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

Model HRK-63-8 Knee Array Coil

I am sorry, but the provided text does not contain information about the acceptance criteria or a study proving that a device meets those criteria. The document is an FDA 510(k) clearance letter for an MRI knee array coil (HRK-63-8), indicating that it has been determined to be substantially equivalent to legally marketed predicate devices.

The letter mentions:

• Device Name: HRK-63-8 Knee Array Coil
• Regulation Number: 21 CFR 892.1000
• Regulation Name: RF Coil for Magnetic Resonance Imaging System
• Indications for Use: "To be used in conjunction with a Magnetic Resonance Scanner to produce diagnostic images of the knee that can be interpreted by a trained physician."

However, it does not include:

• A table of acceptance criteria or reported device performance metrics.
• Details about a study conducted to demonstrate performance, including sample sizes, data provenance, expert qualifications, or adjudication methods for ground truth.
• Information on MRMC comparative effectiveness studies or standalone algorithm performance.
• Details about training sets or how ground truth for training was established.

This document is primarily concerned with regulatory clearance based on substantial equivalence, not a detailed technical performance study with specific acceptance criteria.

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