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The eCoil Imaging System for the GE 3.0T family of scanners is a receive-only coil intended for use as a Magnetic Resonance Diagnostic Device (MRDD) for high-resolution magnetic resonance imaging, including spectroscopy, of the human prostate and surrounding pelvic tissue. The purpose of the interface device for the eCoil Imaging System is to provide interface and support functions to allow the use of MEDRAD 3.0T disposable endorectal coils with GE 3.0T family of scanner systems and Torso Array coils. Only trained healthcare professionals are intended to operate this device.

The MEDRAD 3.0T eCoil Imaging System maintains a similar intended use, similar operational parameters, similar labeling and is used in a manner similar to the predicate devices. The device is a receive-only surface coil with active and passive decoupling and RF signal pre-amplification. It interfaces with 3.0T GE family of scanners and MEDRAD 3.0T Endorectal Coils and GE 8-channel Torso Array. It does not require tuning to be set in production since the interface device has a preamplifier.

The provided text does not contain information about acceptance criteria, device performance, or a study specifically designed to demonstrate the device meets acceptance criteria. The document is a 510(k) summary for a premarket notification for the MEDRAD 3.0T eCoil Imaging System, focusing on establishing substantial equivalence to predicate devices. It clearly states that the device is "substantially equivalent" rather than providing a performance study against specific acceptance criteria.

Therefore, I cannot provide a table of acceptance criteria and reported device performance or details about a study proving the device meets these criteria based on the provided text.

Here's an explanation of why the requested information is not available and what the document does provide:

Why the requested information is not in the document:

This document is a 510(k) summary. For devices like the MEDRAD 3.0T eCoil Imaging System (a magnetic resonance diagnostic accessory, product code MOS), the FDA's 510(k) pathway primarily focuses on demonstrating substantial equivalence to a predicate device that is already legally marketed. This means showing that the new device is as safe and effective as a legally marketed predicate device.

To achieve this, manufacturers typically:

• Identify predicate devices.
• Compare the new device's technological characteristics, intended use, and performance to the predicate(s).
• Provide data (often non-clinical, such as engineering tests, bench tests, and sometimes limited clinical data) to support the claim of equivalence.

It generally does not require a full-scale clinical trial with predefined acceptance criteria for performance metrics like sensitivity, specificity, or AUC, especially for accessories like an MRI coil. The evaluation is more about ensuring the new coil functions as intended, integrates safely with the specified MRI scanners, and does not introduce new risks or questions of effectiveness compared to existing technology.

What the document does provide regarding equivalence, not performance against acceptance criteria:

The document focuses on comparing the new device's features and principles of operation to predicate devices to establish substantial equivalence. Key points are:

• Intended Use: The eCoil Imaging System is a receive-only coil for high-resolution MR imaging, including spectroscopy, of the human prostate and surrounding pelvic tissue on GE 3.0T scanners. The interface device allows use of MEDRAD 3.0T disposable endorectal coils with these GE systems and Torso Array coils.
• Comparison to Predicates: The core of the submission is a comparison table showing similarities and differences with two predicate devices (MEDRAD 1.5T Pelvic Imaging System Interface Device and MEDRAD 3.0T Prostate Imaging System Interface Device).
  • Similarities: All are receive-only surface coils, use active and passive decoupling, and have pre-amplification for endorectal coils.
  • Differences: Primarily relate to the scanner interface (1.5T GE vs. 3.0T Siemens Trio vs. 3.0T GE family), specific coil interfaces (MEDRAD 1.5T vs. 3.0T endorectal coils, and GE 8- or 12-channel Body Array vs. GE 8-channel Torso Array), and tuning specifics. The proposed device's tuning does not require setting in production due to a preamplifier, similar to one predicate.

To summarize, this 510(k) is about demonstrating the new coil's engineering and functional equivalence to similar marketed coils, not about proving diagnostic performance against quantitative metrics.

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