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The Medrad Shoulder Coil is a receive only coil intended to be used with the General Electric Superconducting MRI Scanners. This coil is intended to facilitate complete MR imaging of the shoulder anatomy.

The Medrad Shoulder Coil is a receive only coil intended to be used MRI Scanner Systems for imaging of the shoulder anatomy.

The Medrad Shoulder Coil is intended for use only under the supervision of a physician who is trained in the field of Diagnostic Resonance Imaging.

The Medrad Shoulder Coil is a receive only coil designed to enhance the MR Imaging of the shoulder anatomy.

This is a 510(k) premarket notification for a medical device, specifically an MRI shoulder coil. The document describes a comparison between a proposed Medrad Shoulder Coil and a predicate GE Shoulder Coil. The core of the submission is to demonstrate substantial equivalence, rather than a clinical study evaluating a novel diagnostic algorithm.

Therefore, many of the requested categories for AI/algorithm performance studies are not applicable to this document. The device is a physical MRI coil, not a diagnostic algorithm.

Here's the information that can be extracted relevant to acceptance criteria and performance, as much as possible, acknowledging the limitations for an AI-focused request:

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

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

• Sample Size for Test Set: Not explicitly stated for each test (SNR, uniformity). For "Clinical Evaluation," it shows "clinical images for the proposed 1.5T Shoulder Coil have been provided," but the number of images or patients is not specified.
• Data Provenance: Not specified. Retrospective or prospective is not mentioned. Country of origin not mentioned.

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 document describes the performance of a physical MRI coil, not an AI or diagnostic algorithm, so there is no "ground truth" in the traditional sense of expert interpretation for diagnostic accuracy. The "clinical effectiveness" is demonstrated through imaging, implying visual assessment by radiologists, but details about expert involvement are not provided.

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

• Not applicable. No adjudication method for diagnostic accuracy is mentioned, as this is not an AI/diagnostic algorithm study.

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. This is not an MRMC study and does not involve AI assistance. The comparison is between two physical MRI coils.

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

• Not applicable. This is not an algorithm.

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

• Not applicable for diagnostic ground truth. For the physical performance tests (SNR, uniformity, distortion), the "ground truth" would be established by physical measurements and NEMA standards, as well as visual inspection by engineers and physicists regarding the absence of distortion or artifacts. For "clinical effectiveness," the "ground truth" is implied to be the visual quality and diagnostic utility of the images as interpreted by medical professionals, but the method for establishing this is not detailed.

8. The sample size for the training set

• Not applicable. This pertains to a physical device, not an AI algorithm that requires a training set.

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

• Not applicable. This pertains to a physical device, not an AI algorithm.

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