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The Phased Array Knee and Foot Coil is a specialty receive-only RF coil, used for obtaining diagnostic images of the knee and foot anatomy in Magnetic Resonance Imaging systems. The indications for use are the same as for standard MR Imaging. The Phased Array Knee and Foot Coil is designed for use with GE Signa HFO/i (0.7 Tesla) MRI scanner (K992746) manufactured by GE Medical Systems.

The Phased Array Knee and Foot Coil is designed to provide Magnetic Resonance Images of the knee and foot anatomies. The Phased Array Knee and Foot Coil has been designed for use with the GE Signa HFO/i 0.7T scanner.

Anatomic Regions: Knee and Foot Nuclei Excited: Hydrogen

The indications for use are the same as for standard imaging:

The Signa HFO/i 0.7T system is indicated for use as an NMR device that produces images that: (1) correspond to the distribution of protons exhibiting NMR signal, (2) depend upon NMR parameters (proton density, spin lattice relaxation time T1, spin-spin relaxation time T2) and (3) display the soft tissue structure of the head and whole body. When interpreted by a trained physician, these images yield information that can be useful in the determination of a diagnosis.

The Knee and Foot Coil package consists of a knee coil (two sizes: small and large) and an attachable foot coil. The electrical circuitry is enclosed in a durable housing assembly made of polyurethane, fiberglass, and ABS/PVC plastic alloy, which are fire rated and have high impact and tensile strength. The Knee Coil is mechanically split into two halves for easier coil handling and more accurate positioning of the patient's knee in the coil. The Foot Coil is contoured to accommodate the foot and is mechanically attached to the knee coil.

The provided document is a 510(k) summary for the "Legend 5000 Phased Array Knee and Foot Coil," an accessory for Magnetic Resonance Imaging systems, and does not describe a study that proves the device meets specific performance acceptance criteria in the way a clinical study for a new AI diagnostic would.

Instead, the document establishes substantial equivalence to predicate devices based on similarities in intended use, indications for use, materials, design, and safety features. The "Safety and Effectiveness" section outlines product features and compares them to legally marketed predicate devices, implying that if the new device shares similar characteristics and functions, it is considered safe and effective for its stated purpose.

Therefore, the requested information elements (acceptance criteria, reported performance, sample sizes, expert qualifications, adjudication, MRMC studies, standalone performance, ground truth types, and training set details) are not applicable or not explicitly stated in this type of regulatory submission for an MRI accessory. This document focuses on demonstrating equivalence rather than proving performance against specific quantitative metrics through a clinical study.

Here's a breakdown of why these elements are largely absent or not directly addressed:

• Acceptance Criteria & Reported Performance: This document doesn't define specific numerical acceptance criteria for diagnostic accuracy (e.g., sensitivity, specificity, AUC) or report quantitative performance metrics related to image quality or diagnostic yield for the coil itself. The acceptance is based on the comparison to predicate devices and the general understanding that it produces diagnostic images similar to standard MR imaging.
• Sample Size (Test Set) & Data Provenance: Not applicable. There's no "test set" of patient data in the context of a diagnostic AI study. The performance is inferred from the device's design and mechanism mirroring existing approved devices.
• Number of Experts & Qualifications (Ground Truth): Not applicable. Ground truth as understood in diagnostic AI (e.g., expert consensus on disease presence) is not established or used here. The document relies on the established safety and efficacy of the predicate MRI systems and coils.
• Adjudication Method: Not applicable.
• Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: Not applicable. This type of study assesses human reader performance with and without an AI aid, which is not the purpose of this submission for an MRI coil.
• Standalone (Algorithm Only) Performance Study: Not applicable. The device is a hardware accessory (RF coil), not an autonomous diagnostic algorithm.
• Type of Ground Truth Used: Not applicable. No "ground truth" (e.g., pathology, outcomes data) for clinical diagnosis is being established for this device's performance in a study detailed here. The ground truth for MRI imaging, in general, is its ability to visualize anatomical structures and pathologies, which is well-established for the predicate devices.
• Sample Size for Training Set & How Ground Truth for Training Set was Established: Not applicable. This device is not an AI algorithm that undergoes a "training" phase with a dataset.

In summary, the 510(k) approval for this MRI accessory is granted based on its substantial equivalence to previously cleared devices, rather than a clinical study demonstrating performance against specific quantitative acceptance criteria. The "studies" that support its safety and effectiveness are primarily engineering and design comparisons to predicate devices, ensuring that it operates within known safety parameters and produces images compatible with diagnostic interpretations already established for MRI.

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