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The Premier 9000 8 Channel Phased Array CTL Spine Coil is a receive- only phased array RF coil, used for obtaining diagnostic images of the cervical, thoracic, and lumbar regions of the spine in Magnetic Resonance Imaging Systems. The Premier 9000 8 Channel Phased Array CTL Spine Coil is designed for use with the Excite 1.5T MRI system manufactured by GE Medical Systems, Inc. The indications for use are the same as for standard MR Imaging.

The Premier 9000 8 Channel Phased Array CTL Coil is designed to provide Magnetic Resonance Images of the cervical, thoracic and lumbar regions of the spine. The Premier 9000 8 Channel Phased Array CTL Coil is designed for use with the GE Excite 1.5T scanner manufactured by GE Medical Systems, Inc.

Anatomic Regions: cervical, thoracic and lumbar regions of the spine Nuclei Excited: Hydrogen

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

The 1.5T 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 Premier 9000 8 Channel Phased Array CTL Spine Coil is a twelve element receive only phased array coil. The coil is shaped to conform to the contours of the spine and has been designed to maximize comfort and ease of use. 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 Resonance Imaging Accessory, specifically the Premier 9000 8 Channel Phased Array CTL Spine Coil. The objective of a 510(k) submission is to demonstrate that the device is substantially equivalent to a predicate device already legally marketed in the US. The "study" described herein is essentially a comparison to predicate devices, rather than a traditional clinical study with detailed performance metrics against specific acceptance criteria.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for this 510(k) rely on demonstrating substantial equivalence to predicate devices, particularly the Premier 7000 Phased Array CTL Spine Coil (K980157). The "device performance" in this context refers to the features and safety aspects of the new device being comparable to or the same as the predicate.

2. Sample Size Used for the Test Set and Data Provenance

The document does not describe a traditional test set involving patient data or images for performance evaluation of the new coil against specific efficacy metrics.

Instead, the "study" is a comparative analysis of the device's design, materials, and functional principles against previously cleared predicate devices. The data provenance is based on the design specifications and safety features of the new coil, compared to the established specifications and safety features of the predicate devices. This type of submission relies on engineering and design control documentation rather than clinical data from a test set.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable. There was no "test set" in the context of clinical images or patient data requiring expert ground truth establishment for this 510(k) submission. The ground truth, in a broader sense of regulatory approval, is the established safety and effectiveness of the predicate devices, which were previously cleared by the FDA based on their own submissions and assessments (which may or may not have involved expert review of clinical data).

4. Adjudication Method for the Test Set

Not applicable. Since there was no clinical test set for independent review requiring adjudication, no adjudication method is mentioned.

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 accessory (a coil), not an AI-powered diagnostic algorithm. Therefore, an MRMC study related to AI assistance is not relevant to this submission.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable. This device is a physical MRI coil, not a standalone algorithm.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The document focuses on demonstrating substantial equivalence in terms of safety and intended use rather than diagnostic accuracy. Therefore, the "ground truth" used is regulatory compliance through comparison to predicate devices, referencing their established safety profiles, design characteristics, and intended uses. This is primarily based on engineering specifications, material safety data, and functional design principles proven safe and effective in previously cleared devices.

8. The Sample Size for the Training Set

Not applicable. This device is an MRI accessory, not a learning algorithm that requires a training set.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no training set for this device.

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