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The Knee Coil manufactured by Shenzhen RF Tech Co.,Ltd. is transmit/receive coil and is designed for use as general purpose coil. The Knee Coil is designed to be use with GEHC 1.5T MRI systems to produce diagnostic images of the knee, palm, sole, ankle, elbow, wrist that can be interpreted by a trained physician.

The 1.5T HD T/R Knee Array is transmit/receive phased array coil to produce diagnostic images of images of the knee, palm, sole, ankle, elbow, wrist. The 1.5T HD T/R Knee Array is tuned to receive RF frequency corresponding to the proton precession in a 1.5 Tesla magnetic field, which is governed by the Larmor equation.

Here is a summary of the acceptance criteria and study information for the 1.5T HD T/R Knee Array device, based on the provided text:

Device: 1.5T HD T/R Knee Array (10-F34127)
Predicate Device: Shenzhen RF Tech Co.,Ltd. 8ch T/R Knee Coil (K223225)

1. Table of Acceptance Criteria and Reported Device Performance:

The document primarily focuses on demonstrating substantial equivalence to a predicate device through technological comparison and standard compliance, rather than providing specific quantitative acceptance criteria for device performance parameters like SNR and image uniformity. However, it states that the device "met specified requirements" for these tests.

2. Sample size used for the test set and the data provenance:

The document describes bench testing for image uniformity, SNR, and coil surface heating. It does not specify a "test set" in terms of subject or patient data. The data provenance is from laboratory bench testing. The country of origin for the testing is not explicitly stated, but the manufacturer is Shenzhen RF Tech Co., Ltd. from China. The study appears to be entirely retrospective in the sense that it relies on lab measurements and comparisons to established standards and a predicate device's specifications.

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):

This information is not provided as the submission focuses on technical performance verification through bench testing against standards, not on clinical accuracy or diagnostic interpretation by experts.

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

This information is not applicable/none as the testing described is technical bench testing, not a clinical study requiring adjudication of expert interpretations.

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:

No MRMC comparative effectiveness study was done. This device is an MRI coil, a hardware component, not an AI-powered diagnostic tool. Therefore, the concept of human readers improving with AI assistance is not relevant to this submission.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

This information is not applicable/none. The device is an MRI coil and does not involve an algorithm for standalone performance evaluation in the context of diagnostic decision-making.

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

The "ground truth" for this submission is based on established engineering and medical device standards (e.g., NEMA MS-1, NEMA MS-3, IEC 60601 series, ISO 10993 series) and comparison to the specifications and performance of the legally marketed predicate device (K223225). For image quality parameters like SNR and uniformity, the ground truth is defined by the requirements outlined in the NEMA standards.

8. The sample size for the training set:

This information is not applicable/none as this is a hardware device (MRI coil) and does not involve a "training set" in the context of machine learning.

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

This information is not applicable/none for the reasons stated in point 8.

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The 1.5T 24E Posterior Array by Shenzhen RF Tech Co., Ltd is receive-only coil and designed to be used with GE 1.5T MRI systems to produce diagnostic images of spine, when used with other coils, it also includes abdomen, torso, pelvis, prostate, cardiac, hips, and long bone imaging that can be interpreted by a trained physician.

The 1.5T 24E Posterior Array is receive only phased array coil to produce diagnostic images of Spine, when used with other coils, it also includes abdomen, torso, pelvis, prostate, cardiac, hips, and long bone.

The 1.5T 24E Posterior Array is tuned to receive RF frequency corresponding to the proton precession in a 1.5 Tesla magnetic field, which is governed by the Larmor equation.

The provided text is a 510(k) Summary for a medical device (1.5T 24E Posterior Array, a receive-only MRI coil). This type of document is submitted to the FDA to demonstrate substantial equivalence to a legally marketed predicate device, not necessarily to prove that the device meets specific acceptance criteria for performance in the same way an AI-based diagnostic device might.

The document focuses on engineering and basic performance tests typical for an MRI coil, rather than on diagnostic accuracy metrics. Therefore, many of the requested categories for acceptance criteria and study details (like sample sizes for test sets, expert ground truth, adjudication methods, MRMC studies, standalone performance for AI, and training set details) are not applicable to this type of device and submission.

