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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 KAC-63 Knee Array Coil

This document package is a 510(k) clearance letter and an Indications for Use statement for the KAC-63 Knee Array Coil. This type of regulatory document typically does not contain detailed studies or acceptance criteria tables like those for AI/ML-based diagnostic devices.

Instead, the process for a device like a coil focuses on demonstrating substantial equivalence to a predicate device. This usually involves:

• Performance Benchmarking: Demonstrating that the new device performs at least as well as, and is safe and effective as, the predicate device in terms of image quality, signal-to-noise ratio (SNR), and other physical parameters relevant to its function.
• Safety Testing: Ensuring the device meets electrical safety standards, biocompatibility (if applicable), and does not pose undue risks to patients during MRI scanning.
• Compliance with Standards: Adhering to relevant industry standards for medical devices and MRI equipment.

Therefore, I cannot provide the requested information (acceptance criteria table, study details, sample sizes, expert qualifications, etc.) because this type of information is not present in the provided documents for a device like an MRI coil. These documents confirm regulatory clearance based on substantial equivalence, rather than a clinical performance study with specific diagnostic accuracy metrics, which would be common for AI-driven diagnostic software.

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