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The 3.0T 8 Channel Neurovascular (NV) Array 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 in Magnetic Resonance Imaging Systems. The 3.0T 8 Channel Neurovascular (NV) Array Coil is designed for use with the 3.0T MRI systems manufactured by GE Medical Systems.

The 3.0T 8 Channel Neurovascular (NV) Array 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 3.0T 8 Channel Neurovascular (NV) Array Coil is designed for use with the GE 3.0T scanner manufactured by GE Medical Systems, Inc.

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

The 3.0T 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 3.0T 8 Channel Neurovascular (NV) Array Coil is a multi-element phased array receive only coil. The coil has a rigid enclosure. The open, patient friendly design eases patient handling and positioning 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.

Here's an analysis of the provided text regarding the acceptance criteria and study for the 3.0T 8 Channel Neurovascular (NV) Array Coil:

Summary of Device Performance Study

The provided document (K032618) is a 510(k) premarket notification for a medical device. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving novel safety and effectiveness through extensive clinical trials as would be required for a New Drug Application (NDA) or a Premarket Approval (PMA) application. Therefore, the "study" described herein is a comparison to predicate devices and relies on established performance characteristics, rather than a clinical trial with specific endpoints and patient outcomes.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for this 510(k) submission are implied by comparison to the predicate devices. The device is deemed acceptable if its features, intended use, and indications for use are similar to legally marketed predicate devices, and if it addresses safety concerns (like RF burns and resonant loops) in a similar manner.

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

• Sample Size: The document does not describe a "test set" in the traditional sense of a clinical study involving patients or a defined set of images for evaluation. The safety and effectiveness are established through comparison to predicate devices (Millennium 9000 Phased Array Neurovascular coil and Champion 5000 Peripheral Vascular coil, both manufactured by USA Instruments, Inc.).
• Data Provenance: This is not a study involving patient data. The "data" here refers to the design specifications, technical characteristics, and regulatory history of the predicate devices, which are presumed to be established as safe and effective. The manufacturer is USA Instruments, Inc., located in Aurora, Ohio, USA. The nature of the comparison is retrospective, as it relies on previously cleared devices.

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

Not applicable. As this is a 510(k) submission based on substantial equivalence to predicate devices, there was no independent "test set" requiring ground truth established by experts in the context of clinical image interpretation or diagnosis of pathology. The FDA's review process itself involves expertise to determine substantial equivalence based on engineering, regulatory, and clinical considerations.

4. Adjudication Method for the Test Set

Not applicable. There was no "test set" requiring adjudication in the context of image interpretation or clinical outcomes.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is typically conducted to evaluate the diagnostic performance of a new imaging modality or AI algorithm, often comparing it against established methods or human readers. The 510(k) process for this device focused on validating its technical specifications and equivalency to existing, cleared coils, not on a new diagnostic algorithm or comparative diagnostic effectiveness study.

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

Not applicable. This device is an MRI accessory (a receive-only coil), not an algorithm or AI software. It does not perform any diagnostic interpretation independently; rather, it facilitates the acquisition of MRI images which are then interpreted by human clinicians.

7. The Type of Ground Truth Used

The "ground truth" used in this submission is the established safety and effectiveness of the legally marketed predicate devices. The new device's features and performance are compared against these predicates to demonstrate that it raises no new questions of safety or effectiveness. This is implicit regulatory ground truth rather than clinical ground truth (like pathology or outcomes data).

8. The Sample Size for the Training Set

Not applicable. This device is a hardware component (an MRI coil), not an AI algorithm. Therefore, there is no "training set" in the context of machine learning.

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

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

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