Here's an analysis of the provided information, addressing the relevant points and noting non-applicable ones:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance

The document indicates "sample clinical images have been obtained with the 1.5T 24E Posterior Array from different anatomical sites and using various pulse sequences" but does not specify the sample size (number of patients or images) for this clinical evaluation. The data provenance (e.g., country of origin, retrospective/prospective) is also not specified. This is typical for a 510(k) for an MRI coil, where the focus is on engineering metrics and general image quality rather than diagnostic accuracy.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable for this type of device submission. The clinical evaluation involves a qualitative assessment of image quality for diagnostic use, rather than a diagnostic accuracy study requiring ground truth established by multiple experts. The statement "can be interpreted by a trained physician" implies general medical expertise rather than a specific number or qualification of experts establishing ground truth for a test set.

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

Not applicable for this type of device submission, as it relates to diagnostic disagreement resolution, which is not described.

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 device is an MRI receive coil, not an AI diagnostic device. No MRMC study was conducted or required.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

Not applicable. This device is hardware (an MRI coil), not an algorithm.

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

For the "sufficient quality for diagnostic use" assessment in the clinical evaluation, the "ground truth" would implicitly be the opinion of "a trained physician" that the images are adequate for diagnosis, rather than a formal ground truth like pathology or outcomes data. This is a general judgment of image utility, not a specific diagnostic accuracy evaluation.

8. The sample size for the training set

Not applicable. This is not an AI/algorithm-based device and does not have a training set.

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

Not applicable. This is not an AI/algorithm-based device and does not have a training set.

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The 8ch T/R Knee Coil manufactured by Shenzhen RF Tech Co.,Ltd is transmit/receive coil and is designed for use as general purpose coil. The 8ch T/R Knee Coil is designed to be use with GE 1.5T MRI systems to produce diagnostic images of the knee, palm, sole, ankle, elbow, wrist that can be interpreted by a trained physician.

The 8ch T/R Knee Coil is transmit/receive phased array coil to produce diagnostic images of images of the knee, palm, sole, ankle, elbow, wrist. The 8ch T/R Knee Coil is tuned to receive RF frequency corresponding to the proton precession in a 1.5 Tesla magnetic field, which is governed by the Larmor equation.

The provided text describes the 510(k) premarket notification for the "8ch T/R Knee Coil" by Shenzhen RF Tech Co., Ltd. This document primarily focuses on demonstrating substantial equivalence to a predicate device and safety and performance through bench testing, rather than an AI/ML-based device requiring extensive clinical study for performance metrics like sensitivity and specificity.

Therefore, the following information is extracted from the provided text according to the specific questions:

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

The document doesn't explicitly state "acceptance criteria" in a quantitative performance table (e.g., specific SNR thresholds for passing). Instead, it states that the device "met specified requirements" for various tests as demonstrated through bench testing. The criteria are implied to be conformance to the listed standards.

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

The document describes "bench testing" of the device. There is no mention of a "test set" in the context of patient data or clinical images. The testing involved physical tests of the device itself. Therefore, sample size and data provenance in this context are not applicable in the way they would be for an AI/ML diagnostic algorithm.

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. This device is an MRI coil, not an AI diagnostic algorithm requiring expert "ground truth" for image interpretation.

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

Not applicable, as there is no "test set" in the context of clinical images requiring 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. This device is an MRI coil, not an AI solution intended to assist human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This device is an MRI coil, not a standalone AI algorithm.

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

Not applicable. The "ground truth" for this device's testing relates to established engineering and safety standards (e.g., material biocompatibility, electrical safety, signal-to-noise ratio measurements, image uniformity).

8. The sample size for the training set

Not applicable. This device is an MRI coil and does not involve AI/ML modeling that requires a "training set."

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

Not applicable. There is no training set for this device.

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The 8ch Wrist Coil by Shenzhen RF Tech Co.,Ltd is receive-only coil and is designed for use as general purpose coil. The 8ch Wrist Coil is designed to be use with GE 1.5T MRI systems to produce diagnostic images of the wrists and fingers that can be interpreted by a trained physician.

The 8ch Wrist Coil is receive only phased array coil to produce diagnostic images of the wrists and fingers in adult population.
The 8ch Wrist Coil is tuned to receive RF frequency corresponding to the proton precession in a 1.5 Tesla magnetic field, which is governed by the Larmor equation.
The 8ch Wrist Coil is based on phased array technique to produce the images from 8 different channels with intergraded preamplifiers. The 8ch Wrist Coil is tuned to the proton frequency of 63.86MHz.

