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Imaging of:

• Diagnostic imaging of the knee, ankle and foot regions
• Fluid visualization
• 2D and 3D imaging
• MR angiography
• MR fluoroscopy

The QD KNEE/FOOT COIL is QD volume coil that can transmit RF and receive NMR signal from like the knee or other extremity regions.

The QD KNEE/FOOT COll. is comprised of coil element and PC board. The coil element shapes STIR type coil. The PC board switches transmit mode and receive mode with PIN diodes and combines the NMR signals.

The QD KNEE/FOOT COIL is constructed with the same materials that are currently in use for the released QD KNEE COIL.

The provided text describes a 510(k) summary for a medical device called the "QD KNEE/FOOT COIL." It does not contain information about acceptance criteria or a study that proves the device meets specific acceptance criteria in the way a clinical study for an AI/ML medical device would.

This document is a premarket notification for a hardware accessory (an MRI coil) and primarily focuses on demonstrating substantial equivalence to a predicate device, rather than performance against a set of quantitative acceptance criteria in a study. The information provided is about the device's technical specifications and intended use.

Therefore, many of the requested categories cannot be answered from the provided text.

Here's a breakdown of what can be extracted and what cannot:

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

The document doesn't outline specific "acceptance criteria" in the sense of predefined thresholds for performance metrics (e.g., sensitivity, specificity, accuracy) that an AI device would need to meet. Instead, it details safety parameters and imaging performance parameters, which are more akin to technical specifications for the hardware. The "reported device performance" is largely qualitative, referring to sample images.

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