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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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