Search Results

The Phased Array Shoulder Coil does not change the intended use of the Picker 1.5 T EDGE system.

The 1.5 T EDGE system is intended for use as a NMR device that produces images that: (1) correspond to the distribution of protons exhibiting NMR, (2) depend upon NMR parameters (proton density, flow velocity, spin-lattice relaxation time T1, spin-spin relaxation time T2) and (3) display the soft tissue structure of the head and whole body. When interpreted by a trained physician, these images yield information that can be useful in the determination of a diagnosis.

The Phased Array Shoulder Coil is indicated for use in the following anatomic regions and with the designated nuclei:

Shoulder and other related joint structures Anatomic Regions:

Nuclei Excited: Hydrogen

The Picker Phased Array Shoulder Coil is a receive-only coil designed to provide imaging of the shoulder and other joint structures. The coil is designed to give improved signalto-noise ration (SNR), image resolution and image acquisition time over that of the Body Coil.

This document describes a medical device, the Phased Array Shoulder Coil, and asserts its substantial equivalence to a predicate device. However, it does not contain the type of study data, acceptance criteria, or performance metrics typically associated with AI/ML device evaluations.

Instead, this document focuses on comparing a new MRI coil (a hardware accessory) to a previously cleared MRI coil. The determination of "safety and effectiveness" is based on showing that the new coil is "substantially equivalent" to an existing, legally marketed device (the predicate device) in terms of its design, materials, and intended use, rather than demonstrating performance against specific clinical metrics.

Therefore, many of the requested categories for AI/ML device studies are not applicable to the information provided in this document.

Here's an analysis based on the provided text, highlighting what is and is not present:

1. Table of acceptance criteria and the reported device performance

Note: The "acceptance criteria" here are implied by the substantial equivalence framework – the new device must be sufficiently similar to the predicate device in terms of design, operation, and intended use as not to raise new questions of safety or effectiveness. There are no explicit quantitative performance metrics or user study results presented to prove specific performance targets were met. The claim of "improved SNR, image resolution and image acquisition time" is a design goal statement, not a quantified performance result relative to the predicate or a specific benchmark in this document.

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

• Not applicable (N/A). This document does not detail a clinical study with a "test set" in the context of AI/ML validation. The "study" is a comparison of technical specifications and intended use to a predicate device.

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)

• N/A. No expert ground truth establishment for a test set is described.

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

• N/A. No adjudication method is 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

• N/A. This device is an MRI coil, not an AI/ML algorithm intended to assist human readers.

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

• N/A. This device is an MRI coil, not an AI/ML algorithm.

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

• N/A. The assessment is based on a comparison of device specifications and intended use to a predicate device, not on clinical ground truth data from specific diagnostic cases.

8. The sample size for the training set

• N/A. This product is an MRI coil and does not involve AI/ML training.

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

• N/A. This product is an MRI coil and does not involve AI/ML training or ground truth establishment in this context.

Ask a specific question about this device