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The E-scan XQ is intended for diagnostic nuclear magnetic resonance imaging of the hip, knee, ankle, foot, shoulder, elbow, wrist, hand, calf, thigh, arm and forearm. The device produces transverse, sagittal, coral and oblique cross-sectional images, displaying the internal structure of the limbs and joints being imaged. The images that are produced correspond to the spatial distribution of protons (hydrogen nuclei) that check the magnetic resonance properties and depend upon the MR parameters (spin-lattice relaxation time (T1), spin-spin relaxation time (T2), nuclei density, flow velocity and chemical shift). If interpreted by a medical expert, these images can provide diagnostically useful information.

The E-Scan MRI system is substantially equivalent to the currently available E-Scan system cleared via K012728.

The provided 510(k) summary for the E-Scan XQ Magnetic Resonance Diagnostic Device does not contain information regarding acceptance criteria or a study proving the device meets specific performance criteria beyond substantial equivalence to predicate devices.

The document focuses on:

• Submitter Information: Details of the manufacturer and contact person.
• Device Identification: Trade name, common name, classification, and product code.
• Predicate Devices: Lists similar devices previously cleared by the FDA.
• Intended Use: Description of the device's diagnostic purpose and areas of the body it images.
• Technological Characteristics: States that the device is "substantially equivalent" to an existing cleared E-Scan system.
• FDA Clearance Letter: Confirms substantial equivalence to predicate devices.

Therefore, it is not possible to fill out the requested table or provide details about a performance study, sample sizes, expert qualifications, or ground truth based solely on the provided text.

Explanation for the absence of requested information:

510(k) submissions primarily focus on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving the device meets specific acceptance criteria through extensive clinical performance studies. While the device's output (images) is intended to be interpreted by a medical expert for diagnostically useful information, the 510(k) summary itself does not detail a specific study proving the device's diagnostic accuracy or performance against pre-defined acceptance criteria. The FDA's clearance is based on the device being "substantially equivalent" in terms of intended use, technological characteristics, and safety and effectiveness to existing predicate devices.

To obtain the requested information, one would typically need to review a more detailed technical file, design validation reports, or clinical study reports that might have been submitted to the FDA as part of the overall 510(k) submission, but this information is not present in the provided summary.

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