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The ECHELON Rapid Cardiac Coil is a receive-only, multiple array coil used for magnetic resonance imaging of the musculoskeletal structures, soft tissue and vascular structures of various anatomic regions. It is designed to be used the Hitachi ECHELON 1.5T MRI system.

The ECHELON Rapid Cardiac Coil is a receive only RF phased array coil, used for obtaining diagnostic images of the cardiac region, in an open Magnetic Resonance Imaging (MRI) system.
The ECHELON Rapid Cardiac Coil is a receive-only coil designed to contour to the outline of the shoulder. The coil consists of 12 elements. The signal output of each element is independently processed by the MRI system to enhance performance.

This document describes a 510(k) premarket notification for the ECHELON Rapid Cardiac Coil, a receive-only, multiple array coil for magnetic resonance imaging. The submission focuses on demonstrating substantial equivalence to a predicate device, rather than presenting a novel device requiring extensive performance studies with specific acceptance criteria and detailed clinical trial data.

Therefore, the requested information regarding acceptance criteria, study details, expert involvement, and ground truth establishment, as it pertains to a de novo approval process or performance claim, is largely not applicable to this 510(k) submission.

Here's a breakdown based on the provided text:

• Acceptance Criteria and Reported Device Performance: This submission does not define specific performance metrics with acceptance criteria, as it's a substantial equivalence claim. The "device performance" is implicitly that it functions similarly to the predicate device for cardiac MRI. The coil's specification document (DCA # 2-001017) is stated to contain requirements for supporting contrast-enhanced MRA for the heart and surrounding vasculature, as well as cardiac perfusion studies, which the coil is designed to acquire.

• Sample Size and Data Provenance: Not applicable. No clinical study data from a "test set" is presented in this 510(k) submission to evaluate performance against acceptance criteria. The submission focuses on device characteristics and intended use.

• Number of Experts and Qualifications for Ground Truth: Not applicable. Ground truth establishment with experts is typically for evaluating diagnostic accuracy or clinical utility in a performance study, which is not the focus of this 510(k).

• Adjudication Method: Not applicable for the same reasons as above.

• Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: Not applicable. No comparative effectiveness study, especially one involving human readers with and without AI assistance, is mentioned or conducted as such studies are beyond the scope of a 510(k) for an MRI coil.

• Standalone (Algorithm Only) Performance Study: Not applicable. This device is a hardware component (an MRI coil), not an algorithm or AI system.

• Type of Ground Truth Used: Not applicable. Since there's no clinical performance study presented that requires ground truth for diagnostic accuracy, no specific type of ground truth is mentioned.

• Sample Size for Training Set: Not applicable. This is a hardware device; there is no AI algorithm being "trained" in this context.

• How Ground Truth for Training Set Was Established: Not applicable for the same reasons as above.

Summary of available information related to performance and equivalence:

The submission focuses on demonstrating substantial equivalence to the Predicate Device: MR-RCC-150 Cardiac Coil (K063513).

The core argument for equivalence is stated as:

• "The technological characteristics of the ECHELON Rapid Cardiac Coil are exactly the same to the predicate device as listed in Section 10 - Substantial Equivalence Discussion." (Section not provided in the input, but this is the claim).
• The coil specification document (DCA # 2-001017) outlines requirements for the coil to support contrast-enhanced MRA for the heart and surrounding vasculature, and cardiac perfusion studies. The submission states that "a design requirement of the coil is the ability to acquire these images."

In essence, the "study" proving the device meets its acceptance criteria (which are primarily related to functional equivalence and technical specifications) is the design and engineering process that ensured the coil's technological characteristics and intended uses match those of the predicate device, as documented in internal specifications like DCA # 2-001017. The FDA's 510(k) clearance confirms that, based on the submitted information, the FDA found the device substantially equivalent to its predicate.

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