The provided text is a 510(k) Summary for the 8ch Wrist Coil, a medical device. This document focuses on demonstrating substantial equivalence to a predicate device, rather than providing a detailed study of an AI algorithm's performance. Therefore, much of the requested information regarding AI algorithm performance (e.g., acceptance criteria for AI, training set details, multi-reader multi-case studies) is not present in this document.

However, based on the information provided, I can address the aspects related to the device's performance and validation, particularly in relation to its physical and imaging characteristics:

Acceptance Criteria and Device Performance for 8ch Wrist Coil

The document primarily focuses on demonstrating that the 8ch Wrist Coil performs "as well as" the predicate device and meets established industry standards for MRI coils.

1. Table of Acceptance Criteria and Reported Device Performance

The study proving the device meets these criteria is the "Summary of verification Tests," which states: "Bench testing was conducted to demonstrate that image uniformity, SNR and coil surface heating met specified requirements. The test results also show that the 8ch Wrist Coil achieved the expected results and satisfied the standards listed above."

Regarding AI-specific criteria, the document does not present information about an AI algorithm. This device is a passive MRI coil, not an AI software. Therefore, the following points are not applicable based on the provided text:

• 2. Sample size used for the test set and the data provenance: Not applicable for a hardware device validation based on bench testing. The "test set" here refers to the physical coil and its performance measurements.
• 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for hardware performance is established by metrology and standard comparisons (e.g., NEMA, IEC).
• 4. Ground truth Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
• 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, as this is a hardware device, not an AI algorithm.
• 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
• 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): For the hardware coil, the "ground truth" for its performance (SNR, uniformity) is established by adherence to recognized industry standards (NEMA MS-1, NEMA MS-3) and validated bench testing procedures.
• 8. The sample size for the training set: Not applicable (no AI component).
• 9. How the ground truth for the training set was established: Not applicable (no AI component).

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The 1.5T 8ch Flex Suite manufactured by Shenzhen RF Tech Co.,Ltd is receive-only coil and is designed for use as general purpose coil. The 1.5T 8ch Flex Suite is designed to be use with GE 1.5T MRI systems to produce diagnostic images of upper and lower extremities, head, spine and cardiac that can be interpreted by a trained physician.

The 1.5T 8ch Flex Suite is receive-only phased array coil for imaging the upper and lower extremities, head and spine in adult population. The 1.5T 8ch Flex Suite consists of three flexible and lightweight coil of different size that can be wrapped or orientated flat, in order to accommodate various anatomic shapes and sizes.

The 1.5T 8ch Flex Suite is tuned to receive RF frequency corresponding to the proton precession in a 1.5 Tesla magnetic field, which is governed by the Larmor equation.

The provided text describes a 510(k) premarket notification for a medical device, the "8ch Flex Suite," an MRI receive-only coil. However, the document focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study proving the device meets specific performance acceptance criteria for an AI/ML algorithm.

Therefore, the requested information regarding acceptance criteria, study details for AI/ML performance, sample sizes for test and training sets, expert involvement, and ground truth establishment cannot be extracted from this document, as it pertains to a different type of device clearance (an MRI coil, not an AI diagnostic algorithm) and a different regulatory pathway (substantial equivalence, not a de novo or PMA requiring detailed performance studies against defined criteria for an algorithm).

The document mentions "Clinical images evaluation testing for the proposed device was evaluated by connected to compatible MRI system," and that "Based on above testing, the proposed 8ch Flex Suite was found to have a safety and effectiveness profile that is similar to the predicate device." This suggests image quality and clinical utility were assessed, but the specifics of how this was done, what metrics were used, or any quantitative "acceptance criteria" for image performance are not provided. The comparison focuses on technical specifications and intended use matching a predicate device.

To directly answer your request based on the provided text:

• 1. A table of acceptance criteria and the reported device performance: Not applicable/provided. The document focuses on demonstrating substantial equivalence to a predicate device based on technical characteristics and intended use, not on specific performance metrics for an AI/ML algorithm against predefined acceptance criteria.
• 2. Sample sized used for the test set and the data provenance: Not applicable/provided. There is no mention of a "test set" in the context of an AI/ML algorithm's performance. The clinical evaluation refers to the performance of the coil itself.
• 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable/provided. No ground truth establishment for an AI/ML algorithm is described.
• 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable/provided.
• 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/provided. This device is an MRI coil, not an AI assistance tool for human readers.
• 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable/provided. This is not an algorithm.
• 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable/provided.
• 8. The sample size for the training set: Not applicable/provided. This is not an AI/ML device.
• 9. How the ground truth for the training set was established: Not applicable/provided.

