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E-scan XQ is a magnetic resonance (MR) system that produces transversal, sagittal and coronal and oblique images of the limbs and joints. It is intended for imaging portions of the upper limb, including the hand, wrist, forearm, elbow, upper arm and shoulder, and imaging portions of the lower limb, including the foot, ankle, calf, knee, thigh and hip.

E-scan XQ MR images correspond to the spatial distribution of protons (hydrogen nuclei) that determine magnetic resonance properties and are dependent on the MR parameters, including spin-lattice relaxation time (T1), spin-spin relaxation time (T2), nuclei density, flow velocity and "chemical shift". When interpreted by a medical expert trained in the use of MR equipment, the images can provide diagnostically useful information.

The DPA Shoulder Coil is to be used with the E-scan XQ magnetic resonance imaging system. It is a receiving coil and is the result of the combination of two different coils. The first is a coil designed to be "worn" by the patient and connected in a series with 4 tuning capacitors positioned under the primary coil and is composed of 3 turns designed to improve the image homogeneity and having spatially complementary sensitivity with respect to the primary coil. The coil allows for imaging of both the left and right shoulder, due to the symmetrical mechanical connection between its base and the magnet.

The provided text is a 510(k) premarket notification summary for the E-scan XQ MRI System, specifically addressing the addition of a DPA Shoulder Coil. This document primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed clinical study with performance criteria. Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert qualifications, and ground truth establishment is largely absent from this document.

Here's an analysis based on the provided text, highlighting the information that is and is not available:

1. Table of Acceptance Criteria and Reported Device Performance

Not available. The document does not specify quantitative acceptance criteria or provide performance metrics such as sensitivity, specificity, or accuracy of the device for diagnostic tasks. The focus is on the "technological characteristics" of the new shoulder coil being "similar" to the predicate, and producing diagnostically useful images when interpreted by a medical expert.

2. Sample Size for the Test Set and Data Provenance

Not available. The document describes the device and its intended use but does not mention any specific test set of cases, their size, or their origin (country, retrospective/prospective). This is typical for a 510(k) submission where substantial equivalence is demonstrated through engineering and functional comparisons, not necessarily new clinical performance data for diagnostic accuracy.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

Not applicable/Not available. Since no specific test set or diagnostic performance study is described, there's no mention of experts establishing ground truth for such a study. The document generally states that images provide "diagnostically useful information" when "interpreted by a medical expert trained in the use of MR equipment." This is a general statement about the expected use of an MR system, not a specific study methodology.

4. Adjudication Method for the Test Set

Not applicable/Not available. As no test set for diagnostic performance is detailed, no adjudication method is described.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No. The document does not describe any MRMC comparative effectiveness study where human readers' performance with and without AI assistance was evaluated. The device itself is an MRI system and coil, not an AI-assisted diagnostic tool.

6. Standalone Performance Study (Algorithm only without human-in-the-loop performance)

No. The device is an MRI system. By its nature, it requires a human expert ("a medical expert trained in the use of MR equipment") to interpret the images. There is no mention of an algorithm-only standalone performance study.

7. Type of Ground Truth Used

Not available. Since no specific performance study with a test set is detailed, the type of ground truth used to evaluate diagnostic accuracy is not mentioned. The document focuses on the physical properties of the MR images (spatial distribution of protons, relaxation times, etc.) rather than diagnostic outcomes.

8. Sample Size for the Training Set

Not applicable. The E-scan XQ MRI System is a hardware device; it does not appear to employ machine learning or AI that would require a "training set" in the computational sense.

9. How the Ground Truth for the Training Set Was Established

Not applicable. As there is no training set for a machine learning algorithm, there is no description of how ground truth would be established for it.

Summary of what is present in the document:

• Device Description: The DPA Shoulder Coil for the E-scan XQ MRI system is a receiving coil connected in series with tuning capacitors. It's designed to be "worn" by the patient and improve image homogeneity and Signal-to-Noise Ratio (SNR).
• Intended Use: The E-scan XQ MR system, with the DPA Shoulder Coil, is intended for imaging portions of the upper and lower limbs, specifically mentioning the shoulder. It produces transversal, sagittal, coronal, and oblique images corresponding to the spatial distribution of protons.
• Technological Characteristics (Comparison to Predicate): The document affirms that the "technological characteristics of the DPA 7 Shoulder coil are similar to the characterisitics of the predicate device DPA receiving coils." It lists physical dimensions for various coils (Knee, Hand, Foot/Ankle) for both the predicate and the modified E-scan XQ, highlighting the addition of the Shoulder coil.
• Predicate Device: Esaote E-Scan (K990968, K001894), Esaote Hip Coil (K012728), Esaote E-Scan XQ (K020164, K032121).
• Regulatory Conclusion: The FDA determined the device is substantially equivalent to legally marketed predicate devices, allowing it to proceed to market subject to general controls.

This 510(k) largely relies on demonstrating that the new shoulder coil does not raise new questions of safety and effectiveness compared to existing, cleared MRI coils and systems, rather than presenting new clinical performance data for diagnostic accuracy.

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E-scan XQ is a magnetic resonance (MR) system that produces transversal, sagittal and coronal and oblique cross-section images of the limbs and joints. It is intended for imaging the arm, including the hand, wrist, forearm, elbow, upper arm and shoulder, and imaging the leg, including the foot, ankle, calf, knee, thigh and hip.

E-scan XQ MR images correspond to the spatial distribution of protons (hydrogen nucle) that determine magnetic resonance properties and are dependent on the MR parameters, including spin-latice relaxation time (TI), spin-spin relaxation time (T2), nuclei density, flow velocity and "chemical shift". When interpreted by a medical expert trained in the use of MR equipment, the images can provide diagnostically useful information.

The E-scan XQ is a magnetic resonance (MR) system. The modified system is composed of a patient positioning table, magnetic unit, operating console (PC unit, keyboard, mouse, monitor, operating table), electronics box with filter panel, and modular shielding box. The modifications from the cleared version (K020164) include a modified system configuration, new operating tables, upgrading of the electronics, and a new software release. These modifications are stated to not affect the intended use or alter the fundamental scientific technology of the device.

This document is a 510(k) premarket notification for modifications made to the E-Scan XQ MRI system. It's not a study report proving a device meets acceptance criteria through clinical or technical performance testing with a specific outcome measure like diagnostic accuracy. Instead, it demonstrates substantial equivalence to a previously cleared device (E-Scan XQ K020164) based on similar technological characteristics and unchanged intended use.

Therefore, many of the requested categories (acceptance criteria, reported performance, sample size, ground truth, expert consensus, MRMC study, standalone performance) are not applicable (N/A) in the context of this type of submission. The comparison is primarily against the specifications of the predicate device, not clinical performance metrics against a defined standard.

However, I can extract the information provided regarding the modification and the comparison to its predicate.

Here's a summary of the relevant information:

1. Table of Acceptance Criteria and Reported Device Performance

As this is a 510(k) amendment for modifications, the "acceptance criteria" are implicitly the maintenance of, or improvement upon, the technological characteristics of the predicate device, while ensuring the intended use is not altered. The "reported device performance" is a comparison of the modified device's technical specifications against the predicate.

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Ask a specific question about this device