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The Neurovascular Coil is a receive-only phased array RF coil, used for obtaining diagnostic images of the brain, cervical spine, soft tissues and vasculature of the head, neck and upper chest extending to the cardiac region in Magnetic Resonance Imaging Systems. The Millennium 5000 Neurovascular Coil is designed for use with the Altaire 0.7T MRI system manufactured by Hitachi Medical Systems, Inc. The indications for use are the same as for standard MR Imaging.

The Millennium 5000 Phased Array Neurovascular Coil is designed to provide Magnetic Resonance Images of the brain, cervical spine, soft tissues and vasculature of the head, neck and upper chest. The Millennium 5000 Phased Array Neurovascular Coil is designed for use with the Altaire 0.7T scanner manufactured by Hitachi Medical Systems.

The indications for use are the same as for standard imaging:

The 0.7T MRI system is indicated for use as an NMR device that produces images that: (1) correspond to the distribution of protons exhibiting NMR signal, (2) depend upon NMR parameters (proton density, 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 Millennium 5000 Phased Array Neurovascular Coil is a 4-element quadrature phased array, receive-only coil. The coil consists of three sections: a main coil base, an open designed head former, and a detachable chest plate. The split-top, three piece design minimizes claustrophobic effects and maximizes patient comfort. The coil elements and accessory electronics are enclosed in a rigid plastic housing, which is fire rated and has a high impact and tensile strength.

This document is a 510(k) premarket notification for a medical device called the "Millennium 5000 Phased Array Neurovascular Coil." It describes the device and claims substantial equivalence to previously cleared devices, rather than presenting a study to prove performance against specific acceptance criteria.

Therefore, the requested information elements related to a study (like sample sizes, ground truth establishment, expert adjudication, MRMC studies, standalone performance, training sets, clinical outcomes, etc.) are not available in this document.

The document primarily focuses on demonstrating that the new device has similar characteristics and intended use to existing devices, which is the basis for a 510(k) clearance, not a clinical performance study with predefined acceptance criteria.

However, I can extract information regarding the device's intended use, description, and comparison to predicate devices, which serves as the "performance" relevant to a 510(k) submission.

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

Since this is a 510(k) submission based on substantial equivalence, the "acceptance criteria" are implicitly met by demonstrating similarity to predicate devices, and the "reported device performance" is a description of its features and intended use, aligning with those of the predicates.

Regarding the other requested points, they are not applicable or estimable from the provided document as it is a 510(k) submission based on substantial equivalence, not a clinical performance validation study:

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/Not provided. This document does not describe a test set or clinical study data. It relies on comparison to existing legally marketed devices.

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/Not provided. No ground truth establishment is described for a test set.

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

• Not applicable/Not provided. 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

• Not applicable/Not provided. This is a hardware device (MRI coil), not an AI-assisted diagnostic product. No MRMC study was performed or described.

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

• Not applicable/Not provided. This is a hardware device, not an algorithm.

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

• Not applicable/Not provided. No ground truth is described.

8. The sample size for the training set

• Not applicable/Not provided. There is no "training set" as this is not an AI or software device that undergoes training.

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

• Not applicable/Not provided. No training set or ground truth for it is relevant to this submission.

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