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To be used in conjunction with a Magnetic Resonance Scanner to produce diagnostic images of the head and neck that can be interpreted by a trained physician.

Model NVA-127-16-A Neurovascular Array Coil

This document is a 510(k) clearance letter from the FDA for a medical device called the "Model NVA-127-16-A Neurovascular Array Coil". This letter is NOT a study report and therefore does not contain information about acceptance criteria or a study proving that the device meets those criteria.

The information provided in the document focuses on:

• Device Name and Manufacturer: Invivo Corporation, Model NVA-127-16-A Neurovascular Array Coil
• Regulation Information: 21 CFR 892.1000, Magnetic resonance diagnostic device, Class II, Product Code: MOS
• Date of Clearance: October 12, 2005
• Substantial Equivalence: The FDA determined the device is substantially equivalent to legally marketed predicate devices.
• Indications for Use: "To be used in conjunction with a Magnetic Resonance Scanner to produce diagnostic images of the head and neck that can be interpreted by a trained physician."

Therefore, I cannot provide the requested information regarding acceptance criteria, study details, sample sizes, ground truth, or expert qualifications as it is not present in the provided text.

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To be used in conjunction with a Magnetic Resonance Scanner to produce diagnostic images of the head and neck, that can be interpreted by a trained physician.

Model NVA-127-8 Neurovascular Array Coil

The provided text is an FDA 510(k) clearance letter for a medical device (MRI Neurovascular Array Coil). It does not contain any information about acceptance criteria, study design, or device performance metrics.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based only on the input provided. The letter simply states that the device is substantially equivalent to legally marketed predicate devices and is cleared for marketing.

To answer your request, I would need a different document, such as a summary of safety and effectiveness, a clinical study report, or the 510(k) submission itself, which would detail the performance data and the methods used to collect it.

Ask a specific question about this device

Ask a specific question about this device