for use with GE 3.0T MRI systems for foot and ankle imaging. This is a 510(k) premarket notification for a medical device that aims to demonstrate substantial equivalence to a legally marketed predicate device.
The document describes non-clinical tests performed to support the substantial equivalence claim, rather than a study evaluating the performance of an AI or diagnostic algorithm. Therefore, many of the requested elements for describing the acceptance criteria and study that proves a device meets those criteria, particularly those related to diagnostic performance, ground truth, expert readers, and AI assistance, are not applicable to this type of submission.
Here's a breakdown of the information that can be extracted from the provided text:
1. A table of acceptance criteria and the reported device performance
The document states that the following performance data were provided in support of substantial equivalence:
- SNR (Signal-to-Noise Ratio) test report
- Surface temperature test report
- Uniformity test report
However, the specific acceptance criteria (e.g., minimum SNR value, maximum surface temperature, uniformity percentage) and the actual reported device performance values for these tests are not detailed in the provided summary. The document only lists that the reports were provided.
2. Sample sizes used for the test set and the data provenance
Given that this is a hardware device (an MRI coil) and the tests are related to its physical performance (SNR, temperature, uniformity) rather than diagnostic accuracy on patient data, the concept of "test set sample size" as it applies to patient images is not applicable. The tests would have been performed on the coil itself, likely under various controlled phantom or in-vivo conditions, but the sample size would refer to the number of measurements or repetitions, not patient scans.
The data provenance (e.g., country of origin, retrospective/prospective) is also not applicable as there is no patient data or clinical study described in this summary.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This is not applicable. Ground truth, expert consensus, and qualifications of experts are relevant for diagnostic performance studies (e.g., how accurate an AI algorithm is at detecting a disease based on expert labels). For an MRI coil, the "ground truth" for SNR, temperature, and uniformity would be established by physical measurements and engineering specifications, often against a phantom or standardized test conditions, not by human experts interpreting images for diagnostic accuracy.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
This is not applicable for the same reasons as #3. Adjudication methods are used in diagnostic studies to resolve discrepancies between readers or AI outputs.
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
This is not applicable. This document describes a physical device (MRI coil), not an AI diagnostic algorithm. Therefore, there is no mention of human readers, AI assistance, or MRMC studies.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
This is not applicable. This document is for an MRI coil, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
As explained above, the concept of "ground truth" as typically used in diagnostic performance studies is not applicable here. The "truth" for the performance tests (SNR, temperature, uniformity) would be based on validated measurement techniques and engineering standards.
8. The sample size for the training set
This is not applicable. There is no "training set" as this is not an AI/machine learning device.
9. How the ground truth for the training set was established
This is not applicable for the same reason as #8.
Summary of what is known from the document regarding the device's performance validation:
The document focuses on demonstrating that the 8ch Foot Ankle Coil is substantially equivalent to a predicate device. This is achieved primarily through non-clinical performance testing focused on hardware characteristics critical to MRI image quality and safety.
- Tests Performed: SNR test, Surface temperature test, and Uniformity test.
- Purpose: To support the claim that the differences from the predicate device do not raise new questions of safety or effectiveness.
- Conclusion (from the submission): "The non-clinical data support the safety and effectiveness of the device. The device should perform as intended in the specified use conditions. Shenzhen RF Tech Co., Ltd. considers the 8ch Foot Ankle Coil does not raise any new issues of safety or effectiveness, and performs as well as the legally marketed predicate device."
Without the actual test reports, the specific numerical acceptance criteria and performance results (e.g., the exact SNR achieved, max temperature measured) cannot be provided.
§ 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.