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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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