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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.

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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.

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.

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8ch Foot Ankle Coil manufactured by RFT is a receive-only RF surface coil designed for use with the SIGNA Pioneer only. 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. -

The provided document is a 510(k) summary for the Shenzhen RF Tech Co., Ltd.'s 8ch Foot Ankle Coil. It details the device's characteristics, comparison to a predicate device, and performance data used to support its substantial equivalence. However, it does not contain specific acceptance criteria, detailed study results proving the device meets those criteria, or information on reader studies, ground truth establishment for AI models, or AI training data.

The document focuses on non-clinical performance data (biocompatibility, electrical safety/EMC, and bench testing) and a qualitative mention of "clinical tests" demonstrating anatomical equivalence, rather than quantitative performance metrics for disease detection or diagnostic accuracy.

Therefore, many of the requested details about acceptance criteria, study specifics, and AI-related information cannot be extracted from this document.

Here's a breakdown of what can be inferred or explicitly stated based on the provided text:

1. A table of acceptance criteria and the reported device performance

The document does not provide a table of acceptance criteria with specific quantitative targets and corresponding reported performance values for diagnostic accuracy or clinical outcomes. Instead, it lists types of tests conducted:

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size for Clinical Tests: Not specified. The document only mentions "Analyses in sagittal, coronal, and axial planes were run on the 8ch Foot Ankle Coil to show that anatomies of the submitted and predicate coils have substantial equivalence." This suggests a small, qualitative visual comparison rather than a large, statistically powered clinical study.
• Data Provenance: Not specified.
• Retrospective or Prospective: Not specified.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. The document describes a medical device (MRI coil), not an AI algorithm requiring expert-established ground truth for diagnostic accuracy. The "clinical tests" described seem to be about visual comparison of image quality, not disease diagnosis.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. As above, this is for image interpretation/diagnosis, not a hardware device's performance evaluation.

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 document is for a medical device (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. This is a hardware device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For the "clinical tests," the ground truth was visual comparison of anatomical visualization/image quality, likely against the predicate device's images, to demonstrate "substantial equivalence." There is no mention of pathology, outcomes data, or disease-specific expert consensus as the primary ground truth for this device's evaluation. For biocompatibility and electrical safety, the "ground truth" is compliance with established standards and test protocols.

8. The sample size for the training set

Not applicable. This is not an AI device.

9. How the ground truth for the training set was established

Not applicable. This is not an AI device.

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