(115 days)
8ch Foot Ankle Coil manufactured by RFT is a receive-only RF surface coil designed for use with GE 1.5T 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 comprises the coil and the base plate. The coil conforms to patients' anatomy, accommodating various foot contours while minimizing patient discomfort. The base plated from the coil part is used to place the patients' anatomy on the table.
8ch Foot Ankle Coil is 8-channel phased array RF receive only coils with integrated preamplifiers. The coil designs consist of RF chokes with switching diodes to provide decoupling which isolates the coil elements from RF fields during RF transmission.
This document is a 510(k) premarket notification for the "8ch Foot Ankle Coil" submitted by Shenzhen RF Tech Co., Ltd. It declares substantial equivalence to a predicate device. The document primarily focuses on non-clinical testing and does not contain information about acceptance criteria or a study proving the device meets them in the context of clinical performance.
Therefore, most of the requested information regarding acceptance criteria, device performance, sample sizes, expert involvement, and ground truth establishment cannot be extracted from the provided text.
Here's an attempt to answer the questions based on the available information, with significant parts indicating "Not explicitly stated" as the clinical study details are absent.
1. A table of acceptance criteria and the reported device performance
The document only lists non-clinical tests that were performed. It does not provide specific acceptance criteria or quantitative performance results for clinical attributes.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Clinical Performance Criteria (e.g., image quality, diagnostic accuracy) | Not explicitly stated. The document mentions "Sample clinical images" but provides no quantitative performance metrics or acceptance criteria for them. |
| Non-Clinical Test Criteria (implied by performing the tests) | Non-Clinical Test Results |
| Biocompatibility | Performed (Section 15) |
| IEC 60601-1-2 (Electromagnetic compatibility) | Performed (Section 17) |
| IEC 60601-1 (Electrical safety) | Performed (Section 17) |
| Maximum B1 Peak | Performed (Section 18) |
| Signal to Noise ratio and uniformity (according to NEMA standard) | Performed (Section 18) |
| Blocking Network analysis | Performed (Section 18) |
| Surface temperature test normal condition | Performed (Section 18) |
| Surface temperature test unplugged condition | Performed (Section 18) |
2. Sample size used for the test set and the data provenance
- Sample size for test set: Not explicitly stated. The document mentions "Sample clinical images included in Section 20 were performed with all compatible GE 1.5T MRI systems." No specific number of images or patients is provided, nor is the data provenance (country of origin, retrospective/prospective).
- Data provenance: Not explicitly stated for the "sample clinical images."
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable/Not explicitly stated. The document doesn't describe ground truth establishment for the clinical images, as it's not a clinical performance study.
4. Adjudication method for the test set
Not applicable/Not explicitly stated. The document doesn't describe clinical performance testing or adjudication.
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. The device is an MRI coil, not an AI-powered diagnostic tool. No MRMC study was mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. The device is a hardware component (MRI coil), not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not applicable/Not explicitly stated. Since detailed clinical performance evaluation is not described, the type of ground truth for any potential clinical images remains unstated. The "sample clinical images" are likely for visual demonstration rather than rigorous validation against a gold standard.
8. The sample size for the training set
Not applicable. The device is an MRI coil, not an AI model that requires a training set.
9. How the ground truth for the training set was established
Not applicable. The device is an MRI coil, not an AI model.
In summary, this 510(k) submission primarily focuses on demonstrating substantial equivalence through non-clinical performance and safety testing. It provides very limited information regarding clinical image analysis or quantitative clinical performance, which are usually the focus of "acceptance criteria" and subsequent "studies" for diagnostic algorithms or devices directly claiming diagnostic performance. The "sample clinical images" are likely intended to show image quality rather than serve as a rigorous clinical performance study set.
§ 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.