In summary, the provided document is a 510(k) summary for an MRI coil, not an AI/ML diagnostic device. Therefore, the information requested about AI/ML acceptance criteria and performance studies is not contained within this text.

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The 1.5T 8ch Flex Suite manufactured by Shenzhen RF Tech Co., Ltd is receive-only coil and is designed for use as general purpose coil. The 1.5T 8ch Flex Suite is designed to be use with GE 1.5T MRI systems to produce diagnostic images of upper and lower extremities, head and spine that can be interpreted by a trained physician.

The 1.5T 8ch Flex Suite is receive-only phased array coil for imaging the upper and lower extremities, head and spine in adult population. The 1.5T 8ch Flex Suite consists of three flexible and lightweight coil of different size that can be wrapped or orientated flat, in order to accommodate various anatomic shapes and sizes.
The 1.5T 8ch Flex Suite is tuned to receive RF frequency corresponding to the proton precession in a 1.5 Tesla magnetic field, which is governed by the Larmor equation.
The 1.5T 8ch Flex Suite is flexible and can be wrapped around the anatomy of interest, which is similar to its predicate device.
The 1.5T 8ch Flex Suite is general purpose receive only coil with 8 elements and intergraded preamplifiers.
The 1.5T 8ch Flex Suite is based on phased array technique for combining the images from 8 different channels. The 1.5T 8ch Flex Suite is tuned to the proton frequency of 63.86MHz.

Here's a breakdown of the acceptance criteria and study information for the 8ch Flex Suite, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document describes a receive-only MRI coil, not an AI-powered diagnostic device. Therefore, the "acceptance criteria" discussed are primarily related to the coil's physical, electrical, and imaging performance, ensuring it functions safely and effectively as an MRI accessory. The document doesn't present a standard table of "acceptance criteria" for diagnostic accuracy common in AI/standalone device submissions (e.g., sensitivity, specificity, AUC).

Instead, the submission focuses on demonstrating substantial equivalence to a predicate device through non-clinical and limited clinical testing. The "performance" is implicitly tied to meeting the standards and showing comparable image quality to the predicate.

2. Sample Size Used for the Test Set and Data Provenance

• Test Set Sample Size: The document does not specify a numerical sample size for the clinical test set (i.e., how many patients/scans were used). It only states that "Analyses in axial, sagittal and coronal planes were run on the 8ch Flex Suite."
• Data Provenance: Not specified. The document does not mention the country of origin of the data or whether it was retrospective or prospective.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

This information is not provided in the document. The "clinical tests" described are for evaluating image quality for substantial equivalence, not typically for establishing a diagnostic ground truth against a specific disease. The interpretation is stated to be by a "trained physician" for the intended use, but the number or qualifications of experts for the comparative study are not detailed.

4. Adjudication Method for the Test Set

This information is not provided in the document. Given the nature of the "clinical tests" described (comparing image quality for substantial equivalence), a formal adjudication method for diagnostic ground truth might not have been central to this type of submission.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• No, an MRMC comparative effectiveness study was not done. The document describes clinical tests to demonstrate substantial equivalence of image quality between the 8ch Flex Suite and a predicate device. It does not involve human readers interpreting images with and without AI assistance, nor does it address an effect size of AI on human reader performance. This device is an MRI coil, not an AI diagnostic tool.

6. Standalone (Algorithm Only Without Human-in-the-Loop) Performance Study

• Not applicable. The 8ch Flex Suite is an MRI coil, a hardware component for image acquisition, not an algorithm or AI software that performs standalone diagnostic functions.

7. Type of Ground Truth Used

• For the "clinical tests" described, the implicit ground truth is comparable image quality sufficient for diagnostic interpretation by a trained physician when compared against the predicate device. It's not about definitive diagnosis of a specific pathology through expert consensus, pathology, or outcomes data in the way an AI diagnostic algorithm would be evaluated. The aim is to show the coils produce diagnostically acceptable images.

8. Sample Size for the Training Set

• Not applicable. This device is an MRI coil and does not involve AI or algorithms that require a training set.

9. How the Ground Truth for the Training Set Was Established

• Not applicable. As stated above, there is no training set for an MRI coil.

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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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