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

Model KFA-12 Knee, Foot, and Ankle Array Coil

The provided text is a 510(k) premarket notification letter from the FDA regarding an MRI coil (Model KFA-12 Knee, Foot, and Ankle Array Coil). This document does not contain information about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment as it would for an AI/CADe device.

Instead, this letter confirms the device's substantial equivalence to legally marketed predicate devices and outlines the regulatory requirements for marketing the device. The core of a 510(k) for this type of device (an MRI coil) typically focuses on demonstrating that the new device has the same intended use and performance characteristics as a legally marketed predicate device, without raising new questions of safety and effectiveness.

Therefore, I cannot extract the information required in your request about acceptance criteria and study details from the provided text because it primarily concerns regulatory approval for a medical device (an MRI coil), not an AI/CADe software that would have performance metrics like sensitivity, specificity, or reader study results.

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