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The MEDRAD Phased Array Neurovascular Coil is a receive-only coil intended to be used with Siemens 1.5T MRI Scanners. The coil will facilitate complete MR imaging, including spectroscopy, of the intracranial/extracranial, neurovascular, skull base and C-spine regions without moving the patient or the coil; i.e., no scan room intervention.

The MEDRAD 8-Receiver Phased Array Neurovascular Coil for Siemens maintains a similar intended use, similar operational parameters, similar labeling and is used in a manner similar to the predicate device. It is a phased array receive-only coil with a region of interest from the vertex of the skull to the aortic arch. It is compatible with all phased array Siemens 1.5T platforms with 8-receiver capability and all Siemens system pulse sequences and appropriate imaging options. No external tuning or matching is necessary. The coil plugs into the Siemens MRI system by way of cable sockets in the patient table. Imaging configurations include High resolution Head, Neck, or Head + Neck (Full), depending on user-selected coil elements. The housing material is made from polyurethane; fire rated UL 94V-0. Comfort pad, positioning pads, and knee pad material is made from polyurethane foam sprayed with a Guardian coating and is fire rated to C-117. The table pad material is made from Ethylene Vinyl Acetate foam sprayed with a Guardian coating and is fire rated to C-117.

The provided text is a 510(k) summary for a medical device: "MEDRAD 8-Receiver Phased Array Neurovascular Coil for Siemens." This document primarily focuses on demonstrating substantial equivalence to a predicate device and does not contain information about acceptance criteria, device performance studies, sample sizes, expert ground truth establishment, or any details typically found in a clinical study report for device effectiveness.

Therefore, most of the requested information cannot be extracted from the provided text.

Here's what can be stated based on the given document:

1. A table of acceptance criteria and the reported device performance: This information is not present in the 510(k) summary. The document describes the device and compares its features to a predicate, but does not include quantitative performance metrics or acceptance criteria for those metrics.

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. This document does not describe a clinical study with a test set. It describes a device and its similarity to a predicate.

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. There is no mention of a test set or ground truth establishment.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.

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-powered diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable.

8. The sample size for the training set: Not applicable. The document does not describe a machine learning algorithm or a training set.

9. How the ground truth for the training set was established: Not applicable.

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