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The 18ch T/R Knee Coil is intended for use with GE 3.0T MR systems to produce diagnostic images of the knee that can be interpreted by a trained physician.

The 18ch T/R Knee Coil is a transmit/receive. 18-channel phased array coil designed for magnetic resonance imaging (MRI) using the GE 3T MR systems. The 18ch T/R Knee Coil is intended to be used for imaging the knee.

The 18ch T/R Knee Coil is a reusable, non-invasive device with limited exposure with regard to duration of contact with the body. All coil elements are enclosed in a rigid plastic housing which is fire-rated, has impact and tensile strength, and has been tested for biocompatibility.

The 18ch T/R Knee Coil also includes the accessories listed in Table 1. The accessories consist only of patient comfort pads.

The provided text is a 510(k) Summary for a medical device called the "18ch T/R Knee Coil," a transmit/receive, 18-channel phased array coil designed for magnetic resonance imaging (MRI) of the knee. The document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed clinical study with specific acceptance criteria and performance metrics typically found for AI/software devices.

Therefore, many of the requested points related to acceptance criteria, sample sizes for test/training sets, ground truth establishment, expert adjudication, and MRMC studies are not applicable or cannot be extracted from this type of regulatory submission for a hardware device like an MRI coil.

However, I can extract the relevant performance data and conclusions regarding the substantial equivalence to the predicate device.

Here's a breakdown of the information that can be extracted and where the requested information is not applicable:

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

For an MRI coil, "acceptance criteria" are typically related to fundamental safety and performance standards rather than diagnostic accuracy metrics. The document references compliance with these standards.

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

This information is not applicable for the type of device and study described. This document pertains to the regulatory clearance of an MRI hardware component based on engineering and bench testing, not a clinical study involving patient data with a "test set" in the context of an algorithm or diagnostic accuracy.

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 applicable. Ground truth for diagnostic interpretation is not relevant for the engineering and safety testing of an MRI coil.

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

This information is not applicable. No adjudication method was used as there was no clinical test set requiring expert interpretation.

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 information is not applicable. This device is an MRI coil, not an AI, CAD, or software device. No MRMC study was performed.

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

This information is not applicable. This is a hardware device, not an algorithm.

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

This information is not applicable. Ground truth in the context of diagnostic accuracy is not relevant here. The "ground truth" for this device's performance is compliance with established engineering, electrical safety, and imaging standards (e.g., NEMA standards for SNR and uniformity).

8. The sample size for the training set

This information is not applicable. This is not an AI/ML device with a training set.

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

This information is not applicable. This is not an AI/ML device.

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